IEC 60601-1 2006 (Original) PDF

Elektrilised meditsiiniseadmed.
Osa 1: Oldised nouded

esmasele ohutusele ja olulistele toimimisnaitajatele
Medical electrical equipment - Part 1: General

requirements for basic safety and essential
performance
EESTI STANDARDIKESKUS
ESTONIAN CENTRE FOR STANDARDISATION
"'£t"C
EESTISTANDARDIEESSONA NATIONAL FOREWORD
See Eesti standard EVS-EN 6060 1 - This Estonian standard EVS-EN 6060 1 -
1 :2006+A 1 1 :201 1 sisaldab Euroopa standardi E N 1 :2006+A 1 1 :201 1 consists of the English text of the
6060 1 - 1 :2006+AC:201 O+A 1 1 :201 1 ingl iskeelset European standard EN 6060 1 -
teksti. 1 :2006+AC:201 O+A 1 1 :201 1 .
Standard on joustunud sellekohase teate This standard has been endorsed with a notification
avaldamisega EVS Teatajas. published in the official bulletin of the Estonian Centre
for Standardisation.
Euroopa standard imisorganisatsioonid on teinud Date of Availability of the European standard is

Euroopa standardi rahvuslikele liikmetele 01.01.2007.
kattesaadavaks 01.01.2007.
Standard on kattesaadav Eesti Sta ndard ikeskusest. The standard is available from the Estonian Centre for
Standardisation.
Tagasisidet standardi sisu kohta on voimalik edastada, kasutades EVS-i veebilehel asuvat tagasiside vormi voi
saates e-kirja meil iaadressile standardiosakond@evs.e e.
ICS 1 1 .040
Standardite reprodutseerimise ja levitamise iii gus kuulub Eesti Standardikeskusele

Andmete paljundamine , taas tekitamine, kopeerimine , s alvestamine elektr oonsesse s us teemi v 6i edas tamine uksk 6ik millises vormis v 6i
millisel teel ilma Ees ti S tand ardikeskuse kirjaliku l oata on keel atud.
Kui Teil on k usimusi s tand ardite au torikai tse koh ta, v 6tke palun uhendust Ees ti S tand ardikeskusega:
Aru 10, 10317 Tallin n , Ees ti ; www.evs.ee ; tele fon 605 5050; e- pos t in fo@evs.ee
The right to reproduce and distribute standards belongs to the Estonian Centre for Standardisation
No par t of this pu bli cati on m ay be reproduced or u tili zed in any form or by any means, ele ctronic or mech ani cal , including ph otocopying,
withou t a wri tten permission from the Es tonian Cen tre for S tand ardis ati on .
I f you h ave any questi ons abou t copyright, ple ase con tact Es ton i an Cen tre for S tand ardis ati on :
Aru 10, 10317 Tallin n , Es ton i a; www.evs.ee ; ph one 605 5050; e-m ail in fo@evs.ee
EUROPEAN STANDARD EN 60601-1
NORME EUROPEENNE
EUROPAISCHE NORM October 2006
ICS 1 1 .040 Supersedes EN 60601-1 : 1 990 + amendments
English version
Medical electrical equipment

Part 1: General requirements for basic safety
and essential performance
(IEC 60601-1 :2005)
Appareils electromedicaux Medizinische elektrische Gerate

Partie 1 : Exigences generales Teil 1 : Allgemeine Festlegungen
pour Ia securite de base fUr die Sicherheit einschliel11ich
et les performances essentielles der wesentlichen Leistungsmerkmale
(CEI 6060 1-1 :2005) (IEC 6060 1-1 :2005)
This European Standard was approved by CENELEC on 2006-09-1 2. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotech nical Standardization
Comite Europeen de Normalisation Electrotechnique
Eu ropaisches Komitee fUr Elektrotechnische Norm ung
Central Secretariat: rue de Stassart 35, B 1 050 Brussels

-
© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1 :2006 E

EN 6060 1 - 1 : 2 006 -2 -
Foreword
The text of docum e nt 62A/505A//FD I S , future editi on 3 of I EC 6060 1 - 1 , prepared by SC 62A, Common
aspects of electrical equ i pm ent used i n m edical practice, of I EC TC 62, Electrical equ i pm ent i n
m edi cal practice, was subm itted t o t h e I EC-CENELEC parall el vote and was approved b y CEN ELEC
as EN 6060 1 -1 o n 2006-09- 1 2 .
T h e followi ng date was fixed:
- latest date by which the EN has to be i m plem ented

at national l evel by publication of an identical
nati onal standard or by endorsement ( dop) 2007-07-01
This European Standard su persedes EN 6060 1 - 1 : 1 990 and its amendments. However,
EN 6060 1 -1 : 1 990 remai ns valid u ntil all the parts 2 that are used in conj u nction with it have been
withdrawn. No date of withdrawal of conflicti ng nati onal standards (dow) has therefore been fixed.
However, when Part 1 is used for appliances not covered by a part 2, EN 6060 1 - 1 : 1 990 is not to be
used after 2009-09- 1 2 .
This EN 6060 1 - 1 : 2006 h a s been significantly restructured com pared t o EN 6060 1 - 1 : 1 990.
Requ i rements i n the electrical section have been further aligned with those for i nformation technol ogy
equipm ent covered by EN 60950- 1 and a requirem ent for including a R I S K MANAGEMENT
PROCESS has bee n added. For a n expanded description of this revision, see Clause A.3.
This European Standard has been prepared u nder a m andate given to C E N E LEC by the European
Comm ission and the Eu ropean Free Trade Association and covers essential requirements of
EC Di rectives 90/385/EEC and 93/42/EEC. See Annex ZZ.
I n this standard the foll owi ng print types are used:
requirements and defi nitions: i n rom an type;
test specifications: in italic type;
informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text
of tables is also in a smaller type;
TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 AND ALSO GIVEN I N
THE INDEX: I N SMALL CAPITALS.
I n referri ng to the structure of this standard, the term
" clause" m eans one of the seventeen n u m bered divisions with i n the table of contents, i ncl usive of
all s u bdivisions (e.g. Clause 7 i n cl udes su bclauses 7. 1 , 7.2, etc.);
"subclause" m eans a n u m bered su bdivision of a clause (e.g. 7. 1 , 7.2 and 7.2. 1 are all su bclauses
of Clause 7).
References to clauses within this standard are preceded by the term " Clause" followed by the cla use
n u m ber. References to su bclauses within this standard are by n u m ber only. I n this standard, the
conju nctive " or" is used as an " i n cl usive or" so a statem e nt is true if any com bination of the co nditi ons
is true.
The verbal forms used i n this standard conform to usage described i n Annex G of the I SO/I EC
Di rectives, Part 2. For the pu rposes of this standard, the auxi li ary verb:
"shall" m eans that com pl iance with a requirement or a test is m a ndatory for compli ance with this
standard;
"should" m eans that com pliance with a requirem ent or a test is recom m ended but is n ot
m a ndatory for com pli ance with this sta ndard;
" m ay" is used to describe a permissible way to achieve com pliance with a require m ent or test.
- 3 - EN 6060 1 - 1 : 2 006
An asterisk (* ) as the fi rst character of a title or at the begi n n i n g of a paragraph or table title indicates
that there is guidance or rationale related to that item i n Annex A
Annexes ZA and ZZ have been added by CEN ELEC.
In the official versio n , for Bibli ography, the followi ng notes h ave to be added for the standards
indicated:
I E C 60073 NOTE Harmonized as EN 60073:2002 (not m odified) .
I E C 60086-1 NOTE Harmonized as E N 60086- 1 :2001 (not mod ified).
IEC 601 27-6 NOTE Harmonized as E N 60 1 2 7-6 : 1 994 (not mod ified).
IEC 60309-1 NOTE Harmonized as E N 60309- 1 : 1 999 (not mod ified).
IEC 6031 7-43 NOTE Harmonized as EN 603 1 7-43 : 1 997 (not mod ified).
IEC 60601 - 1 - 1 NOTE Harmonized as E N 6060 1 - 1 - 1 : 2001 (not modified) .
I E C 6060 1 - 1 -4 NOTE Harmonized as E N 6060 1 - 1 -4 : 1 996 + A 1 : 1 999 (not modified) .
I EC 60601 -2-49 NOTE Harmonized as EN 6060 1 -2-49:2001 (not modified) .
I E C 60695- 1 - 1 NOTE Harmonized as E N 60695- 1 - 1 : 2000 (not modified) .
I E C 60721 series NOTE Harmonized i n E N 6072 1 series (not modified) .
I E C 60990 NOTE Harmonized as E N 6099 0 : 1 999 (not m odified) .
I E C 6 1 000-4- 1 1 NOTE Harmonized as E N 6 1 000-4- 1 1 :2004 (not modified) .
I E C 6 1 0 1 0- 1 NOTE Harmonized as E N 6 1 0 1 0-1 :2001 (not mod ified).
IEC 6 1 1 40 NOTE Harmonized as E N 6 1 1 40: 2002 (not m odified) .
I E C 62 079 NOTE Harm o n i ze d as EN 62079:2001 (not modified) .
I E C 62304 NOTE Harmonized as EN 62304:2006 (not m odified) .
I S O 407 NOTE Harmonized as EN ISO 1 3407: 2004 (not modified).
ISO 8041 NOTE Harmonized as E N I S O 804 1 : 2 005 (not mod ified) .
I S O 1 3485 NOTE Harmonized as EN ISO 1 3485:2003 (not modified).
E nd orsement notice
The text of the I nternational Standard I EC 6060 1 - 1 : 2005 was approved by CEN ELEC as a European
Standard without any modificati on.
EN 6060 1 - 1 : 2 006 -4 -
A nnexZA
(normative)
N ormative references to international publications

with their correspond ing E uropean publications
The foll owi ng referenced docum e nts are i n dispensable for the applicati on of this docum e nt. For dated
references, only the edition cited a pplies. For u ndated references, the l atest edition of the referenced
docu m ent (including any amendments) appli es.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publicatio n Year Title EN/H D Year
1l
I EC 60065 ( m od) 2001 Audio, video and si milar electronic EN 60065 2002
apparatus - Safety requirem ents + carr. March 2006
I EC 60068-2-2 1 974 Enviro n m e ntal testi ng EN 60068-2-2 1 993
2)
A1 1 993 Part 2: Tests - Tests B: Dry heat A1 1 993
3)
A2 1 994 A2 1 994
I EC 60079-0 El ectrical apparatus for explosive gas EN 60079-0 2006
2)
( m od) atm ospheres
3)
Part 0: General req u i rements
I EC 60079-2 El ectrical apparatus for explosive gas EN 60079-2 2004
2)
atm ospheres + carr. April 2006
Part 2: Pressurized e nclosu res "p"
I EC 60079-5 El ectrical apparatus for explosive gas
2)
atm ospheres
Part 5: Powder fi l l i ng ' q '
I EC 60079-6 El ectrical apparatus for explosive gas
2)
atm ospheres
Part 6: Oil-i m m ersion "o"
I EC 60083 Plugs and socket-outlets for dom estic and
2)
similar general use standardized i n mem ber
3)
countries of I EC
2) 3)
I EC 60085 El ectrical i nsulation - Thermal classification EN 60085 2004
2)
I EC 60086-4 Prim ary batteries EN 60086-4 2000
3)
Part 4: Safety of l ith i u m batteries
I EC 601 1 2 M ethod for the determ i n atio n of the proof EN 601 1 2 2003
and the com parative tracki ng i n dices of solid
insulati ng m aterials
1)
2)
3)
EN 60068-2-2 i nc l udes supplem ent A : 1 976 to I E C 60068-2-2.
Undated refere nce.
Valid e d ition at date of issue.
- 5 - EN 6060 1 - 1 : 2 006

I EC 601 27- 1 2006 Miniature fuses EN 601 27-1 2006
Part 1 : Defi n iti ons for m i n i ature fuses and
4l
general requi rem ents for miniature fuse
l i n ks
I EC 60227-1 1 993 Polyvinyl chl oride insulated cables of rated
5l
A1 1 995 voltages up to and including 450/750 V
A2 1 998 Part 1 : General req u i rements
I EC 60245-1 2003 Ru bber insulated cables - Rated voltages u p
2)
to and i ncluding 450/750 V
3)
Part 1 : General req u i rements
I EC 60252-1 AC m otor capacitors EN 60252-1 2001

Part 1 : General - Perform ance, testing and
2) 3)
rating - Safety requirem ents - Guide for
i nstallati o n and operatio n
I EC 60320-1 Appli ance couplers for household a n d EN 60320-1 2001

similar general pu rposes
I EC 60335-1 ( m od) 2001 Household and similar electrical appli ances EN 60335-1 2002
- Safety A1 1 2004
Part 1 : General req u i rements A1 2 2006
+ carr. J uly 2006
I EC 60364-4-41 2005 Low-voltage el ectrical i nstallations HD 60364-4-4 1 2006

( m od) Part 4-4 1 : Protection for safety - Protection
agai nst electric shock
I EC 60384- 1 4 2005 Fixed capacitors for use in el ectronic EN 60384- 1 4 2005

equipm ent
Part 1 4: Sectional specification - Fixed
capacitors for electromagnetic i nterference
su ppression and connecti o n to the su pply
mains
I EC 604 1 7 Data Graphical sym bols for use on equipm ent
2) 3)
base
I EC 60445 Basic and safety pri nci ples for m an-machine EN 60445 2000
i nterface, m arki ng and identificati on -
Identifi cati on of equipm ent term i nals and of
term i n ations of certai n designated
2)
conductors, i ncl uding general rules for an
3)
alphan um eric system
I EC 60447 Basic and safety pri nci ples for m an-machine EN 60447 2004
i nterface, m arki ng and identificati on -
Actuating pri nciples
4)
5)
HD 2 1 . 1 S4:2002, Cables of rated v oltages up to and including 4501750 V and having thermoplastic insulation
Part 1: General requirements, which is related to, but not d i rectly equivalent with, I E C 602 2 7- 1 , applies instead.
HD 22.1 S4:2002, Cables of rated voltages up to and including 4501750 V and having cross-linked insulation - Part 1:
General requirements, which is related to, but not directly equivalent with, IEC 60245- 1 , applies instead.
EN 6060 1 - 1 : 2 006 -6 -

I EC 60529 1 989 Degrees of protection provided by EN 60529 1 99 1
2) 3)
enclosu res ( I P Code) + carr. May 1 993
A1 1 999 A1 2000
I EC 6060 1 - 1 -2 M edical electrical equ i pm ent EN 6060 1 - 1 -2 2001

Part 1 -2: General requirem ents for safety -
2) 3)
Collateral standard: Electrom agnetic
com pati bil ity - Requirem ents and tests
I EC 6060 1 - 1 -3 M edical electrical equ i pm ent EN 6060 1 - 1 -3 1 994

Part 1 : General requirem ents for safety - 3 .
Collateral standard: General requirements
2) 3)
for radiation protecti on i n diagnostic X-ray
equipm ent
2) 3)
Part 1 -6: General requirem ents for safety -
Collateral standard: Usabi lity

Part 1 -8: General requirem ents for safety - + carr. October 2006
Collateral standard: General requirem ents,
tests and guida nce for alarm systems i n
m edi cal el ectrical equipm ent and m edical
electrical systems
I EC 60664-1 ( m od) 1 992 I nsulati on coordi nati on for equipm ent within
2) 3)
+ A1 2000 low-voltage systems
+ A2 2002 Part 1 : Princi ples, requirements and tests EN 60664-1 2003
I EC 60695- 1 1 - 1 0 Fire hazard testi ng EN 60695-1 1 -1 0 1 999

Part 1 1 -1 0: Test fla m es - 50 W horizontal
and vertical fla m e test m ethods
I EC 60730-1 ( m od) 1 999 Automatic electrical controls for househo l d EN 60730-1 2000
and similar use A1 2 2003
A1 ( m od) 2003 Part 1 : General req u i rements A1 2004
A1 3 2004
A1 4 2005
I EC 60825-1 1 993 Safety of laser products EN 60825-1 1 994

Part 1 : Equipm ent classificatio n , + carr. February 1 995
A1 1 997 requirements and user' s guide A1 2002
A2 2001 A2 2001
+ carr. April 2004
I EC 6085 1 -3 1 996 Wi nding wires - Test m ethods EN 6085 1 -3 1 996

A1 1 997 Part 3: Mechanical properties A1 1 997
A2 2003 A2 2003

A1 1 997 Part 5: Electrical properties A1 1 997
A2 2004 A2 2004

A1 1 997 Part 6: Thermal properties A1 1 997
I EC/TR 60878 2003 Graphical sym bols for electrical equipment -

in m edical practice
-7 - EN 6060 1 - 1 : 2 006
2)
Publicatio n Year
I EC 60884-1 Plugs and socket-outlets for household a n d -
6l
similar pu rposes
I EC 60950-1 ( m od) 2001 I nformation technology equipm ent - Safety EN 60950-1 2001
Part 1 : General req u i rements + carr. April 2004
A1 1 2004
7l
I EC 6 1 058-1 ( m od) 2000 Switches for appliances
+ A1 2001 Part 1 : General req u i rements EN 6 1 058-1 2002
I EC 6 1 558-1 ( m od) 1 997 Safety of power transformers, power supply EN 6 1 558-1 1 997
u nits and similar + carr. April 2003
2)
A1 1 998 Part 1 : General req u i rements and tests A1 1 998
3)
A1 1 2003
I EC 6 1 558-2-1 Safety of power transformers, power su pply EN 6 1 558-2-1 1 997

u nits and similar
2)
Part 2-1 : Particular req uirements for
3)
separati ng transformers for gen eral use
2)
I EC 6 1 672- 1 El ectroacoustics - Sound level m eters EN 6 1 672-1 2003
3)
Part 1 : Specifications
2)
I EC 6 1 672-2 El ectroacoustics - Sound level m eters EN 6 1 672-2 2003
3)
Part 2: Pattern evaluation tests
I EC 6 1 965 M echanical safety of cathode ray tubes EN 6 1 965 2003
2)
ISO 3 1 Series Quantities and u n its of space and ti m e
2)
ISO 780 Packagi ng - Pictorial m arki ng for handling of EN I SO 780 1 999
goods
2)
ISO 1 000 Sl u n its and recom m e n dations for the use of -
their m u ltiples and of certai n other u n its
ISO 1 853 Conducti ng and dissi pative rubbers,
2)
vulcanized or thermoplastic - Measurement
of resistivity
ISO 2878 Ru bber, vulcanized - Antistatic and
2)
conductive products - Determi nation of
electrical resistance
ISO 2882 Ru bber, vulcanized - Antistatic and

conductive products for hospital use -
Electrical resistance l i m its
7)6) EN 60950-1 is s u perseded by EN 60950- 1 :2006, which is based o n I EC 60950- 1 : 2005, m o d .

E N 6 1 558-1 is s u perseded b y E N 6 1 558- 1 : 2 005, w h i c h is based o n I EC 6 1 558- 1 : 2005.
EN 6060 1 - 1 : 2 006 - 8 -
2)
ISO 3746 Acoustics - Determi nation of sound power EN I SO 3746 1 995
levels of noise sources using sound
pressure - Survey m ethod usi ng an
enveloping m easurement surface over a
reflecti ng pl ane
ISO 3864-1 2002 Graphical sym bols - Safety colours and

safety signs
Part 1 : Desi gn pri nci ples for safety signs i n
workplaces and public areas
A nnexZZ
(informative)
Coverag e ofE ssential R equirements ofE C D irectives
Comm ission and the Eu ropean Free Trade Association and withi n its scope the standard covers all
relevant essential requirem ents as given i n Annex I of the EC Di rectives 90/385/EEC and 93/42/EEC.
Compl iance with this standard provides one m eans of conform ity with the specified essential
requirements of the Di rectives concerned.
WAR N I NG: Other requirements and other EC Di rectives m ay be appl i cable to the products fal l i n g
with i n the scope o f t h i s standard.
INTERNATIONAL IEC
STANDARD 60601-1
T h i r d editi o n
2 0 05- 1 2
Medical electrical equipment-
Part 1:
General requirements for basic safety
This English-language version is derived from the original

bilingual pub lication by leaving out all French-language
pages. Missing page numbers correspond to the French
language pages.
Reference n u m b e r
I EC 60601 - 1 :2005(E)
P u b l ication n um be r i n g
As from 1 Janu ary 1997 al l I EC pu bli cati ons are issued w i th a design ati on i n the
60000 series. For e x am ple , I EC 34-1 is n ow re ferred to as I EC 60034-1.
Conso l i d ated ed itions
The I EC is n ow pu bl ishing con s ol i d ated ve rs i on s o f i ts pu bli cati ons . For e x am ple ,

e d i ti on n u m be rs 1.0, 1.1 and 1.2 re fe r , respe ctive ly, to the base pu bli cati on , the
base pu bli cati on i n cor por ati n g am e n d m e n t 1 and th e base pu bli cati on i n cor por ating
am e n d m e n ts 1 and 2.
F u rt h e r i n fo rmat io n on I E C p u b l icat i o n s
The te ch n i cal con te n t o f I EC pu bl i cati ons is ke pt u n d e r cons tant review by the I EC,
th us ensuring th at the con te n t re fle cts cu rre n t te ch n ol ogy. I n form ati on rel ati ng to
th is pu bli cati on , i n cluding i ts v alid i ty, is av ai l able in the I EC Catal og u e of
pu bli cati ons (see be l ow) in ad d i ti on to new edi ti ons , am end me n ts and corrigend a.
I n form ati on on the s u bje cts under considerati on and w ork in pr ogress u n d e r taken
by the te ch n i cal com m i tte e w h i ch h as pre pared th is publi cati on , as well as the l i s t
o f pu bli cati ons issued , is als o av ai l able from th e fol l ow i n g :
IEC Web S i te (www . iec.ch)
Catalogue of IEC publications

The on-line catal ogue on the I EC web site (www.iec. ch/search pu b) e n ables you to
s e ar ch by a v ari e ty of cri teri a i n cluding tex t s e ar ch e s , te ch n i cal com m i ttees
and d ate of pu bli cati on . On-line i n for m a ti on is als o av ai l able on re ce n tly issued
pu bli cati ons , w i th d r awn and repl aced pu bl i cati ons, as well as corri gend a.
IEC Just Published

Th is s um m ary of rece n tly issued pu bli cati ons (www . ie c. ch/online news/ jus tpu b)
is als o av ail able by e m ai l . Ple ase con tact the Cu s tom e r Se rv i ce Ce n tre (see
be l ow) for fu r th e r i n form ati on .
Customer Service Centre

I f you h ave any q u e s ti ons reg arding th is pu bli cati on or need fu r th e r assis tan ce ,
ple ase con tact the Cus tom e r Se rvi ce Ce n tre:
Em ai l : custserv @ie c. ch
Te l : +41 22 919 02 11
Fax: +41 22 919 03 00
INTERNATIONAL IEC
STANDARD 60601-1
T h i r d editi o n
2005- 1 2
Medical electrical equipment-
Part 1:
General requirements for basic safety
© I EC 2005 Copyrig ht - a l l r i g hts rese rved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical,
including photocopying and m icrofilm, without permission in writi ng from the publisher.
I nternational Electrotechnical Commission, 3, rue de Varembe, PO Box 1 3 1 , CH-1 21 1 Geneva 20, Switzerland
Telephone: +41 22 9 1 9 02 1 1 Telefax: +41 22 9 1 9 03 00 E-mail: inmail@iec.ch Web: www . iec.ch
Comm ission Electrotec h n ique l n ternationale P R I C E CODE XN

I n ternational Electrotec h n i cal Comm ission
Me)f(,QyHapo,qHa5l 3neKTpoTexH�LJecKa5l KoM�cc�Hl
For price, see cu�rent catalogue
6060 1 - 1 © I EC : 2005 -3-
C ONTENTS
F O R EW O R D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
I NT R O D U CT I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5
Scope, o bj ect a n d r e l ated sta n d a rds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9

1.1 * S c o pe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9
1 .2 O bj e ct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9
1 .3 * C o l l ateral sta n dards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
1 .4 * P a rti c u l a r sta n dards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1
2 * N o r m ative refe ren ces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1
3 * Te r m i n o l ogy a n d d efi n i t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4 G e n e ral req u i re m e nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4. 1 * C o n d it i o n s for a pp l i cati o n to ME E Q U I P M ENT or ME SYS T E M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4.2 * R I S K MANAG E M ENT PROCESS for M E E Q U I P M ENT o r M E SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 9
4.3 * E S S E NTIAL P E RFORMANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
4.4 * EXPECTED S E RVICE L I F E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
4.5 * E q u i v a l ent safety for M E E Q U I P M E NT o r M E SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3
4.6 * M E E Q U I P M E NT o r M E SYSTEM parts that contact t h e PATI E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3
4.7 * S I NGLE FAULT CONDITION for ME E Q U I P M E NT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.8 C o m p o n e nts o f M E E Q U I PMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5
4.9 * U s e o f COMPONE NTS W I TH H I G H- I NTEGRITY CHARACTERIS T I CS i n M E E Q U I P M E N T . . . . . . . 8 5
4 . 1 0 * P owe r s u pply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
4. 1 1 P owe r i n put . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
5 * G e n e ral req u i re m e nts for testi n g ME E Q U I P M ENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
5. 1 * TYPE TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
5.2 * N u m be r o f s a m ples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1
5.3 Am b i e nt tem perat u r e , h u m i dity, atm o s p h e r i c pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1
5.4 Oth e r c o n d i t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1
5.5 S u pply voltages, type o f cu rrent, n atu re o f s u pply, fre q u e n cy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3
5.6 Re pai rs a n d m odificati o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3
5.7 * H u m i dity preco n diti o n i n g treat m e nt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3
5.8 S e q u e n c e o f tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5
5.9 * Dete r m i n ati o n o f APPLI E D PARTS a n d ACCESSI BLE PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
6 * C l assifi cati o n of ME E Q U I P M E NT a n d ME SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
6. 1 G e n e ral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
6.2 * Protecti o n agai nst el ectri c s h ock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9
6.3 * Protecti o n agai nst harmful i n g ress o f water o r pa rti c u l ate m atte r . . . . . . . . . . . . . . . . . . . . . . 1 0 1
6.4 M ethod(s) o f ste ri l izati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 1
6.5 S u itabil ity for u s e i n a n OXY G E N R I C H ENVIRONMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 01
6.6 * M o d e o f o pe rati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 1
6060 1 - 1 © I EC : 2005 -5-
7 M E E Q U I PMENT i d e ntifi cati o n , m a rki n g a n d doc u m e nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 1

7. 1 G e n e ral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
7.2 M a r ki n g o n t h e o uts i d e o f M E E Q U I P M ENT o r M E E Q U I P M E NT parts . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0 5
7.3 M a r ki n g o n t h e i ns i d e o f M E E Q U I P M E N T o r M E E Q U I P M E N T parts . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 3
7.4 M a r ki n g o f controls a n d i nstr u m e nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 7
7.5 S afety s i g n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 9
7.6 Sym bols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 1
7.7 C o l o u rs o f t h e i ns u l at i o n o f co n d u ctors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 1
7.8 * I n d i cator l i g hts a n d controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 3
7.9 ACCO MPANY I NG DOCUME NTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 23
8 * Protecti o n agai nst el ectrical HAZARDS from ME E Q U I PMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 35
8. 1 F u n d a m ental r u l e of protect i o n agai nst el ectric s h o c k . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 35
8.2 R e q u i r e m e nts r e l ated t o power s o u rces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 37
8.3 Cl assifi cati o n o f APPLI E D PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 37
8.4 L i m itati o n o f volta g e , c u rrent o r e n e rgy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3 9
8.5 S e pa rati o n o f pa rts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4 5
8.6 * P rotectiv e earth i n g , f u n ct i o n a l e a rt h i n g a n d pote ntial e q u al izati o n of
ME EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6 1
8 .7 LEAKAGE CURRE NTS a n d PAT I E N T AUXILIARY CURRE NTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 67
8.8 I ns u l at i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 0 1
8.9 * C R E E PAGE DI STANCES a n d A I R CLEARANCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 3
8 . 1 0 C o m p o n e nts a n d wi ri n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
8. 1 1 M A I N S PARTS, c o m p o n e nts a n d l ayout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
9 * P rotecti o n agai nst MECHANICAL HAZARDS of ME E Q U I P M E N T a n d ME SYSTEMS . . . . . . . . . . . . . . . . 2 5 9
9. 1 M E CHA N I CAL HAZARDS of ME E Q U I P M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
9.2 * HAZARDS ass o c i ated with m ovi n g parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 6 1
9.3 * HAZARD associ ated with s u rfaces , corn e rs a n d edges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 1
9.4 * I nsta b i l ity HAZARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 1
9.5 * Expel l e d pa rts HAZARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 8 1
9.6 Acousti c e n e rgy ( i n c l u d i n g i nfra- a n d u ltras o u n d ) a n d vi brati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 8 1
9.7 * P ress u re vessels a n d parts s u bj e ct t o p n e u m at i c a n d hydra u l i c press u re . . . . . . . . . . 285
9.8 * HAZARDS associ ated with s u pport syst e m s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9 1
1 0 * Protecti o n agai nst u nwanted a n d excessive rad i ati o n HAZA R DS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 1
1 0 . 1 X- R a d i ati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 1
1 0 . 2 A l p h a , beta, g a m m a , n e utron a n d oth e r part i c l e radiati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 3
1 0 . 3 M i c rowave radiati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303
1 0 . 4 * Lasers a n d l i ght e m itti n g di odes ( L EOs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 3
1 0 . 5 Oth e r v i s i b l e e l ectro m a g n etic radi ati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303
1 0 . 6 I nfrared radiati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 5
1 0 . 7 U ltravi o l et radiati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 5
11 * P rotecti o n agai nst excess ive tem peratures a n d oth e r HAZA R DS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305
11.1 * Excessive t e m peratures in M E E Q U I P M ENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 0 5
1 1 . 2 * F i re prevent i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 3
1 1 . 3 * Co nstructi o n a l req u i r e m e nts for fi re E NCLOS URES of ME E Q U I PMENT . . . . . . . . . . . . . . . . . . . . 323
6060 1 - 1 © I EC : 2005 -7-
1 1 . 4 * M E E Q U I P M E NT a n d ME SYSTEMS i ntended for u s e with fl a m m able

a n aesthet i cs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
1 1 . 5 * M E E Q U I P M E NT and M E SYSTEMS i ntended for u s e in c o nj u n ct i o n with
fl a m m a bl e a g e nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
1 1 . 6 Overflow, s p i l l a g e , l e a ka g e , i n g ress of water o r parti c u l ate m atte r , c l ea n i n g ,
disi nfecti o n , steri l izati o n a n d c o m pati b i l ity with s u bsta n ces used with t h e
M E E Q U I P M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
1 1 . 7 B i o c o m pati b i l ity of M E E Q U I PMENT and M E S Y S T E M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 3
1 1 . 8 * I nterr u pti o n o f t h e powe r s u pply I S U PPLY M A I N S to M E E Q U I P M ENT . . . . . . . . . . . . . . . . . . . . . . 3 3 3
1 2 * Accu racy o f c o n t r o l s a n d i nstr u m e n ts a n d protect i o n agai nst h a z a r d o u s outputs . . . . . . . . 333
1 2 . 1 Accu racy of controls and i nstr u m e nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 3
1 2 . 2 USA B I L I TY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 3
1 2 . 3 Alarm syste m s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
1 2 . 4 Protecti o n agai nst h azardous o utput. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3 3
1 3 * HAZARDOUS S I TUATI ONS a n d fa u l t c o n diti o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337
13.1 S pecifi c HAZA RDO US S I TUATI ONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337
1 3 . 2 S I NGLE FAULT CONDITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339
1 4 * P RO G RAMMABLE E LECTRICA L M E D I CAL SYSTEMS ( P E M S ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 1
14.1 * G e n e ral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 1
1 4 . 2 * D o c u m e ntat i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 1
1 4 . 3 * R I S K MANAG E M ENT p l a n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 3
1 4 . 4 * P E M S DEV E LOPMENT L I F E -CYCLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 3
1 4 . 5 * P r o b l e m res o l ut i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 3
1 4 . 6 R I S K MANAG E M E NT PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353
1 4 . 7 * R e q u i re m ent s pecifi cati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 5
1 4 . 8 * Architect u r e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 5
1 4 . 9 * Des i g n a n d i m pl e m e ntati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357
1 4 . 1 0 * V E R I F I CATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357
1 4 . 1 1 * P E MS VAL I DATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357
1 4 . 1 2 * M o d ificat i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 359
1 4 . 1 3 * C o n n ecti o n of PEMS by N E TWORK/DATA C O U P L I N G to other e q u i pm ent . . . . . . . . . . . . . . . . 3 5 9
1 5 Co nstructi o n o f M E E Q U I PMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 359
15.1 * Arra n g e m e nts of controls and i n d i cators of M E E Q U I P M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 9
1 5 . 2 * S e rv i c e a b i l ity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 359
1 5 . 3 M e c h a n i ca l stre ngth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 1
1 5 . 4 M E E Q U I PMENT c o m p o n e nts a n d g e n e ral ass e m bl y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 369
1 5 . 5 * M A I N S S U PPLY TRANSFORMERS of M E E Q U I PMENT and tra nsform e rs provi d i n g
separati o n i n acco r d a n ce with 8 . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 379
16 * M E SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 387
16.1 * G e n e ral req u i re m e nts for t h e M E SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 387
1 6 . 2 * ACCO MPANY I N G DOCU M E NTS of an M E SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389
1 6 . 3 * P owe r s u pply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
1 6 . 4 ENCLOS URES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
1 6 . 5 * S E PARATI O N D E V I C E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 9 1
1 6 . 6 * LEAKAGE CURRE NTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 9 3
1 6 . 7 * P rotecti o n agai nst MECHANICAL HAZARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395
6060 1 - 1 © I EC : 2005 -9-
1 6 . 8 I nterr u pti o n of t h e power s u pply to pa rts of a n M E SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395

1 6 . 9 M E S Y S T E M co n n ecti o n s and wi r i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 9 5
1 7 * E l ectro m a g netic c o m pati b i l ity of M E E Q U I P M E NT a n d M E SYS T E M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 399
A n n ex A ( i nform ative) G e n eral g u i da n ce and rati o n a l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 0 1

A n n ex B ( i nform ative) S e q u e n c e o f testi n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1 3
A n n ex C ( i nfo r m ative) G u i d e to m a rki n g a n d l a bel l i n g req u i r e m e nts for ME E Q U I P M E NT
a n d ME SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2 1
A n n ex D ( i nform ative) Sy m bo l s o n m a rki n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 629
A n n ex E ( i nform ative) Exa m pl es of t h e co n n ecti o n of t h e m eas u ri n g device ( M D) for
m ea s u re m ent of t h e PAT I E NT LEAKA G E C U R R E N T and PAT I E NT AUXILI ARY C U R R E N T . . . . . . . . . . . . . . . . . . 647
A n n ex F ( i nform ative) S u itable m eas u r i n g s u pply circu its . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5 1
A n n ex G ( n o r m ative) P rotect i o n agai nst HAZARDS o f i g n it i o n o f fl a m m a bl e a n a esth eti c
m ixtu res . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 657
A n n ex H ( i nform ative) P E M S struct u r e , P E M S DEVELO P M E N T L I F E -CYCLE a n d
doc u m e ntat i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 687
A n n ex I ( i nfo r m ative) M E S Y S T E M S aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1 3
A n n ex J ( i nform ative) S u rvey of i ns u l ati o n paths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 725
A n n ex K ( i nform ative) S i m pl ified PAT I E NT LEAKA G E C U R R E N T d i a g r a m s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 731
A n n ex L ( n o r m ative) I ns u l ated wi n d i n g wires for use wit h o ut i nt e r l e av e d i ns u l at i o n . . . . . . . . . . . . 737
B i b l i o graphy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 743
I N D EX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 749
I N D EX OF AB B R EV I AT I O N S AN D A C R O N Y M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 775
F i g u re 1 - Detach a b l e m ai ns c o n n ecti o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
F i g u re 2 - Ex a m pl e of t h e defi n e d term i n als and c o n d u ctors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5
F i g u re 3 - Ex a m pl e o f a CLASS I M E E Q U I PMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 7
F i g u re 4 - Ex a m pl e o f a m etal - e nclosed CLASS I I M E E Q U I P M E NT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
F i g u re 5 - S c h e m at i c fl ow c h a rt for c o m p o n e nt q u alifi cati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
F i g u re 6 - Sta n d a rd test fi n g e r . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
F i g u re 7 - Test h o o k . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
F i g u re 8 - Test pi n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4 1
F i g u re 9 - Appli cati o n of test voltage to bridged PAT I E N T CONNECTIONS for
D E F I B R I LLATION-PROOF APPLI E D PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 55
F i g u re 1 0 - A p p l i cati o n of test voltage to i n d i v i d u a l PAT I E NT CONNECTI O N S for
D E F I B R I LLATION-PROOF APPLI E D PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 59
F i g u re 1 1 - A p p l i cati o n of test voltage to test t h e d e l i v e red d efi bri l l ati o n e n e rgy . . . . . . . . . . . . . . . . . 1 6 1

6060 1 - 1 © I EC : 2005 - 11 -
F i g u re 1 2 - Exa m p l e of a m eas u r i n g device a n d its fre q u e ncy c h a racte risti cs . . . . . . . . . . . . . . . . . . . . . 1 6 9

F i g u re 1 3 - M e a s u ri n g circuit for t h e EARTH LEAKA G E CURRENT of CLASS I ME e q u i p m e nt,
with o r wit h o u t APPLI E D P A R T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7 5
F i g u re 1 4 - M e a s u ri n g circuit for t h e TOUCH CURRENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 77
F i g u re 1 5 - M e a s u ri n g circuit for t h e PAT I E NT LEAKA G E CURRENT fro m t h e PAT I E NT
CONNECTION to e a rth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 79
F i g u re 1 6 - M e a s u ri n g circuit for t h e PAT I E NT LEAKA G E CURRENT v i a t h e PAT I E NT
CONNECT I O N ( s ) of a n F-TYPE APPLI E D PART to e a rth caused by a n exte r n a l voltage on t h e
PAT I E NT CONNECT I O N ( S ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8 1
F i g u re 1 7 - M e a s u ri n g circuit for t h e PAT I E NT LEAKA G E CURRENT fro m PAT I E NT

CONNECT I O N ( S ) to e a rth caused by an exte r n a l voltage on a S I GNAL I N P UT/O U TPUT PART . . . . . . . 1 83
F i g u re 1 8 - M e a s u ri n g circuit for t h e PAT I E NT LEAKA G E CURRENT fro m PAT I E NT
CONNECT I O N ( s ) to e a rth caused by an exte r n a l voltage on a m etal ACCESSI BLE PART t h at
is not PROTECTIVELY EART H E D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 85
F i g u re 1 9 - M e a s u ri n g circuit for t h e PAT I E NT AUXI LIARY CURRENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 87
F i g u re 2 0 - M e a s u ri n g ci rcuit for t h e total PAT I E NT LEAKAGE CURRENT with a l l PAT I E NT
CONNECTIONS of a l l APPLI E D PARTS of t h e s a m e ty pe (TYPE B APPLI E D PARTS , TYPE BF
APPLI E D PARTS or TYPE CF APPLI E D PARTS) co n n ected toget h e r . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 89
F i g u re 2 1 - B a l l -pressure test a ppa ratus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 3

F i g u re 22 - C R E E PAGE DI STANCE a n d A I R CLEARANCE - Exa m pl e 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3 9
F i g u re 2 3 - C R E E PAGE DI STANCE a n d A I R CLEARANCE - Exa m pl e 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3 9
F i g u re 2 5 - C R E E PAGE DI STANCE a n d A I R CLEARANCE - Exa m pl e 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3 9
F i g u re 27 - C R E E PAGE DI STANCE a n d A I R CLEARANCE - Exa m pl e 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 1
F i g u re 2 8 - C R E E PAGE DI STANCE a n d A I R CLEARANCE - Exa m pl e 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 1
F i g u re 3 1 - C R E E PAGE DI STANCE a n d A I R CLEARANCE - Exa m pl e 1 0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
F i g u re 32 - R ati o between HYDRAULIC TEST PRESSURE and MAXI M U M P E R M I S S I BLE
WORK I N G PRESSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289
F i g u re 33 - H u m a n body test m ass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299

F i g u re 34 - S park i g n iti o n test a pparatus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 7
F i g u re 3 5 - M ax i m u m a l l owable c u rrent I as a fu n ct i o n of t h e m ax i m u m a l l owable
voltage U m ea s u re d in a p u re l y resistive ci rcuit in a n OXY G E N RI C H ENVIRONMENT . . . . . . . . . . . . . . . . 3 1 7
F i g u re 36 - M ax i m u m a l l owable voltage U as a fu n ct i o n of t h e ca p acita n ce C
m e a s u red i n a c a pa citive c i r c u it used i n an OXY G E N R I C H E N V I R O N M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 9
F i g u re 37 - M ax i m u m a l l owable c u rrent I as a f u n ct i o n of t h e i n d u cta n c e L m eas u re d
i n a n i n d u ctive c i r c u i t i n a n OXY G E N R I C H ENVIRONMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1 9
F i g u re 38 - B affl e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327
F i g u re 3 9 - Area of t h e bottom of a n E NCLOS URE as s pecifi ed in 1 1 . 3 b) 1 ) . . . . . . . . . . . . . . . . . . . . . . . . . 327
F i g u re A. 1 - I d e ntifi cati o n of M E E Q U I P M E NT, APPLI E D PARTS and PATI E N T CONNECTI O N S
in a n E C G m o nitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 3
6060 1 - 1 © I EC : 2005 - 13 -
F i g u re A . 2 - Exa m pl e of t h e i ns u l ati o n of an F-TY P E APPLI E D PART with t h e i ns u l ati o n

i n corpo rated i n t h e M E E Q U I P M E NT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 5
F i g u re A. 3 - I d e ntifi cati o n of ME E Q U I P M E NT, APPLI E D PARTS a n d PATI E N T CONNECTI O N S
in a PAT I E NT m o n itor with i nvasive pressure m o n itori n g fac i l ity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 7
F i g u re A . 4 - I d e ntifi cati o n of M E E Q U I P M E NT, APPLI E D PARTS a n d PATI E N T CONNECTI O N S
in a m u ltifu n cti o n PAT I E NT m o nitor with i nvasive pressure m o n itori n g fac i l ities . . . . . . . . . . . . . . . . . . . . . 4 1 9
F i g u re A. 5 - I d e ntifi cati o n of APPLI E D PARTS a n d PAT I E NT CO N N ECTI ONS i n a n X-ray M E
SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 1
F i g u re A . 6 - I d e ntifi cati o n of ME E Q U I P M E NT, APPLI E D PARTS a n d PATI E N T CONNECTI O N S i n
a transcuta n e o u s e l ectro n i c n e rve sti m u lator ( T E N S ) i nt e n d e d t o b e wo rn o n t h e
PAT I E NT ' s belt a n d co n n e cted to el ectrodes a p pl i e d to t h e PAT I E NT ' s u pper arm . . . . . . . . . . . . . . . . . . . 4 2 1
F i g u re A . 7 - I d e ntifi cati o n o f M E E Q U I P M E NT o r M E SYS T E M , APPLI E D PARTS a n d PAT I E NT

CONNECTIONS i n a perso n a l c o m puter with a n E C G m o d u l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423
F i g u re A. 8 - P i ctori a l representati o n of t h e rel ati o n s h i p of HAZA R D , s e q u e n c e of eve nts ,
HAZARDOUS S I TUATION a n d HARM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429
F i g u re A. 9 - Exa m pl e of PAT I E NT ENVIRONMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 1
F i g u re A. 1 0 - F l o ati n g c i r c u it . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 469
F i g u re A. 1 1 - I nterr u pti o n of a powe r-carry i n g c o n d u cto r betwe e n M E E Q U I P M E NT parts
i n s e pa rate E NCLOS URES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 475
F i g u re A. 1 2 - I de ntifi cati o n of M E A N S O F PAT I E N T PROTECT I O N and M E A N S O F O P E RATOR
PROTECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 8 3
F i g u re A. 1 3 - Al l ow a b l e protective earth i m pedance w h e re t h e fa u l t c u rrent i s l i m ited . . . . . . . . 497

F i g u re A. 1 4 - P r o b a b i l ity of ve ntri c u l a r fibri l l at i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 0 9
F i g u re A. 1 5 - Ex a m pl e of a m e as u ri n g c i r c u it f o r t h e PAT I E NT LEAKA G E CURRENT f r o m a
PAT I E NT CONNECTION to e a rth for ME E Q U I P M E NT with m u lti p l e PATI E NT CONNECTIONS . . . . . . . . . . . . . 5 1 9
F i g u re A. 1 6 - I nsta b i l ity test c o n diti o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
F i g u re A. 1 7 - Ex a m pl e of d eterm i n i n g T E NS I L E SAFETY FACTOR u s i n g T a b l e 21 . . . . . . . . . . . . . . . . . . . . 555
F i g u re A. 1 8 - Ex a m pl e of d eterm i n i n g des i g n and test l oads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
F i g u re A. 1 9 - Ex a m pl e of h u m a n body m ass d i stri buti o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
F i g u re E . 1 - TYPE B APPLI E D P A R T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 647
F i g u re E . 2 - TYPE BF APPLI E D PART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 647
F i g u re E . 3 - TYPE CF APPLI E D PART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 649
F i g u re E . 4 - PATI E N T AUXILIARY CURRENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 649
F i g u re E . 5 - load i n g of t h e PAT I E NT CONNECTIONS if s pecifi ed by t h e MANUFACTU R E R . . . . . . . . . . 649
F i g u re F . 1 - M e as u r i n g s u pply circuit with one s i d e of t h e S U PPLY MAINS at
a p prox i m ately e a rth pote ntial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5 1
F i g u re F . 2 - M e as u r i n g s u pply circuit with S U PPLY MAINS a p prox i m ately sy m m etrical to
earth pote ntial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5 1
F i g u re F . 3 - M e as u r i n g s u pply c i r c u it for polyphase M E E Q U I P M E N T s pecifi e d for
co n n e cti o n to a polyph ase S U PPLY MAINS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 653
F i g u re F . 4 - M e as u r i n g s u pply circuit for s i n gl e- p h as e M E E Q U I P M E N T s pecifi ed for
co n n e cti o n to a polyph ase S U PPLY MAINS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 653
6060 1 - 1 © I EC : 2005 - 15 -
F i g u re F . 5 - M e as u r i n g s u pply circuit for ME E Q U I P M E NT havi n g a s e pa rate power

s u pply u n it o r i nt e n d e d to receive its power from a n oth e r e q u i pm e n t in a n M E SYSTEM . . . . . . . . . 6 5 5
F i g u re G . 1 - M axi m u m a l l owa b l e cu rrent /zR as a fu n ct i o n o f t h e m ax i m u m a l l owa b l e
v o l t a g e UzR m e asured i n a p u re l y resistive circuit w i t h t h e m ost fl a m m a b l e m ixture of
eth e r v a po u r with a i r . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 669
F i g u re G . 2 - M ax i m u m a l l owable voltage Uzc as a f u n ct i o n of t h e c a pacita n ce Cmax
m e a s u red i n a ca pacitive circuit with t h e m ost fl a m m a b l e m ixt u re of eth e r v a p o u r with a i r . 6 7 1
F i g u re G . 3 - M ax i m u m a l l owa b l e c u rrent /zL as a f u n ct i o n of t h e i n d u ctance L m ax
m e as u red i n an i n d u ctive ci rcuit with t h e m ost fl a m m able m ixture of ether v a p o u r with a i r . . 67 1
F i g u re G . 4 - M ax i m u m a l l owa b l e c u rrent /zR as a f u n ct i o n of t h e m axi m u m a l l owable
voltage UzR m e asured in a p u re l y resistive circuit with t h e m ost fl a m m a b l e m ixture of
eth e r v a po u r with oxyg e n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 679
F i g u re G . 5 - M ax i m u m a l l owa b l e voltage Uzc as a f u n ct i o n of the c a pacita n ce Cmax
m e a s u red i n a ca pacitive circuit with t h e m ost fl a m m a b l e m ixt u re of eth e r v a p o u r with
oxy g e n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 681
F i g u re G . 6 - M ax i m u m a l l owa b l e c u rrent /zL as a f u n ct i o n of t h e i n d u ctance L m ax
m e a s u red i n an i n d u ctive c i r c u it with t h e m ost fl a m m able m ixture of eth e r v a p o u r with
oxy g e n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 681
F i g u re G . 7 - Test a ppa ratus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 685
F i g u re H . 1 - Exa m pl es of P E M S/ P E S S structu res . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 689
F i g u re H . 2 - A P E M S DEVELOPMENT L I F E-CYCLE m od e l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 691
F i g u re H . 3 - P E M S d o c u m e ntati o n req u i re m e nts from C l ause 1 4 a n d I S O 1 49 7 1 : 2 0 0 0 . . . . . . . . 6 9 9
F i g u re H . 4 - Ex a m pl e o f pote ntial param eters req u i red to be s pecified for
N E TWORK/DATA COUPLING ..................................................................................................... 71 1
F i g u re 1 . 1 - Ex a m pl e of t h e constructi o n of a M U LTIPLE SOCKET-OUTLET ( M S O ) . . . . . . . . . . . . . . . . . . . . . . 72 1
F i g u re 1 . 2 - Ex a m pl es of a p pl i cati o n of M U LTI PLE S OCKET-OUTLETS ( MSO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 723
F i g u re J . 1 - I ns u l ati o n ex a m pl e 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 725
F i g u re K. 1 - M E E Q U I P M ENT with a n E NCLOS URE made of i ns u l ati n g m aterial . . . . . . . . . . . . . . . . . . . . . . . . 731
F i g u re K . 2 - M E E Q U I P M ENT with a n F-TYPE APPLI E D PART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 731
F i g u re K. 3 - M E E Q U I P M ENT w i t h a n APPLI E D PART a n d a S I GNAL I N P UT/O UTPUT PART . . . . . . . . . . . . . 733
F i g u re K . 4 - M E E Q U I P M ENT w i t h a PAT I E NT CONNECTION o f a TYPE B APPLI E D PART t h a t i s
not PROTECTIVELY EART H E D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 733
F i g u re K. 5 - M E E Q U I P M ENT w i t h a PAT I E NT CONNECTION o f a TYPE B F APPLI E D PART t h at
is not PROTECTIVELY EART H E D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3 5
6060 1 - 1 © I EC : 2005 - 17 -
T a b l e 1 - U n its o u ts i d e t h e Sl u n its system that m ay be used o n ME EQUI P M E NT . . . . . . . . . . . . . . . . . 119

T a b l e 2 - C o l o u rs of i n d i cator l i g hts a n d t h e i r m e a n i n g for M E E Q U I P M E NT . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 23
T a b l e 3 - * Al l owa b l e v a l ues of PAT I E NT LEAKA G E CURRE NTS a n d PATI E N T AUXI LIARY
CURRE NTS u n de r NORMAL CONDITION a n d S I NG L E FAULT CONDITI O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
T a b l e 4 - * Al l owa b l e v a l ues of PAT I E NT LEAKA G E CURRE NTS u n der t h e s peci a l test
con diti o n s i d e ntified i n 8 . 7 . 4 . 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 73
T a b l e 5 - L e g e n ds of sym bols for F i g u re 9 to F i g u re 1 1 , F i g u re 1 3 to F i g u re 2 0 , F i g u r e
A. 1 5 , A n n ex E a n d An n ex F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9 1
T a b l e 6 - Test voltages for s o l i d i n s u l ati o n form i n g a MEANS OF P ROTECTION . . . . . . . . . . . . . . . . . . . . . . . 207
T a b l e 7 - Test voltages for M E A N S O F O P E RATOR PROTECT I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 0 9
T a b l e 8 - M u lt i p l i cati o n factors for A I R CLEARANCES f o r a l t i t u d e s u p to 5 000 m . . . . . . . . . . . . . . . . . . . . 2 1 5
T a b l e 9 - M aterial g r o u p cl assificat i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 7
T a b l e 1 0 - M A I NS TRA NS I E NT VOLTAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1 9
T a b l e 1 1 - M i n i m u m CREEPAGE DI STANCES a n d A I R CLEARANCES betwee n parts of
o p posite pola rity of t h e MAINS PART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
T a b l e 1 2 - M i n i m u m CREEPAGE DI STANCES a n d A I R CLEARANCES provi d i n g M EANS O F
PAT I E NT PROTECT I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
T a b l e 1 3 - M i n i m u m A I R CLEARANCES provi d i n g MEANS O F O P E RATOR PROTE CTION from

t h e MAINS PART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Table 1 4 - Additi o n a l AIR CLEARANCES for i ns u l at i o n in MAINS PARTS with PEAK WORKING
a
VOLTAGES exceed i n g the peak val u e of the NOMI NAL MAINS VO LTAG E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
T a b l e 1 5 - M i n i m u m AIR CLEARANCES for MEANS O F O P E RATOR PROTECT I O N in S ECONDARY
CI RCU I TS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 1
T a b l e 1 6 - M i n i m u m CRE EPAGE DI STANCES provi d i n g MEANS OF O P E RATOR PROTECT I O N . . . . . . . . 2 3 3
T a b l e 1 7 - N O M I NAL cross-sect i o n a l area o f c o n d u ctors o f a POW E R S U P P LY CORD . . . . . . . . . . . . . . . 2 5 1
T a b l e 1 8 - Test i n g o f cord a n c h o rages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5 3
T a b l e 1 9 - M E CHA N I CA L HAZARDS covered b y this c l a use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 1
T a b l e 2 0 - Acce pta b l e g a ps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
Table 21 - D eterm i n at i o n of T E NS I L E SAFETY FACTOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293
Table 22 - Al l owable m axi m u m tem peratures of parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 305
Table 2 3 - Al l owa b l e m axi m u m te m peratu res fo r M E E Q U I P M E N T pa rts that are l i kely to
be t o u c h e d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307
T a b l e 24 - Al l owa b l e m axi m u m tem peratu res fo r ski n contact with M E EQUI PMENT
APPLI E D PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307
T a b l e 2 5 - Acce pta b l e pe rforati o n of t h e bott o m of a n E NCLOS URE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Table 26 - * T e m pe rat u r e l i m its of m otor wi n d i n gs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345
T a b l e 27 - M ax i m u m m otor wi n d i n g steady-state t e m perature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349
T a b l e 2 8 - M e c h a n i c a l stre n gth test a p pl i ca b i l ity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 1
T a b l e 2 9 - D ro p h e i g ht . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 365
T a b l e 3 0 - Test torq u es for rotati n g controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 377
6060 1 - 1 © I EC : 2005 - 19 -
T a b l e 3 1 - M ax i m u m a l l owable t e m peratu res of transfo r m e r wi n d i ngs u n d e r overload

and s h o rt-ci rcuit conditions at 25 oc (± 5 °C) a m bi e n t tem perature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8 1
T a b l e 32 - Test c u rrent f o r tra nsfo r m e rs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8 3
T a b l e A. 1 - V a l u e s o f A I R CLEARANCE a n d CREEPAG E D I S TANCE derived from T a b l e 7 of
I EC 6 1 0 1 0- 1 : 2 0 0 1 a n d T a b l e 1 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 525
Table A . 2 - C R E E PAGE D I S TANCES to avoid fa i l u re due to tracki n g from I E C 60664- 1 . . . . . . . . . . . 527
T a b l e A. 3 - I nsta b i l ity test c o n d iti o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 543
T a b l e A . 4 - Al l owable ti m e ex pos u re for level of accele rati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
Table A. 5 - G u i d a n c e on s u rface t e m peratu res for M E E Q U I P M ENT that creates l ow
tem peratu res (cools) for th e r a peutic pu rposes or as part of its o p e rati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . 565
Table C . 1 - M a rki n g on the o u ts i d e of M E E Q U I P M ENT, M E SYSTEMS o r t h e i r pa rts . . . . . . . . . . . . . . . . . 621
Table C . 2 - M a rki n g o n the i ns i d e of M E E Q U I P M E N T , M E SYSTEMS o r t h e i r pa rts . . . . . . . . . . . . . . . . . . . 623
T a b l e C . 3 - M a rki n g of controls a n d i nstru m e nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 623
T a b l e C . 4 - ACCO MPANY I NG DOCUME NTS , g e n e ral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 625
Table C . 5 - ACCO MPANY I NG DOCUME NTS , i nstru cti o n s for u s e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 625
Table 0 . 1 - G e n eral sym bols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 631
T a b l e 0 . 2 - Safety s i g n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 641
T a b l e 0 . 3 - G e n eral c o d e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 645
Table G . 1 - Gas-ti ghtn ess of cord i n l ets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 675
T a b l e H . 1 - N E TWORK/DATA COUPLI N G classifi cati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707
Table 1 . 1 - S o m e ex a m pl es of M E SYSTEMS for i l l ustrati o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 717
T a b l e L . 1 - M a ndrel d i a m eter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 739
T a b l e L . 2 - Oven tem pe rat u re . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 739
6060 1 - 1 © I EC : 2005 - 21 -
INTERNATIONAL ELECTROTEC HNICA L C OMMISSION
M EDICAL ELE CTRICAL EQU IP M ENT -
P art 1 : G eneral requirements for basi c safe ty

FOREWOR D
1 ) The I nternational E lectrotechnica l Comm ission (I E C) i s a worldwide organization for standardization comprising
a l l national e l ectrotechnical c o m m ittees ( I E C Natio nal Comm ittees). The object of IEC i s to promote
international co-operation o n all questions concerning standardization i n the electrical and electronic fields. To
this end and in addition to other activities, I EC publishes I nternational Standards, Techn ical Specifications,
Technical Reports, P u blicly Ava i l a ble S pecifications (PAS) a n d G u ides (hereafter referred to as " I E C
Publ ication(s)") . T h e i r preparat ion is entrusted t o tech nical c o m m ittees; a n y I E C National Comm ittee interested
i n the s u bject dealt with may partici pate i n this preparatory work. I nternational, gove rnmental and non
gove rnme ntal organ izations liaising with the IEC also partici pate i n this preparation. I EC collaborates closely
with the I nternational Organization fo r Sta ndardizati o n (ISO) i n accordance with conditions dete rmined by
agreement betwe e n the two organizations.
2) The fo rmal decisions o r agree m e nts of IEC o n technical matters express, as nearly as possible, a n international
consensus of opinion o n the relevant s u bjects since each technical com m ittee has representation from a l l
interested I E C Natio nal Co m m ittees.
3) I E C P u blications have the form of reco m m endations for international use and are accepted by I EC National
Comm ittees i n that sense. While a l l reaso nable efforts are made to ensure that the technical content of I E C
P u blications is accu rate , I E C can not b e held responsible for t h e way i n which they a r e used o r for any
m i s i nterpretation by any end user.
4) In order to promote international u n iform ity, IEC National Comm ittees u n d e rtake to a p ply IEC Pub lications
transparently to the maxi m u m extent possible i n their national and reg i o n a l publicatio n s . Any divergence
between any IEC P u blication a n d the correspo nding natio nal o r regional publication shall be clearly i n d icated in
the latter.
5) I E C provides no m a rking procedure to i n d icate its approval and can not be re ndere d responsible for any
e q u i pm e nt declare d to be i n conform ity with a n I EC Publ icati o n .
6 ) A l l users s h o u l d ensure that t h e y have t h e latest edition o f this publicat i o n .
7 ) No liability shall attach to I EC o r i t s d i rectors, e m ployees, servants o r agents including i n dividual experts and
m e m bers of its technical c o m m ittees and IEC Natio n a l Comm ittees for any perso n a l i nj u ry, property damage o r
o t h e r d a m a g e of any nature whatsoever, whether d i rect o r ind irect, o r f o r costs ( i n c l u d i n g l e g a l fees) and
expenses arising out of the publicatio n , use of, o r reliance u p o n , this IEC P u blication o r a ny other I E C
P u blicatio n s .
8 ) Attention is drawn to the Norm ative refe rences cited i n this publicati o n . Use of t h e refe re nced publ ications i s
indispensable f o r the correct application of this publ icatio n .
9 ) Atte nti o n is drawn t o t h e possibil ity that s o m e o f t h e elements o f this I E C P u blication m a y b e t h e s u bject of
patent rights. I EC shall not be held responsible for identifying any o r a l l such patent rights.
I nternati o n a l Sta n dard I EC 6060 1 - 1 h as been prepared by s u bco m m ittee 62A: C o m m o n

aspects o f el ectrical e q u i pm ent used i n m ed i c a l practice, o f I E C tec h n i ca l co m m ittee 6 2 :
E l ectrical e q u i p m e nt i n m ed i c a l practice.
T h i s t h i rd editi o n c a n c e l s a n d repl aces t h e second editi o n p u b l i s h ed in 1 98 8 , its Am e n d m ent 1

( 1 9 9 1 ) a n d Am e n d m e n t 2 ( 1 9 9 5 ) . T h i s editi o n constitutes a tec h n i ca l rev i s i o n . T h i s editi o n has
been s i g n ifica ntly restru ctu red. R e q u i r e m e nts in t h e e l e ctrical s e cti o n have been furt h e r
a l i g n e d with t h o s e f o r i nformati o n tech n o l ogy e q u i p m e nt covered b y I EC 6 0 9 5 0 - 1 a n d a
req u i re m e nt for i n cl u d i n g a R I S K MANAG E M E NT PROCESS h as b e e n a d d e d . F o r an ex p a n d e d
desc ri pti o n o f t h i s revisi o n , s e e C l a u s e A . 3 .
6060 1 - 1 © I EC : 2005 - 23 -
T h e text of t h i s sta n d a rd is based o n t h e fo l l owi n g docu m e nts:
FDIS Report o n voting
62A/505A/FDI S 62A/5 1 2/RVD
F u l l i nfo r m at i o n on t h e voti n g for t h e a p proval of t h i s sta n dard c a n be f o u n d i n t h e report o n

voti n g i n d i cated i n t h e a bove t a b l e .
T h i s p u b l i cati o n has been d rafted i n accordance w i t h t h e I S O/I EC D i rectives, Part 2 .
I n t h i s sta n dard t h e fol l owi n g pri nt types a r e u s e d :

R e q u i r e m e nts a n d d efi n i t i o n s : i n r o m a n type.
Test specifications: in italic type.
I nformative material appearing outside of tables, such as notes, examples and refe re nces: i n smaller type.
Normative text of tables is also i n a smaller type.
TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN D E F I N E D IN C LAUSE 3 A N D ALSO
G I V E N IN THE I N DEX: IN S MALL CA P I TALS.
I n referri n g to t h e structure of this sta n d a r d , the term

" cl a use" m e a n s one of t h e seventeen n u m bered d i v i s i o n s wit h i n the table of co ntents ,
i n c l u s i v e o f a l l s u bd i v i s i o n s ( e . g . C l a u s e 7 i n cl udes s u bc l a u s e s 7 . 1 , 7 . 2 , etc . ) ;
" s u bc l a use" m e a n s a n u m bered s u bd i v i s i o n o f a c l a u s e ( e . g . 7 . 1 , 7 . 2 a n d 7 . 2 . 1 a r e a l l
s u bc l a uses o f C l a u s e 7 ) .
Refe r e n ces to c l a u s es with i n t h i s sta n dard are preceded b y t h e t e r m " C l a u s e " fo l l owed b y t h e
c l a u s e n u m ber. R efe ren ces t o s u bc l a uses with i n t h i s sta ndard a r e b y n u m be r o n l y .
I n t h i s sta n da r d , t h e c o nj u n ctive " o r" i s u s e d as a n " i n c l usive or" so a stat e m ent i s t r u e if a n y

co m bi n at i o n o f t h e conditions i s t r u e .
T h e v e r b a l fo rms used i n t h i s sta n dard co nfo rm to u s a g e descr i b e d i n An n ex G o f t h e I SO/I EC

Di rectives, Part 2 . For t h e p u rposes of t h i s sta n da rd , t h e a ux i l i a ry verb:
" s h a l l " means t h at c o m p l i a n c e with a re q u i re m e nt o r a test i s m a n datory for c o m p l i a nce
with this sta n d ard;
" s h o u l d" m ea n s that co m pl i a nce with a re q u i re m ent o r a test is reco m m e n d e d but i s n ot
m a n datory for c o m p l i a n c e with t h i s sta n d a rd ;
" m ay" is used t o descri be a perm issi b l e way to a c h i eve co m pl i a n ce with a req u i re m e n t o r
test.
An aste risk (* ) as the fi rst c h a racter of a titl e o r at the b e gi n n i n g of a paragraph o r table titl e
i n di cates t h at there is g u i da n ce or rati o n a l e r e l ated to t h at item i n An n ex A.
T h e c o m m ittee has decided t h at t h e c o nte nts of this pu b l i cati o n w i l l re m a i n u n c h a n g e d u nt i l

t h e m a i nt e n a n c e res u l t d a t e i n d i cated o n t h e I E C we b s i t e u n d e r " http : //websto re . i ec. c h " i n t h e
data r e l ated to t h e s pecifi c p u b l i cati o n . At t h i s date, t h e p u b l i cati o n wi l l b e
reco nfi r m e d ;
wit h d rawn ;
repl a ced b y a rev i s e d editi o n , o r
ame nded.
6060 1 - 1 © I EC : 2005 - 25 -
INTRODUCTION
I n 1 976, I E C s u bco m m ittee 62A p u b l i s h e d t h e fi rst editi o n of I EC/T R 6 05 1 3 , Basic aspects of

the safety philosophy for electrical equipm ent used in m edical practice. T h e fi rst editi o n of
I EC/TR 60 5 1 3 prov i d e d t h e basis for deve l o p i n g :
- t h e fi rst editi o n of I EC 6060 1 - 1 (the parent s afety sta n dard for M E D I CA L ELECTRICA L
EQUIPMENT);
- t h e I EC 6060 1 - 1 -xx s e r i es of c o l l ateral sta n d a rds for M E D I CA L E LECTRICA L E Q U I P M E NT ;

- t h e I EC 6060 1 -2-xx s e r i es of part i c u l a r sta n d a rds for pa rti c u l a r types of M E D I CA L
E LECTRICAL E Q U I P M E NT ; and
- t h e I EC 6060 1 -3-xx s e ri es of perfo r m a n c e sta n d a rds for part i c u l a r types of M E D I CA L

E LECTRICAL E Q U I P M E NT .
Awa re of t h e n eed and t h e u r g e n cy for a sta n dard coveri n g e l ectrical e q u i p m e nt used i n

m ed i c a l practice, t h e m aj o rity of N at i o n a l C o m m ittees voted i n 1 977 i n fav o u r of t h e fi rst
editi o n of I E C 6060 1 - 1 , based on a d raft t h at at t h e ti m e repres e nted a fi rst a p proach to t h e
probl e m . T h e extent o f t h e scope, t h e c o m p l exity o f t h e e q u i p m e nt c o n c e r n e d , a n d t h e
s pe cifi c n atu re o f s o m e of t h e protective m ea s u res a n d t h e correspo n d i n g tests f o r verify i n g
th e m , re q u i re d years o f effort i n order t o prepare t h i s fi rst sta n d a r d , w h i c h c a n n ow b e s a i d t o
h a v e s e rv e d a s a u n iversal refere n c e s i nce its p u b l i cati o n .
H owever, t h e freq u e n t a pp l i cati o n o f t h e fi rst editi o n rev e a l e d room for i m prov e m e nt. T h ese
i m prov e m e nts were a l l t h e m o re d e s i r a b l e i n v i ew of t h e c o n s i d e ra b l e s u ccess t h at t h i s
sta ndard has e njoyed s i n ce i t s p u b l i cati o n .
T h e careful work o f revis i o n s u bs e q u e ntly u n d e rtaken a n d conti n u ed over a n u m be r o f y e a rs

res u lted i n t h e p u b l i cati o n of t h e s e c o n d e d iti o n i n 1 98 8 . T h i s e d iti o n i n corpo rated a l l t h e
i m prov e m e nts t h at co u l d be reas o n a bly expected u p to t h at ti m e . F u rt h e r devel o p m e nts
re m a i n e d u n d e r co nstant study. T h e s e c o n d editi o n was a m e n d e d i n 1 99 1 a n d t h e n agai n i n
1 995.
T h e o ri g i n a l I E C a pproach w a s to p r e p a r e se pa rate BAS I C SAF ETY a n d perform a n ce sta n d a rds

for M E D I CA L E LECTRICAL E Q U I P M E N T . T h i s was a natural exte nsi o n of the h isto rical a p proach
take n at the n ati o n a l and i nternati o n a l l evel with oth e r el ectrical e q u i p m e n t sta n d a rds ( e . g .
those for d o m esti c e q u i pm ent), where BAS I C SAF ETY is r e g u l ated t h r o u g h m a n datory sta n d a rds
but oth e r perform a n ce s pecificat i o n s are r e g u l ated by m a rket press u r e . I n this co ntext, it h as
been s a i d that, " T h e a b i l ity of a n e l e ctric kett l e to b o i l wate r is n o t critical to its s afe u s e ! "
I t i s n ow recognized t h at t h i s i s n ot t h e s i t u ati o n with m a n y i t e m s of M E D I CA L ELECTRICA L

E Q U I P M E NT , and RESPONSIBLE ORGANIZATI ONS have to d e pe n d o n sta n d a rds to e n s u r e
E S S E NTIAL PE RFORMANCE as we l l as BAS I C SAF ETY. S u c h a reas i n c l u d e t h e accu racy with w h i c h
t h e e q u i p m e n t controls t h e d e l i v e ry of e n e rgy o r t h e r a p e u t i c s u bstances t o t h e PAT I E NT , o r
processes a n d d i s p l ays p h ys i ol og i c a l data that wi l l affect PAT I E NT m a n ag e m e nt.
T h i s recogn iti o n m ea n s t h at se pa rati n g BAS I C SAF ETY a n d perfo r m a nce is s o m ewhat

i n a ppropriate in a d d ress i n g the HAZARDS that res u l t from i n a d e q u ate des i g n of M E D I CA L
E LECTRICAL E Q U I P M E NT . Many part i c u l a r sta n dards in t h e I EC 6 060 1 -2-xx s e r i es a d d ress a
range of E S S E NTIAL PE RFORMANCE re q u i re m e nts that c a n n ot be d i rectly ev a l u ated by t h e
RESPONSIBLE ORGANIZATION wit h o ut a p plyi n g s u c h sta n dards. ( H owever, t h e cu rrent I EC 6 0 6 0 1
series i n c l u des fewer req u i re m e nts f o r E S S E NTIAL P E RFORMANCE t h a n f o r BAS I C SAFETY ) .
6060 1 - 1 © I EC : 2005 - 27 -
I n a ntici pati o n of a t h i rd editi o n of I E C 606 0 1 - 1 , I EC s u bc o m m i ttee 62A prepared a s e c o n d

editi o n o f I EC/TR 605 1 3 [ 1 2] 1 ) i n 1 99 4 . I t w a s i ntended t h at t h e s e c o n d editi o n o f I E C/T R
60 5 1 3 wo u l d prov i d e g u i d a n c e for devel o p i n g t h i s editi o n of I EC 606 0 1 - 1 , a n d fo r t h e furt h e r
dev e l o p m e n t o f t h e I EC 6060 1 - 1 -xx a n d I E C 6060 1 -2-xx series.
In order to a c h i ev e consist e n cy in i nte r n ati o n a l sta n dards, a d d ress present expectati o n s i n

t h e h e alth care c o m m u n i ty a n d a l i g n with d ev e l o p m e nts i n I EC 6 0 6 0 1 -2-xx, t h e s e c o n d editi o n
o f I E C/T R 6 05 1 3 i n c l u des two m aj o r n ew pri n c i pl e s :
- t h e fi rst c h a n g e is t h at t h e c o n c e pt of " SAFETY " has been b r o a d e n e d from t h e BAS I C SAF ETY
cons i d e rati o n s in t h e fi rst a n d s e c o n d editions of I E C 6 0 6 0 1 - 1 to i n c l u d e ESSENTIAL
P E RFORMANCE m atters, ( e . g . t h e accu racy of physi o l o g i ca l m o n itori n g e q u i p m e nt ) .
Appli cat i o n o f this pri n c i p l e l eads to t h e c h a n g e o f t h e titl e o f t h i s p u b l i cati o n fro m " M e d i ca l
e l ectrical e q u i p m e nt, P a rt 1 : G e neral re q u i re m e nts f o r safety" i n t h e s e c o n d editi o n , t o
" M ed i c a l e l ectrical e q u i p m ent, Part 1 : G e neral re q u i re m e nts f o r bas i c s afety a n d esse nti a l
perform a n c e " ;
- t h e s e c o n d c h a n g e is t h at, i n s pecify i n g m i n i m u m safety req u i re m e nts , provi s i o n is m ade
for assessi n g t h e a d e q u acy of t h e des i g n PROCESS w h e n t h i s is t h e only practi cal m et h o d
o f assess i n g t h e safety of certa i n tech n o l o gi es s u ch as prog ra m m a b l e el ectro n i c syste m s .
Appli cat i o n o f t h i s p r i n c i p l e i s o n e o f t h e factors l e a d i n g to i ntroducti o n o f a g e n eral
req u i re m e nt to ca rry o ut a R I S K MANAG E M E NT PROCES S . In paral l el with t h e devel o p m ent of
t h e t h i r d e d iti o n of I EC 606 0 1 - 1 , a j o i nt proj ect with I SO/TC 2 1 0 resu lted i n t h e p u b l i cati o n
o f a g e n e ral sta n d a rd f o r R I S K MANAG E M E N T o f m ed i c a l devices. C o m p l i a n ce with t h i s
editi o n o f I E C 6060 1 - 1 req u i res t h at t h e MANUFACTURER h ave a R I S K MANAG E M E N T PROCESS
com ply i n g with I SO 1 497 1 in place (see 4 . 2 ) .
T h i s sta n d ard c o ntai ns req u i r e m e nts c o n ce r n i n g BAS I C SAFETY a n d E S S E NTIAL P E RFORMANCE

t h at are g e n e r a l l y a pp l i c a b l e to M E D I CA L E LECTRI CAL E Q U I P M E NT . For certa i n types of M E D I CA L
E LECTRICAL E Q U I P M ENT, th ese req u i re m e nts are either s u pp l e m e nt e d o r m odifi ed by t h e special
req u i r e m e n ts of a c o l l ateral o r parti c u l a r sta n da r d . W h e re pa rti c u l a r sta n d ards exist, this
sta ndard s h o u l d n ot be used a l o n e .
1 ) Figures i n square brackets refer t o t h e Bibliography.

6060 1 - 1 © I EC : 2005 - 29 -
M EDICAL ELE CTRICAL EQU IP M ENT -
P art 1 : G eneral requirements for basi c safe ty

1 S c o p e , o bject a n d re l ated sta n d a rd s
1.1 * Scope
T h i s I nternati o n a l Sta n d a rd a p p l i es to the BAS I C SAFETY and E S S E NTIAL P E RFORMANCE of
M E D I CA L E LECTRICAL E Q U I P M E NT and M E D I CAL ELECTRICA L SYST E M S , h e reafte r referred to as
M E E Q U I P M E N T a n d M E SYS T E M S .
I f a clause o r s u bc l a u s e i s s pecifi c a l l y i nt e n d e d to be a p p l i c a b l e to M E E Q U I PMENT only, o r to

M E SYSTEMS o n ly, the titl e a n d content of t h at c l a use o r s u bc l a u s e wi l l say so. I f t h at i s n ot t h e
cas e , t h e c l a u s e o r s u bc l a u s e a pp l i e s b o t h to M E E Q U I P M E N T a n d to M E SYS T E M S , as r e l ev a nt.
HAZARDS i n h e rent in t h e i ntended physi o l o g i c a l fu n ct i o n of M E E Q U I P M ENT o r M E S Y S T E M S with i n

t h e s c o pe o f t h i s sta ndard a r e n o t covered b y s pe cific req u i re m e nts i n t h i s sta n dard except i n
7.2. 1 3 a n d 8.4. 1 .
NOTE See also 4 . 2 .
T h i s sta ndard c a n a l s o be a p p l i e d to e q u i p m e nt used f o r c o m pensati o n o r a l l ev i ati o n of

disease, i nj u ry or d i s a b i l ity.
I n vitro d i a g n ostic e q u i p m e nt t h at does not fall wit h i n the d efi n i t i o n of M E E Q U I P M ENT is

covered by the I EC 6 1 0 1 0 s e ri es 2) . T h i s sta ndard does not a p p l y to the i m pl a nta b l e parts of
activ e i m plantable m ed i c a l devi ces covered by I SO 1 4708- 1 3) .
1 .2 O bj ect
T h e o bj ect of t h i s sta n d a rd is to s pecify g e n e ral req u i re m e nts a n d to s e rve as t h e basis for
parti c u l a r sta n d a rds.
1 .3 * C o l l ateral sta n d ards

I n the I EC 6060 1 s e r i e s , col l ateral sta n d a rds s pe cify g e n e ra l r e q u i r e m e nts for BAS I C SAFETY
a n d E S S E NTIAL P E RFORMANCE a pp l i c a b l e to:
a s u bg r o u p of M E EQUI P M E NT ( e . g . radi o l o g i ca l e q u i p m e nt) ;
a s pecifi c c h a racte ristic of a l l ME E Q U I P M ENT not f u l l y addressed i n t h i s sta n d a r d .
Appl i ca b l e col l ateral sta n dards bec o m e n o r m ative a t t h e d ate of t h e i r p u b l i cati o n a n d s h a l l

a p p l y toget h e r with t h i s sta n d a r d .
NOTE 1 W h e n eva l uating com pliance with I E C 6060 1 - 1 , it is permissible t o inde pendently assess com pliance with
the col lateral sta ndards.
2) I EC 6 1 0 1 0 (a l l parts), Safety requirements for electrical equipment for measurement, control, and laboratory
use
3) ISO 1 4708- 1 , Implants for surgery - A ctive implantable medical devices - Part 1: General requirements for
safety, marking and for information to be provided by the manufacturer
6060 1 - 1 © I EC : 2005 - 31 -
NOTE 2 When declaring complia nce with I E C 6060 1 - 1 , the declare r should specifically l i st the col lateral standards
that have been applied. This a l l ows the reader of the declaration to understand which col lateral standards were
part of the eva l uati o n .
N O T E 3 Members of I E C m a intain a register of va l i d I nternational Standards. Users of this standard should consult
this register to determ ine which collateral standards have been published.
I f a col l ateral sta n d a rd a ppl i es to M E E Q U I P M E N T for w h i c h a pa rti c u l a r sta n dard exists , t h e n

t h e parti c u l a r sta ndard takes prio rity ov e r t h e c o l l ateral sta n d a rd .
1 .4 * Part i c u l a r sta n d ards

I n the I E C 60601 s e r i e s , parti c u l a r sta n d a rds m ay m odify, repl ace o r d e l ete re q u i re m e nts
conta i n ed i n t h i s sta n dard as appropri ate fo r t h e particu l a r M E E Q U I PMENT u n de r c o n s i d e rati o n ,
a n d m ay a d d oth e r BAS I C SAFETY a n d E S S E NTIAL P E RFORMANCE re q u i re m e nts .
NOTE Members of I E C and I S O m a i ntain registers of valid I nternational Sta ndards. Users of this standard should
consult these registers to determine which particular standards have been published.
A r e q u i r e m e n t of a parti c u l a r sta n d ard takes p r i o rity ov e r this sta n da r d .
2 * N o rmative refere n ces
T h e fol l owi n g referenced doc u m e nts are i n di s pe n s a b l e for t h e a pp l i cati o n of this doc u m e nt.
For d ated refe re nces, o n l y the editi o n cited a p p l i e s . For u n dated refere n c e s , the l atest e d iti o n
o f t h e referenced d o c u m ent ( i n c l u d i n g a n y a m e n d m e nts ) appl i es .
ATTENTIO N : Additional col lateral standards o f the I EC 6060 1 series, w h ich are issued
s u bsequent to publ ication of this stan dard , become normative at the date of their pu bl ication
and shall be considered as bei ng included among the normative references below. See 1 . 3 .
NOTE I nformative references are l isted i n the Bibliography o n page 743.
I EC 6 0 0 6 5 : 2 0 0 1 , A udio, video and similar electronic apparatus - Safety requirements
I EC 6006 8-2-2 : 1 97 4, Environmental testing - Part 2: Tests. Tests B: Dry heat

Am e n d m ent 1 ( 1 9 93)
Am e n d m ent 2 ( 1 994)
I EC 60079-0, Electrical apparatus for explosive gas atm ospheres - Part 0: General
requirements
I EC 60079-2, Electrical apparatus for explosive gas atmospheres - Part 2: Pressurized

enclosures "p"
I EC 60079-5, Electrical apparatus for explosive gas atmospheres - Part 5: Powder filling "q "
I EC 60079-6, Electrical apparatus for explosive gas atmospheres - Part 6: Oil-immersion "o"
6060 1 - 1 © I EC : 2005 - 33 -
I EC 6 0 0 8 3 , Plugs and socket-outlets for domestic and similar general use standardized in
member countries of IEC
I EC 6 0 0 8 5 , Electrical insulation - Therm al classification
I EC 60086-4, Prim ary b atteries - Part 4: Safety of lithium batteries
I EC 6 0 1 1 2 , Method for the determination of the proof and the comparative tracking indices of
solid insulating m aterials
I EC 6 0 1 27- 1 , Miniature fuses - Part 1 : Definitions for miniature fuses and general
requirements for miniature fuse-links
I EC 60227- 1 : 1 9 9 3 , Polyvinyl chloride insulated cables of rated voltages up to and including

4501750 V - Part 1 : General requirements 4l
Am e n d m ent 1 ( 1 9 95)
Am e n d m ent 2 ( 1 9 98)
I EC 60245- 1 : 2 0 0 3 , Rubber insulated cables - Rated voltages up to and including 4501750 V

Part 1 : General requirements
I EC 60252- 1 , AC motor capacitors - Part 1: General - Performance, testing and rating -

Safety requirements - Guide for installation and operation
I EC 60320- 1 , Appliance couplers for household and similar general purposes - Part 1 :
General requirements
I EC 6 0 3 3 5- 1 : 2 0 0 1 , Household and similar electrical appliances - Safety - Part 1: General

requirements
I EC 60364-4-4 1 , Electrical installations of buildings - Part 4-4 1 : Protection for safety -

Protection against electric shock
I EC 60384- 1 4 : 2 0 0 5 , Fixed capacitors for use in electronic equipm ent - Part 1 4 : Sectional
specification: Fixed capacitors for electromagnetic interference suppression and connection to
the supply m ains
I EC 604 1 7- 0 8 : 2002 , Graphical symbols for use on equipment 5)
I EC 60445, Basic and safety principles for m an-machine interface, m arking and identification
- Identification of equipment terminals and of terminations of certain designated conductors,
including general rules for an alphanum eric system
I EC 60447, Basic and safety principles for m an-machine interface, m arking and identification
- Actuating principles
I EC 60529: 1 98 9 , Degrees of protection provided by enclosures (IP Code) 6l

Am e n d m ent 1 ( 1 9 99)
4 ) There exists a conso lidated e d i t i o n 2 . 2 including I E C 602 2 7- 1 : 1 993 and i t s A m e nd m e nt 1 ( 1 995) and
A m e nd m e nt 2 (1 998) .
5) "DB" refers to the j o i nt I S O - I E C on-line database .
6) There exists a consol idated ve rs ion 2 . 1 , including I EC 60529 : 1 989 and its Amendm ent 1 ( 1 999).
6060 1 - 1 © I EC : 2005 - 35 -
I EC 606 0 1 - 1 -2 , Medical electrical equipment - Part 1 -2: General requirements for safety -
Collateral standard: Electrom agnetic compatibility - Requirem ents and tests
I EC 6060 1 - 1 -3 , Medical electrical equipm ent - Part 1: General requirem ents for safety - 3.
Collateral standard: General requirements for radiation protection in diagnostic X-ray
equipment
I EC 606 0 1 - 1 -6 , Medical electrical equipment - Part 1-6: General requirements for safety -
Collateral standard: Usability
I EC 6060 1 - 1 -8 , Medical electrical equipment - Part 1-8: General requirements for safety -
Collateral standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical system s
I EC 60664- 1 : 1 9 9 2 , Insulation coordination for equipm ent within /ow-voltage systems - Part 1 :
Principles, requirem ents and tests 7)
Am e n d m ent 1 (2000)
Am e n d m ent 2 (2002)
I EC 60695- 1 1 - 1 0 , Fire hazard testing - Part 1 1 - 1 0: Test flames - 50 W horizontal and vertical
flame test m ethods
I EC 60730- 1 : 1 9 9 9 , A utom atic electrical controls for household and similar use - Part 1 :
General requirements 8)
Am e n d m ent 1 (2003)
I EC 60825- 1 : 1 9 9 3 , Safety of laser products - Part 1 : Equipment classification, requirements

and user's guide 9)
Am e n d m ent 1 ( 1 9 97)
Am e n d m ent 2 (20 0 1 )
I EC 6085 1 -3 : 1 996, Winding wires - Test m ethods - Part 3: Mechanical properties 1 0)

Am e n d m ent 1 ( 1 9 97)
Am e n d m ent 2 (2003)
I EC 6085 1 -5 : 1 996, Winding wires - Test m ethods - Part 5: Electrical properties 1 1 )

Am e n d m ent 1 ( 1 9 97)
Am e n d m ent 2 (2004)
I EC 608 5 1 -6 : 1 996, Winding wires - Test methods - Part 6: Thermal properties

Am e n d m ent 1 ( 1 9 97)
I EC 6 0 8 7 8 : 2 0 0 3 , Graphical symbols for electrical equipment in m edical practice
7) There exists a conso lidated e d ition 1 . 2 including I EC 60664- 1 : 1 992 a n d its A m e nd m e nt 1 (2000) and
A m e nd m e nt 2 (2002) .
8) There exists a conso lidated edition 3 . 1 , i ncluding I E C 60730- 1 : 1 999 a n d its A m e nd m e nt 1 (2003)
9) There exists a conso lidated e d ition 1 . 2 , including I E C 60825- 1 : 1 993 and its Ame ndment ( 1 997) and
A m e nd m e nt 2 (200 1 ) .
1 0l There exists a conso lidated edition 2 . 1 , including I E C 6085 1 -3: 1 996 a n d its A m e nd m e nt 1 ( 1 997).
1 1 ) There exists a conso lidated edition 3 . 2 , including I E C 6085 1 -5: 1 996 and its Amendment 1 (1 997) and
A m e nd m e nt 2 (2004) .
6060 1 - 1 © I EC : 2005 - 37 -
I EC 60884- 1 , Plugs and socket-outlets for household and similar purposes - Part 1 : General
requirements
I EC 6 0 9 5 0- 1 : 2 0 0 1 , Information technology equipm ent - Safety - Part 1: General requirements
I EC 6 1 0 5 8- 1 : 2000, S witches for appliances - Part 1: General requirements 1 2)

Am e n d m ent 1 (20 0 1 )
I EC 6 1 5 5 8- 1 : 1 997, Safety of power transformers, power supply units and similar - Part 1 :
General requirements and tests 1 3)
Am e n d m ent 1 ( 1 9 98)
I EC 6 1 5 5 8-2- 1 , Safety transformers, power supply units and similar - Part 2: Particular
requirements for separating transformers for general use
I EC 6 1 672- 1 , Electroacoustics - Sound level meters - Part 1 : Specifications
I EC 6 1 672-2, Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
I EC 6 1 9 6 5 , Mechanical safety of cathode ray tubes
I SO 31 ( a l l parts ) , Quantities and units
I SO 7 8 0 , Packaging - Pictorial marking for handling of goods
I SO 1 00 0 , Sf units and recommendations for the use of their m ultiples and of certain other
units
I SO 1 85 3 , Conducting and dissipative rubbers, vulcanized or thermoplastic - Measurement of

resistivity
I SO 2 8 7 8 , Rubb er, vulcanized - Antistatic and conductive products - Determination of

electrical resistance
I SO 2882 1 4) , Rubber, vulcanized - Antistatic and conductive products for hospital use -
Electrical resistance limits
I SO 37 46, Acoustics - Determination of sound power levels of noise sources using sound
pressure - Survey m ethod using an enveloping m easurement surface over a reflecting plane
I SO 3 864- 1 : 2 0 0 2 , Graphical symbols - Safety colours and safety signs - Part 1: Design
principles for safety signs in workplaces and public areas
1 2) There exists a conso lidated edition 3 . 1 , including I E C 6 1 058- 1 :2000 and its A m e nd m e nt 1 (200 1 )
1 3) There exists a conso lidated edition 1 . 1 , including I EC 6 1 558-1 : 1 997 a n d its Amendm ent 1 ( 1 998).
1 4) ISO 2882 was withdrawn o n 1 February 2005 and n o re place m e nt standard has been identified.
6060 1 - 1 © I EC : 2005 - 39 -
I SO 5349- 1 , Mechanical vibration - Measurement and evaluation of human exposure to hand

transmitted vibration - Part 1 : General requirements
I SO 7000- 0 8 : 2 0 0 4 1 5) , Graphical symbols for use on equipment - Collection of symbols
I SO 70 1 0 : 20 0 3 , Graphical symbols - Safety colours and safety signs - Safety signs used in
workplaces and public areas
I SO 96 1 4- 1 , Acoustics - Determination of sound power levels of noise sources using sound

intensity - Measurement at discrete points
I SO 1 0 993 ( a l l parts ) , Biological evaluation of medical devices
I SO 1 1 1 34 , Sterilization of health care products - Requirements for validation and routine

control - Industrial m oist heat sterilization
I SO 1 1 1 35 , Medical devices - Validation and routine control of ethylene oxide sterilization
I SO 1 1 1 37 , Sterilization of health care products - Requirements for validation and routine

control - Radiation sterilization
I SO 1 3 852, Safety of machinery - Safety distances to prevent danger zones being reached by
the upper limbs
I SO 1 4 9 7 1 : 20 0 0 , Medical devices - Application of risk m anagem ent to medical devices
I SO 1 5223, Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied
I SO 23529, Rubber - General procedures for preparing and conditioning test pieces for
physical test m ethods
3 * Te rm i n o l ogy a n d d efi n it i o n s
For t h e pu rposes o f t h i s doc u m e nt, t h e fol l owi n g t e r m s a n d defi n it i o n s a pply.
N O T E 1 Where the t e r m s "voltage" and "current" are u s e d i n this d o c u m e n t , t h e y mean the r . m .s . v a l u e s of a n

alternating, d i rect o r com posite voltage o r c u rrent u n less stated otherwise .
NOTE 2 The term "electrical equipm e nt" is used to mean M E EQU I PM E NT (see 3 . 63) or other electrical e q u i pment.
This standard also uses the term "equipme nt" to mean ME EQU I P M ENT o r other e l ectrical o r non-e lectrical e q u i pment
in the co ntext of an M E SYSTEM (see 3 . 64) .
NOTE 3 An index is fo u n d beg i n n i n g on page 749.
1 5) "DB" refers to the j o i nt I S O - I E C on-line data base.

6060 1 - 1 © I EC : 2005 - 41 -
3.1
ACCESS COVER
part of an E NCLOS URE or G UARD prov i d i n g the poss i b i l ity of access to el ectrical e q u i pm ent
pa rts for t h e p u r pose of a dj ustm e nt, i nspect i o n , replacem ent o r re pai r
3.2
ACCESSIBLE PART
part of el ectrical e q u i p m ent oth e r t h a n an APPLI E D PART that c a n be t o u c h e d by m e a n s of t h e
sta ndard test fi n g e r
NOTE See also 5 . 9 . 2 . 1 .
3.3
ACCESSORY
additi o n a l part for use with e q u i pm ent i n o rder t o :
ach i ev e t h e I NT E N D E D U S E ,
a d a pt it to some speci a l use,
- faci l itate its u s e ,
e n h a n c e i t s perfo r m a nce, o r
e n a b l e i t s fu n cti o n s to be i nteg rated w i t h t h o s e o f oth e r e q u i p m ent
[ I EC 60788 : 2 0 04 , rm-83-06 m odified]
3.4
ACCOMPANYING DOC U M E NT
d o c u m e n t acc o m panyi n g ME E Q U I PM E N T , an ME SYS T E M , e q u i p m ent o r an ACCESSORY a n d
contai n i n g i nformati o n for t h e RESPONSIBLE ORGANIZATI O N o r O P E RATO R , pa rti c u l arly regardi n g
BAS I C SAFETY a n d E S S E NTIAL P E RFORMANCE
3.5
A I R CLEARANCE
s h o rtest path i n a i r betwe e n two c o n d u ctive parts
NOTE Adapted from I E C 60664- 1 , definition 1 . 3 . 2 .
3.6
APPLIANCE COUPLER
m e a n s e n a bl i n g t h e co n n ecti o n of a flex i b l e cord to e l ectrical e q u i p m e nt wit h o ut the use of a
TOOL, consisti n g of two parts: a MAINS CONNECTOR a n d a n APPLIANCE I N LET
NOTE See Figure 1 .
6060 1 - 1 © I EC : 2005 - 43 -
c:
cb
Key
c:
l c: (i) APPLIANCE COUPLER
0 APPLIANCE INLET
® DETACHABLE POWER SUPPLY CORD
0 ME EQUIPMENT
FIXED mains socket-outlet/
® MULTIPLE SOCKET-OUTLET (MSO)
® MAINS CONNECTOR
0 MAINS PLUG
IEC 2384105
F ig u re 1 - Detachable ma i n s con n ection

(see defi n itions)
3.7
APPLIANCE INLET
part of a n APPLI ANCE COUPLER either i ntegrated in o r F I X E D to e l ectrical e q u i pm ent
NOTE See Figure 1 and F i g u re 2.
3.8
* APPL I E D PART
part of M E E Q U I P M E NT that i n NORMAL USE n e cessarily com es i nto physical co ntact with t h e
PAT I E NT f o r M E E Q U I P M ENT o r a n M E SYSTEM to perform its f u n ct i o n
NOTE 1 S e e Figure 3 , Figure 4 a n d F i g u re A . 1 t o F i g u re A . 7 (inclusive) .
NOTE 2 S e e also 4 . 6 regard i n g t h e treatment o f parts that do not fa l l wit h i n t h e defi nition o f A P P L I E D PARTS but
need to be treated as A P P L I E D PARTS as a result of a p plyi ng the R I S K MANAG E M E N T PROCESS.
NOTE 3 See also 3 . 78 for the defi nition of the associated term PAT I E N T CON N ECTI O N .
3.9
* BAS IC I NSULATION
i ns u l at i o n prov i d i n g basic protect i o n agai nst el ectri c s h o c k
[ l EV 826- 1 2- 1 4 , m o d ified]
NOTE BASIC I N S U LATION provides one M EA N S O F PROTECTION .
6060 1 - 1 © I EC : 2005 - 45 -
Key
G) APPLIANCE INLET (see also Figure 1 )

@ PATIENT CONNECTION
@ Conduit
@ DETACHABLE POWER SUPPLY CORD
® ENCLOSURE
0 ® FIXED wiring
0 FUNCTIONAL EARTH CONDUCTOR
® FUNCTIONAL EARTH TERMINAL
® SIGNAL INPUT/OUTPUT PART
@ MAINS CONDUCTOR
(iJ) MAINS PART
@ MAINS TERMINAL DEVICE
@ POWER SUPPLY CORD
@_
_ _ @ PROTECTIVE EARTH CONDUCTOR
@ PROTECTIVE EARTH TERMINAL
@
4J @
@ MAINS PLUG
@ POTENTIAL EQUALIZATION CONDUCTOR
r-iO\ Terminal for the connection of a

@
I I
\C'V POTENTIAL EQULIZATION CONDUCTOR
@
---tl
�
LJ- -1 4 - - IEC 2385105
F i g u re 2 - Exam p l e of t h e defi ned term i n als a n d co n d u ctors

(see defi n itions)
6060 1 - 1 © I EC : 2005 - 47 -
Key
G) MAINS PLUG with protective earth contact
0 DETACHABLE POWER SUPPLY CORD
0 APPLIANCE COUPLER
0 Protective earth contact and pin
® BASIC INSULATION
0 ENCLOSURE
® SECONDARY CIRCUIT
® MAINS PART
@ APPLIED PART
@ Motor
@ PROTECTIVELY EARTHED screen
®@ @ SUPPLEMENTARY INSULATION
@
4 6
Shaft that is an ACCESSIBLE PART
IEC 2386105
F ig u re 3 - Exam p l e of a CLASS I ME EQU I P M E NT

(see defi n itions)
Key
G) MAINS PLUG
0 POWER SUPPLY CORD
0 BASIC INSULATION
0 SUPPLEMENTARY INSULATION
® ENCLOSURE
0 MAINS PART
® APPLIED PART
® REINFORCED INSULATION
@ Motor
IEC 2387105
F ig u re 4 - Exam p l e of a meta l-enclosed CLASS 1 1 M E EQUIPMENT

(see defi n itions)
6060 1 - 1 © I EC : 2005 - 49 -
3. 1 0
* BAS IC SAFETY
fre e d o m from u n acceptable R I S K di rectly caused by phys i cal HAZARDS when M E E Q U I PMENT is
used u n der NORMAL CONDITION and S I NG L E F A U L T CONDI TI O N
3. 1 1
CATEGORY AP
rati n g for M E E Q U I P M ENT or an M E E Q U I P M ENT part c o m plyi n g with s pecifi e d req u i re m e nts o n
constructi o n , m a rki n g a n d doc u m e ntati o n i n order t o avo i d s o u rces o f i g n it i o n i n a FLAMMABLE
ANAESTH E T I C MIXTURE W I TH A I R
3. 1 2
CATEGORY APG
rati n g for M E E Q U I P M ENT or a n M E E Q U I P M ENT part c o m plyi n g with s pecifi e d req u i re m e nts o n
constructi o n , m a rki n g a n d doc u m e ntati o n i n order t o avo i d s o u rces o f i g n it i o n i n a FLAMMABLE
ANAESTH E T I C MIXTURE W I TH OXY G E N O R N I TROUS OXI DE
3. 1 3
CLASS I
term refe rri n g to el ectri cal e q u i p m e n t i n w h i c h protecti o n a g a i nst el ectric s h ock does n ot rely
o n BAS I C I NS U LATION only, but which i n cl udes an additi o n a l safety preca uti o n in t h at m e a n s are
prov i d e d for ACCES S I BLE PARTS of m etal o r i nternal parts of m etal to be PROTECTIVELY EART H E D
NOTE See Figure 3 .
3. 1 4
CLASS I I
t e r m refe rri n g t o e l ectrical e q u i p m e nt i n w h i c h p rotect i o n agai nst e l ectric s h o c k d o e s n ot rely
o n BAS I C I NS U LATI O N o n l y , but in which additi o n a l safety precaut i o n s such as DOUBLE
I NS ULAT I O N o r R E I NFORCED I NS U LATI O N are provi d e d , there be i n g no provi s i o n for protective
earth i n g o r rel i a n c e u po n i nstal l at i o n c o n d it i o n s
NOTE 1 See Figure 4 .
N O T E 2 CLASS I I e q u ipment can be provided w i t h a F U NCTIONAL EARTH T E R M I NAL o r a FU NCTIONAL EARTH
CON D U CTOR. See also 8.6.8 and 8 . 6 . 9 .
3. 1 5
CLEARLY LEGIBLE
capable of bei n g read by a person with normal v i s i o n
NOTE See also 7 . 1 . 2 .
3. 1 6
COLD CONDITION
con diti o n o btai n e d if e l e ctrical e q u i pm ent is d e - e n ergized for a s uffi ci ently l o n g ti m e to attai n
t h e a m bi e nt t e m perature
3. 1 7
* COMPONENT WITH HIGH-INTEGRITY C HARACTERISTICS
com p o n e nt where one o r m o re c h a racteristics e n s u re that its fu n cti o n is fa u l t-free in r e l at i o n
to t h e s afety req u i re m e n ts o f this sta n d ard d u ri n g t h e EXPECTED S E RV I C E L I F E o f t h e
M E E Q U I P M E N T i n NORMAL USE a n d reas o n a bl y fo res e e a b l e m i s u s e
6060 1 - 1 © I EC : 2005 - 51 -
3. 1 8
* CONTINUOUS OPERATION
o p e rati o n in N O R M A L U S E for a n u n l i m ited period of ti m e wit h o u t t h e s pecifi e d l i m its of
tem perature be i n g exceeded
3. 1 9
CREEPAG E DISTANCE
s h o rtest distance a l o n g the s u rface of the i n s u l ati n g m aterial betw e e n two c o n d u ctive parts
[ l EV 1 5 1 - 1 5- 5 0 , m o d ified]
3.20
* D E F I B RI L LATION-PROOF APPLIED PART
APPLI E D PART that is protected agai nst t h e effects of a d i s c h a rg e of a cardiac d efi b r i l l ator to
the PAT I E NT
3.21
* DETAC HABLE POWER S UPPLY CORD
flexi b l e cord i nt e n d e d to be c o n n ected to e l ectrical e q u i p m e nt by m ea n s of a s u itable
APPLIANCE COUPLER for m a i ns s u pply pu rposes
NOTE See Figure 1 , Figure 2 and F i g u re 3 .
3.22
* DIRECT CARDIAC APPLICATI ON
use of APPLI E D P A R T t h at can come in di rect contact with t h e PATI E NT ' s h e a rt
3.23
* DOUBLE INS ULATION
i ns u l at i o n c o m p ri s i n g both BAS I C I NS U LATI O N and S U P P L E M E NTARY I NS U LAT I O N
[ I EV 1 95-06-08]
NOTE DOU B L E I N S U LATION provides two M EA N S OF PROTECTI O N .
3.24
* DUTY CYCLE
m ax i m u m activat i o n ( o n ) ti m e fol l owed by m i n i m u m deactiv ati o n ( off) ti m e n ecess a ry for t h e
safe operati o n o f t h e M E E Q U I P M E NT
3.25
EARTH LEAKAGE CURRE NT
cu rrent flowi n g from t h e MAINS PART t h r o u g h o r across t h e i ns u l ati o n i nto t h e PROTECTIVE
EARTH CONDUCTOR
3.26
* E NCLOSURE
exterior s u rface of el ectrical e q u i pm ent or pa rts t h e reof
NOTE For the purpose of testing to this sta ndard, metal fo i l , with specified d i mensions, applied i n contact with
parts of the exte rior surface made of material with low cond uctivity o r made of insu lating material is considere d a
part of the ENCLOS U R E (see F i g u re 2, F i g u re 3 a n d Figure 4) .
3.27
* ESS ENTIAL PERFORMANCE
perfo r m a n c e n ecessary to a c h i ev e fre e d o m from u n accepta b l e R I S K
NOTE EssENTIAL P E R F O R M A N C E is most easily understood b y considering whether its a bsence o r degradation
would result i n a n u nacceptable R I S K .
6060 1 - 1 © I EC : 2005 - 53 -
3.28
EXPECTED S E RVICE LIFE
m ax i m u m period of u s efu l l ife as defi n e d by t h e MANUFACTU R E R
3.29
F -TYPE ISOLAT E D ( F LOATING ) APPLIED PART ( h e re i n F-TYPE APPLI E D PART)
APPLI E D PART i n w h i c h the PAT I E NT CONNECTIONS are i s o l at e d from oth e r parts of t h e
M E E Q U I P M E N T to s u c h a degree t h a t n o c u rrent h i g h e r t h a n th e a l l owa b l e PAT I E NT LEAKAGE
CURRENT fl ows if an u n i ntended voltage o ri g i n ati n g from an ext e r n a l s o u rce is co n n ected to
the PAT I E NT , a n d t h e re by a p p l i e d between the PAT I E NT CO N N ECT I O N a n d e a rth
NOTE F-TYPE A P P L I E D PARTS are either TYPE B F A P P L I E D PARTS o r TYPE C F A P P L I ED PARTS.
3.30
FIXED
term m e a n i n g faste n e d o r otherwise secured at a s pecifi c l ocati o n e i t h e r perm a n e ntly o r s o
t h at it c a n o n l y be detached b y m ea n s o f a TOOL
EXAMPLE 1 Permanently affixed by welding , etc.
EXAMPLE 2 Affixed by means of faste n e rs (screws, n uts, etc.) m a king removal/opening i m poss ible without using
a TOO L .
3.31
F LAM MABLE ANAESTHETIC M IXTURE W I T H AIR
m ixture of a fl a m m a b l e a n a esthetic v a p o u r with air in such a c o n ce ntrati o n t h at i g n it i o n c a n
occ u r u n de r s pecifi e d c o n diti o n s
3.32
F LAM MABLE ANAESTHETIC M IXTURE WITH OXYG EN OR NITROUS OXIDE
m ixture of a fl a m m a b l e a n aestheti c v a p o u r with oxy g e n o r with n itro us oxi d e in s u c h a
c o n c e ntrati o n t h at i g n it i o n c a n occur u n d e r s pecifi ed c o n diti o n s
3.33
* F UNCTIONAL CONNECTION
co n n e cti o n , el ectrical o r oth e rwise, i n c l u d i n g those i nt e n d e d to tra nsfer s i g n a l s , data, power
o r s u bst a n ces
NOTE Con nection to a FIXED SU PPLY M A I N S socket-outlet, whether single o r m u lti p l e , is not considered to result i n
a FU NCTIONAL C O N N ECTI O N .
3.34
F UNCTIONAL EARTH CONDUCTOR
co n d u ctor to be c o n n ected to a F U NCTIONAL EARTH T E RM I NA L
NOTE See Figure 2 .
3.35
* F UNCTIONAL EARTH TERMINAL
term i n a l , d i rectly c o n n ected to a ci rcuit or to a scree n i n g part, t h at is i nt e n d e d to be e a rt h e d
f o r fu n cti o n a l pu rposes
NOTE See Figure 2 , Figure 3 and F i g u re 4.
3.36
G UARD
part of e q u i p m e nt s pecifi c a l l y used to provi d e protect i o n by m e a n s of a physical barr i e r
6060 1 - 1 © I EC : 2005 - 55 -
NOTE Depending on its construction, a G U A R D c a n be called a cas i n g , cover, scree n , door, enclosing guard, etc .
A GUARD can act:
- a l o n e ; it i s then o n ly effective when it is i n place;
- i n conjunction with a n interlocking device with o r without g u a rd locking; i n this case, protection is e nsured
whatever the positi o n of the G U A R D .
3.37
HAND-HELD
term refe rri n g to e l ectrical e q u i p m e n t i ntended to be s u pported by t h e h a n d d u ri n g NORMAL
USE
3.38
* HARM
phys i ca l I nJ u ry or d a m a g e to t h e h e alth of people or a n i m al s , or d a m a g e to pro pe rty or t h e
e n v i r o n m ent
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2.2, m o dified]
3.39
HAZARD
pote ntial s o u rce of HARM
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 3]
3.40
* HAZARDOUS SI TUATION
ci rcu m stance in w h i c h p e o p l e , property, o r the e n v i r o n m ent are ex pos e d to one o r m o re
HAZARD(S)
[ I SO/I EC G u i de 5 1 : 1 99 9 , defi n i t i o n 3 . 6]
3.41
HIGH VOLTAGE
voltage over 1 000 V a . c. o r over 1 500 V d . c . o r over 1 500 V p e a k val u e
3.42
HYDRAULIC TEST PRESSURE
press u r e a p p l i e d to test a vessel o r part of it
NOTE See 9 . 7 . 5 .
3.43
I NSULATION CO-ORDINATION
m ut u a l correlati o n of i ns u l at i o n c h a racteri sti cs of e l ectri cal e q u i p m ent taki n g i nto acco u nt t h e
expected m i cro- e n v i ro n m e n t a n d oth e r i nfl u e n c i n g stresses
3.44
* INTENDED USE
INTENDED PURPOSE
use of a p r o d u ct, PROCESS o r service in acco rda n ce with the s pecifi cati o n s , i nstru cti o n s a n d
i nfo r m at i o n prov i d e d b y t h e MANUFACTU RER
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 5]
NOTE I NT E N D E D usE should not be confused with N O R M A L u s E . While both include the concept of use as intended
by the M A N U FACT U R E R , I N T E N D E D u s E focuses o n the medical pu rpose while N O R M A L u s E incorporates not only the
medical purpose, but m a intenance, service, transport, etc. as well.
6060 1 - 1 © I EC : 2005 - 57 -
3.45
INTERNAL E LECTRI CAL POWE R SOURCE
e l ectrical power s o u rce for ope rati n g e q u i p m ent t h at is a part of t h e e q u i p m e n t a n d w h i c h
produ ces e l e ctrical c u rrent f r o m s o m e oth e r f o r m o f e n e rgy
EXAMPLE Chemical, mechanical, solar, o r nuclear
NOTE A n I NT E R N A L ELECTRICAL POW E R S O U R C E can be inside the principal part of equi pment, attached to the
outside, o r contained i n a sepa rate ENCLOS U R E .
3.46
INTERNALLY POWERED
term refe rri n g to e l ectrical e q u i p m ent t h at is a b l e to o pe rate from a n I N TERNAL E L E CTRI CAL
POWER S O URCE
3.47
LEAKAGE C U RRENT
cu rrent t h at is n ot fu n cti o n a l
NOTE The fo llowing LEAKAGE C U R R ENTS are defi n e d : EARTH L EAKAGE C U R R ENT, TOUCH C U RRENT a n d PATIENT
LEAKAGE C U R R E N T .
3.48
MAINS CONNECTOR
part of a n APPLI ANCE COUPLER i ntegral with o r i nt e n d e d to be attac h e d to a flexi b l e cord t h at is
i ntended to be c o n n ected to t h e S U PPLY MAINS
NOTE A M A I N S C O N N ECTOR is intended to be inserted i nto the A P P L I A N C E I N LET of e l ectrical equipment (see
Figure 1 and F i g u re 2 ) .
3.49
* MAINS PART
e l ectrical circuit t h at is i ntended to be c o n n ected to t h e S U PPLY M A I N S
N O T E 1 The M A I N S P A R T i n c l u d e s a l l conductive parts t h a t a r e n o t separated f r o m the S U P P LY M A I N S b y at least one
M EA N S O F PROTECT I O N .
NOTE 2 For the pu rpose of t h i s definition, t h e PROTECT IVE EARTH C O N D U CTOR is n o t regarded a s a part o f the
M A I N S PART (see F i g u re 2 a n d F i g u re 3) .
3 . 50
* MAINS PLUG
pa rt, i nte gral with o r i nt e n d e d to be attach e d to a POWER S U PPLY CORD of el ectrical e q u i pm ent,
to be i ns e rted i nto a m a i ns socket-o utl et
NOTE 1 See Figure 1 .
NOTE 2 See also I E C 60083 and I E C 60309-1 [8] .
3.51
MAINS S UPPLY TRANSFORMER
static piece of e q u i pm ent with two o r m o re wi n d i n gs wh i c h , by el ectro - m a g n etic i n d u cti o n ,
transforms a n alternati n g voltage a n d c u rrent fro m a S U PPLY MAI NS i nto a voltage a n d cu rrent
u s u a l l y of different v a l u e s at the s a m e fre q u e n cy
3 . 52
MAINS TERMINAL DEVICE
T E R M I NA L D E V I C E by which t h e el ectrical c o n n ecti o n to t h e S U PPLY MAINS i s m a d e
NOTE S e e Figure 2 .
6060 1 - 1 © I EC : 2005 - 59 -
3 . 53
MAINS TRANS IENT VOLTAGE
h i g h est peak voltage ex pected at t h e power i n put to t h e el ectrical e q u i pm ent, arisi n g from
exte r n a l tra n s i e nts on t h e S U PPLY MAINS
3 . 54
MAINS VOLTAGE
voltage of a S U PPLY MAINS between two l i n e c o n d u ctors of a polyphase system o r voltage
betwe e n t h e l i n e co n d u ctor a n d t h e n e utral c o n d u ctor of a s i n g l e- phase system
3.55
MANUFACTURER
natu ral o r legal pers o n with res p o n s i b i l ity for t h e des i g n , m a n ufacture, packag i n g , o r l a be l l i n g
o f M E E Q U I P M E NT, asse m b l i n g a n M E SYS T E M , o r a d a pti n g M E E Q U I P M ENT o r a n M E SYS T E M ,
regardless of whether these operati o n s are performed by t h at person o r o n that person ' s
b e h a lf by a t h i rd party
NOTE 1 I S O 1 3485 [30] defi nes "labe l l i ng" as written, printed or graphic matter
- affixed to a medical device or any of its containers or wrappers, or
- accompanying a medical device,
related to identification, technical description, and use of the medical device, but excluding shipping documents. In this standard,
that material is described as markings and ACCO M PA N Y I N G DOCUM ENTS.
NOTE 2 "Adapting" incl udes making s u bstantial modifications to ME EQU I PM E NT o r a n ME SYSTEM a l ready i n use.
NOTE 3 In some j u risdictions, the RES PON S I B L E ORGAN IZAT I O N can be considered a M A N U FACTU R E R when involved
i n the activities describe d .
NOTE 4 Adapted from I S O 1 4971 :2000, defi nition 2 . 6 .
3 . 56
* MAXI M U M MAINS VOLTAG E
voltage used for test p u r poses related to t h e voltage of t h e S U P P LY MAINS a n d co n n e cted to
certai n ME E Q U I PMENT pa rts
NOTE The value for MAXI M U M M A I N S VOLTAGE is determ i ned accord i n g to 8 . 5 . 3 .
3 . 57
* MAXI M U M PERMISSIBLE WORKING PRESSURE
m ax i m u m press u re permitted on a com p o n e nt accordi n g to a decl arat i o n of t h e m a n ufactu rer
of s u c h c o m po n e n t
3 . 58
* M EANS OF OPERATOR PROTECTION
MOOP
MEANS O F PROTECTION fo r red uci n g the RISK d u e to el ectric s h o c k to pers o n s oth e r t h a n t h e
PAT I E NT
3 . 59
* M EANS OF PAT I E NT PROTECTION
MOPP
MEANS O F PROTECTION for reduci n g the R I S K due to e l ectric s h ock to the PAT I E NT
6060 1 - 1 © I EC : 2005 - 61 -
3.60
* M EANS OF PROTECTION
MOP
m e a n s for reduci n g t h e R I S K d u e to e l ectri c s h o c k i n accord a n ce with t h e re q u i re m e nts of t h i s
sta ndard
NOTE M E A N S O F PROTECT ION i nclude ins ulatio n , A I R CLEARANCES, C R E EPAGE D I STA N C E S , i m pedances, a n d
PROTECT IVE EARTH CO N N EC T I O N S .
3.61
M ECHANICAL HAZARD
HAZARD co n n ected with or produced by phys i cal force
3.62
M ECHANICAL PROTECTIVE DEVICE
device t h at e l i m i n ates o r reduces m ec h a n i c a l R I S K to a n accepta b l e l evel a n d which o perates
in the case of S I NG L E FAULT CONDI T I O N
3.63
* M E DICAL E L ECTRICAL EQUIPMENT
M E EQUIPMENT
el ectrical e q u i p m ent havi n g a n APPLI E D PART o r transferri n g e n e rgy to o r from t h e PAT I E NT o r
detecti n g s u c h e n e rgy transfer to o r from t h e PAT I E NT a n d w h i c h i s :
a) prov i d e d w i t h n ot m o re t h a n o n e co n n ecti o n t o a parti c u l a r S U P P LY MA I NS ; a n d
b) i nt e n d e d b y its MANUFACTURER to be u s e d :
1 ) i n t h e d i a g n os i s , treatm ent, o r m o nitori n g o f a PAT I E NT ; o r
2) f o r c o m p e n s ati o n o r a l l ev i at i o n o f disease, i nj u ry o r d i s a b i l ity
NOTE 1 M E EQU I P M ENT includes those ACCESS O R I E S as defi ned by the M A N UFACTU R E R that a re necessary to ena ble
the NORMAL U S E of the ME EQU I PM E NT.
NOTE 2 Not a l l electrical e q u ipment used i n medical practice fa lls wit h i n t h i s defi nition (e . g . some i n vitro
diag nostic equipment) .
NOTE 3 The i m plantable parts of active i m planta ble medical devices can fa l l within this defi nitio n , but they are
exc luded from the scope of this standard by a p propriate word i n g i n Clause 1 .
NOTE 4 This standard uses the term "electrical e q u i pm e nt" to m e a n M E EQU I P M E N T o r other e lectrical equi pment.
NOTE 5 See also 4 . 1 0 . 1 , 8 . 2 . 1 and 1 6 . 3 .
3.64
* M E DICAL E L ECTRICAL SYSTEM
M E SYSTEM
com bi n ati o n , as s pecifi e d by its MANUFACTU R E R , of items of e q u i pm ent, at l east o n e of w h i c h
is M E E Q U I P M ENT to be i nter- c o n n ected b y F U NCTIONAL CONNECTION o r b y u s e o f a M U LTI PLE
SOCKET -OUTLET
NOTE E q u i pment, when m e ntioned i n this sta ndard, should be taken to include ME EQU I P M ENT.
3.65
MOBILE
term referri n g to TRANSPORTABLE e q u i p m e nt i ntended to be m ov e d from o n e locati o n to
a n ot h e r w h i l e s u pported by its own wheels o r e q u i v a l e nt m ea n s
6060 1 - 1 © I EC : 2005 - 63 -
3.66
* MODEL OR TYPE REFERENCE
co m bi n at i o n of fi g u re s , l etters o r both used to i de n tify a pa rti c u l a r m od e l of e q u i pm ent o r
ACCESSORY
3.67
* MULTIPLE SOCKET-OUTLET
MSO
one o r m o re socket-outl ets i nt e n d e d to be c o n n ected t o , o r i ntegral wit h , fl ex i bl e c a b l es o r
cords o r M E E Q U I P M E NT f o r S U PPLY MAI NS o r e q u i v a l e n t voltage
NOTE A M U LT I P L E socKET-OUTLET can be a sepa rate item o r a n integral part of equipment .
3.68
* NETWORK/DATA COUPLING
a n y m ea n s to tra n s m it o r receive i nformati o n to o r from oth e r e q u i pm ent in accord a n c e with
t h e MANUFACTU R E R ' S spe cifi cati o n s
3.69
NOMINAL (va l u e)
v a l u e q u oted for refe rence p u rposes t h at is s u bj ect to agreed to l e ra n ces
EXAMPLE NOM I N A L MAINS VOLTAGE o r N O M I NAL d i a m eter of a screw
3.70
NORMAL CONDITION
con diti o n in which all m e a n s prov i ded for protect i o n agai nst HAZARDS are i ntact
3.71
NORMAL U S E
o p e rati o n , i n cl u d i n g ro uti n e i ns pecti o n a n d adj u stm e nts b y a n y O P E RATOR, a n d sta nd-by,
accord i n g to t h e i nstr u cti o n s for u s e
NOTE NoRMAL u s E s h o u l d n o t be confused with I NT E N D E D u s E . W h i l e both include t h e concept o f u s e a s
intended b y the M A N U FACTU R E R , I N T E N D E D u s E focuses o n the medical p u rpose w h i l e N O R M A L u s E incorporates not
only the medical purpose , but m a intena nce , s e rvice, tra nsport, etc . as well.
3.72
OBJECTIVE EVIDENCE
i nfo r m at i o n w h i c h can be prov e n true, based on facts o bt a i n e d t h r o u g h observat i o n ,
m ea s u re m ent, test o r oth e r m ea n s
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 8]
3.73
* OPERATOR
pers o n h a n d l i n g e q u i pm e n t
NOTE See also 3.1 0 1 .
3.74
OVE R-CURRE NT RELEASE
protective device t h at causes a circuit to o p e n , with or wit h o ut ti m e-del ay, wh e n the cu rrent i n
t h e device exceeds a pre dete r m i n ed val u e
[ I EV 44 1 - 1 6- 3 3 , m o d ified]
6060 1 - 1 © I EC : 2005 - 65 -
3.75
* OXYG E N R I C H ENVIRO N M E NT
e n v i r o n m ent i n w h i c h t h e c o n c e ntrati o n of oxyg e n i s :
a) g re ater t h a n 25 % for a m bi e nt pressures u p t o 1 1 0 kPa; o r
b) t h e parti a l press u re o f oxygen i s g reate r t h a n 27 , 5 k P a a t am bient pressures exceeding
1 1 0 kPa
3.76
PAT I E NT
l i v i n g be i n g ( person or a n i m a l ) u n d e rgo i n g a m e d i c a l , s u rg i c a l or d e ntal proce d u r e
3.77
* PATIENT AUXILIARY CURRENT
cu rrent fl owi n g in the PAT I E N T in NORMAL U S E betwee n any PATI E NT CONNECTION and a l l oth er
PAT I E NT CONNECTIONS and n ot i ntended to produce a p h ys i o l ogical effect
3.78
* PATIENT CONNECTION
i n d i v i d u a l point o n t h e APPLI E D PART t h r o u g h which c u rrent c a n fl ow between the PAT I E NT a n d
t h e M E E Q U I P M ENT i n NORMAL CONDITION o r S I NG L E FAULT CONDITI O N
3.79
* PATIENT ENVIRO N M E NT
a n y v ol u m e i n w h i c h i ntenti o n al or u n i ntenti o n a l co ntact c a n o c c u r between a PAT I E NT a n d
pa rts o f t h e M E EQUI P M E NT o r M E SYSTEM o r betwe e n a PAT I E NT a n d oth e r persons to u c h i n g
pa rts o f t h e M E E Q U I P M E N T o r M E SYSTEM
3.80
PAT I E NT LEAKAGE CURRE NT
cu rrent:
- fl owi n g from t h e PAT I E NT CONNECTIONS v i a t h e PAT I E NT to e a rt h ; o r
o ri g i n ati n g f r o m t h e u n i ntended a ppearance o f a v o l t a g e from a n exte r n a l s o u rce o n t h e
PAT I E NT a n d fl owi n g fro m t h e PAT I E NT v i a t h e PAT I E N T CONNECTIONS o f a n F-TYPE APPLI E D
PART to e a rth
3.81
* PEAK WORKING VOLTAG E
h i g h est peak or d . c . v a l u e of a WORKI NG VOLTAG E , i n c l u d i n g repetitive peak i m p u l s es
g e n e rated i n t h e e l ectri cal e q u i pm ent, but not i n cl u d i n g exte r n a l tra n s i e nts
[ I EC 60950- 1 : 2 0 0 1 , defi n iti o n 1 . 2 . 9 . 7 , m o d ified]
3.82
PEMS DEVELOPMENT L I F E -CYCLE
n ecess a ry activities occu rri n g d u r i n g a period of ti m e that sta rts at the concept p h a s e of a
proj e ct a n d fi n i s h es w h e n t h e PEMS VAL I DATION is com pl ete
NOTE See also 3.90.
6060 1 - 1 © I EC : 2005 - 67 -
3.83
PEMS VALI DATION
PROCESS of eval u ati n g a PEMS o r a co m po n e n t of a PEMS d u ri n g o r at t h e end of the
devel o p m ent PROCESS, to d eterm i n e w h et h e r it sati sfi es t h e req u i r e m e nts for its I NTENDED USE
NOTE See also 3.90.
3.84
PERMANENTLY INSTALLED
term m ea n i n g el ectri c a l l y c o n n ected to the S U PPLY MAINS by m e a n s of a perm a n e nt co n n e cti o n
t h at c a n o n l y be d eta c h e d b y t h e u s e o f a TOOL
3.85
PORTABLE
term referri n g to TRANSPORTABLE e q u i p m e nt i ntended to be m ov e d from o n e locati o n to
a n ot h e r w h i l e be i n g carried by o n e o r m o re persons
3.86
POTENTIAL EQUALIZATION CONDUCTOR
c o n d u ctor oth e r t h a n a PROTECTIVE EARTH CON DUCTOR o r a n e utral c o n d u ctor, p rovi d i n g a
d i rect co n n ecti o n between e l e ctrical e q u i pm ent a n d t h e pote nti a l e q u a l izati o n busbar of t h e
el ectrical i nsta l l at i o n
3.87
POWER S UPPLY CORD
flexi b l e cord, FIXED to o r ass e m b l e d with e l ectrical e q u i p m e nt for c o n n ecti o n to S U PPLY MAINS
NOTE See Figure 1 to F i g u re 4 (inclusive) .
3.88
PROCE DURE
s pecifi c way to perform an activity
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 9]
3.89
PROCESS
set of i nter-rel ated resou rces a n d activities which tra nsform i n p uts i nto outputs
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 0]
3.90
PROGRAM MABLE E L ECTRICAL M EDICAL SYSTEM
PEMS
ME EQUIPMENT o r an ME SYSTEM conta i n i n g one or m o re PROGRAMMABLE E LECTRONIC
S U BSYSTEMS (PESS)
3.91
PROGRAM MABLE E LECTRONIC SUBSYSTEM
PESS
syste m based on one o r m o re ce ntral processi n g u n its, i n c l u d i n g t h e i r s oftwa re and i nterfaces
6060 1 - 1 © I EC : 2005 - 69 -
3.92
PROPE RLY I NSTALLED
i nsta l l e d in acco r d a n ce with t h e ACCO MPANYI NG DOCU M E NTS
3.93
PROTECTIVE EARTH CONDUCTOR
co n d u ctor to be co n n e cted betwe e n the PROTECTIVE EARTH T E R M I NA L a n d a n exte r n a l
protective earth i n g syst e m
NOTE See Figure 2 .
3.94
PROTECTIVE EARTH CONNECTION
co n n ecti o n to the PROTECTIVE EARTH T E RM I NA L prov i d e d for protective p u r poses and com plyi n g
with t h e re q u i re m e nts o f t h i s sta n dard
3.95
PROTECTIVE EARTH TERMINAL
term i n a l c o n n ected to c o n d u ctive pa rts of CLASS 1 e q u i pm ent for s afety p u rpos e s . T h i s term i n a l
i s i nt e n d e d t o be co n n e cted t o a n exte r n a l protective eart h i n g system b y a PROTECTIVE EARTH
CONDUCTOR
NOTE See Figure 2 .
3.96
PROTECTIVELY EARTHED
co n n e cted to t h e PROTECTIVE EARTH T E R M I NA L fo r protective pu rposes by m ea n s com plyi n g
with t h e re q u i re m e nts o f t h i s sta n dard
3.97
RATED (va l u e)
term refe rri n g to a v a l u e ass i g n e d by t h e MANUFACTURER for a s pecified o p e rati n g c o n d iti o n
3.98
RECORD
d o c u m e n t w h i c h fu r n i s h es OBJECTIVE EVI DENCE of activities perfo r m e d o r res u lts a c h i ev e d
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 1 ]
3.99
* RE I N FORC E D INSULATION
s i n g l e i ns u l ati o n system t h at provides two M E A N S O F PROTECT I O N
3. 1 00
RESI DUAL RISK
R I S K remai n i n g after protective m eas u res h ave been taken
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 2]
3. 1 0 1
RESPONSIBLE ORGANIZATION
e n tity acco u ntable fo r t h e u s e and m a i nt e n a n c e of a n M E EQUI P M E NT o r a n M E SYSTEM
NOTE 1 The accountable entity can be, for exa m p l e , a hospita l , a n i ndividual c l i nician o r a laypers o n . In home use
appl ications, the PATI E N T , OPERATOR and RESPON S I B L E ORGA N I ZATION can be one a n d the same pers o n .
N O T E 2 E d ucation and tra i n i n g is included i n "use."
6060 1 - 1 © I EC : 2005 - 71 -
3. 1 02
RISK
com bi n ati o n of t h e probabil ity of occurrence of HARM a n d t h e S E V E R I TY of that HARM
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 3]
3. 1 03
RISK ANALYSIS
syst e m at i c u s e of ava i l a b l e i nfo r m at i o n to i d e ntify HAZARDS and to esti m ate t h e R I S K
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 4]
3. 1 04
RISK ASSESSM ENT
ove r a l l PROCESS c o m pris i n g a RISK ANALY S I S and a RISK EVALUATI O N
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 5]
3. 1 05
RISK CO NTROL
PROCESS t h r o u g h w h i c h d e c i s i o n s are reached a n d protective m ea s u res are i m pl e m e nted for
red uci n g R I S KS to, o r m a i ntai n i n g R I S KS with i n , s pe cifi ed l evels
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 6]
3. 1 06
RISK EVALUATION
j u d g e m ent, on t h e basis of R I S K ANALYSI S , of w h et h e r a RISK w h i c h is accepta b l e h as been
ach i ev e d in a g i v e n co ntext based o n t h e c u rrent v a l ues of s o c i ety
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 7]
3. 1 07
RISK MANAG E MENT
syst e m at i c a p p l i cati o n of m a n a g e m ent p o l i c i e s , PROCEDURES and practices to t h e tasks of
a n alyzi n g , eva l u ati n g and contro l l i n g R I S K
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 8]
3. 1 08
RISK MANAG E MENT FILE
set of RECORDS and other d o c u m e nts, n ot n ecess arily conti g u o u s , t h at are produced by a R I S K
MANAG E M E NT PROCESS
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 1 9]
NOTE A l l safety related i nformation including M A N U FACT U R E R ' s calculations, test results , etc. is considered to be
part of the R I S K M A N A G E M E N T F I L E . See also 4 . 2 .
3. 1 09
SAFE WORKING LOAD
m ax i m u m exte r n a l m ec h a n i cal l o a d ( m ass) on e q u i p m e n t or an e q u i pm ent part t h at is
permitted i n NORMAL U S E
3. 1 1 0
* S ECONDARY C I RCUIT
circuit which i s se parated from t h e MAINS PART by at l east one M E A N S O F PROTECT I O N and
derives its power from a transform er, converter o r e q u ival e nt i s o l at i o n dev i c e , o r from a n
I NTERNAL E L E CTRI CAL POW E R SOURCE
NOTE See also 8 . 9 . 1 . 1 2 .
6060 1 - 1 © I EC : 2005 - 73 -
3.1 1 1
SELF -RESETTING THERMAL CUT-OUT
THERMAL CUT-OUT that a ut o m at i c a l l y resto res the cu rrent after t h e relevant part of e l ectrical
e q u i pm ent has cooled
3. 1 1 2
* S EPARATION DEVICE
com p o n e nt o r a rra n g e m e nt of c o m p o n e nts with i n put parts and output parts that, for safety
reas o n s , preve nts a transfer of u nwanted voltage or cu rrent between parts of an ME SYSTEM
3. 1 1 3
S E RVICE P E RSONNEL
i n d i v i d u a l s o r e n tity accountable to t h e RESPONS I B LE ORGANI ZATI O N t h at i nsta l l , ass e m bl e ,
m a i nta i n o r repai r M E E Q U I P M E NT, M E SYSTEMS o r e q u i p m e n t
3. 1 1 4
S EVERITY
m eas u re of the poss i bl e c o n s e q u e n ces of a HAZARD
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 2 1 ]
3. 1 1 5
* SIGNAL I NPUT/OUTPUT PART
SIP/SOP
part of ME E Q U I PM E N T , not bei n g an APPLI E D PART, i nt e n d e d to d e l i v e r or receive s i g n al s to o r
f r o m oth e r el ectrical e q u i pm ent, for ex a m pl e , fo r display, reco rdi n g o r d ata p rocessi n g
3. 1 1 6
S I NGLE FAULT CONDITION
con diti o n in w h i c h a s i n g l e m ea n s for reduci n g a R I S K is d efectiv e o r a s i n g l e a b n o r m a l
con diti o n is present
NOTE See 4 . 7 and 1 3 . 2 .
3. 1 1 7
S I NGLE FAULT SAFE
c h a racteristic of M E EQUI PMENT o r its parts w h e re by it re m ai n s free of u n accept a b l e RISK
d u r i n g its EXPECTED S E RV I C E L I F E u n de r S I NG L E FAULT CONDITIONS
NOTE See 4.7.
3. 1 1 8
STATIONARY
term refe rri n g to e q u i p m e nt t h at is not i nt e n d e d to be m ov e d from o n e place to a n oth e r
3. 1 1 9
SUPPLEME NTARY I NSULATION
i n d e p e n d e nt i ns u l at i o n a p p l i e d in additi o n to BAS I C I NS U LATION in order to prov i d e protect i o n
agai nst e l ectric s h ock i n t h e e v e n t o f a fai l u re o f BAS I C I NS U LATI O N
[ l EV 826- 1 2- 1 5 , m o d ified]
NOTE S U PP L E M ENTARY I N SU LATION provides one M EA N S OF PROTECTI O N .

6060 1 - 1 © I EC : 2005 - 75 -
3. 1 20
* S UPPLY MAINS
s o u rce of el ectrical e n e rgy n ot form i n g part of M E E Q U I P M E N T o r M E SYSTEM
NOTE This a lso includes battery syste m s and converter systems i n a m bulances and the like.
3. 1 2 1
TENSILE SAFETY FACTOR
rat i o between T E N S I L E STRENGTH a n d the stress co rres p o n d i n g to the TOTAL LOAD
3. 1 22
TENSILE STRENGTH
m ax i m u m tensi l e stress a test piece wi l l withsta n d befo re r u ptu r i n g
3. 1 23
TERMI NAL DEVICE
part of el ectrical e q u i p m e nt by wh i c h el ectrical co n n ecti o n is m ad e
NOTE A TERM I NA L D EV I C E can contain several i ndividual contacts.
3. 1 24
THERMAL CUT -OUT
device that, d u r i n g a n a b n o r m a l c o n d iti o n , l i m its the tem perature of el ectrical e q u i p m e n t o r of
part of it, by a u t o m at i c a l l y o pe n i n g the ci rcuit o r by reduci n g the cu rrent, a n d t h at is so
constructed t h at its setti n g c a n n ot be altered ex c e pt by q u a l ified S E RV I C E P E RS O N N E L
3. 1 25
THERMAL STAB ILITY
con diti o n u n de r which t h e te m perature of a n o bj e ct does not i n crease by m o re than 2 oc ov e r
a period of 1 h
3. 1 26
THERMOSTAT
tem perature s e n s i n g control t h at is i nt e n d e d to keep a tem perature wit h i n a s pe cifi c range o r
a bove/below a preset v a l u e
3. 1 27
TOOL
extra-corporeal o bj ect t h at can be used to s e c u r e o r rel ease fast e n e rs o r to m a ke adj ustm e nts
NOTE Coins and keys are considered TOOLS with i n the co ntext of this sta ndard.
3. 1 28
TOTAL LOAD
m ax i m u m total l o a d i n g of a part i n c l u d i n g t h e m ax i m u m SAFE WORKI NG LOA D , where a pp l i c a b l e ,
a n d t h e stat i c a n d dy n a m i c fo rces occurr i n g i n NORMAL USE
NOTE 1 Examples of dynamic forces include forces caused by acceleration o r d eceleration of masses.
NOTE 2 Where a load is divided over several parallel s u pporting parts and the distribution over these parts is not
dete rmined uneq uivocally, the least favo urable possibility is to be considered.
6060 1 - 1 © I EC : 2005 - 77 -
3. 1 29
TOUCH CURRE NT
LEAKAGE C U R R E N T fl owi n gfrom t h e E NCLOS URE o r from parts t h e reof, excl u d i n g PAT I E NT
CONNECTI O N S , access i b l e to
a n y O P E RATOR o r PAT I E NT i n NORMAL U S E , t h r o u g h an exte r n a l path
oth e r t h a n the PROTECTIVE EARTH CONDUCTO R , to e a rth o r to a n oth e r part of the E NCLOS URE
NOTE The meaning of this term i s the same as that of "enclosure leakage c u rrent" i n the first and second
editions of this sta ndard. The term has been changed to a l i g n with I E C 60950-1 a n d to reflect the fact that the
measure m e nt now applies also to parts that are norm a l ly PROTECTIVELY EARTH E D .
3. 1 30
TRANSPORTABLE
term refe rri n g to e q u i pm ent t h at is i ntended to be m oved fro m o n e place to a n oth e r whet h e r or
not c o n n ected to a s u pply a n d without a n a ppreci a b l e restri cti o n of range
EXAMPLE MOBI L E e q u i pm e nt and PORTABLE equi pment.
3. 1 3 1
TRAPPING ZONE
access i b l e l ocati o n o n o r with i n the M E E Q U I PMENT, M E SYSTEM o r in the e q u i p m e n t
e n v i r o n m ent where a h u m a n body o r a part o f t h e h u m a n b o d y i s exposed to a trapp i n g ,
crus h i n g , s h e a r i n g , i m pact, c utti n g , e nta n g l e m ent, drawi n g i n , sta bbi n g o r abras i o n HAZARD
3. 1 32
* TYPE 8 APPL I E D PART
APPLI E D PART com ply i n g with t h e s pecifi e d req u i re m e nts of t h i s sta n d a rd to prov i d e protect i o n
agai nst e l ectri c s h ock, parti c u l arly regard i n g a l l owa b l e PAT I E NT LEAKAG E CURRENT a n d PAT I E NT
AUXILI ARY CURRENT
NOTE 1 A TYPE B APPLIED PART is m a rked with sym bol IEC 6041 7-5840 (D8:2002-1 0) (see Table D . 1 , sym bo l 1 9)
or, when applicable, with sym boi i E C 6041 7-5841 (DB:2002-1 0) (see Ta ble D . 1 , sym bol 25). See also 3 . 2 0 .
N O T E 2 T Y P E B A P P L I E D PARTS are n o t s u itable f o r D I R ECT C A R D I A C APPLICAT I O N .
NOTE 3 See a l s o 4.6 regard i n g t h e treatment o f parts that do n o t fa l l wit h i n t h e defi nition o f A P P L I E D PARTS but
need to be considered as A P P L I E D PARTS as a result of applying the R I S K MANAG E M ENT PROCESS.
3. 1 33
* TYPE BF APPL I E D PART
F-TYPE APPLI E D PART c o m plyi n g with t h e s pecifi e d req u i r e m e nts of this sta n d ard to prov i d e a
h i g h e r degree of p rotect i o n a g a i nst el ectric s h o c k t h a n t h at prov i d e d by TY P E B APPLI E D PARTS
NOTE 1 A TYPE B F A P P L I E D PART is m a rked with sym boi i E C 604 1 7-5333 (D8 : 2 002-1 0) (see Table D . 1 , sym bol 20)
or, when applicable, with sym bol 6041 7-5334 (DB : 2002 - 1 0) (see Table D . 1 , sym bo l 26) . See also 3 . 2 0 .
N O T E 2 T Y P E B F A P P L I E D PARTS are n o t s u itable for D I R ECT C A R D I A C A P P L I CATI O N .
NOTE 3 See also 4.6 regard i n g the treatment of parts that do not fa l l wit h i n the defi nition of A P P L I E D PARTS but
3. 1 34
* TYPE CF APPL I E D PART
F-TYPE APPLI E D PART c o m plyi n g with t h e s pecifi e d req u i r e m e nts of this sta n d ard to prov i d e a
h i g h e r degree of p rotect i o n a g a i nst el ectric s h o c k t h a n t h at prov i d e d by TY P E BF APPLI E D PARTS
NOTE 1 A TYPE C F A P P L I E D PART is m a rked with sym boi i EC 6041 7-5335 (D8:2002 - 1 0) (see Table D . 1 , sym bol 2 1 )
or, when applicable, with sym bol 6041 7-5336 (DB : 2002 - 1 0 ) (see Table D . 1 , sym bo l 27). See also 3 . 2 0 .
6060 1 - 1 © I EC : 2005 - 79 -
NOTE 2 See also 4.6 regard i n g the treatment of parts that do not fa l l wit h i n the defi nition of A P P L I E D PARTS but
3. 1 35
TYPE TEST
test on a re prese ntative s a m p l e of the e q u i p m ent with t h e o bj ective of determ i n i n g if the
e q u i p m e nt, as d e s i g n e d and m a n ufact u re d , c a n m e et t h e r e q u i re m e nts of this sta n d a rd
3. 1 36
USABILITY
c h a racteristic t h at esta b l i s hes effectiveness, effici e n cy a n d O P E RATO R l e a r n a b i l ity a n d
satisfact i o n
[ I EC 6060 1 - 1 - 6 : 2 0 0 4 , defi n i t i o n 2 . 2 1 1 ]
3. 1 37
USABILITY E N G I N E E RING
a p pl i cati o n of kn owl edge a b o ut h u m a n b e h avi o u r, a b i l i t i e s , l i m itati o n s , and oth e r
c h a racte risti cs t o t h e d e s i g n o f tools, m ac h i n es , e q u i pm ent, devices, syste m s , tasks, j o b s ,
a n d envi ro n m e nts to ach i eve a d e q u ate USAB I L I TY
[ I EC 6060 1 - 1 - 6 : 2 0 0 4 , defi n i t i o n 2 . 2 1 2]
3. 1 38
VERI F I CATION
confi r m at i o n by exa m i n at i o n and prov i s i o n of OBJECTIVE EVIDENCE t h at s pecifi ed req u i re m e nts
have been fulfi l l e d
NOTE I n design a n d development , V E R I FICATION co ncerns the PROC ESS o f exa m i n i n g the result o f a given activity
to determine conform ity with the stated requirements for that activity.
[ I SO 1 4 9 7 1 : 20 0 0 , d efi n i t i o n 2 . 22]
3. 1 39
* WORKING VOLTAGE
h i g h est voltage to w h i c h the i ns u l at i o n or t h e com ponent u n der c o n s i d e rati o n i s , o r can be,
s u bj ecte d w h e n t h e e l e ctrical e q u i pm ent is o p e rati n g u n de r c o n d i t i o n s of NORMAL U S E
[ I EC 60950- 1 : 2 0 0 1 , defi n iti o n 1 . 2 . 9 . 6]
4 G e n e ra l req u i reme nts
4. 1 * Cond itions fo r a p p l i cation to ME EQU I P M E NT or ME SYSTEMS

U n l ess oth e rwise s pecifi e d , the re q u i re m e nts of this sta n dard s h a l l apply in NORMAL U S E a n d
reas o n ably forese e a b l e m i s u s e .
When a p plyi n g t h i s sta n dard to M E E Q U I P M E NT o r M E SYSTEMS i nt e n d e d f o r t h e c o m pensat i o n o r

a l l ev i at i o n o f disease, i nj u ry o r d i s a b i l ity, t h e defi n it i o n s a n d req u i re m e nts t h at u s e t h e term
PAT I E NT s h a l l be c o n s i d ered as a p plyi n g to the pers o n for wh o m t h e M E E Q U I P M E NT o r M E
S Y S T E M is i nt e n d e d .
4.2 * R I S K MANAG E MENT PROCESS for M E EQU I P M E NT o r M E SYSTE MS

A R I S K MANAG E M E NT P R O C E S S com plyi n g with I SO 1 49 7 1 s h a l l be p e rfo r m e d .
I n a p plyi n g I SO 1 497 1 :
T h e term " m ed i c a l dev i c e " s h a l l ass u m e t h e s a m e m e a n i n g as M E E Q U I P M E NT o r
M E SYS T E M .
6060 1 - 1 © I EC : 2005 - 81 -
T h e term "fault c o n diti o n s " refe rred to i n I SO 1 49 7 1 s h a l l i n c l u d e , but s h a l l n ot be l i m ited

to, S I NG L E F A U L T C O N D I T I O N S i d e ntifi e d in t h i s sta n d a r d .
T h e pol i cy f o r determ i n i n g accepta b l e R I S K a n d t h e accept a b i l ity o f t h e RESI DUAL R I S K ( s )
s h a l l be esta b l i s h e d by t h e MANUFACTURER.
Where this sta n dard o r a n y of its col l ateral o r parti c u l a r sta n d a rds s pecify ve rifi a b l e
req u i re m e nts address i n g parti c u l a r R I S KS , a n d t h e s e req u i r e m e nts a re c o m p l i e d with, t h e
RESI DUAL R I S KS add ressed b y these req u i re m e nts s h a l l be pre s u m e d to be accepta b l e
u n less t h e re i s OBJECTIVE EVI DENCE to t h e co ntrary.
NOTE 1 This standard specifies re quirements that are generally applicable to R I SKS associated with ME EQU I P M ENT
o r ME SYST E M S , and is i ntended to se rve as a tool during the R I S K MANAGEMENT PROCESS. The R I S K MANAG E M EN T
PROCESS should ide ntify n o t o n ly t h o s e HAZARDS addressed b y this sta ndard, b u t a l l HAZARDS, their associated
R I S KS and RISK CONTROL measure s .
N O T E 2 Conditions o r faults t h a t can give r i s e to HAZARDS a r e identified i n the c l a u s e s of this sta ndard. I n these
cases, it will often be necessary to carry o ut a RISK M A NAG E M E N T PROC ESS to d eterm ine what the actual HAZARDS
are and the tests that need to be done to show that the identified HAZARDS do not arise i n the specified
c i rc u m stances.
NOTE 3 I t is recognized that the M A N U FACTU R E R m ight not be a ble to fo llow all the PROCESSES identified i n this
standard for each constituent com ponent of the ME EQU I P M ENT o r ME SYST E M , such as proprietary c o m ponents,
s u bsystems of non-medical orig i n , and legacy devices. In this case, the M A N U FACTU R E R should take special
account of the need for additio nal RISK CONTROL measure s .
N O T E 4 Where requirements of this standard refer to freedom from u n a cceptable R I S K , acceptability o r
unacceptabil ity of this R I S K is determ ined b y the M A N U FACT U R E R i n accordance w i t h the M A N UFACT U R E R ' s pol icy for
determining acceptable R I S K .
N O T E 5 N o t a l l the R I S KS associated w i t h M E EQU I P M ENT and M E SYST E M S a r e s u bject to specific req u i re m e nts o f
this standard (see 1 . 1 ) .
Compliance is checked b y inspection of the RISK MANAGEMENT FILE. The requirements of this
clause and all requirem ents of this standard referring to inspection of the RISK MANAGEMENT
FILE are considered to be satisfied if the MANUFA CTURER has:
established a RISK MANA GEMENT PROCESS;
established acceptable levels of RISK; and
demonstrated that the RESIDUAL RISK(s) is acceptable (in accordance with the policy for
determining acceptable RISK) .
4.3 * ESSENTIAL P E RFORMANCE

The MANUFACTU R E R s h a l l i d e ntify w h i c h fu n cti o n s of the M E E Q U I PMENT a n d M E SYSTEMS are
ESSENTIAL PE RFORMAN C E . W h e re t h i s sta n d a rd s pecifies t h at ESS E NTIAL PE RFORMANCE is to be
m a i nt a i n e d fo l l owi n g a parti c u l a r test, these f u n ct i o n s s h a l l be u s e d and c o m p l i a n c e s h a l l be
c h e c ke d by i ns pecti o n , a n d if n ecess a ry, by f u n ct i o n a l test.
NOTE Where req u irements of this standard refer to ESSENTIAL P E R FOR MANC E , that ESSENTIAL PERFORMANCE is
dete r m i ned by the M A N UFACT U R E R i n accordance with the M A N U FACT U R E R ' s pol icy for RISK acceptability.
Compliance is checked by inspection of the RISK MANA GEMENT FILE.
4.4 * EXPECTED S E RVICE LIFE

T h e MANUFACTU RER s h a l l state t h e EXPECTED S E RVICE L I F E of t h e M E E Q U I P M ENT o r M E SYSTEM
in the RISK MANAG E M E NT F I L E .
Compliance i s checked b y inspection of the RISK MANA GEMENT FILE.

6060 1 - 1 © I EC : 2005 - 83 -
4.5 * Eq u ivalent safety fo r M E EQUIPMENT o r M E SYSTEMS

Where this sta ndard s pe cifies req u i re m e nts a d d ress i n g pa rti c u l a r R I S KS , alternative m ea n s of
a d d ress i n g t h ese R I S KS are accepta b l e prov i d e d t h at the MANUFACTURER can j u stify t h at the
RESI DUAL R I S KS t h at res u lt from a p plyi n g t h e alternative m ea n s are e q u a l to o r less than t h e
RESI DUAL R I S KS t h a t r e s u l t from a pplyi n g t h e req u i r e m e nts o f t h i s standard.
4.6 * M E EQU I P M E NT o r M E SYSTEM parts t h at con tact t h e PATI E N T

T h e R I S K MANAG E M ENT PROCESS s h a l l i n c l u d e a n assess m e nt o f w h et h e r pa rts that c a n co m e
i nto co ntact with t h e PAT I E NT but fa l l outside of t h e defi n it i o n of A P P L I E D PARTS s h a l l b e s u bject
to t h e re q u i re m e nts for APPLI E D PARTS. If t h e R I S K MANAG E M E NT P ROCESS dete r m i nes that s u c h
pa rts a r e s u bj e ct to t h e req u i re m e nts f o r APPLI E D PARTS, t h e n a l l t h e relevant re q u i re m e nts
a n d tests of t h i s sta n d ard s h a l l a pply, except t h at 7 . 2 . 1 0 does n ot a p p l y to s u c h parts .
4. 7 * SINGLE FAULT CONDITION fo r ME EQU I P M E NT
M E E Q U I PMENT s h a l l be so desi g n e d a n d m a n ufactu red t h at it re m a i ns S I N G L E FAULT SA F E , o r

t h e R I S K re m ai ns acceptable as dete r m i n e d t h r o u g h a p p l i cati o n of 4 . 2 .
NOTE 1 The N O R M A L C O N D I T I O N S ide ntified i n 8 . 1 a ) are take n i nto consideration d u ring eva l uation o f compli ance
with any req u i re m e nt of this standard that they m ight affect.
ME E Q U I PMENT i s c o n s i d ered S I NG LE FAULT SAFE if:
a) it e m pl oys a s i n g l e m e a n s for red u c i n g a R I S K that h as a n eg l i g i bl e probabil ity of fai l u re

( e . g . R E I NFORCED I NS U LAT I O N , s us pe n d e d m asses with out M E CHANICA L PROTECTIVE DEVICES
e m pl oyi n g a TENSILE SAFETY FACTOR of 8X, COMPO N E N T W I TH H I G H- I NTEG RITY
CHARACTE RISTICS ) , o r
b) a S I NG L E FAULT CONDI T I O N occ u rs , b u t :

t h e i n itial fa u l t wi l l be detected d u ri n g t h e EXPECTED S E RV I C E L I F E of t h e M E E Q U I P M E NT
a n d befo re a s e c o n d m ea n s for red u ci n g a R I S K fails ( e . g . s u s p e n d e d m asses with
MECHANICAL PROTECTIVE DEVI C E S ) ; or
the probabil ity t h at the s e c o n d m e a n s of r e d u ci n g the RISK wi l l fail d u r i n g the EXPECTED

S E RV I C E LIFE of the M E E Q U I PMENT i s n e g l i g i b l e .
Where a S I NG L E FAULT CONDITION causes a n oth e r S I NGLE FAULT CONDI T I O N , t h e two fai l u res are
c o n s i d ered as one S I NG L E FAULT CONDI T I O N .
D u r i n g a n y test u n de r S I NG L E FAULT CONDI T I O N , only one fa u l t at a ti m e shall be appl i e d .

NOTE 2 Faults are ge nera l ly d ivided into 3 probabil ity cate gories:
a) so remote that they can be ignored. The R I S KS arising from these faults are c o nsidered accepta ble;
b) pro bable enough that they need to be considered, but i m probable enough that they need only be considered
one at a time (single fault) . Faults of this category include all those identified as S I N G L E FAU LT CONDITIONS i n
this sta ndard, and a ny o t h e r faults ide ntified i n applying I S O 1 49 7 1 t h a t m e e t the S I N G L E FA U LT C O N D I T I O N
crite ria;
c) so l i kely, so u n predictable o r undetectable that they a re considered to be a N O R M A L CONDITION and need to be
considered i ndivid u a l ly a n d col lectively.
6060 1 - 1 © I EC : 2005 - 85 -
T h e resu lts of t h e R I S K ANALYS I S s h a l l be used to d eterm i n e w h i c h fa i l u res s h a l l be teste d . T h e

fai l u re o f a n y o n e c o m po n e n t at a ti m e t h at c o u l d res u l t i n a HAZARDOUS S I TUATI O N , i n c l u d i n g
those m e nti o n ed i n 1 3 . 1 , s h a l l be s i m u lated, phys i c a l l y o r t h e o reti cally. T h e eva l u at i o n of
w h et h e r a c o m po n ent is s u bj e ct to fa i l u re s i m u l ati o n s h a l l take i nto acco u n t t h e R I S K
ass ociated with t h e fai l u re of t h e c o m p o n e nt d u r i n g t h e EXPECT E D S E RV I C E L I F E of t h e
M E E Q U I PMENT. T h i s eval u ati o n s h a l l be acco m pl i s h e d b y a pplyi n g t h e pri n c i ples o f R I S K
MANAG E M E N T . T h e eva l u at i o n s h a l l t a k e i nto acco u nt i s s u es s u c h as r e l i a b i l ity, T E N S I L E SAFETY
FACTORS a n d rati n g of co m po n e nts. Additi o n a l l y , d u ri n g t h e s i m u l at i o n of S I NGLE FAULT
CONDI T I O N S , c o m po n ent fa i l u res that are h i g h ly probable or u n detecta b l e s h a l l be s i m u l ated.
N O T E 3 See a l s o Note 2 i n 4 . 2 .
T h i s req u i re m e nt a n d r e l ev a nt tests shall n ot be applied to fai l u res of DOUBLE o r R E I N F O RCED

I NS ULAT I O N o r COMPONENTS WITH H I G H- I NTEG R I TY CHARACT E R I ST I CS .
Compliance is determined by applying the specific requirem ents and tests associated with the
SINGLE FA ULT CONDITIONS identified in 1 3 . 2, and tests for the failures identified from evaluation
of the results of the RISK ANALYSIS. Compliance is confirm ed if the introduction of any of the
SINGLE FA ULT CONDITIONS describ ed in 1 3. 2, one at a time, does not lead directly to the
HAZARDOUS SITUATIONS describ ed in 1 3. 1, or any other outcome that results in an
unacceptable RISK.
4.8 Com po n e nts of ME EQUIPMENT

A l l c o m p o n e nts , i n c l u d i n g wi r i n g , the fai l u re of which c o u l d result in a HAZARDOUS S I TUAT I O N
s h a l l be used in accord a n ce with their s pecifi ed rat i n g s u n l ess a s pecifi c excepti o n is m ade i n
t h i s sta ndard o r t h r o u g h t h e R I S K MANAG E M E NT PROCE S S . T h e re l i a bi l ity of co m po n e nts that are
used as M E A N S O F PROTECT I O N shall be assessed for t h e c o n d i ti o ns of use i n the
M E E Q U I PMENT. T h ey shall c o m ply with one of t h e fol l owi n g (see a l s o 4 . 5 ) :
a) t h e a p p l i c a b l e s afety req u i re m e nts of a rel evant I E C or I SO sta n da r d ;

NOTE 1 F o r t h e compo n ents, i t is n o t necessary t o carry o ut identical o r eq uivalent tests a l ready performed to
check com pliance with the component sta ndard.
b) where there i s no r e l ev a nt I E C o r I SO sta n d a rd , the re q u i re m e nts of this sta n dard have to

be a p p l i e d .
NOTE 2 If there are neither req u irements i n this standard n o r i n a n I E C o r I S O sta ndard, a n y other appl icable
source (e . g . standards for other types of devices, natio nal sta ndards) could be used to demo nstrate compliance
with the RISK M A N A G E M E N T PROCESS.
See F i g u re 5 for a s c h e m at i c flow c h a rt for a) a n d b ) .
Compliance is checked b y inspection and, where necessary, b y test. The tests of this
standard for motors (see 1 3. 2. 8 and 1 3. 2. 1 3. 3) and transformers (see 1 5. 5. 3) are considered
to be comprehensive and together with the evaluation of the m otor or transform er insulation
system according to Table 22 represent all testing required by this standard. ME S YS TEM
components that provide isolation from non-ME E Q UIPMENT are e valuated to Clause 1 6.
4.9 * U s e of COMPONENTS WITH HIGH-INTE G RITY CHARACTERISTICS i n ME EQU I P M E NT

A COMPONENT WITH H I G H- I NTEG R I TY CHARACTERISTICS s h a l l be u s e d w h e n a fa u l t i n a parti c u l a r
com p o n e nt c a n g e n e rate a n u n accepta b l e R I S K . COMPONE NTS WITH H I G H- I NTEG RITY
CHARACTE R I S TI CS s h a l l be s e l ected a n d eval u ated consistent with th e i r c o n d iti o n s of use a n d
reas o n ably forese e a b l e m is use d u ri n g t h e EXPECTED S E RV I C E L I F E o f t h e M E E Q U I P M E NT .
6060 1 - 1 © I EC : 2005 - 87 -
Compliance is checked by inspection of the RISK MANAGEMENT FILE and the selection criteria
for the COMPONENTS WI TH HIGH-INTEGRITY CHARA CTERISTICS.
Component
Relevant
I EC or ISO component standards?
Additional safety requirement of the

relevant component standard to be tested
Satisfactory
IEC 2388105
Fig u re 5 - Schematic flow chart for component q ualification

(see 4 . 8)
4. 1 0 * Power s u pply
4. 1 0.1 Sou rce of power fo r M E EQU I P M E NT

M E E Q U I PMENT s h a l l be s u itable for co n n ecti o n to a S U PPLY MA I N S , be s pecifi ed for co n n ecti o n
to a se pa rate power s u pply o r be powe red b y a n I NTE RNAL E LECTRICAL POWER SOURCE .
Alte r n atively, a com bi nation of these s o u rces m ay be u s e d .
Compliance i s checked b y inspection of the A CCOMPANYING DO CUMENTS.

6060 1 - 1 © I EC : 2005 - 89 -
4. 1 0 . 2 S U P P L Y MAINS f o r M E EQU I PM E NT a n d M E SYSTEMS

For M E E Q U I P M E NT i nt e n d e d to be c o n n ected to S U PPLY MA I NS , the fol l owi n g RATED voltages
s h a l l n ot be exceeded:
2 5 0 V for HAND- H E L D M E E Q U I PMENT;
2 5 0 V d . c . o r s i n g l e- p hase a . c . o r 500 V polyphase a . c . for M E E Q U I P M ENT and M E SYSTEMS
with a RATED i n put :s; 4 kVA; or
500 V for a l l oth e r M E E Q U I PMENT a n d M E SYS T E M S .
S U P PLY MAINS in t h i s sta n dard s h a l l be ass u m ed to h av e t h e fol l ow i n g c h a ra cteristi cs :

overvoltage category I I for m a i n s tra n s i e nts u n l ess a h i g h e r category is s pecifi e d by t h e
MANUFACTURER;
n o voltage in excess of 1 1 0 % o r l owe r than 90 % of the N O M I NA L voltage betwee n any of

t h e c o n d u ctors of the system o r between a n y of these c o n d u ctors and earth (see 7 . 9 . 3 . 1 ) ;
NOTE 1 I EC 6060 1 - 1 -2 conta ins req u i re m e nts and tests for voltage d i ps , short i nterruptions a n d voltage
va riations o n the S U P P LY M A I N S . See also 1 . 3 .
- v o ltages that are pract i c a l l y s i n us o i dal a n d form i n g a practi c a l l y sym m etri cal s u pply
syste m in case of polyph ase s u pply;
a fre q u e n cy of :s; 1 kHz;
a fre q u e n cy devi ati o n of :s; 1 Hz from t h e NOMI NAL fre q u e n cy u p to 1 00 Hz and :s; 1 % from
t h e N O M I NA L fre q u e n cy fro m 1 00 Hz to 1 kHz;
- t h e protective m e asu res as d escri bed i n I EC 6 0364-4-4 1 ;
NOTE 2 I f M E EQU I P M ENT o r a n M E SYSTEM is intended to be o perated from a S U P P LY M A I N S with
characteristics different from the S U P P LY M A I N S described in this subclause, additional safety measures could
be necessary.
a d . c . voltage ( as m e as u red by a m ov i n g c o i l m eter o r e q u i v a l e nt m et h o d ) havi n g a peak

to- peak r i p p l e n ot exce edi n g 1 0 % of t h e av erage v a l u e .
Where pea k-to- peak r i p p l e exceeds 1 0 % o f t h e average v a l u e , t h e p e a k voltage h a s t o be

a p pl i e d .
4. 1 1 Power i n p u t
T h e steady-state m easured i n put o f t h e M E E Q U I PMENT o r M E SYSTEM a t RATED v o l t a g e a n d at
o p e rati n g setti n gs i n d i cated i n t h e i nstru cti o n s for u s e s h a l l n ot exceed t h e m a rked rati n g by
m o re t h a n 1 0 % (see 7 . 2 . 7 ) .
Compliance is checked b y inspection and b y the follo wing tests.

The ME EQUIPMENT or ME S YS TEM is operated as specified in the instructions for use until
the input has reached a stable value. Input is measured and compared with m arkings and
the contents of the technical description.
ME E Q UIPMENT or an ME S YS TEM m arked with one or m ore RA TED voltage ranges is tested
at both upper and lower limits of the range, unless each marking of RA TED input is related
to the mean value of the relevant voltage range, in which case the test is perform ed at a
voltage equal to the m ean value of that range.
The steady state current is m easured with a true r. m . s. reading instrument.
6060 1 - 1 © I EC : 2005 - 91 -
Power input, if expressed in volt-amperes, is either m easured with a volt-ampere meter or

determined as the product of the steady state current (m easured as described abo ve) and
the supply voltage.
A s u pp l i e r certifi cati o n m ay be used in place of t h e a bove m eas u r e m e nt as t h e basis fo r

steady state c u rrent or power i n put s pecifi cati o n .
5 * G e n e ra l req u i reme nts fo r test i n g M E EQU I PMENT
5. 1 * TYPE TESTS
The tests described in this sta n dard are TYPE TESTS . The tests to be perfo r m e d a re
dete r m i n e d taki n g i nto c o n s i d e rati o n t h e re q u i re m e nts of C l a u s e 4 , i n parti c u l a r 4 . 2 .
A test n e e d n ot be perfo r m e d if a n alysis s h ows t h at t h e c o n d iti o n be i n g tested h a s been

a d e q u ately eva l u ated by oth e r tests o r m eth ods.
T h e res u lts of t h e R I S K ANALYS I S are used to determ i n e which c o m bi n ati o n (s) of s i m u lta n e o u s
fau lts are to be tested.
NOTE T h e test results m ight necessitate a revision of the R I S K ANALYS I S .
5.2 * N umber of samples

T Y P E TESTS are perfo r m e d o n a re prese ntative s a m pl e of t h e ite m be i n g tested .
NOTE M u ltiple sam ples can be util ized s i m u ltaneously if the va l i d ity of the results is not significantly affected.
5.3 Am b i e n t tem peratu re, h um i d ity, atmos p h eric p ress u re
a) Afte r t h e ME E Q U I P M E NT to be tested h as been s et u p for NO RMAL U S E (accord i n g to 5 . 7 ) ,

tests a re perfo r m e d with i n t h e r a n g e o f envi ro n m e ntal c o n d iti o ns i n d i cated i n t h e tech n i c a l
desc ri pti o n (see 7 . 9 . 3 . 1 ) .
b) M E E Q U I PMENT is s h i el d e d from oth e r i nfl u e n ces (for exa m pl e , d r a u ghts ) , that m i g h t affect
t h e v a l i dity of t h e tests.
c) I n cases where a m b i e nt tem pe ratu res c a n n ot be m a i ntai n e d , the test c o n d iti o n s are to be
conse q u e ntly m od ifi ed a n d resu lts adj usted acco rdi n gly.
5.4 Other con d itions
a) U n l ess oth e rwise s pecifi ed in t h i s sta n d a rd , M E E Q U I P M E N T is to be tested u n de r t h e l east

fav o u ra b l e worki n g c o n diti o n s as s pecifi ed i n the i nstr u cti o n s for use t h at a re i d e ntifi ed
d u r i n g R I S K ANALYS I S .
b ) M E E Q U I PMENT havi n g o p e rati n g val ues t h at c a n b e adj usted o r contro l l e d b y a n y o n e oth e r

t h a n S E RV I C E P E RS O N N E L s h a l l b e a dj usted a s part o f t h e tests t o val u es l east fav o u ra b l e for
the r e l ev a nt test, but in accorda n ce with the i nstru cti o n s for u s e .
c) I f t h e test resu lts are i nfl u e nced b y t h e i n l et press u re a n d f l o w o r c h e m ical c o m pos iti o n o f a
coo l i n g l i q u i d , t h e test is perfo r m e d wit h i n t h e l i m its for these c h a racteri st i cs as prescri bed
in t h e tec h n i cal descr i pti o n .
d) Where cool i n g water is req u i re d , pota b l e water is u s e d .

6060 1 - 1 © I EC : 2005 - 93 -
5.5 S u pply voltages, type o f cu rrent, n atu re o f s u pply, freq u e n cy
a) Where test resu lts are i nfl u e nced by dev i at i o n s of t h e s u pply v oltage from its RATED v a l u e ,
t h e effect o f s u c h devi ati o n s i s take n i nto account.
T h e s u p ply voltage during tests i s accordi n g to 4 . 1 0 o r accord i n g to t h at m a rked o n t h e

M E E Q U I P M E N T (see 7 . 2 . 6 ) , w h i c h ever i s l east fav o u ra b l e .
b) M E E Q U I PMENT h av i n g a M A I N S PART i nt e n d e d fo r c o n n ecti o n t o a . c. S U PPLY M A I N S is o n l y

tested with a . c . a t RATED fre q u e n cy ( if m a rked) ± 1 Hz u p to a n d i n c l u d i n g 1 0 0 Hz a n d
± 1 % a bove 1 00 H z . M E E Q U I P M E NT m a rked with a RATED freq u e n cy range i s tested a t t h e
l east favo u ra b l e freq u e n cy wit h i n t h at r a n g e .
c) M E E Q U I PMENT des i g n e d f o r m o re t h a n o n e RATED voltage, o r f o r both a . c . a n d d . c . , is

tested in c o n d iti o n s ( descri bed in 5.4) related to t h e l east fav o u ra b l e voltage and n at u r e of
s u pply, for ex a m pl e , n u m be r of phases (except for s i n g l e - p h ase s u pply) and ty pe of
cu rrent. I t could be n ecess a ry to perfo rm some tests m o re th a n o n ce i n o rd e r to esta b l i s h
w h i c h s u pply confi g u rati o n i s l e ast favo u r a b l e .
d) M E E Q U I PMENT havi n g a MAINS PART i ntended f o r co n n ecti o n to d . c . S U PPLY MAINS is o n l y

tested with d . c . W h e n perform i n g t h e tests , t h e poss i bl e i nf l u e n c e o f pola rity o n t h e
o p e rati o n o f t h e M E E Q U I P M E NT i s t a k e n i nto c o n s i derati o n , accord i n g to t h e i nstructi o n s for
u s e . See also 8 . 2 . 2 .
e) M E E Q U I PMENT for w h i c halternative ACCESSORIES o r co m po n e nts s pecifi ed i n t h e

ACCOMPANY I NG DOCU M E N TS (see 7 . 9 . 2 . 1 4 a n d 7 . 9 . 3 . 2 ) are avai l a b l e i s tested w i t h those
ACCES SORI E S o r c o m p o n e nts t h at give t h e l east fav o u rable con diti o n s .
f ) I f t h e i nstructi o n s f o r u s e specify t h at M E EQUI P M E NT i s i nt e n d e d to receive its power fro m a

separate power s u pply, it is c o n n ected to s u c h a power s u pply. S e e also 7 . 2 . 5 a n d 8 . 2 . 1 .
NOTE What was referred to i n the first and second e d itions of this standard a s a "specified power s u pply" is
now considered either as another part of the same ME EQU I P M ENT o r as a n other e q u ipment i n a n ME SYST E M .
5.6 Repa i rs a n d mod ifications

In t h e event of t h e n ecess ity fo r repairs o r m o difi cati o n s after a fa i l u re o r a probabil ity of
future fa i l u re d u ri n g t h e s e q u e n c e of tests , t h e testi n g l a b o ratory and t h e s u p pl i e r of t h e
M E E Q U I P M E N T for t h e test c a n a g re e , e i t h e r u p o n t h e prese ntati o n of a n ew s a m p l e o n w h i c h
a l l tests i n fl u e n c i n g t h e res u lt are perfo r m e d agai n o r , preferably, u p o n m a k i n g a l l t h e
n ecess a ry repai rs o r m o d ificat i o n s after w h i c h o n l y r e l e v a n t tests a re re peate d .
5.7 * H um i d ity precond itio n i ng treatment

Prior to t h e tests of 8 . 7 . 4 and 8 . 8 . 3 , all M E E Q U I P M E NT o r its p a rts s h a l l be s u bj ecte d to a
h u m i dity preco n d iti o n i n g treat m e nt.
M E E Q U I PMENT o r its parts s h a l l be set up c o m pl ete ( o r w h e re n ecessary parti a l l y ) . C overs

used d u ri n g trans port a n d storage are deta c h e d .
T h i s treat m e n t i s a p p l i e d o n l y to th ose M E EQUI PMENT pa rts w h i c h a r e i nfl u e n ced b y t h e

cl i m atic c o n d iti o n s t h at a re s i m u l ated b y t h e test.
6060 1 - 1 © I EC : 2005 - 95 -
P a rts that c a n be d eta c h e d wit h o u t t h e use of a TOOL are d eta c h e d but are treated
s i m u l t a n e o u s l y with the m aj o r part.
AccEss COV E RS that c a n be o p e n e d o r deta c h e d wit h o ut t h e u s e of a T O O L a re o pe n e d a n d

deta c h e d .
T h e h u m i dity preco n d iti o n i n g treat m e nt i s perfo r m e d i n a h u m i d ity cabi n et co ntai n i n g a i r with

a r e l ative h u m i dity of 9 3 % ± 3 %. The tem pe rature of the air in the cabi n et, at all pl aces
w h e re M E E Q U I P M E NT c a n be l ocate d , is m a i ntai n e d with i n 2 o c of a n y c o nv e n i e nt v a l u e T i n
t h e r a n g e of + 20 o c to + 32 o c . Before be i n g placed i n t h e h u m i dity cabi n et, ME E Q U I P M ENT
s h a l l be bro u g ht to a tem pe rat u r e betwe e n T and T + 4 o c , and k e pt at this tem perature for at
l east 4 h befo re t h e h u m i d ity treat m e nt.
M E E Q U I PMENT and its parts is kept i n t h e h u m i dity cabi n et for 4 8 h .
Where t h e R I S K MANAG E M ENT PROCESS s u g g ests t h at t h e M E E Q U I P M E N T c a n b e exposed to

h i g h h u m i d ity fo r exte n d e d peri ods ( s u c h as M E E Q U I P M E NT i nt e n d e d for out-door u s e ) , t h e
period i s exte n ded a p propriately.
Afte r t h e treatm ent, the M E E Q U I P M E NT i s reass e m bl e d , if n ecessary.
5.8 Seq u e n ce of tests

U n l ess stated oth e rwise, the tests i n this sta n d a rd are s e q u e nced i n s u c h a way t h at t h e
resu lts o f a n y test do n ot i nfl u e n c e t h e res u lts o f a s u bs e q u ent test.
NOTE I t is recommended that all tests be performed i n the sequence given i n Annex B.
*
5.9 Determ i n ation of APPL I E D PARTS a n d ACCESSIBLE PARTS
5.9. 1 APPLIED PARTS

APPLI E D PARTS are i d e ntifi ed by i ns pect i o n a n d by refe rence to t h e ACCO MPANYI NG DOCUME NTS
See a l s o 4 . 6 .
5.9.2 ACCESSIBLE PARTS

*
5.9. 2 . 1 Test f i n g e r
P a rts of M E E Q U I P M ENT t h at are to be regarded as ACCESSI B L E PARTS are i d e ntifi ed by
i ns pecti o n a n d w h e re n e cessary by test. I n case of d o u bt, access i b i l ity is d eterm i n ed by a test
with the sta n d ard test fi n g e r s h own in F i g u re 6 , a p pl i e d in a bent or stra i g ht positi o n :
- for a l l positi o n s of ME E Q U I PMENT w h e n o pe rated as i n NORMAL U S E ,
eve n after o p e n i n g o f ACCESS COVERS a n d rem oval o f parts , i n c l u d i n g l a m ps , f u s e s a n d
fus e h o l ders, wit h o u t t h e use o f a TOOL o r accord i n g to t h e i nstructi o n s for u s e .
The standard test finger i s applied without appreciable force in every possible position, except
that ME EQUIPMENT intended to be used on the floor and having a m ass in any operational
condition exceeding 45 kg is not tilted. ME E Q UIPMENT which, according to the technical
description, is intended for mounting into a cabinet, is tested in its final mounting position.
Openings preventing the entry of the standard test finger of Figure 6 are mechanically tested
by m eans of a straight unjointed test finger of the same dimensions, which is applied with a
force of 30 N. If this finger enters, the test with the standard test finger of Figure 6 is
repeated, the finger being pushed through the opening if necessary.
6060 1 - 1 © I EC : 2005 - 97 -
1 80
5 ± 0,5
80
Electrical 60
connection
--------@j----- !- �
· �
Section
A-A B-B
Cyllndncal
050
I n sulating material
Handle
Stop plate
-� �
'
Spherical
Detail X
(Example)
s:l _ _ Chamfer all edges
E4 I F9} -®D-
View on back side
Part3 Part 2 Part 1
- - - - -
IEC 2389105
Linear dimensions in millimetres

Tolerances on d i m ensions without specific tolerances:
- 1 4' and 37' angles: ± 1 5'
- o n rad i i : ± 0 , 1 mm
- o n linear dimensions:
0
� 15 m m : mm
0,1
> 1 5 m m � 25 m m : ± 0 , 1 mm
> 25 mm: 0,3 m m
��· but in one and the same d i rection o n ly.

±
Material o f finger: heat-treated ste e l , for exa m p l e .
Both joints of this finger can be bent through an angle of 90 +
NOTE 1 Using the pin and groove solution is o n ly one of the possible a pproaches i n o rd e r to l i m it the bending
angle to 90' . For this reason, d i mensions and tolerances of these deta ils are not given i n the drawi n g . The actual
design m ust insure a 90' bending angle with a 0' to + 1 0' tolerance.
NOTE 2 Dimensions i n parentheses are for info rmation only.
NOTE 3 The test finger is taken from I EC 60950- 1 , F i g u re 2A. That test finger i s based o n I EC 6 1 032 1 6) , Figure 2 ,
test probe B . I n some cases, the tolerances are different.
Fig u re 6 - Standard test fi nger

(see 5 . 9 . 2 . 1 )
1 6) I EC 6 1 032 : 1 997, Protection of persons and equipment by enclosures - Probes for verification
6060 1 - 1 © I EC : 2005 - 99 -
5.9.2.2 Test h o o k
M E E Q U I PMENT o p e n i n g s are m ec h a n i c a l l y tested b y m ea n s o f t h e test h o o k (see F i g u re 7 ) , i f
t h e h o o k can be i ns e rted.
The test hook is inserted in all openings in question and is subsequently pulled with a force of
20 N for 10 s and in a direction substantially perpendicular to the surface in which the relevant
opening is present. Any additional parts that have b ecom e accessible are identified by using
the standard test finger of Figure 7 and by inspection.
Dimensions i n m i l l i m etres
5
IEC 2390105
Materi a l : steel
Fig u re 7 - Test hook

(see 5 . 9 . 2 . 2 )
5.9.2.3 Actuating mec h a n i sms

C o n d u ctive parts of actu ati n g m e c h a n i s m s of e l e ctrical co ntrols t h at are access i bl e after t h e
r e m ov a l o f h a n d l es , knobs, l ev e rs a n d t h e l i ke are r e g a r d e d as ACCE S S I BLE PARTS . C o n d u ctive
pa rts of actu ati n g m ec h a n i s m s are n ot considered ACCESSI BLE PARTS if r e m ov a l of h a n d l e s ,
k n o b s , etc. req u i res t h e u s e o f a TOOL a n d i ns pecti o n o f t h e R I S K MANAG E M ENT F I LE
d e m o nstrates t h at t h e r e l evant part is u n l i ke l y to bec o m e d eta c h e d u n i ntenti o n a l l y d u r i n g t h e
EXPECTED S E RVICE L I F E o f t h e M E E Q U I P M ENT. S e e also 1 5 . 4 . 6 . 1 .
6 * Classificat i o n of M E EQU I PMENT a n d M E SYSTEMS
6.1 Gen eral

For p u rposes of this sta n d a rd , M E E Q U I P M ENT, o r parts t h e reof, i n cl u d i n g APPLI E D PARTS , s h a l l
b e classified a s fo l l ows .
6.2 * P rotection ag a i n st elect ric s h ock

M E E Q U I PMENT e n e rgized from a n exte r n a l el ectrical power s o u rce s h a l l be cl ass ifi e d as
CLASS I M E E Q U I P M E NT o r CLASS II M E E Q U I P M ENT (see 7 . 2 . 6 ) . O t h e r M E E Q U I P M E N T s h a l l be
cl assifi ed as I NTE RNALLY POWE RED M E E Q U I PM E NT .
6060 1 - 1 © I EC : 20 0 5 - 1 01 -
I NTERNALLY POWERED ME EQUIPMENT havi n g a m ea n s of c o n n ect i o n to a S U PPLY MAINS s h a l l

com ply with t h e req u i re m e nts f o r CLASS I ME EQUI PMENT o r CLASS I I ME EQUIPMENT w h i l e S O
co n n ected, a n d with t h e re q u i re m e nts f o r I NTE RNALLY POWERED ME EQUI PMENT wh i l e n ot S O
co n n ecte d .
APPLI E D PARTS s h a l l be cl assified as TYPE B APPL I E D PARTS, TYPE BF APPLI E D PARTS o r TYPE C F
APPLI ED PARTS (see 7 . 2 . 1 0 a n d 8 . 3 ) . APPLI E D PARTS m ay be cl assifi ed as DEFI BRI LLATI ON-PROOF
APPLI ED PARTS (see 8 . 5 . 5 ) .
6.3 * P rotection aga i nst h a rmfu l i n g ress o f water or particu late matter
ENCLOS URES s h a l l be classifi e d accord i n g to t h e d e g ree of protect i o n agai nst h a rmful i n g ress
of water a n d parti c u l ate m atter as detai l e d in I EC 60529 (see 7 . 2 . 9 a n d 1 1 . 6 . 5) .
NOTE 1 This classification i s IPN1 N2, where:
- N1 is an integer indicating degree of protection agai nst particulate matter or t h e letter "X" .
- N2 is an integer indicating the degre e of protection agai nst i n g ress of water or the letter "X".
NOTE 2 See also Ta ble D . 3 .
6.4 M ethod(s) of ste r i l ization

M E EQUI PMENT o r its pa rts i ntended to be ste r i l ized s h a l l be c l assifi ed accordi n g to the
m ethod(s) of ste ril izati o n as i n d i cated in t h e i nstru cti o n s for use ( s e e 7 . 9 . 2 . 1 2 and 1 1 . 6 . 7 ) .
EXAMPLE 1 By ethylene oxide gas
EXAMPLE 2 By irradiation such as g a m m a ray
EXAMPLE 3 By m o ist heat such as by a utoclave
EXAMPLE 4 By other methods validated and described by the M A N U FACT U R E R
6.5 S u ita b i l ity for use i n an OXYGE N RICH ENVIRO N M E NT

M E EQUI PMENT a n d ME SYSTEMS i nt e n d e d for u s e i n a n OXYGEN RICH E NV I RONMENT s h a l l be
cl assifi ed for s u c h u s e (see 1 1 . 2 . 2 ) .
6.6 * Mode o f operation

ME EQUI PMENT s h a l l be cl ass ifi e d for e i t h e r CONTI NUOUS OPERATION o r n o n-CONTI NUOUS
OPERATION (see 7 . 2 . 1 1 ) .
7 M E EQU IPMENT i d e ntificat i o n , m a rki n g a n d d o c u ments

NOTE A n nex C contains a guide to assist the reader i n locating the m a r king and l a b e l l i n g re quirements for
ME EQU I P M ENT and ME SYST E M S contained i n other clauses of this sta ndard.
7.1 Gen eral
7. 1 . 1 * U SABILITY of t h e i d e n t ificat i o n , mark i n g a n d d oc um e n ts

T h e MANUFACTURER s h a l l a d d ress i n a USAB I L I TY E NG I N E ERING PROCESS t h e RISK of poor
USAB I L I TY ass ociated with t h e design of t h e ME EQUIPMENT' s i d e ntifi cati o n , m a rki n g a n d
d o c u m ents. S e e I EC 6 06 0 1 - 1 -6 a n d a l s o s e e 1 . 3 a n d 1 2 . 2 .
Compliance is checked b y inspection of the results o f the USABILI TY ENGINEERING PROCESS.
6060 1 - 1 © I EC : 20 0 5 - 1 03 -
7. 1 . 2 * Leg i b i l ity of marki n g s

T h e m a rki n gs re q u i re d by 7 . 2 , 7 . 3 , 7 . 4 , 7 . 5 a n d 7 . 6 s h a l l be CLEARLY LEGI BLE u n der t h e
fol l owi n g c o n diti o n s :
- for warn i n g state m e nts , i nstructiv e stat e m e nts , s afety s i g n s a n d d rawi ngs on t h e outs i d e
o f ME EQUIPM ENT: from t h e i nt e n d e d pos iti o n o f t h e person perfo r m i n g t h e related fu n cti o n ;
- for FIXED ME EQUIPMENT: w h e n t h e ME EQUIPM ENT is m o u nted i n its positi o n of NORMAL U S E ;
- f o r TRANSPORTABLE ME E Q U I P M E N T a n d fo r STATIONARY ME EQUIPM ENT t h at is n ot FIXED
ME EQUI PMENT: in NORMAL USE o r after disl o d g i n g t h e ME EQUIPM ENT from a wa l l agai nst
w h i c h it has been positi o n e d , o r after t u rn i n g the ME EQUIPMENT from its positi o n of NORMAL
USE a n d , in t h e case of d i s m o u nt a b l e rack u n its, afte r thei r re m ov a l from the rack;
- for m a rki ngs on t h e i ns i d e of ME EQUIPMENT o r ME EQUI PMENT parts: w h e n v i ewed from t h e
i ntended pos iti o n o f t h e person perfo r m i n g t h e rel ated f u n cti o n .
Compliance for clear legibility is checked b y the following test:
The ME EQUIPMENT or its part is positioned so that the viewpoint is the intended position of the
OPERA TOR; or the viewpoint is at any point within the base of a cone sub tended by an angle of
30 • to the axis normal to the centre of the plane of the m arking and at a distance of 1 m . The
ambient illuminance is the least favourable level in the range of 1 00 lx to 1 500 lx. The
observer has a visual acuity of 0 on the log Minimum Angle of Resolution (log MAR) scale or 616
(20120), corrected if necessary.
The observer correctly reads the m arking from the viewpoint.
7. 1 . 3 * D u ra b i l ity of m a r k i n g s
T h e m a rki n gs req u i red by 7.2, 7 . 3 , 7.4, 7.5 and 7.6 shall be rem ovable o n l y with a TOOL o r by
a p preci a b l e force a n d s h a l l be s uffi c i e ntly d u ra b l e to r e m a i n CLEARLY LEG I BLE d u ri n g t h e
EXPECTED S ERVICE LIFE o f t h e ME EQUIPM ENT. I n c o n s i d e r i n g t h e d u ra b i l ity of t h e m a rki n g s , t h e
effect o f NORMAL U S E s h a l l be ta k e n i nto accou nt.
Compliance is checked by inspection and the following tests:
a) After all the tests of this standard have b een performed (see the recommended sequence
of tests in Annex B) :
markings are tested to the requirements of 7. 1 . 2; and
adhesive labels are not to have worked loose or become curled at the edges.
b) For markings required by 7. 2, 7. 4, 7. 5 and 7. 6, an additional test for durability is to be

perform ed. Markings are rubbed by hand, without undue press ure, first for 15 s with a cloth
rag soaked with distilled water, then for 1 5 s with a cloth rag soaked with methylated spirit
and then for 1 5 s with a cloth rag soaked with isopropyl alcohol.
6060 1 - 1 © I EC : 20 0 5 - 1 05 -
7.2 M arki ng o n t h e outside o f M E EQU I P M E NT o r M E EQU I P M E NT parts (see also T a b l e C . 1 )
7.2. 1 M i n imum req u i rements for marking on ME EQU I P M E NT a n d on i nterc h a n g eable

parts
If the size of t h e ME E Q U I PMENT, an ME EQUIPM ENT part o r an ACCESSORY, o r the nature of its
E NCLOS U R E , does not a l l ow affix ati o n of a l l m a rki n gs s pecifi ed i n 7 . 2 . 2 to 7 . 2 . 20 ( i n c l u si v e ) ,
t h e n a t l e ast t h e m a rki n gs as i n d i cated i n 7 . 2 . 2 , 7 . 2 . 5 , 7 . 2 . 6 ( n ot f o r PERMANE NTLY I NSTALLED
ME E Q U I PMENT), 7 . 2 . 1 0 and 7 . 2 . 1 3 ( i f a p p l i c a b l e ) s h a l l be affix e d and t h e remai n i n g m a rki n gs
s h a l l be recorded i n f u l l i n t h e ACCOMPANYING DOCUME NTS . W h e re no m a rki n g of t h e
ME EQUIPMENT i s practi c a b l e , these m a rki n gs m ay be affix e d to t h e i n divi d u a l packa g i n g .
A n y m ateri a l , c o m po n ent, ACCESSORY o r ME EQUIPM ENT t h at is i nt e n d e d fo r a s i n g l e u s e o r its

packa g i n g s h a l l be m a rked " D o N ot R e u s e " o r with symbol I S O 7 0 0 0- 1 0 5 1 ( 0 8 : 2004-0 1 ) (see
T a b l e 0 . 1 , symbol 28) .
7.2.2 * I d e n t ification
M E EQUI PMENT and its deta c h a b l e co m po n e nts shall be m a rked with t h e name o r trademark of
t h e MANUFACTU RER, a n d with a MODEL OR TYPE REFERENCE u n l e ss m i s i d e ntifi cati o n does not
present a n u n accepta b l e RISK.
S oftwa re t h at fo r m s part of a PEMS s h a l l be i d e ntifi ed with a u n i q u e i d e ntifi er, such as rev i s i o n

l evel o r date o f rel ease/i s s u e . T h e i d e ntifi cati o n s h a l l be avai l a b l e to d e s i g n ated pers o n s , e . g .
S ERVICE PERSONNEL. T h e i d e ntifi cati o n does not n e e d to be o n t h e o uts i d e o f t h e
ME EQUI PMENT.
7.2.3 * Cons u l t ACCOM PANYING DOC UM ENTS

When a ppropriate, sym bol I SO 7000- 1 64 1 ( 0 8 : 2004- 0 1 ) (see T a b l e 0 . 1 , sym bo l 1 1 ) m ay be
used to advise the OPERATOR to c o n s u l t the ACCOMPANYI NG DOCUM ENTS . When c o n s u l ti n g t h e
ACCOMPANYI NG DOCUME NTS is a m a n d atory acti o n , safety s i g n I EC 6 0 8 7 8 Safety 0 1 (see T a b l e
0 . 2 , safety s i g n 1 0) s h a l l be used i nstead o f sym bol I S O 7000- 1 6 4 1 .
7.2.4 * ACCESSORI E S
AccESSORI ES s h a l l be m a rked w i t h t h e n a m e o r trade- m a r k of t h e i r MANUFACTURER o r s u ppl i er,
and with a MODEL OR TYPE REFERENCE . Where n o m a rki n g of t h e ACCESSORIES is practi c a b l e ,
these m a rki n gs m ay be affixed to t h e i n di v i d u a l packag i n g .
7.2.5 M E EQUIPMENT i nte n d ed t o receive power from other eq u i pment

I f M E EQUIPM ENT i s i ntended to receive its power from oth e r e q u i pm ent i n c l u d i n g ME EQUIPM ENT
in an ME SYSTEM and c o n n ecti o n to a n ot h e r s o u rce c o u l d res u l t in an u n accepta b l e RISK, t h e
MODEL OR TYPE REFERENCE o f t h e s pecifi e d oth e r e q u i p m e nt s h a l l be m a rked a dj a c e nt to t h e
r e l e v a n t c o n n ecti o n poi nt. S e e a l s o 7 . 9 . 2 . 3 , 8 . 2 . 1 a n d 1 6 . 3 .
6060 1 - 1 © I EC : 20 0 5 - 1 07 -
7.2.6 C o n n ection t o the S UPPLY MAINS

ME EQUI PMENT s h a l l be m a rked with t h e foll owi n g i nfo r m at i o n :
t h e RATED s u pply voltage(s) o r RATED voltage range(s) t o w h i c h it m ay b e co n n e cted. A
RATED s u pply voltage ra n g e s h a l l h ave a h y p h e n (-) betwe e n t h e m i n i m u m a n d m axi m u m
voltages. W h e re m u lti p l e RATED s u pply voltages o r m u lti p l e RATE D s u pply voltage ran ges
are give n , they s h a l l be s e pa rated by a s o l i d u s (/) ;
EXAMPLE 1 RATED s u pply voltage range: 1 00-240 V. This means that the M E EQU I P M ENT is designed to be
con nected to a S U P P LY M A I N S having a N O M I NAL voltage between 1 00 V and 240 V .
EXAMPLE 2 M u ltiple RATED s u pply voltage: 1 2012201240 V . This means that t h e M E EQU I PM E NT is designed
to be switched to a l low connection to a S U P PLY MAINS having a N O M I NAL voltage of 1 2 0 V o r 220 V o r 240 V.
NOTE 1 M a rking of RATED s u pply voltage is taken from I E C 6 1 293 1 7) _

nature of s u pply, fo r ex a m pl e , n u m be r of phases ( ex ce pt for s i n gl e- p h as e s u p ply) a n d ty pe
of cu rrent. Symbols I EC 6 0 4 1 7-5032, 5032- 1 , 5032-2, 50 3 1 , a n d 5033 ( a l l 0 8 : 2 002- 1 0)
m ay be used for this pu rpose (see T a b l e 0 . 1 , sym bols 1 , 2, 3, 4 a n d 5 ) ;
NOTE 2 F o r alternating c u rrent, t h e RATED frequency i n h e rtz is sufficient t o ide ntify t h e type o f current.
the RATED s u pply freq u e n cy o r RATED fre q u e n cy range in h e rtz;
EXAMPLE 3 RATED s u pply frequency range: 50-60 Hz. This means that t h e ME EQU I PM E NT is designed to be
con nected to a S U P P LY MAINS having a N O M I NAL frequency between 50 Hz and 60Hz.
For CLASS I I ME E Q U I PMENT, symbol I EC 604 1 7-5 1 72 ( 0 8 : 200 3-02) (see Table 0 . 1 , sym bol
9).
Except for PERMANE NTLY I NSTALLED ME EQUIPM ENT, these m a rki n g s s h a l l a ppear o n t h e o utsi d e
o f t h e part t h at conta i n s t h e S U PPLY MAINS c o n n ect i o n a n d prefera bly adj acent to t h e
co n n ecti o n poi nt. F o r PERMANE NTLY I NSTALLED ME EQUIPMENT, t h e NOMI NAL s u pply v o l t a g e o r
v o l t a g e r a n g e to w h i c h it can be c o n n ected m ay be m a rked o n t h e i ns i d e o r t h e o u ts i d e o f t h e
ME EQUI PMENT, prefe rably adj a c e nt to t h e s u pply c o n n ecti o n term i n al s .
7.2.7 E lectrical i n p u t power from t h e S UPPLY MAINS

The RATED i n put s h a l l be given in a m peres o r v o lt-am peres o r where t h e power factor exceeds
0 , 9 , in watts .
I n t h e case of ME EQUI PMENT for o n e or several RATED voltage ran ges, t h e RATED i n put s h a l l
a lways b e g i v e n f o r t h e u p per a n d l owe r l i m its o f t h e r a n g e o r r a n g e s , i f t h e range(s) i s/are
g re ater t h a n ± 1 0 % of the m ea n val u e of t h e given r a n g e .
I n t h e case o f r a n g e l i m its wh i c h do n ot differ b y m o re t h a n 1 0 % from the m e a n va l u e ,

m a rki n g o f t h e i n put a t t h e m ea n v a l u e o f t h e r a n g e i s s uffi c i ent.
I f t h e rati n g of ME EQUIPM ENT i n c l u des both l o n g-ti m e a n d m o m e ntary c u rrent o r volt-a m pere
rati n g s , the m a rki n g s h a l l i n c l u d e both l o n g-ti m e and the m ost r e l ev a nt m o m e ntary v olt
a m pe re rati n gs , e a c h pl a i n ly i d e ntifi e d and i n d i cated in the ACCOM PANYING DOCUMENTS.
1 7) I EC 6 1 293 : 1 994, Marking of electrical equipment with ratings related to electrical supply - Safety requirements
6060 1 - 1 © I EC : 20 0 5 - 1 09 -
T h e m a rked i n put of M E EQUIPMENT prov i d e d with m ea n s for t h e co n n ecti o n of s u p ply

c o n d u ctors of oth e r e l ectrical e q u i p m e nt s h a l l i n c l u d e t h e RATED (and m a rked) output of s u c h
means.
7.2.8 O utput co n n ectors
7 . 2. 8 . 1 M a i n s power output
For M ULTIPLE SOCKET-OUTLETS t h at are i ntegral with ME E Q U I PM E NT, s e e 1 6 . 9 . 2 . 1 b).
7.2.8.2 Other power sou rces

With t h e exce pti o n of M ULTI PLE SOCKET-OUTLETS or c o n n ecto rs i ntended o n l y for s pecifi ed
e q u i p m e nt, e q u i p m e n t parts o r ACCESSORI E S , o utput co n n e ctors of ME EQUI PMENT i nt e n d e d to
d e l i v e r power s h a l l be m a rked with the fol l owi n g i nformati o n :
- RATED output voltage;
- RATED cu rrent or power (wh e n a p p l i c a b l e ) ;
- output fre q u e n cy (wh e n a p p l i c a b l e ) .
7.2.9 I P c lass ification

M E EQUI PMENT o r its pa rts shall be m a rked with a sym bol , using t h e l etters IP fo l l owed by t h e
des i g n at i o n s d e s c r i b e d i n I E C 60529, accordi n g t o t h e classifi c ati o n i n 6 . 3 ( s e e T a b l e 0 . 3 ,
Code 2 ) .
M E EQUI PMENT cl assifi ed I PXO o r I P OX n eed n ot be m a rked a s s u c h .
7.2. 1 0 * APPL I E D PARTS

T h i s r e q u i r e m e n t does n ot a pply to parts t h at h ave been i d e ntifi e d accordi n g to 4 . 6 .
T h e deg ree o f protect i o n agai nst e l ectri c s h ock a s cl assifi ed i n 6 . 2 fo r a l l APPLI ED PARTS s h a l l
b e m a rked with t h e r e l ev a nt sym bo l , i . e . , TYPE B APPL I E D PARTS with sym bol I E C 6 0 4 1 7-5840,
TYPE BF APPLI E D PARTS with symbol I E C 6 0 4 1 7-5333 o r TYPE CF APPLI ED PARTS with sym bo l
I EC 604 1 7-5335 ( a l l 0 8 : 2002- 1 0) (see T a b l e 0 . 1 , sym bols 1 9 , 20 a n d 2 1 ) .
For DEFIBRI LLATION-PROOF APPLI ED PARTS , symbols I E C 6 0 4 1 7-584 1 , I EC 6 0 4 1 7-5334, o r

I EC 604 1 7-5336 s h a l l be used as a pp l i c a b l e ( a l l 0 8 : 2002-1 0) ( s e e T a b l e 0 . 1 , sym bols 2 5 , 2 6
a n d 27).
T h e relevant sym bol s h a l l be m a rked adj a c e nt to o r o n t h e co n n ector for the APPLI ED PART,
u n l ess either:
- there is no s u c h co n n ecto r, i n w h i c h case t h e m a rki n g s h a l l be on t h e APPLI E D PART; o r
- t h e c o n n ector is used f o r m o re t h a n o n e APPLI ED PART a n d t h e d iffe rent APPLI ED PARTS
have diffe rent c l assifi cati o n s , i n w h i c h case each APPLI ED PART s h a l l be m a rked with t h e
relevant sym b o l .
For c l e a r diffe rentiati o n w i t h sym bol I E C 604 1 7-5333, symbol I EC 6 0 4 1 7-5840 s h a l l n ot be

a p p l i e d in such a way as to give t h e i m press i o n of bei n g i nscri b e d with i n a s q u are (see Table
0 . 1 , symbols 1 9 a n d 20).
I f t h e protect i o n agai nst t h e effect of t h e d i s c h arge of a cardiac defi b ri l l ator is partly in t h e

PAT I E NT c a b l e , s afety s i g n I SO 7 0 1 0-W00 1 , s h a l l be pl aced n e a r t h e r e l e v a n t o u t l e t (see T a b l e
0 . 2 , safety s i g n 2 ) . T h e i nstru cti o n s f o r use s h a l l expl a i n t h at protect i o n o f t h e ME EQUIPMENT
agai nst t h e effects of t h e discharge of a cardiac defi bri l l ator is d e p e n d ent u p o n t h e use of
a p propriate c a b l e s .
6060 1 - 1 © I EC : 20 0 5 - 111 -
7 . 2. 1 1 Mode of operation
I f no m a rki n g i s provi d e d , ME EQUIPM ENT is ass u m ed to be s u ita b l e fo r CONTI NUOUS OPERATIO N .
For ME EQUIPMENT i nte n d e d f o r n o n-CONTINUOUS OPERATION, t h e DUTY CYCLE s h a l l be i n di cated
u s i n g an a p propriate m a rki n g givi n g the m ax i m u m activat i o n ( o n ) ti m e a n d the m i n i m u m
de activati o n ( off) ti m e .
7.2. 1 2 * F u ses
Where t h e fuse- h o l d e r is an ACCESSI BLE PART, t h e type a n d f u l l rati n g of t h e fuse (volta g e ,
cu rrent, o pe rati n g s pe e d a n d breaki n g capacity) s h a l l be m a rked a dj acent to t h e fuse- h o l d e r .
7.2. 1 3 P h ys io log ical effects (safety s i g n s a n d war n i ng statements)

ME EQUI PMENT prod u c i n g phys i o l ogical effects t h at are n ot o bv i o u s to the OPERATOR and can
cause HARM to the PAT I E NT o r OPERATOR s h a l l bear a s u itable s afety s i g n (see 7 . 5) . The s afety
s i g n s h a l l a ppear i n a pro m i n e n t l ocati o n so t h at it wi l l be CLEARLY LEG I BLE i n NORMAL USE after
t h e ME EQUIPM ENT h as been PROPE RLY I NSTALLE D.
T h e i nstru cti o n s for use s h a l l descri be t h e n atu re of t h e HAZARD and t h e p reca uti o n s for
avo i d i n g it o r m i n i m is i n g t h e ass ociated RISK.
7.2. 1 4 H I G H VOLTAGE TERMINAL DEVICES

H I G H VOLTAGE TERMINAL DEVICES on the o uts i d e of ME EQUIPM ENT t h at are acces s i b l e wit h o u t
t h e u s e o f a TOOL s h a l l be m a rked with sym bol I E C 604 1 7-5036 ( 0 8 : 2 0 0 2 - 1 0) ( s e e T a b l e 0 . 1 ,
symbol 24).
7 . 2. 1 5 Cool i n g co nd itions
R e q u i r e m e nts for coo l i n g prov i s i o n s for ME EQUI PMENT (for exa m pl e , s u pply of water o r a i r)
s h a l l be m a rked.
7.2. 1 6 Mechan ical sta b i l ity

For req u i re m e nts o n ME EQUIPMENT with a l i m ited sta b i l ity, see 9 . 4 .
7.2. 1 7 P rotective packag i ng

If speci a l h a n d l i n g m eas u res have to be taken d u ri n g trans port or storage, t h e packagi n g s h a l l
b e m a rked accord i n gly ( s e e I SO 780) .
T h e perm i s s i b l e envi ro n m e ntal c o n diti o n s for transpo rt a n d sto rage s h a l l be m a rked on t h e

o u ts i d e o f t h e packagi n g (see 7 . 9 . 3 . 1 a n d I S O 1 52 2 3 ) .
W h e r e prem ature u n packi n g o f ME EQUIPM ENT o r i t s pa rts c o u l d res u lt i n a n u n accepta b l e R I S K ,

t h e packa g i n g s h a l l be m a rked w i t h a s u itable s afety s i g n (see 7 . 5 ) .
EXAMPLE 1 H u m idity sensitive M E EQU I P M E N T .
EXAMPLE 2 M E EQU I P M ENT conta i n i n g hazardous substances a n d materia l s .
T h e packa g i n g of ME EQUI PMENT o r ACCESSORI ES s u p p l i e d ste r i l e s h a l l be m a rked as ste r i l e

( s e e I SO 1 5223 ) .
7.2. 1 8 External press u re sou rce

T h e RATED m axi m u m s u pply press u r e from an exte r n a l s o u rc e s h a l l be m a rked on t h e
ME EQUIPMENT adj acent to each i n put co n n ecto r.
6060 1 - 1 © I EC : 20 0 5 - 1 13 -
7.2. 1 9 FUNCTIONAL EARTH TERMI NALS

A FUNCTIONAL EARTH TERMINAL s h a l l be m a rked with symbol I E C 604 1 7-50 1 7 ( 0 8 : 2002- 1 0)
(see T a b l e 0 . 1 , symbol 7 ) .
7 . 2 . 20 Remova ble p rotective mea n s

I f ME EQUIPMENT h as altern ative a p pl i cati o n s t h at req u i re t h e removal o f a p rotective m e a n s t o
use a parti c u l a r fu n cti o n , t h e protective m e a n s s h a l l be m a rked t o i n d i cate t h e n ecessity for
replace m ent w h e n the relevant f u n ct i o n i s no l o n g e r n e e d e d . No m a rki n g is req u i red w h e n an
i nterlock i s provi d e d .
Compliance with the requirem ents of 7. 2 is checked b y inspection and by application of the
tests and criteria in 7. 1. 2 and 7. 1. 3.
7.3 M a r k i n g o n the i ns id e o f M E EQU I P M E NT o r M E EQU I P M E NT parts (see a l s o T a b l e C . 2)
7.3. 1 Heat i n g elements or lampholders

The m axi m u m power l o a d i n g of h e ati n g e l e m e nts o r l a m p h o l d e rs des i g n ed for u s e with
h e ati n g l a m ps s h a l l be m a rked near t h e h e ater o r in the h e ater itse lf.
For h e ati n g e l e m e nts o r l a m p h o l d e rs des i g n e d for use with h eati n g l a m ps that can be
c h a n g e d o n l y by S ERVICE P E RSONNEL with the use of a TOOL, a n i d e ntifyi n g m a rki n g referri n g to
i nfo r m at i o n stated in the ACCOMPANYI NG DOCUM ENTS is s uffi ci e nt.
7.3.2 * H I G H VOLTAGE parts

T h e pres e n c e of H I G H VOLTAGE pa rts s h a l l be m a rked with sym bol I EC 6 0 4 1 7-5036 ( 0 8 : 2002-
1 0) (see Table 0 . 1 , sym bol 24) o r with s afety s i g n 3 (see Table 0 . 2 , safety sign 3 ) . S e e also
7.5.
7.3.3 Batteries
The type of battery and the m o d e of i ns e rt i o n ( if a pp l i cable) s h a l l be m a rked (see 1 5 . 4 . 3 . 2 ) .
F o r batteries i ntended t o b e c h a n g e d o n l y b y S ERVICE PERSONNEL with t h e u s e o f a TOOL, a n

i d e ntify i n g m a r ki n g refe rri n g t o i nformati o n state d i n t h e ACCOMPANYI NG DOCUME NTS i s
s uffi c i e nt.
Where l i th i u m batteries o r fuel cells a re i n corpo rated and w h e re i n correct replace m ent wo u l d
res u l t i n a n u n acce pta b l e RISK, a warn i n g i n d i cati n g t h at r e p l a c e m ent b y i n a d e q u ately tra i n e d
pers o n n e l co u l d res u l t i n a HAZARD ( s u c h a s excessive tem perat u res, fire o r ex p l os i o n ) s h a l l
b e g i v e n i n additi o n t o t h e i d e ntify i n g m a rki n g referri n g to i nfo r m at i o n stated i n t h e
ACCOMPANYI NG DOCUMENTS.
7.3.4 * F u ses, THERMAL C UT-OUTS a n d OVE R-CURRENT RELEAS ES

F u s es a n d replaceable THE RMAL CUT-OUTS and OVER-CURRENT RE LEASES t h at are access i b l e
o n l y b y t h e u s e o f a TOOL s h a l l b e i d e ntifi ed either b y ty pe a n d f u l l rati n g a dj a c e nt t o t h e
com p o n e nt (voltage, c u rrent, o pe rati n g s pe e d a n d breaki n g ca pacity ) , o r b y a refe rence to
i nfo r m at i o n in the ACCOM PANY I NG DOCUMENTS.
6060 1 - 1 © I EC : 20 0 5 - 1 15 -
7.3.5 PROTECTIVE EARTH TERMI NALS

PROTECTIVE EARTH TERMI NALS s h a l l be m a rked with sym bol I E C 6 0 4 1 7-50 1 9 ( 0 8 : 2002- 1 0)
(see T a b l e 0 . 1 , sym bol 6) u n less t h e PROTECTIVE EARTH TERM I NAL is i n an APPLIANCE I NLET
accord i n g to I EC 60320- 1 .
M a rki n gs that a re on or adj a ce n t to PROTECTIVE EARTH TERMI NALS s h a l l not be affix e d to parts
t h at h av e to be re m ov e d to m a ke t h e c o n n ecti o n . T h ey s h a l l re m a i n v i s i b l e after t h e
co n n ecti o n has b e e n m a d e .
7.3.6 FUNCTIONAL EARTH TERMI NALS

FUNCTIONAL EARTH TERMI NALS s h a l l be m a rked with symbol I E C 604 1 7-50 1 7 ( 0 8 : 2 0 0 2- 1 0)
(see T a b l e 0 . 1 , symbol 7 ) .
7.3.7 S u pply term i nals

Term i n a l s for s u pply c o n d u ctors shall be m a rked adj a c e nt to t h e term i n a l s u n less it c a n be
d e m o nstrated t h at n o HAZARDOUS SI TUATION c a n res u l t if c o n n ecti o n s are i nterc h a n g e d .
I f ME EQUIPMENT is s o s m a l l t h a t t h e term i n al m a rki ngs c a n n ot be affix e d , t h ey s h a l l be

i n cl u d e d in t h e ACCOMPANYI NG DOCUMENTS .
Term i n a l s t h at are prov i d e d ex c l u s i v e l y for t h e c o n n ecti o n of th e n e utral s u pply c o n d u cto r i n

PERMANE NTLY I NSTALLED M E EQUIPMENT s h a l l b e m a rked with t h e a ppropriate code from
I EC 60445 (see T a b l e 0 . 3 , Code 1 ) .
I f m a rki n g for co n n ecti o n to a th ree-ph ase s u pply i s n ecess a ry, i t s h a l l b e accordi n g to

I EC 60445.
M a rki n gs t h at are o n o r adj acent to el ectrical c o n n ecti o n p o i nts s h a l l not be affixed to pa rts
t h at h av e to be re m ov e d to m a ke t h e c o n n ecti o n . T h ey s h a l l re m a i n v i s i b l e after t h e
co n n ecti o n has b e e n m a d e .
7.3.8 Temperat u re o f s u pply term i n als

I f a n y poi nt wit h i n a term i n al box o r wi r i n g com part m e nt i nte n d e d for c o n n ecti o n of t h e power
s u pply co n d u ctors for PERMANE NTLY I NSTALLED ME EQUIPMENT ( i n c l u d i n g s u c h c o n d u ctors
t h e m selves ) , att a i n s a tem perature of m o re t h a n 75 oc d u r i n g NORMAL USE a n d NORMAL
CONDI TION at the m ax i m u m a m bi e n t o p e rati n g tem perature as i n di cated in the tec h n i ca l
descri pti o n (see 7 . 9 . 3 . 1 ) , t h e ME EQUIPM ENT s h a l l be m a rked w i t h t h e fol l owi n g o r a n
e q u ival e nt stat e m ent:
" Fo r s u p ply c o n n ecti o n s , use wi ri n g m aterials s u itable for at l east X ° C . "
w h e re "X" is g reater t h a n t h e m axi m u m tem perature m e asured i n t h e term i n a l box o r w1 n n g
com part m e n t i n NORMAL USE a n d NORMAL CONDI TION. T h i s state m e nt s h a l l b e l ocated at o r n e a r
t h e poi nt w h e re t h e s u pply co n n ecti o n s a r e to be m ad e . T h i s state m e nt s h a l l n ot be affixed t o
pa rts t h at h a v e t o be re m oved to m a ke t h e co n n ecti o n . It s h a l l be CLEARLY LEGI BLE after t h e
co n n ecti o n s have been m ad e .
Compliance with the requirem ents of 7. 3 is checked b y inspection a n d by application of the

6060 1 - 1 © I EC : 20 0 5 - 1 17 -
7.4 M a r k i n g o f controls and i nstruments (see a l s o T a b l e C . 3 )
7.4. 1 Power switc hes

Switches u s e d to control power to ME EQUIPM ENT or its parts, i n c l u d i n g m a i ns switc h e s , s h a l l
h a v e t h e i r " o n " a n d " off" positi o n s :
m a rked with sym bols I EC 6 0 4 1 7-5007 ( 0 8 : 2002- 1 0) a n d I EC 6 0 4 1 7-5008 ( 0 8 : 2002- 1 0)
(see T a b l e 0 . 1 , sym bois 1 2 a n d 1 3) ; o r
- i n d i cated by a n adj acent i n di cator l i ght; o r
- i n d i cated by oth e r u n a m bi g u o us m e a n s .
I f a p u s h b utto n with bista b l e pos itions is u s e d :

- it s h a l l be m a rked with symboi i EC 604 1 7-5 0 1 0 ( 0 8 : 2002- 1 0) (see T a b l e 0 . 1 , symbol 1 4) ;
and
- t h e status s h a l l be i n d i cated by an a dj a c e nt i n d i cator l i g ht; o r
- t h e status s h a l l be i n d i cated by other u n a m bi g u o us m ea n s .
I f a p u s h butt o n with m o m e ntary o n positi o n i s u s e d :
- it s h a l l be m a rked with sym bol 6 0 4 1 7-50 1 1 ( 0 8 : 2 0 02- 1 0) ( s e e T a b l e 0 . 1 , sym bol 1 5) ; o r

- t h e status s h a l l be i n d i cated by an a dj a c e nt i n d i cator l i g ht; o r
- t h e status s h a l l be i n d i cated by other u n a m bi g u o us m ea n s .
7.4.2 Control devices

Diffe rent positi o n s of control devices a n d d iffe rent positi o n s of switc h es on ME EQUIPM ENT
s h a l l be i n di cated by fi g u res, l ette rs o r oth e r v i s u a l m e a n s , e . g . by use of sy m bo l s I EC 604 1 7-
5264 ( 0 8 : 2002- 1 0) a n d I EC 604 1 7-5265 ( 0 8 : 20 0 2- 1 0) (see Tabl e 0 . 1 , sym bols 1 6 a n d 1 7) .
I f i n NORMAL USE, t h e c h a n g e of setti n g of a control co u l d res u lt i n a n u n accepta b l e RISK t o t h e

PAT I E NT, s u c h c o n t r o l s s h a l l be prov i d e d w i t h either:
- an ass o c i ated i n d i cati n g dev i c e , e . g . i n stru m e nts or s c a l e , o r
- an i n dication of t h e d i recti o n i n w h i c h t h e m ag n i t u d e of t h e f u n ct i o n c h a n ges. S e e a l s o
1 5.4.6.2.
7.4.3 U n its o f meas u re

N u m e r i c i n d i cati o n s of param eters on ME EQUIPMENT s h a l l be ex p ressed i n Sl u n its accord i n g
t o I SO 3 1 except t h e base q u a ntities l isted i n T a b l e 1 m ay be ex p ressed i n t h e i n d i cated u n its,
w h i c h are o uts i d e the S l u n its syste m .
For a p p l i cati o n of S l u n its, t h e i r m u lt i p l e s a n d certa i n ot h e r u n its, I SO 1 0 00 a pp l i e s .
Compliance with the requirem ents of 7. 4 is checked b y inspection and by application of the
6060 1 - 1 © I EC : 20 0 5 - 1 19 -
Table 1 - U n its outside the S l u n its system t h at may be u sed on M E EQU I PM E NT
Unit
Base q uantity
Name Symbol
revo l ution r
gon gon o r g rade
Plane angle degree 0
m i nute of angle
second of a ngle "
m i nute min
Time hour h
day d
E n e rgy e l ectron volt eV
Volume litre I"
Pressure of
respiratory m i l l i m etres of m e rc u ry mmHg
gases, blood,
and other body
centimetres of water c m H 20
fluids
Pressure of bar bar

gases m i l l i ba r mbar
• For cons istency, i n i nternati onal standards o n ly the sym bol "I" is
used for litre, although the sym bo l "L" is also given i n I S O 3 1 .
7.5 Safety s i g n s
For t h e p u rpose o f t h i s c l a u s e , m a rki n gs used to co nvey a warn i n g , pro h i biti o n o r m a n d atory
act i o n t h at m iti gates a R I S K that is n ot o bv i o u s to t h e O P E RATOR s h a l l be a safety s i g n s e l ected
from I SO 7 0 1 0 .
NOTE 1 I n this context, warn i n g i s used t o m e a n , "There i s certain danger"; prohibition i s used t o m e a n , "You m ust
not . . . "; and m a ndatory action i s used to m e a n , "You m ust. .. " .
Where a safety s i g n is not ava i l a bl e to i n d i cate a parti c u l a r des i re d m e a n i n g , t h e m e a n i n g

m ay b e o bta i n ed b y o n e o f t h e fo l l owi n g m ethods.
a) C o nst r u cti n g a s afety sign accord i n g to ISO 3864- 1 : 2002, C l a use 7 (for t h e co rres po n d i n g
tem pl ates, s e e T a b l e D . 2 , s afety s i g n s 1 , 4 a n d 8 ) .
b) U s i n g t h e g e n e ral wa r n i n g s i g n I SO 70 1 0 : 2 0 0 3-W0 0 1 (see T a b l e D . 2 , s afety s i g n 2 ) pl aced

toget h e r with a s u p pl e m e ntary sym bol o r text. T h e text associ ated with t h e g e n e ra l wa rni n g
s i g n s h a l l be a n affi rm ative state m e nt ( i . e . , a safety notice) descri bi n g t h e p r i n c i pal R I S K( s )
fores e e n ( e . g . " C a u s es b u r n s " , " R i s k of explos i o n " , etc . ) .
c ) U s i n g t h e g e n e ra l pro h i biti o n s i g n I SO 70 1 0 : 2003- P 0 0 1 (see T a b l e D . 2 , s afety s i g n 4 )

placed toget h e r with a s u pp l e m e ntary symbol o r text. T h e text associated with t h e g e n e ra l
pro h i biti o n s i g n s h a l l be a state m e nt ( i . e . a safety n otice) descri b i n g what is pro h i bited
( e . g . " D o n ot o p e n " , " D o n ot d r o p " , etc . ) .
d) U s i n g t h e g e n e ral m a n datory acti o n s i g n I SO 70 1 0 : 20 0 3- M 0 0 1 (see T a b l e D . 2 , s afety s i g n

9) placed toget h e r with a s u ppl e m e ntary symbol o r text. T h e text ass ociated with t h e
g e n e ra l m a n datory acti o n s i g n s h a l l be a co m m a n d ( i . e . a safety n otice) descri bi n g
req u i red acti o n ( e . g . "Wear protective gl oves " , " S c r u b befo re e nteri n g " , etc . ) .
6060 1 - 1 © I EC : 20 0 5 - 1 21 -
If t h e re is i ns uffi c i e nt space to place t h e affirm ative state m e nt together with t h e s afety s i g n o n

t h e M E E Q U I P M ENT, it m ay be pl aced i n t h e i n structi o n s f o r u s e .
NOTE 2 T h e colours for safety signs a r e specified i n I S O 3864-1 a n d it is i m portant t o u s e t h e specified colour.
NOTE 3 A safety notice should include the a p propriate precautions o r include instructions o n how to reduce the
RISK (e . g . "Do not use for . . . " , "Keep away from . . . " , etc . ) .
S afety s i g n s , i n c l u d i n g a n y s u p p l e m e ntary sym bol o r text, shall be ex pl a i n e d i n t h e

i nstru cti o n s for u s e (see 7 . 9 . 2 ) .
Compliance is checked b y inspection.
7.6 Symbols
7.6. 1 Explanation of symbols

T h e m e a n i ngs of t h e sym bols u s e d for m a rki n g s h a l l be ex p l a i n e d in t h e i n structi o n s for use.
7.6.2 Symbols from An n ex D

Sym bols req u i red by t h i s sta ndard s h a l l conform to t h e re q u i re m e nts i n t h e refe renced I EC o r
I SO p u b l i cati o n . An n ex D provides t h e symbol g r a p h i c a n d descri pt i o n f o r these sym bols as a
q u i c k refe rence.
7.6.3 Symbols for co n t ro l s a n d performance

Sym bols used for controls a n d perfo r m a n c e s h a l l co nfo rm to t h e re q u i re m e nts of t h e I EC or
I SO p u b l i cati o n w h e re the sym bol is defi n e d , w h e n a p p l i c a b l e . S e e a l s o 7 . 2 . 1 3 .
NOTE I E C 60878 provides a su rvey of titl es, descriptions a n d graphical representations of sym bols for electrical
e q u i pm e nt used i n medical practice.
Compliance with the requirements of 7. 6 is checked by inspection.
7.7 Colou rs o f the i n s u lation o f cond uctors
7. 7 . 1 PROTECTIVE EARTH CONDUCTOR

A PROTECTIVE EARTH CONDUCTOR s h a l l be i d e ntified t h r o u g h o u t its l e n gth by green and yel l ow
co l o u red i ns u l ati o n .
7.7.2 PROTECTIVE EARTH CONNECTIONS

Any i ns u l at i o n o n c o n d u ctors i ns i d e M E E Q U I P M E N T t h at form PROTECTIVE EARTH CONNECTIONS
s h a l l be i d e ntifi ed by the co l o u rs green a n d y e l l ow at l e ast at the term i n ati o n of t h e
c o n d u ctors.
EXAMPLE Conductors of a m u lti-conductor cord that are con nected i n para l l e l , where the maxi m u m a l lowed
resistance of the PROTECTIVE EARTH CON N ECTIONS would be exceeded if o n ly the green and ye l l ow coloured
cond uctor were used.
7.7.3 G reen and yel low i n s u lation

I de ntifi cati o n by green and yel l ow i ns u l ati o n s h a l l only be used fo r:
PROTECTIVE EARTH CON DUCTORS (see 8 . 6 . 2 ) ;
c o n d u ctors a s s pecifi e d i n 7 . 7 . 2 ;
POTENTIAL EQUALIZAT I O N CONDUCTORS (see 8.6.7);
F U NCTI O NAL EARTH CONDUCTORS (see 8.6.9).
7.7.4 N e u tral cond u ctor

C o n d u ctors in POW E R S U PPLY CORDS i nte n d e d to be c o n n ected to the n e utral c o n d u ctor of t h e
s u pply system s h a l l be c o l o u red " l i g ht bl u e " as s pecifi ed i n I E C 6 0227- 1 o r i n I E C 60245- 1 .
6060 1 - 1 © I EC : 20 0 5 - 1 23 -
7.7.5 POWER S U PPLY CORD cond uctors
C o l o u rs of c o n d u ctors in POWER S U PPLY CORDS s h a l l be in accord a n ce with I EC 60227- 1 or

with I E C 60245- 1 .
Compliance with the requirements of 7. 7 is checked by inspection.
7.8 * I nd icato r l i g hts and controls
7.8. 1 Colo u rs of i n d icator l ig hts

The co l o u rs of i n d i cator l i g hts and t h e i r m e a n i ngs s h a l l com ply with T a b l e 2.
NOTE IEC 6060 1 - 1 -8 conta ins specific requirement for the colour, flash ing frequency a n d DUTY CYC L E of a l a rm
ind icator lights.
Dot- m atrix a n d oth e r a l p h a n u m e ric d i s pl ays are n ot c o n s i dered to be i n d i cator l i g h ts .
Table 2 - C o l o u rs o f i n d icato r l i g hts a n d t h e i r mea n i n g

for M E E QU I P M E NT
Colou r Meaning
Red Wa rning - i m m ediate response by the O P E RATOR is req u ired
Yel low Caution - pro m pt response by the OPERATOR is req u i red
G reen Ready fo r use
Any other colour Meaning other than that of red , ye l l ow o r g reen
7.8.2 Colo u rs o f controls

T h e co l o u r red s h a l l be used only for a co ntrol by which a f u n ct i o n i s i nterrupted in case of
e m e rg e ncy.
Compliance with the requirements of 7. 8 is checked by inspection. See also 1 5. 4. 4 .
7.9 ACC O M PANYI N G DOCUM E NTS
7.9. 1 * Gen eral (see a l s o T a b l e C . 4 )

M E EQUI PMENT s h a l l be acco m pa n i ed b y d o c u m e nts co ntai n i n g a t l e ast t h e i nstr u cti o n s f o r u s e
a n d a tec h n i ca l descri pt i o n . T h e ACCOMPANYI NG DOCU ME NTS s h a l l be r e g a r d e d as a part o f t h e
ME EQUI PMENT.
NOTE The purpose of the ACCOM PANYI N G DOC U M ENTS is to promote the safe use of the M E EQU I P M ENT during its
EXPECTED SERVICE L I F E .
T h e ACCOMPANYI NG DOCUME NTS s h a l l i de n tify t h e ME EQUIPM ENT by i n cl u d i n g , as a p p l i c a b l e ,

t h e fol l owi n g :
n a m e o r trade- n a m e o f t h e MANUFACTURER a n d a n a d d ress t o w h i c h t h e RESPONSIBLE
ORGANIZATI ON c a n refe r;
MODEL OR TYPE REFERENCE (see 7 . 2 . 2 ) .
Acco MPANY I NG DOCU ME NTS m ay b e prov i d e d el ectro n i ca l l y , e . g . el ectro n i c fi l e fo r m at o n C D

R O M . I f t h e ACCOMPANY I NG DOCUME NTS a r e prov i d e d e l ectro n i ca l ly, t h e R I S K MANAG EMENT
PROCESS s h a l l i n c l u d e c o n s i d e rati o n of which i nfo r m ati o n also n eeds to be prov i d e d as hard
copy o r as m a rki n gs o n t h e ME EQUIPM ENT, e . g . to cover e m e rg e n cy o pe rati o n .
T h e ACCOMPANYI NG DOCUME NTS s h a l l s pecify a n y speci a l s ki l l s , trai n i n g a n d kn owl edge

req u i red of t h e i ntended OPERATOR o r t h e RESPONSIBLE ORGANIZATION a n d a n y restri cti o n s on
l ocati o n s o r envi ro n m e nts in w h i c h t h e ME EQUIPMENT c a n be used.
6060 1 - 1 © I EC : 20 0 5 - 1 25 -
T h e ACCO MPANYI NG DOC U M E NTS s h a l l be written at a l ev e l cons istent with t h e e d u cati o n ,

trai n i n g a n d a n y s peci a l n e e ds o f t h e perso n (s) fo r w h o m t h ey a re i nt e n d e d .
Compliance i s checked b y inspection.
7.9.2 I nstructions f o r use (see a l s o T a b l e C . 5)
7 . 9. 2 . 1 * Gen eral
The i nstr u cti o n s for use s h a l l d o c u m ent:
t h e u s e of t h e M E E Q U I P M ENT as i ntended by t h e MANUFACTU R E R ,
t h e fre q u e ntly used f u n cti o n s , and
a n y k n own contrai n d i cati o n ( s ) to t h e u s e of t h e M E E Q U I P M E NT .
T h e i nstru cti o n s for use shall i n c l u d e a l l a p pl i ca b l e cl ass ifi cati o n s s pecifi ed in C l a use 6 , all
m a rki n gs s pecifi e d i n 7 . 2 , a n d t h e ex pl a n at i o n of s afety signs and symbols ( m a rked o n t h e
M E E Q U I PM E N T ) .
NOTE 1 T h e instructions f o r u s e a r e i ntended f o r t h e OPERATOR a n d t h e RESPO N S I B L E ORGAN IZATION and s h o u l d

contain only t h e info rmation m o s t l i kely t o b e useful t o the OPERATOR o r R E S P O N S I B L E ORGAN IZAT I O N . Additio nal
deta ils can be contained i n the technical description. See also 7 . 9 . 3 .
N O T E 2 G u idance o n the preparation of instructions f o r use is fo u n d i n I EC 62079 [25] . G u idance o n t h e
preparation of educatio nal materials f o r M E E Q U I P M ENT is fo und i n I E C/TR 6 1 258 [24] .
T h e i nstr u cti o n s for u s e s h a l l be i n a l a n g u a g e t h at is acceptable to t h e i nte n d e d O P E RATO R .
7.9.2.2 * War n i ng and safety n otices

T h e i nstr u cti o n s for use s h a l l i n c l u d e a l l wa rn i n g a n d s afety n oti ces.
NOTE General warnings a n d safety notices s h o u l d b e placed i n a specifica l ly identified section o f the
instructions for use. A wa rning o r safety notice that applies o n ly to a specific i nstruction o r action should precede
the instruction to which it a pplies.
For CLASS 1 M E E Q U I P M ENT, t h e i nstr u cti o n s for u s e s h a l l i n cl u d e a warn i n g state m e n t to t h e

effect: "WAR N I N G : To a v o i d t h e r i s k o f e l e ctric s h ock, t h i s e q u i p m ent m ust o n l y be co n n ected
to a s u pply m a i ns with protective eart h . "
T h e i nstructi o n s for u s e s h a l l prov i d e t h e O P E RATOR o r RESPONSIBLE ORGA N I ZAT I O N with

wa r n i ngs regard i n g any s i g n i fi c a nt R I S KS of reci procal i nterfe rence posed by the pres e n ce of
the M E E Q U I P M ENT d u ri n g s pecifi c i nvesti g ati o n s o r treat m e nts .
T h e i nstru cti o n s for u s e s h a l l i n c l u d e i nformati o n regardi n g pote nti a l e l ectr o m a g n et i c or other

i nterfe r e n c e betwe e n t h e M E E Q U I P M ENT and oth e r devices together with adv i c e o n ways to
avo i d o r m i n i m ize such i nterfe re n c e .
I f t h e M E E Q U I P M E NT is prov i d e d with a n i ntegral MULTIPLE SOCKET-OUTLET, t h e i nstru cti o n s for

use s h a l l prov i d e a warn i n g stat e m e n t that c o n n ecti n g e l ectrical e q u i p m ent to the MSO
effectively l eads to creati n g a n M E SYSTEM and the res u l t c a n be a reduced l evel of safety. F o r
t h e re q u i re m e nts t h at are a p p l i c a b l e to a n M E SYS T E M , t h e R E S P O N S I B L E ORGANIZATION s h a l l b e
refe rred to t h i s sta n d a r d .
7.9.2.3 M E EQUIPMENT s pecified for co n n ection t o a separate power s u pply

I f M E E Q U I P M ENT is i nt e n d e d for co n n ecti o n to a sepa rate power s u pply, either t h e power
s u pply s h a l l be specifi e d as part of the M E EQUI P M E NT o r the c o m bi n at i o n s h a l l be s pecifi ed as
a n M E SYS T E M . T h e i nstru cti o n s for use s h a l l state this specifi cati o n .
6060 1 - 1 © I EC : 20 0 5 - 1 27 -
7.9.2.4 E lect rical power sou rce

For m ai ns-ope rated M E E Q U I P M E NT with an additi o n a l power s o u rce n ot a u t o m ati c a l l y
m a i ntai n e d i n a f u l l y u s a b l e c o n d i ti o n , t h e i nstructi o n s f o r u s e s h a l l i n c l u d e a warn i n g
state m e nt referri n g t o t h e necessity for peri o d i c c h e c ki n g o r r e p l a c e m ent o f s u c h a n additi o n a l
power s o u rc e .
I f l e a ka g e from a battery wo u l d res u lt i n a n u n accepta b l e R I S K , t h e i nstru cti o n s for use s h a l l

i n cl u d e a warn i n g t o r e m ove t h e battery i f t h e M E E Q U I P M E NT i s n ot l i ke l y t o be u s e d fo r s o m e
ti m e .
I f a n I NTE RNAL E LECTRI CAL POW E R S O URCE is r e p l a c e a b l e , t h e i n st r u ct i o n s for u s e s h a l l state its

s pecifi cati o n .
I f loss o f t h e power s o u rce wo u l d result i n a n u n accepta b l e R I S K , t h e i nstru cti o n s for u s e s h a l l

conta i n a wa r n i n g t h at t h e M E E Q U I P M E NT m ust be c o n n ected t o a n a p propriate power s o u rce.
EXAMPLE I nternal o r external battery, u n i nterruptible power supply (UPS) o r i nstitutional stand-by generato r.
7.9.2.5 M E EQUIPMENT d escri ption

The i nstr u cti o n s for u s e s h a l l i n c l u d e :
a brief descri pt i o n o f t h e M E E Q U I PMENT;
how t h e M E E Q U I P M ENT fu n cti o n s ; a n d
- t h e s i g n i fi c a nt physical a n d perfo rm a nce c h a racte ristics of t h e ME EQUI P M E NT .
I f a p p l i c a b l e , t h i s descri pt i o n s h a l l i n cl u d e t h e ex pected positi o n s of t h e O P E RATOR, PAT I E NT

a n d oth e r persons n e a r t h e ME E Q U I P M ENT i n NORMAL U S E (see 9 . 2 . 2 . 3) .
T h e i nstr u cti o n s for u s e s h a l l i n cl u d e i nfo rm at i o n o n t h e m ateri a l s o r i n g r e d i e nts t o w h i c h t h e

PAT I E NT o r O P E RATOR is exposed i f s u c h ex posure c a n co nstitute a n u n accepta b l e R I S K (see
1 1 . 7).
T h e i nstructi o n s for u s e shall s pecify a n y restri cti o n s o n other e q u i pm ent o r N E TWORK/DATA
COUPLI NGS , oth e r t h a n those form i n g part of an ME SYS T E M , to w h i c h a S I G NAL I N P UT/OUTPUT
PART m ay be c o n n ecte d .
T h e i nstr u cti o n s f o r u s e s h a l l i n d i cate a n y APPLI E D PART.
7.9.2.6 * I n stallation
I f i n sta l l ati o n of the M E E Q U I P M E NT o r its parts i s req u i re d , the i nstr u cti o n s for u s e s h a l l
conta i n :
a refere n c e t o w h e re t h e i nstal l at i o n i nstruct i o n s a r e t o be fo u n d ( e . g . t h e tec h n ical
descri pti o n ) , o r
contact i nfo r m at i o n f o r p e r s o n s d e s i g n ated b y t h e MANUFACTURER as q u a l i fi e d to perform
t h e i n st a l l ati o n .
7.9.2.7 * I so lation from t h e S UPPLY MAINS

I f a n APPLIANCE COUPLER o r separable pl u g is used as t h e i s o l ati o n m ea n s to satisfy 8 . 1 1 . 1 a ) ,
t h e i nstr u cti o n s f o r u s e s h a l l c o nta i n a n i n structi o n n o t t o positi o n t h e M E E Q U I P M E NT s o t h at i t
is diffi c u l t t o operate t h e d i s co n n ecti o n device.
6060 1 - 1 © I EC : 20 0 5 - 1 29 -
7.9.2.8 Start- u p PROCEDURE

T h e i nstr u cti o n s for u s e s h a l l conta i n t h e n ecess a ry i nfo r m ati o n for t h e O P E RATOR to bri n g t h e
M E E Q U I P M ENT i nto o pe rati o n i n cl u d i n g s u c h ite m s as a n y i n itial c o ntrol setti n g s , co n n ecti o n t o
o r positi o n i n g o f t h e PATI E NT, etc.
The i nstr u cti o n s for use s h a l l d eta i l any treatm ent or h andling needed befo re t h e
M E E Q U I PMENT, i t s parts , o r ACCESSORIES c a n be u s e d .
EXAMPLE A pre-use checklist.
7.9.2.9 O pe rat i n g i nstruct i o n s

T h e i nstruct i o n s f o r use s h a l l conta i n a l l i nfo r m ati o n n ecess a ry to o pe rate t h e M E E Q U I PMENT
in accord a n c e with its s pecificat i o n . This s h a l l i n cl u d e ex p l a n ati o n of t h e fu n ct i o n s of contro l s ,
d i s p l ays a n d s i g n a l s , t h e s e q u e n ce o f operati o n , a n d c o n n e cti o n a n d d i s co n n ecti o n of
detach a b l e pa rts a n d ACCE SSORI E S , a n d repl ace m e nt of m ate r i a l t h at is cons u m ed d u ri n g
o p e rati o n .
T h e m ea n i n gs o f fi g u re s , sym bols, wa r n i n g state m e nts, a bbrevi ati o n s a n d i n di cator l i g h ts o n

M E E Q U I P M E N T s h a l l be ex p l a i n e d i n t h e i nstruct i o n s f o r u s e .
7.9. 2 . 1 0 M essages
The i nstructi o n s for use s h a l l l i st a l l system m essages, error m essages and fa u l t m essages
t h at are g e n e rated, u n l ess these m essages are s e lf-ex p l a n atory.
NOTE 1 These lists can be ide ntified i n groups.
The l i st s h a l l i n cl u d e a n ex pl a n at i o n of m essages i n c l u d i n g i m porta nt causes, and poss i b l e

act i o n (s) b y t h e O P E RATOR, i f a n y , t h at a r e n eces s a ry t o resolve t h e situati o n i n d i cated b y t h e
m essage.
NOTE 2 Req u i re m e nts and guidelines f o r messages generated b y a n a l a rm system a r e fo u n d i n I E C 6060 1 - 1 -8 .
7.9. 2 . 1 1 S h u td own PROCEDURE

T h e i nstr u cti o n s for u s e s h a l l conta i n t h e n ecess a ry i nfo r m at i o n for t h e O P E RATOR to s afely
termi n ate t h e operati o n of t h e M E E Q U I PM E NT .
7.9.2. 1 2 C lea n i n g , d i s i nfect ion a n d ste r i l izat ion

For M E E Q U I P M E NT parts o r ACCESSORIES t h at c a n beco m e conta m i n ated t h ro u g h contact with
t h e PAT I E NT o r with body fl u i ds o r ex pired gases d u ri n g N O R M A L USE , t h e i nstru cti o n s for use
s h a l l conta i n :
deta i l s a b o ut cl e a n i n g a n d d i s i nfect i o n o r ste r i l izati o n m et h o d s that m ay b e u s e d ; a n d
l ist t h e a p p l i c a b l e param eters s u c h a s tem pe ratu re, press u re , h u m i dity, ti m e l i m its a n d
n u m be r o f cycles t h at s u c h M E E Q U I P M E NT parts o r ACCESSORI E S c a n tole rate.
See also 1 1 . 6 . 6 a n d 1 1 . 6 . 7 .
T h i s req u i re m ent does n ot a pply t o a n y m ateri a l , c o m p o n e nt, ACCESSORY o r M E E Q U I P M E NT

t h at is m a rked as i nt e n d e d for a s i n g l e use u n l ess t h e MANUFACTU R E R s pecifies t h at t h e
m ateri a l , c o m po n ent, ACCESSORY o r M E E Q U I P M ENT i s to be c l e a n e d , d i s i nfected o r ste r i l i z e d
before u s e (see 7 . 2 . 1 ) .
6060 1 - 1 © I EC : 20 0 5 - 1 31 -
7.9.2. 1 3 M a i nte n a n ce
T h e i nstru cti o n s for u s e s h a l l i nstr u ct t h e O P E RATOR or RESPONS I BLE ORGANIZATION i n s u ffi c i e nt
deta i l concern i n g preve ntive i ns pecti o n , m a i nte n a n c e a n d cali brati o n to be perfo r m e d by
th e m , i n c l u d i n g t h e fre q u e n cy of s u c h m a i nt e n a n c e .
T h e i nstru cti o n s f o r u s e s h a l l prov i d e i nfo r m ati o n for t h e safe perform a n ce o f s u c h routi n e

m a i nt e n a n c e n ecessary to e n s u r e t h e conti n u ed safe u s e o f t h e M E E Q U I P M E NT.
Additi o n al ly, the i nstru cti o n s for use s h a l l i d e ntify the parts o n w h i c h p reventive i ns pe cti o n
a n d m a i nte n a n c e s h a l l be perfo r m e d b y S E RV I C E PE RSO N N E L , i n c l u d i n g t h e periods to b e
a p p l i e d , b u t n ot n ecessarily i n c l u d i n g deta i l s a bo ut t h e act u a l perform a n ce o f s u c h
m a i nt e n a n c e .
For M E E Q U I P M ENT c o nta i n i n g recharg e a b l e batte ries t h at are i nt e n d e d to be m a i nta i n e d by

a n y o n e oth e r t h a n S E RV I C E P E RS O N N E L , t h e i nstr u cti o n s for use s h a l l conta i n i nstru cti o n s to
e n s u re a d e q u ate m a i nte n a n c e .
7.9. 2 . 1 4 AccESSORI E S , s u p p l ementary eq u i pment, u sed material

T h e i nstru cti o n s for use shall i n c l u d e a l ist of ACCESSORI E S , deta c h a b l e parts a n d m aterials
t h at t h e MANUFACTURER h as d ete r m i n e d are i ntended for u s e with t h e M E E Q U I PM E N T .
I f M E E Q U I P M E NT i s i ntended to receive its power from oth e r e q u i p m e nt i n a n M E SYS T E M , t h e

i nstr u cti o n s for u s e s h al l sufficie ntly s pe cify s u c h ot h e r e q u i p m ent to e n s u re co m pl i a n c e with
the re q u i re m e nts of t h i s sta n d a rd ( e . g . part n u m ber, RATED v o l tage, m ax i m u m o r m i n i m u m
powe r, protect i o n class, i nterm itte nt or conti n u o u s servi ce).
NOTE What w a s referred t o i n t h e first and second editions of t h i s standard as a "specified power su pply" i s
considered either as another part o f t h e same M E EQU I PM E NT o r as other equipm ent i n a n M E SYSTEM . S i m i larly, a
battery charger is considered either as part of the M E EQU I PM E NT or as other e q u i pment in an M E SYSTEM .
7.9.2. 1 5 E n v i ro nmental p rotecti o n

T h e i nstr u cti o n s f o r u s e s h a l l :
i d e ntify a n y R I S KS ass o c i ated with t h e d i s posal o f waste prod u cts , res i d u e s , etc. and o f the
M E E Q U I P M E NT a n d ACCESSORIES a t t h e e n d o f t h e i r EXPECTED S E RV I C E L I F E ; a n d
prov i d e advice o n m i n i m iz i n g th ese R I S KS .
7.9. 2 . 1 6 Refe re nce t o t h e tec h n ical description

T h e i nstruct i o n s for use shall conta i n t h e i nfo r m at i o n s pecifi e d in 7 . 9 . 3 o r a refere n c e to
w h e re the m aterial s pecifi ed in 7 . 9 . 3 i s to be fo u n d ( e . g . in a serv i c e m a n u a l ) .
Compliance with the requirements o f 7. 9. 2 is checked b y inspection o f the instructions for use
in a language of an intended OPERA TOR.
7.9.3 Tec h n ical description (see also T a b l e C . 6 )
7 . 9. 3 . 1 * Gen eral
The tec h n i ca l descr i pt i o n s h a l l prov i d e all d ata t h at i s essential for safe operati o n , trans port
a n d sto rage, a n d m e as u res or c o n d i t i o n s n ecessary for i nstal l i n g t h e ME E Q U I PM E N T , a n d
prepari n g it f o r u s e . T h i s s h a l l i n c l u d e :
6060 1 - 1 © I EC : 20 0 5 - 1 33 -
- t h e i nfo r m at i o n req u i red i n 7 . 2 ;

- t h e perm issi b l e e nvi ro n m e ntal c o n d it i o n s o f u s e i n c l u d i n g c o n d it i o n s for trans port a n d
sto rage. S e e a l s o 7 . 2 . 1 7 ;
a l l c h a racteristics of t h e ME EQUI PMENT, i n c l u d i n g range(s), accu racy, a n d prec i s i o n of t h e
d i s p l ayed v a l ues o r a n i n d i cati o n w h e re t h ey c a n be fo u n d ;
a n y s peci a l i nsta l l ati o n req u i re m e nts s u c h as t h e m ax i m u m perm iss i bl e a pparent
i m pe d a n c e of S U PPLY MAI NS ;
NOTE 1 T h e apparent i m peda nce o f t h e S U P PLY M A I N S is t h e s u m o f t h e i m pedance o f t h e distribution network
plus the i m pedance of the power source.
if l i q u i d i s used for cool i n g , the perm issi b l e range of v a l u e s of i n l et press u re a n d flow, a n d

t h e c h e m ical c o m pos iti o n o f t h e coo l i n g l i q u i d ;
a descri pt i o n o f t h e m e a n s o f i s o l ati n g t h e ME EQUI PMENT fro m t h e S U PPLY MAI N S , if s u c h
m e a n s i s n o t i n corpo rated i n t h e ME EQUIPM ENT ( s e e 8 . 1 1 . 1 b ) ) ;
if a p p l i c a b l e , a descri pt i o n o f t h e m ea n s fo r c h e c k i n g t h e o i l l ev e l i n pa rti a l l y s e a l e d o i l
fi l l ed ME EQUI PMENT o r i t s parts (see 1 5 . 4 . 9) ;
a wa r n i n g state m e nt t h at a d d resses t h e HAZARDS t h at c a n res u l t fro m u n a uth orized
m o d ificat i o n of t h e ME EQUIPMENT, e . g . a stat e m e n t to t h e effect:
"WAR N I N G : No m odifi cati o n of t h i s e q u i p m ent is a l l owed . "
"WAR N I N G : Do n ot m o d ify t h i s e q u i pm ent with out a u t h o ri z at i o n o f t h e m a n ufact u re r . "
"WAR N I N G : I f t h i s e q u i p m ent is m odifi e d , a p p ro p ri ate i n s pe cti o n a n d testi n g m ust be
co n d u cted to e n s u r e conti n u e d safe use of the e q u i pm e nt. "
If t h e tec h n ical descripti o n is separable from t h e i nstru cti o n s for u s e , it s h a l l contai n :

- t h e i nfo r m at i o n req u i red i n 7 . 2 ;
a l l a p p l i c a b l e cl assificat i o n s s pecifi e d i n C l a u s e 6 , a n y warn i n g a n d s afety n ot i ces a n d t h e
ex p l a n at i o n o f s afety s i g n s ( m arked o n t h e ME E Q U I PMENT);
a b r i ef descri pti o n of t h e ME EQUI PMENT, how t h e M E EQUIPMENT f u n ct i o n s and its s i g n ifi cant
phys i ca l a n d perfo r m a n c e c h a racte ristics.
NOTE 2 The tech nical description is intended for the RESPO N S I B L E ORGAN IZATION and SERVICE PERSO N N E L .
T h e MANUFACTURER m ay desi g n ate t h e m i n i m u m q u a l ificati o n s f o r S ERVICE PERSONNEL. I f

pres ent, th ese req u i re m e nts s h a l l be doc u m e nted i n t h e tec h n i cal descripti o n .
NOTE 3 S o m e authorities with j u risdiction i m pose additional req u i re m e nts for q u a l ification o f SERVICE PERSO N N E L .
7.9.3.2 Replacement o f fuses, POWER S UPPLY CORDS a n d oth e r parts

The tec h n i ca l desc ri pt i o n s h a l l contai n , as a p p l i c a b l e , the fo l l owi n g :
- t h e re q u i red ty pe a n d f u l l rati n g o f fuses u s e d i n t h e S U PPLY MAI NS exte r n a l to
PERMANE NTLY I NSTALLED ME E Q U I PMENT, if the ty pe a n d rati n g of these fuses are n ot
a p pa r e nt from t h e i nform ati o n c o n cern i n g RATED cu rrent a n d m ode of operati o n of
ME EQUI PMENT;
- for ME EQUIPMENT h avi n g a n o n - DETACHABLE POWER S UPPLY CORD, a state m e nt as to
w h et h e r the POWER S UPPLY CORD i s replaceable by S ERVICE P E RSONNEL, a n d if s o ,
i nstru cti o n s f o r correct co n n ecti o n a n d a n c h o r i n g to e n s u re t h at t h e req u i re m e nts o f 8 . 1 1 . 3
wi l l c o nti n u e to be m et;
i nstru cti o n s for co rrect replace m ent of i nterc h a n g e a b l e o r deta c h a b l e parts that t h e
MANUFACTURER s pecifies as replaceable b y S ERVI C E PERSONNEL; a n d
6060 1 - 1 © I EC : 20 0 5 - 1 35 -
w h e re repl a c e m e nt of a com p o n e nt co u l d res u l t i n an u n a c c e ptable R I S K , a ppro priate

wa r n i ngs t h at i d e n tify t h e n at u re of t h e HAZARD and, if t h e MANUFACTU R E R s pecifies the
com p o n e nt as replaceable by S E RV I C E PERSONNEL, all i nform ati o n n ecess a ry to s afely
replace t h e co m po n e nt.
7.9.3.3 C i rc u i t d iag rams, component part l ists, etc.

T h e tec h n ical desc ri pti o n s h a l l conta i n a state m e n t t h at the MANUFACTU RER wi l l m a ke ava i l a bl e
o n requ est circuit d i a g r a m s , c o m p o n e n t part l ists, desc ri pti o n s , c a l i brati o n i nstru cti o n s , o r
oth e r i nformati o n that wi l l assist S E RV I C E PERSONNEL to repair t h o s e parts o f M E E Q U I PMENT
t h at are desi g n ated by t h e MANUFACTURER as repairable by S E RV I C E PERSONNEL.
7.9.3.4 * M a i n s isolation
The tec h n ical descri pt i o n shall clea rly i d e ntify any m ea n s used to com ply with t h e
req u i re m e nts o f 8 . 1 1 . 1 .
Compliance with the requirements of 7. 9. 3 is checked by inspection of the technical

description.
8 * P rotect i o n agai nst e lectrical HAZARDS from M E EQU I P M E N T
8.1 F u nd amental r u l e o f p rotection ag a i n s t electric s h ock

T h e l i m its s pecifi ed in 8.4 s h a l l not be ex ceeded for ACCES S I BLE PARTS and APPLI E D PARTS i n
NORMAL CONDI T I O N o r S I NG L E FAULT CONDITI O N . For ot h e r HAZARDOUS S I TUATIONS i n S I NG L E
FAULT CONDI T I O N , s e e 1 3 . 1 .
a) * NORMAL CONDITION i n cl udes a l l of t h e fol l owi n g s i m u l t a n e o u s l y :

- t h e pres e n ce o n a n y S I G NAL I N P UT/OUTPUT PART o f a n y v oltage o r c u rrent f r o m oth e r
e l ectrical e q u i pm ent t h at is perm itted to be c o n n ected accord i n g to t h e ACCOMPANY I NG
DOCU M E NTS as s pecifi e d i n 7 . 9 , o r , if t h e ACCO MPANY I NG DOC U M E NTS place no restri cti o n s
o n s u c h oth e r e l ectrical e q u i pm ent, t h e prese n c e o f t h e MAXI M U M MAI NS VOLTAGE a s
s pe cifi ed i n 8 . 5 . 3 ;
- trans positi o n of s u pply c o n n ecti o n s , fo r ME E Q U I PMENT i nt e n d e d for c o n n e ct i o n to a S U PPLY
MAINS by m ea n s of a MAINS PLUG ;
s h o rt c i r c u it of a n y or a l l i ns u l at i o n t h at does n ot c o m ply with t h e re q u i re m e nts of 8 . 8 ;

s h o rt ci rcuit o f a ny o r a l l CREEPAGE DISTANCES o r A I R CLEARANCES that d o n o t c o m ply with
t h e re q u i re m e n ts of 8 . 9 ;
o p e n circuit of a n y o r a l l earth co n n ecti o n s t h at do not com ply with t h e req u i re m e nts of
8 . 6 , i n c l u d i n g a n y fu n cti o n a l earth co n n ecti o n .
b ) * S I NGLE FAULT CONDITI O N i n c l u de s :

s h o rt circuit o f a n y o n e i ns u l at i o n that com pl i es w i t h t h e req u i re m e nts fo r o n e MEANS O F
PROTECTION as s pecifi ed in 8 . 8 ;
NOTE This includes short c i rc u iting of either constituent part of D O U B L E I N S U LATION that compl ies with 8 . 8 .
s h o rt circuit of a n y o n e CREEPAGE D I S TANCE o r A I R CLEARANCE t h at co m pl i es with the

req u i re m e nts for one MEANS O F PROTECT I O N as s pe cifi ed in 8 . 9 ;
s h o rt circuit a n d o p e n circuit of a n y c o m po n e nt oth e r t h a n a COMPONENT WITH H I G H
I NTEGRITY CHARACTE R I S TI CS t h at is c o n n ected i n para l l e l w i t h i ns u l ati o n , w i t h a n A I R
CLEARANCE o r with a CRE E PA G E D I S TANCE u n l ess s h o rti n g c a n be s h own n ot to be a fai l u re
m ode fo r t h e c o m po n e nt (see also 4 . 8 and 4 . 9) ;
6060 1 - 1 © I EC : 20 0 5 - 1 37 -
o p e n ci rcuit of a n y o n e PROTECTIVE EARTH CON DUCTOR o r i nte r n a l PROTECTIVE EARTH

CONNECTION that c o m pl i es with the re q u i re m e nts of 8 . 6 : t h i s does n ot a p p l y to a
PROTECTIVE EARTH CONDUCTOR of P E R MANE NTLY I NSTALLE D ME EQUI P M E NT, w h i c h i s
c o n s i d ered u n l i kely to b e c o m e d i s c o n n ected;
i nterr u pt i o n of a n y one s u pply c o n d u ctor, except for t h e n e utral c o n d u ctor of polyphase
ME EQUIPMENT o r P E R MA N E NTLY I NSTALLED M E E Q U I P M E NT;
i nterr u pt i o n of any o n e powe r-carryi n g c o n d u ctor betwe e n M E E Q U I P M E NT parts in s e p a rate
E NCLOS U R E S , if t h e R I S K ANALY S I S i n d i cates that t h i s c o n d iti o n m i g ht c a u s e perm itted l i m its
to be exc e e d e d ;
u n i ntended m ov e m e nt o f a co m po n e nt; but o n l y if t h e com p o n e nt i s n ot m o u nted s e c u rely
e n o u g h to e n s u r e that such m ov e m e n t wi l l be v e ry u n l i kely to occ u r d u ri n g t h e EXPECTED
S E RV I C E LIFE of the M E E Q U I PM E N T , as determ i n ed by the RISK MANAG E M E NT PROCESS (see
also 8 . 1 0 . 1 ) ;
accide ntal deta c h m ent of c o n d u ctors a n d co n n e ctors w h e re breaki n g free c o u l d l e a d to a
HAZARDOUS S I TUATI O N . S e e a l s o 8 . 1 0 . 2 .
Dete r m i nati o n o f w h i c h parts a re ACCES S I BLE PARTS is perfo r m e d i n acco rda n ce with 5 . 9 .
LEAKAGE CURRE NTS a r e m eas u re d i n accord a n c e with 8 . 7 .
8.2 Req u i rements related t o power sou rces
8.2. 1 C o n n ection to a sepa rate power sou rce
If M E E Q U I PMENT is specifi ed for co n n ecti o n to a sepa rate power s o u rc e , oth e r t h a n t h e S U PPLY

MA I NS , either the separate power s o u rce s h a l l be c o n s i dered as part of the M E E Q U I P M ENT a n d
a l l r e l ev a nt re q u i re m e nts o f t h i s sta n dard s h a l l a pply, o r t h e co m bi n ati o n s h a l l b e c o n s i dered
as a n M E SYS T E M . S e e a l s o 7 . 2 . 5 , 7 . 9 . 2 . 1 4 , 5.5 f) and C l a u s e 1 6 .
NOTE What was formerly referred to, in the first and second editions of this sta ndard, as a "specified power
s u pply" i s now considered either as another part of the same ME EQU I PM E NT or as another electrical e q u i pm e nt in
a n ME SYSTEM .
Compliance is checked by inspection and by testing as specified in 5. 5 f). If a particular

separate power supply is specified then the relevant tests are perform ed with the
ME EQUIPMENT connected to it. If a generic separate power s upply is specified, then the
specification in the A CCOMPANYING DO CUMENTS is inspected.
8.2.2 C o n n ection t o an exte rnal d . c. power s o u rce
I f M E E Q U I P M E NT i s s pecifi e d for
power s u pp l i e d fro m a n ext e r n a l d . c. powe r s o u rce, no
HAZARDOUS S I TUATI O N , oth e r t h a n a bs e n ce of E S S E NTIAL P E RFORMANCE , s h a l l dev e l o p w h e n a
co n n ecti o n with t h e wro n g p o l a rity is m a d e . T h e ME EQUI P M ENT, w h e n c o n n ecti o n is
s u bs e q u e ntly made with t h e co rrect pola rity, s h a l l prov i d e fre edom from u n a cc e pta b l e R I S K .
Protective devices t h at can be reset by a ny o n e wit h o ut t h e u s e of a T O O L a re accepta b l e
prov i d e d t h at th ese restore co rrect o pe rati o n o n reset.
NOTE The exte rnal d.c. power source can be a S U P P LY MAINS o r another item of electrical equi pment. I n the
latter case, the combi nation is considered to be a n ME SYSTEM as specified i n 8 . 2 . 1 .
Compliance is checked by inspection and, if necessary, by functional tests.
8.3 C lass ification o f APPL I E D PARTS
a) * An APPLI E D PART t h at is s pecifi ed in t h e ACCO MPANYI NG DOCUME NTS as s u itable for DI RECT
CARDIAC APPLICATI O N s h a l l be a TYPE CF APPLI E D PART.
NOTE Other restrictions can apply for cardiac a pplicatio n s .
Compliance is checked by inspection.

6060 1 - 1 © I EC : 20 0 5 - 1 39 -
b) * An APPLI E D PART t h at i n c l u des a PAT I E NT CONNECTION t h at is i nt e n d e d to d e l i v e r e l ectrical

e n e rgy o r a n e l ectrophys i ol o g i c a l s i g n a l to o r from t h e PAT I E NT s h a l l be a TYPE B F APPLI E D
PART o r TYPE CF APPLI E D PART.
c) An APPLI E D PART n ot covered by a) or b) s h a l l be a TYPE B A P PLI E D PART, TYPE B F APPLI E D

PART o r TYPE CF APPLI E D PART.
d) * F o r a part that is i d e ntifi ed accord i n g to 4 . 6 as n e e d i n g to be s u bj ect to t h e req u i re m e nts

for an APPLI E D PART ( except for m a rki n g ) , t h e req u i re m e nts fo r a TYPE B APPLI E D PART s h a l l
a p ply u n less t h e R I S K MANAG E M E NT PROCESS i d e ntifi es a n e e d fo r t h e req u i re m e n ts f o r a
TYPE BF APPLI E D PART or TYPE CF APPLI E D PART to apply.
8.4 L im itation o f voltage, cu rrent or e n e rg y

*
8.4. 1 PATIENT CONNECTIONS i n te n d ed to d e l iver c u r rent
T h e l i m its s pecifi ed in 8 . 4 . 2 d o not a p p l y to c u rrents t h at are i ntended to flow t h r o u g h t h e

b o d y o f t h e PAT I E NT to produce a p h ys i ol o g i c a l effect d u ri n g N O R MAL U S E .
8.4.2 ACCESSIBLE PARTS i n c l u d i n g APPL I E D PARTS
a) T h e c u rrents fro m , to or between PAT I E NT CONNECTIONS s h a l l not exceed t h e l i m its for

PAT I E NT LEAKAGE CURRENT a n d PAT I E NT AUXI LIARY CURRENT s pecified in T a b l e 3 a n d T a b l e 4
w h e n m e asured as s pecifi ed i n 8 . 7 . 4 .
Compliance is checked b y measurem ent according to 8 . 7. 4.
b) * T h e LEAKAGE CU RRENTS fro m , to o r betwe e n ACCE S S I B L E PARTS oth e r than PAT I E NT

CONNECTIONS s h a l l n ot exceed t h e l i m its fo r TOUCH CURRENT s pecifi ed i n 8 . 7 . 3 c) w h e n
m e as u red as s pecifi e d i n 8 . 7 . 4 .
Compliance is checked b y measurem ent according to 8 . 7. 4.
c) * T h e l i m its s pecifi ed in b) a bove do n ot a pply to t h e fol l owi n g parts if t h e p r o b a b i l ity of a

co n n ecti o n to a PAT I E N T , e i t h e r d i rectly or t h ro u g h t h e body of t h e O P E RATOR, t h ro u g h w h i c h
a cu rrent exceed i n g t h e a l l owable TOUCH CURRENT c o u l d flow, i s n e g l i g i b l e i n NORMAL U S E ,
a n d t h e i nstru cti o n s f o r use i nstruct t h e O P E RATOR not to t o u c h t h e relevant part a n d t h e
PAT I E NT s i m u l t a n e o u s l y :
acces s i b l e contacts o f co n n ecto rs ;

contacts of fus e h o l d e rs that are access i b l e d u ri n g repl a c e m e n t of t h e fus e ;
contacts o f l a m p h o l d e rs t h at are access i b l e after r e m ov a l o f t h e l a m p;
parts i n s i d e a n ACCESS COV E R t h at c a n be o p e n e d wit h o ut t h e u s e of a TOOL, or where
a T O O L is n e e d e d but t h e i nstr u cti o n s for use i nstruct a n y O P E RATOR other t h a n S E RV I C E
PERSONNEL to o pe n t h e relevant ACCESS COV E R .
EXAMPLE 1 I l l u m i nated push-buttons

EXAMPLE 2 I ndicator l a m ps
EXAMPLE 3 Recorder pens
EXAMPLE 4 Parts of plug-in modules
EXAMPLE 5 Batteries
6060 1 - 1 © I EC : 20 0 5 - 1 41 -
For s u c h parts , t h e voltage to e a rth or to ot h e r ACCESSI B L E PARTS s h a l l n ot exceed

42 , 4 V peak a . c. o r 6 0 V d . c . in NORMAL CONDITION o r in S I N G LE FAULT CONDI T I O N . The d . c .
l i m it o f 60 V a pp l i es t o d . c . with n ot m o re t h a n 1 0 % pea k-to- p e a k r i p p l e . I f t h e r i p p l e
exceeds t h at a m o u nt, t h e 4 2 , 4 V peak l i m it a p p l i e s . T h e e n e rgy s h a l l not exceed 240 VA
for l o n ge r t h a n 60 s or t h e stored e n e rgy avai l a b l e s h a l l n ot exceed 20 J at a pote ntial u p
t o 2 V.
NOTE I f voltages higher than the l i m its specified i n 8 . 4 . 2 c) are present, the LEAKA G E C U RRENT l i m its referred
to i n 8 . 4 . 2 b) apply.
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the

instructions for use and by m easurement.
d) * T h e voltage a n d e n e rgy l i m its specifi e d i n c) a bove a l s o a p p l y to:

i nternal parts , other t h a n co ntacts of p l u g s , c o n n ectors and socket-o utlets , t h at c a n be
t o u c h e d by the test p i n s h own in F i g u re 8 i n serted t h r o u g h a n o pe n i n g in an
E NCLOS U R E ; a n d
i nternal pa rts t h at c a n be t o u c h e d b y a m etal test rod with a d i a m eter o f 4 m m a n d a

l e n gth of 1 0 0 m m , i nserted t h r o u g h a n y o pe n i n g i n t h e t o p of a n E NCLOS URE or t h r o u g h
a n y o pe n i n g prov i d e d f o r t h e a dj ustm e n t o f pre-set controls t h at m ay be adj usted by
t h e RESPONSIBLE ORGANIZATI O N i n NORMAL USE by u s i n g a TOOL.
S e e also 8 . 9 . 4 concern i n g t h e m eas u r e m e nt of CREEPAGE DI STANCES and AIR CLEARANCES

t h r o u g h s l ots or o p e n i ngs in exte r n a l parts to the sta n dard test fi n g e r .
Compliance i s checked by inserting the test pin or the test rod through relevant openings.
The test pin is inserted in every possible position with minimal force (not m ore than 1 N) .
The test rod is inserted in every possible position through openings provided for the
adjustment of pre-set controls that can be adjusted by the RESPONSIBLE ORGANIZA TION in
NORMAL USE, in case of doubt with a force of 1 0 N.
If the instructions for use specify that a particular TOOL is to be used, the test is repeated
with that TOOL.
The test rod is also freely and vertically suspended through any opening in the top of an
ENCLOSURE.
Dimensions in m i l l i m etres
Electrical 1 5 -� 1
20 4
connection
Steel
N
ci
-H
l{)
N
ISl
I nsulating
material
IEC 2391105
Fig u re 8 - Test pin

(see 8 . 4 . 2 d) )
6060 1 - 1 © I EC : 20 0 5 - 1 43 -
e) Where an ACCESS COV E R that c a n be o pe n e d wit h o ut t h e u s e of a TOOL gives access to

pa rts t h at are at voltages a bove t h e l evels permitted by t h i s s u bc l a u s e , but these parts are
a u t o m at i c a l l y de-en ergized w h e n t h e ACCESS C O V E R i s o p e n e d , t h e dev i ce(s) used to de
e n ergize t h e parts shall m eet t h e req u i re m e n ts s pecifi e d in 8 . 1 1 . 1 for m ai ns i s o l ati n g
switc hes a n d s h a l l re m a i n effective i n S I NGLE FAULT CONDI T I O N . I f it i s poss i b l e to prevent
these devi ces from o p e rati n g , a TOOL s h a l l be req u i re d .
8.4.3 * M E EQU I P M E NT i ntended to be con nected to a power sou rce by a p l u g

M E E Q U I PMENT o r its parts i ntended to be c o n n ected t o a power s o u rce b y m ea n s o f a p l u g
s h a l l b e s o des i g n e d t h a t 1 s after disco n n ecti o n o f t h e pl u g t h e voltage betwe e n t h e p i n s of
t h e p l u g a n d between eith e r s u pply p i n a n d t h e E NCLOS URE does not exceed 60 V or, if t h i s
v a l u e i s exc e e d e d , t h e stored ch arge does n ot exceed 45 �-tC .
Compliance is checked by the following test:
ME E Q UIPMENT is operated at RA TED voltage or at the upper limit of the RA TED voltage range.
ME E Q UIPMENT is disconnected from the power source with any relevant s witch in the "On " and
"Off" positions.
Either the ME EQUIPMENT is disconnected from the power source by means of the plug, in
which case the test is performed as m any tim es as necessary to allow the worst case to be
measured, or a triggering circuit is used to ensure that disconnection occurs at the peak of the
supply voltage waveform.
The voltage b etween the pins of the plug and between any pin and the ENCLOSURE is
measured 1 s after disconnection with an instrument the internal impedance of which does not
affect the test.
The stored charge can be m easured or calculated by any convenient m ethod.
8.4.4 * I n ternal capacitive ci rcu its

C o n d u ctive parts of ca pacitive circu its that beco m e access i bl e after M E E Q U I P M E NT has been
de- e n e rgized and ACCESS COVERS as pres e nt in NORMAL USE have been rem oved i m m ed i ately
t h e reafte r , s h a l l n ot have a res i d u al voltage exceed i n g 6 0 V, o r , if this v a l u e is exceeded,
s h a l l n ot have a sto red c h a rg e exceedi n g 45 �-t C .
I f a u t o m at i c d i s c h a r g i n g i s n ot reas o n a bl y poss i bl e a n d ACCESS COVERS c a n be r e m ov e d o n l y

w i t h t h e a i d o f a TOOL, a dev i c e t h at is i n c l u d e d a n d w h i c h perm its m a n u al disch a rg i n g is
accepta b l e . T h e ca pacitor(s) o r t h e c o n n ected ci rcuitry s h a l l then be m a rked with sym bol
I EC 604 1 7-5036 ( 0 8 : 2002- 1 0 ) (see Table 0 . 1 , sym bol 24) and t h e n o n-auto m at i c d i s c h a rg i n g
device s h a l l b e s pecifi ed i n t h e tec h n ical descri pti o n .
Compliance is checked b y the following test:
ME E Q UIPMENT is operated at RA TED voltage and then de-energized. Any A CCESS COVERS
present in NORMAL USE are removed as quickly as normally possible. Immediately thereafter,
the residual voltage on any accessible capacitors or circuit parts is m easured and the stored
charge calculated.
If a non-autom atic discharging device is specified in the technical description, its inclusion
and m arking are ascertained by inspection.
6060 1 - 1 © I EC : 20 0 5 - 1 45 -
8.5 Separation o f parts
8 . 5. 1 * M EANS OF PROTECTION ( MOP)
8 . 5. 1 . 1 General
M E E Q U I PMENT s h a l l h av e two MEANS OF PROTECT I O N to prevent APPLI E D PARTS a n d oth e r
ACCES S I BLE PARTS from excee d i n g t h e l i m its s pecifi ed i n 8 . 4 .
E a c h MEANS O F PROTECT I O N s h a l l b e cate g o rized a s a MEANS O F PATI ENT PROTECT I O N o r a

MEANS OF O P E RATOR PROTECTI O N , taki n g acco u nt of 4 . 6 . S e e a l s o F i g u re A. 1 2 .
Varn i s h i n g , e n a m el l i n g , oxi d ati o n a n d s i m i l a r protective fi n i s h es , as well as coveri n g with

sea l i n g c o m po u nds t h at can repl asti cize at t e m peratu res to b e expected d u r i n g o p e rati o n
( i ncl u d i n g ste ril izati o n ) , s h a l l n ot be regarded as a MEANS O F PROTECTI O N .
NOTE Coatings a n d other insulation that are intended a s a M EA N S OF PROTECT ION a n d that comply with
I E C 60950- 1 : 2001 are acceptable as a M EA N S OF OPERATOR PROTECTION but not automatica l ly as a M EA N S OF
PAT I E N T PROTECT I O N . For M EANS OF PATI ENT PROTECTI O N , considerations c a n arise as a result of the R I S K
MANAG EM ENT PROCESS.
C o m p o n e nts and wi r i n g form i n g a MEANS O F PROTECT I O N s h a l l com ply with the r e l ev a nt

req u i re m e nts of 8 . 1 0 .
Any i ns u l ati o n , CRE E PA G E DI STANCE, A I R CLEARANCE S , c o m p o n e nt o r earth c o n n ecti o n t h at does

not c o m ply with t h e re q u i re m e nts of 8 . 5 . 1 . 2 and 8 . 5 . 1 . 3 s h a l l n ot be c o n s i d ered as a M E A N S O F
PROTECT I O N . F a i l u re of a n y o r a l l such parts s h a l l be regard e d as NORMAL CONDITI O N .
8 . 5. 1 . 2 M EANS OF PATIENT PROTECTION (MOPP)

S o l i d i ns u l at i o n fo r m i n g a MEANS O F PATI ENT PROTECT I O N s h a l l c o m ply with the d i e l ectric
stre n gth test accordi n g to 8 . 8 at t h e test voltage specifi ed i n Tabl e 6.
C R E E PAGE D I S TANCES and A I R CLEARANCES form i n g a M E A N S O F PAT I E NT PROTECTI O N s h a l l

com ply with t h e l i m its s pe cifi ed i n T a b l e 1 2 .
PROTECTIVE EARTH CONNECTIONS form i n g a MEANS O F PAT I E N T PROTECT I O N s h a l l c o m ply with t h e

req u i re m e nts a n d tests o f 8 . 6 .
A Y 1 capacitor c o m plyi n g with I EC 60384- 1 4 i s c o n s i d e re d e q u ival e nt to o n e MEANS OF

PAT I E NT PROTECT I O N prov i ded t h at it wi l l pass the d i e l ectri c stre n gth test fo r two MEANS O F
PAT I E NT PROTECT I O N . Where two ca pacitors a re used in series, t h ey s h a l l each be RATED for
t h e total WORKI NG VOLTAGE across t h e pai r a n d s h a l l h ave t h e s a m e NOMI NAL ca pacit a n c e .
8 . 5. 1 . 3 M EANS OF OPERATOR PROTECTION (MOOP)

S o l i d i ns u l at i o n form i n g a MEANS O F O P E RATOR PROTECT I O N s h a l l :
com ply with t h e d i e l ectric stre n gth test accordi n g to 8 . 8 a t t h e test voltage s pecifi ed i n
Table 6 ; o r
com ply with t h e req u i re m e nts o f I E C 6 0 9 50- 1 for I NS U LATI O N CO-ORDI NATI O N .
C R E E PAGE DI STANCES a n d A I R CLEARANCES form i n g a MEANS O F O P E RATOR PROTECT I O N s h a l l :

com ply with t h e l i m its s pecifi ed i n T a b l e 1 3 t o T a b l e 1 6 ( i n c l u s i v e ) ; o r
com ply with t h e req u i re m e nts o f I E C 6 0 9 50- 1 for I NS U LATI O N CO-ORDI NATI O N .
6060 1 - 1 © I EC : 20 0 5 - 1 47 -
PROTECTIVE EARTH CONNECTIONS form i n g a MEANS OF O P E RATOR P ROTECTION s h a l l either:

com ply with t h e req u i re m e nts of 8.6; o r
com ply w i t h t h e req u i re m e nts a n d tests o f I E C 60950- 1 f o r protective e a rth i n g .
A Y 2 capacitor c o m plyi n g with I EC 60384- 1 4 i s c o n s i d e re d e q u ival e nt to o n e MEANS OF

O P E RATOR PROTECT I O N prov i d e d t h at it wi l l pass the d i e l ectric str e n gth test for one MEANS OF
O P E RATOR PROTECT I O N . A Y1 capacitor com ply i n g with I E C 6 0 3 8 4- 1 4 is c o n s i d ered e q u ival e nt
to two MEANS OF O P E RATOR PROTECTION prov i d e d t h at it wi l l pass t h e d i e l ect r i c stre n gth test for
two MEANS O F O P E RATOR PROTECTI O N . W h e re two capacitors are u s e d in series, t h ey s h a l l each
be RATED for t h e total WORK I N G VOLTAGE a cross t h e p a i r and s h a l l h ave t h e same N O M I NA L
capacita n c e .
Compliance with 8. 5. 1 . 1 t o 8. 5. 1 . 3 (inclusive) i s checked b y examination of the physical and

electrical configuration of the ME EQUIPMENT to identify points at which insulation, CREEPA GE
DISTANCES, AIR CLEARANCES, impedances of components or PRO TECTIVE EARTH CONNECTIONS
prevent A CCESSIBLE PARTS from exceeding the limits specified in 8 . 4.
NOTE S uch points typically include insu lation betwe e n parts different from e a rth potential a n d ACCESS I B L E PARTS
but can also i nclude, for exa m p l e , insulation between a floating c i rc u it and e a rth o r other c i rc u its. A s u rvey of
insu lation paths i s fo u n d in An nex J .
For each such point, i t is determined whether:

solid insulation complies with the dielectric strength test according to 8. 8 or, for a MEANS
OF OPERA TOR PROTECTION, with the requirements of IEC 60950- 1 for INSULA TION CO
ORDINA TION;
CREEPA GE DIS TANCES and AIR CLEARANCES are as specified in 8. 9 or, for a MEANS OF
OPERA TOR PROTECTION, with the requirements of IEC 60950- 1 for INSULA TION CO
ORDINA TION;
components that are connected in parallel with an insulation, with an AIR CLEARANCE or
with a CREEPA GE DISTANCE comply with 4. 8 and 8. 1 0. 1 ;
PROTECTIVE EARTH CONNECTIONS comply with the requirements of 8 . 6 or, for a MEANS OF
OPERA TOR PRO TECTION, with the requirements of IEC 60950- 1 for protective earthing;
and hence whether a failure at that point is to be regarded as a NORMAL CONDITION or as a
SINGLE FA ULT CONDITION.
Each MEANS OF PROTECTION is categorized in relation to the ME EQUIPMENT part(s) which it

protects from exceeding permitted limits. It is a MEANS OF PA TIENT PROTECTION if it protects
APPLIED PARTS or parts that are identified according to 4. 6 as needing to be subject to the
same requirem ents as APPLIED PARTS. Otherwise it is a MEANS OF OPERA TOR PROTECTION.
The WORKING VOLTAGE is determined by inspection, calculation or measurement, according to

8. 5. 4.
The voltage, current or energy that can appear b etween any A CCESSIBLE PART and any other
A CCESSIBLE PART or earth in NORMAL CONDITION and in SINGLE FA ULT CONDITION is determined
by inspection or calculation or, where necessary, by measurem ent in the relevant conditions.
6060 1 - 1 © I EC : 20 0 5 - 1 49 -
8.5.2 Sepa ration o f PATIENT CONNECTIONS
8 . 5. 2 . 1 * F-TYPE APPLIED PARTS

T h e PAT I E NT CONNECT I O N ( S ) of a n y F-TYPE APPLI E D PART s h a l l be s e parated from a l l ot h e r parts,
i n cl u d i n g the PAT I E NT CONNECT I O N ( S ) of other APPLI E D PARTS, by m e a n s e q u i v a l e n t to o n e
MEANS O F PATI E N T PROTECT I O N for a WORKI NG VOLTAGE e q u a l t o t h e MAXI M U M MAINS VOLTAGE
a n d s h a l l c o m ply with the s pe cifi ed l i m it fo r PAT I E NT LEAKA G E CURRENT with 1 1 0 % of t h e
MAXI M U M MAINS VOLTAGE a p pl i e d .
A s i n g l e F-TYPE APPLI E D PART m ay i n c l u d e m u lt i pl e f u n ct i o n s , i n w h i c h case se pa rati o n

betwe e n s u c h fu n cti o n s i s n ot req u i re d .
I f t h e re i s n o el ectrical s e pa rati o n betwe e n PAT I E NT CONNECT I O N ( s ) o f t h e s a m e o r a n oth e r
f u n ct i o n ( e . g . betwe e n E C G el ectrode a n d pressure cath ete r), t h e n th ese PAT I E NT
CONNECT I O N ( S ) are treated as o n e APPLI E D PART.
Whet h e r m u lt i p l e f u n cti o n s a re to be c o n s i dered as a l l with i n o n e APPLI E D PART o r as m u lti p l e

APPLI E D PARTS is as d efi n e d b y t h e MANUFACTU R E R .
T h e c l assifi cati o n as TY P E B F , TYPE CF o r D E F I B R I LLATI ON-PROOF a p pl i es to t h e w h o l e of o n e
APPLI E D PART.
Compliance is checked by inspection, by the LEAKAGE CURRENT tests of 8. 7.4, by the dielectric
strength test of 8. 8. 3 and by measurement of relevant CREEPA GE DISTANCES and AIR
CLEARANCES.
NOTE The separation means betwee n a n F-TYPE A P P L I E D PART and other parts are s u bject both to these tests,
related to the MAXI M U M M A I N S VOLTA G E , and to tests related to the voltages present within the respective c i rc u its as
specified i n 8 . 5 . 4 . Depending o n the magnitude of the latter voltages, o n e set of tests o r the other could be m o re
stri ngent.
Any protective device co n n ected between PAT I E NT CONNECTI O N S of an F-TYPE APPLI E D PART
a n d t h e E NCLOS URE for t h e p u rpose of prov i d i n g protect i o n agai nst excessive vo ltages s h a l l
n o t operate b e l ow 5 0 0 V r. m . s .
Compliance is checked b y testing the operating voltage o f the protective device.
8.5.2.2 * T Y P E B APPL I E D PARTS

T h e PAT I E NT CONNECT I O N ( S ) of a TYPE B APPL I E D PART t h at is n ot PROTECTI V E LY EARTH E D s h a l l
b e s e pa rated b y o n e MEANS O F PATI ENT PROTECT I O N from m etal ACCE S S I B L E PARTS t h at a re n ot
PROTECTIVELY EARTH E D , u n less:
- t h e m etal ACCESSI BLE PART i s phys i c a l l y conti g u o u s with t h e APPLI E D PART and c a n be
regarded as a part of t h e APPLI E D PART; and
- t h e R I S K t h at t h e m etal ACCES S I BLE PART w i l l m a ke contact with a s o u rce of voltage o r
LEAKAGE CURRENT a bove permitted l i m its i s acceptably l ow.
Compliance is checked by inspection, by the LEAKAGE CURRENT tests of 8. 7.4, by the dielectric
strength test of 8. 8. 3, by measurem ent of relevant CREEPA GE DIS TANCES and AIR CLEARANCES,
and by reference to the RISK MANAGEMENT FILE.
8.5.2.3 * PATIENT leads

Any co n n ector fo r el ectrical co n n ecti o n s o n a PAT I E NT l e a d that:
is at t h e e n d of t h e lead r e m ote from t h e PAT I E NT ; and
conta i n s a c o n d u ctive part that is n ot s e p a rated from a l l PATI E N T CONNECTI O N ( s ) by o n e
MEANS O F PAT I E N T PROTECTI O N for a WORKI NG VOLTAGE e q u a l to t h e MAXI M U M MAI NS
VOLTA G E .
shall be constructed so that t h e s a i d part c a n n ot beco m e c o n n ected to e a rth o r possi b l e

h a z a r d o u s v o l t a g e wh i l e t h e PAT I E NT CONNECTI O N ( S ) contact t h e PAT I E NT.
6060 1 - 1 © I EC : 20 0 5 - 1 51 -
NOTE Where the p h rase "said part" is m e ntioned in this s u bclause, it refers to the " . . . cond uctive part of the
con nector that is not separated from a l l PAT I E N T CONN ECTI O N s . . . . " from the first s e ntence of this subclause.
I n parti c u l a r :
- t h e s a i d part s h a l l n ot c o m e i nto co ntact with a flat c o n d u ctive pl ate o f n ot l ess t h a n
1 0 0 m m d i a m eter;
- t h e A I R CLEARANCE betwe e n c o n n ector p i n s a n d a fl at s u rface s h a l l be at l e ast 0 , 5 m m ;
i f a b l e t o b e p l u gg e d i nto a m a i ns socket, t h e s a i d part s h a l l b e protected from m a ki n g
contact with parts a t MAINS VOLTAGE b y i ns u l ati n g m ea n s provi d i n g a CREEPAGE D I S TANCE of
at l east 1 , 0 m m a n d a d i e l ectric stre n gth of 1 5 0 0 V a n d c o m plyi n g with 8 . 8 . 4 . 1 ;
- t h e stra i g ht u nj o i nted test fi n g e r with t h e s a m e d i m e n s i o n s as t h e sta n d a rd test fi n g e r of
F i g u re 6 s h a l l not m a ke el ectrical contact with t h e s a i d part if a p p l i e d i n t h e l east
fav o u ra b l e pos i t i o n a g a i nst the access o p e n i n g s with a force of 1 0 N, u n l ess the R I S K
MANAG E M E NT PROCESS d e m o n strates t h at n o u n accepta b l e R I S K exi sts fro m co ntact with
o bj e cts other t h a n a m ai ns socket o r a flat s u rface ( e . g . c o r n e rs o r edges).
Compliance is checked by inspection and test as required.
8.5.3 * MAX I M U M MAI NS VOLTAGE

T h e MAXI M U M MAINS VOLTAGE s h a l l be d ete r m i n e d as fo l l ows :
- for s i n g le-phase or d . c . S U PPLY MAINS powe red ME E Q U I P M E N T , i n cl u d i n g I NTE RNALLY
POWERED M E E Q U I P M ENT t h at also has a m e a n s of con n ecti o n to a S U PPLY MA I NS , t h e
MAXI M U M MAINS VOLTAGE is t h e h i g h est RATED s u pply volta g e ; u n l ess t h i s i s l ess t h a n
1 0 0 V, i n w h i c h c a s e t h e MAXI M U M MAINS VOLTAGE i s 2 5 0 V;
- for polyphase ME E Q U I PM E NT , t h e MAXI M U M MAINS VOLTAGE is t h e h i g h est RATED phase to
n e utral s u pply voltage;
- for other I NTE RNALLY POWERED ME E Q U I P M E NT, t h e MAXI M U M MA I NS VOLTAGE is 2 5 0 V.
8.5.4 * WORKI NG VOLTAGE

T h e WORKI NG VOLTAGE for each MEANS O F PROTECTION s h a l l be determ i n ed as fo l l ows:
The i n put s u pply voltage to the M E E Q U I P M E NT s h a l l be t h e RATE D voltage o r t h e voltage
wit h i n t h e RATED voltage range which resu lts i n t h e h i g h est m eas u re d v a l u e .
For d . c . voltages with s u peri m pos e d r i p p l e , t h e WORK I N G VO LTAGE is t h e average v a l u e i f
t h e pea k-to- peak r i p p l e d o e s n ot exceed 1 0 % o f t h e average v a l u e o r t h e p e a k voltage i f
t h e pea k-to- peak r i p p l e exceeds 1 0 % o f t h e average v a l u e .
T h e WORKI NG VOLTAGE f o r e a c h MEANS O F PROTECTI O N form i n g DOUBLE I N S U LATION i s t h e
voltage t o w h i c h t h e DOUBLE I NS U LATION a s a w h o l e i s s u bjected.
For WORKI NG VOLTAGE i nvolvi n g a PAT I E NT CONNECTION n ot co n n ected to e a rt h , t h e s i t u ati o n
i n w h i c h t h e PAT I E NT i s eart h e d ( i ntenti o n a l l y o r acci denta l l y ) i s regarded as a NORMAL
CONDI T I O N .
T h e WORKI NG VOLTAGE between t h e PAT I E NT CONNECTION ( S ) of a n F-TYPE APPLI E D PART a n d

t h e E NCLOS URE is ta k e n a s t h e h i g h est voltage a ppeari n g across t h e i n s u l at i o n i n NORMAL
U S E i n cl u d i n g earth i n g of any part of the APPLI E D PART. See a l s o 8 . 5 . 2 . 1 .
6060 1 - 1 © I EC : 20 0 5 - 1 53 -
For D E F I B R I LLATI O N- P ROOF APPLI E D PARTS , t h e WORK I N G VO LTAGE is dete r m i n e d without

regard to t h e poss i b l e pres e n ce of defi bri l l at i o n voltages. See also 8 . 5 . 5 a n d 8 . 9 . 1 . 1 5 .
I n t h e case of m otors prov i d e d with c a pacitors w h e re a res o n a nce voltage can occ u r
betwe e n t h e poi nt w h e re a wi n d i n g a n d a capacitor a r e c o n n ected toget h e r o n t h e o n e
h a n d a n d a n y term i n a l f o r exte r n a l co n d u ctors o n t h e oth e r h a n d , t h e WORK I N G VOLTAGE
s h a l l be e q u a l to the reso n a nce voltage.
8.5.5 D E F I B RI L LATION-PROOF APPLIED PARTS
8 . 5. 5. 1 * Defi b r i l lation protecti o n

T h e cl ass ifi cati o n D E F I B R I LLATI ON-PROOF APPLI E D PART s h a l l a pply to t h e w h o l e o f o n e APPLI E D
PART.
NOTE 1 This req u i re m e nt does not apply to s e parate functions of the same A P P L I E D PART but the possibil ity of an
OPERATOR receiving a shock from such parts should be considered in the R I S K MANAG E M E N T PROCESS.
See 8 . 9 . 1 . 1 5 for the req u i re m e nts for CREEPAGE D I S TANCES and AIR CLEARANCES associated
with a D E F I B R I LLATI O N- P ROOF APPLI E D PART.
Arr a n g e m e nts used to i s o l ate the PAT I E NT CONNECT I O N ( S ) of a D E F I BRI LLATI ON-PROOF APPLI E D
PART from oth e r parts of M E E Q U I PMENT s h a l l be s o desi g n e d t h at:
a) D u ri n g a d i s c h arge of a cardiac defi bri l l ato r to a PAT I E NT co n n ected to a D E F I B R I LLATION

PROOF APPLI E D PART , hazardous e l ectrical e n e rg i e s , as dete r m i n e d by t h e peak voltage
m e as u red betwe e n t h e p o i nts Y 1 and Y 2 of F i g u re 9 and F i g u re 1 0 exc e ed i n g 1 V, do not
a p pear o n :
t h e E NCLOS U R E , i n c l u d i n g co n n ectors i n PAT I E NT l eads a n d c a b l es when c o n n ected to
the M E E Q U I P M ENT;
NOTE 2 This re q u i re m e nt does not a p ply to a connecting lead from a D E F I B R I L LATION-PROOF APPLIED PART
o r its con nector when it is discon nected from the ME EQU I PM E NT.
a n y S I GNAL I N P UT/OUTPUT PART;

m etal fo i l for test on w h i c h t h e M E E Q U I P M E N T i s placed a n d w h i c h has a n area at l east
e q u a l to the base of the M E E Q U I PMENT; or
PAT I E NT CONNECTIONS of any ot h e r APPLI E D PART (whet h e r o r not cl assifi ed as a
D E F I B R I LLATION-PROOF APPLI E D PA RT).
b) F o l lowi n g ex pos u re to the defi b r i l lati o n voltage, and any necessary recov e ry ti m e stated i n
t h e ACCO MPANYI NG DOCU M E NTS , t h e M E E Q U I P M E NT s h a l l c o m p l y with relevant req u i re m e nts
of t h i s sta n dard a n d s h a l l co nti n u e to prov i d e BAS I C SAFETY a n d E S S E NTIAL P E RFORMANCE .
Compliance is checked by the following tests, for each DEFIBRILL A TION-PROOF APPLIED PART in
turn.
Com m on-mode test
The ME EQUIPMENT is connected to the test circuit as shown in Figure 9. The test voltage is
applied to all the PATIENT CONNECTIONS of the DEFIBRILLA TION-PROOF APPLIED PART connected
together, excluding any that are PRO TECT/ VEL Y EARTHED or functionally earthed.
6060 1 - 1 © I EC : 20 0 5 - 1 55 -
R1 1 kQ Display
device
Zi n > 1 MQ
® Unearthed ACCESSIBLE PARTS
Foil in contact with

-�1-----
)�0
U
non-conductive
parts of ENCLOSURE
/ R 50 Q
PATIENT CONNECTIONS
MAINS
Mains
PART RcL
I
I R 1 00 Q
I
I
FE I
�
I
I
_________________________j
Protective earth Foil at base of

CLASS I ME EQUIPMENT ME EQUIPMENT
IEC 2392105
For legends, see Table 5 .

Components
Vr Test voltage
S Switch for a pplying the test
voltage
Tolerance at ± 2 % , not less than
2 kV
RcL Current l i m iting resistor
o,, 02 S m a l l signal silicon d i odes
Other com ponents toleranced at ± 5 %
Fig u re 9 - Application of test voltage to bridged PATIENT CONNECTIONS

for DEFIBRILLATION-PROOF APPLIED PARTS
(see 8 . 5 . 5 . 1 )
Differen tial-mode test
The ME EQUIPMENT is connected to the test circuit as shown in Figure 1 0. The test voltage is
applied to each PATIENT CONNECTION of the DEFIBRILLA TION-PROOF APPLIED PART in turn with all
the rem aining PATIENT CONNECTIONS of the same DEFIBRILLA TION-PROOF APPLIED PART b eing
connected to earth.
NOTE The differential-mode test is not used when the A P P L I E D PART cons ists of a single PATIENT C O N N ECTI O N .
6060 1 - 1 © I EC : 20 0 5 - 1 57 -
During the above tests:

except for PERMANENTLY INS TALLED ME EQ UIPMENT, the ME EQ UIPMENT is to be tested with
and without the PROTECTI VE EARTH CONDUCTOR connected (i. e. two separate tests);
insulating surfaces of APPLIED PARTS are covered with metal foil or, where appropriate,
immersed in a 0, 9 % saline solution;
any external connection to a FUNCTIONAL EARTH TERMINAL is rem o ved;
- parts specified 8. 5. 5. 1 a) that are not PRO TECTIVELY EARTHED are connected in turn to a
display device;
the ME EQ UIPMENT is connected to the SUPPL Y MAINS and operated in accordance with the
instructions for use.
After the operation of S, the peak voltage b etween the points Y1 and Y2 is m easured. Each
test is repeated with VT reversed.
After any recovery tim e stated in the A CCOMPANYING DOCUMENTS, determine that the
ME EQUIPMENT continues to provide BASIC SAFETY and ESSENTIAL PERFORMANCE.
8.5.5.2 E n e rgy red uction test

D E FI B RI LLATI O N- P ROOF APPL I E D PARTS or PAT I E NT CONNECTIONS of D E F I B R I LLATI ON-PROOF
APPLI E D PARTS s h a l l i n corpo rate a m e a n s so that t h e d efi bri l l ator e n ergy delivered to a 1 00 Q
l o a d is at l e ast 90 % of t h e e n ergy d e l ivered to t h i s l oad with t h e ME E Q U I P M E NT d i s c o n n ecte d .
Compliance i s checked b y the following test:
The test circuit is shown in Figure 1 1 . For this test, the A CCESSORIES such as cables,
electrodes and transducers that are recommended in the instructions for use (see 7. 9. 2. 1 4)
are used. The test voltage is applied to each PATIENT CONNECTION or APPLIED PART in turn with
all the remaining PATIENT CONNECTIONS of the same APPLIED PART being connected to earth.
The PRO CEDURE is as follows.

a) Connect the APPLIED PART or PATIENT CONNECTION to the test circuit.
b) Charge capacitor C to 5 kV d. c. with s witch S in position A .
c) Discharge capacitor C b y actuating the switch S t o position B, a n d m easure the energy E 1
delivered t o the 1 00 Q load.
d) Rem ove the ME EQUIPMENT under test from the test circuit and repeat steps b) and c)
above, measuring the energy E2 delivered to the 1 00 Q load.
e) Verify that the energy E1 is at least 90 % of E2.
6060 1 - 1 © I EC : 20 0 5 - 1 59 -
R1 1 kQ
Display
device
I Zi n > 1 MQ
I
L________l
Foil in contact with

non-conductive
--'--1--- parts of ENCLOSURE
MAINS
Mains RcL
PART
1
L 500 flH
R <:: 1 0 Q
C 32 f1F
IEC 2393105

Components
Vr Test voltage
S Switch for a pplying the test
voltage
R, , R2 Tolerance at ± 2 %, not less than
2 kV
01 , 02 S m a l l signal silicon d i odes
Other com ponents toleranced at ± 5 %
Fig u re 1 0 - Appl ication of test voltage to individual PATIENT CONNECTIONS for

DEFIBRILLATION-PROOF APPLIED PARTS
(see 8 . 5 . 5 . 1 )
6060 1 - 1 © I EC : 20 0 5 - 1 61 -
CD
RcL
�
R 1 00 Q
(non
inductive)
FE L 25 mH
R 1 1 Q - RL,
where is RL the
d.c. resistance
of the inductor L
C 32 flF
IEC 2394105

Components
S Switch for a pplying the test energy
A, B Switch positions
Compone nts toleranced at ± 5 %
F ig u re 1 1 - Ap p l ication of test voltage to test t h e del ivered defi b r i l lation energy

(see 8 . 5 . 5 . 2)
8.6 * P rotective eart h i ng , fu nct i o n a l eart h i n g a n d potential eq u a l ization of

ME EQUIPMENT
8.6. 1 * Applicabil ity of req u i rements

T h e re q u i re m e nts of 8 . 6 . 2 to 8 . 6 . 8 ( i ncl usive) a p ply u n l ess t h e p a rts c o n ce r n e d c o m ply with
t h e re q u i re m e nts and tests of I EC 60950- 1 for protective eart h i n g and serve as MEANS OF
O P E RATOR PROTECT I O N but n ot as MEANS O F PAT I E N T PROTECT I O N .
8.6.2 * P ROTECTIVE EARTH TERM I NAL

T h e PROTECTIVE EARTH T E RM I NA L of M E EQUI P M E NT s h a l l be s u it a b l e for co n n ecti o n to a n
ext e r n a l protective eart h i n g system e i t h e r b y a PROTECTIVE EARTH COND UCTOR i n a POWER
S U PPLY CORD a n d , where a p p r o pri ate , by a s u it a b l e p l u g , or by a F I X E D PROTECTIVE EARTH
CONDUCTO R .
T h e c l a m p i n g m e a n s o f t h e PROTECTIVE EARTH T E RM I NA L o f M E EQUI P M E NT for F I X E D s u pply

c o n d u ctors o r POW E R SUPPLY CORDS shall com ply with t h e req u i r e m e nts of 8 . 1 1 . 4 . 3 . I t shall not
be poss i bl e to loosen t h e cl a m p i n g means wit h o u t t h e a i d of a T O O L .
Screws fo r i nternal PROTECTIVE EARTH CONNECTIONS s h a l l be c o m p l etely covered o r protected

agai nst accide ntal l o o s e n i n g from the o utsi d e of M E E Q U I P M E NT .
6060 1 - 1 © I EC : 20 0 5 - 1 63 -
Where a n APPLIANCE I NLET forms t h e s u pply co n n ect i o n to ME EQUIPMENT, t h e earth p i n of t h e

APPLIANCE I NLET s h a l l be r e g a r d e d as t h e PROTECTIVE EARTH TERM I NAL.
T h e PROTECTIVE EARTH TERMINAL s h a l l n ot be used for t h e m ec h a n ical c o n n ecti o n between

d iffe rent pa rts of t h e ME EQUIPMENT o r t h e fix i n g of a n y c o m po n e nt not r e l ated to protective
earth i n g o r f u n cti o n a l earth i n g .
Compliance is checked b y inspection of m aterials and construction, b y m anual tests, and by

the test of 8. 1 1 . 4. 3.
8.6.3 * P rotective earth i n g o f m o v i n g parts

Any PROTECTIVE EARTH CONNECTION s h a l l n ot be used for a m ov i n g part u n l ess t h e
MANUFACTURER d e m o nstrates t h at t h e co n n ecti o n w i l l re m a i n re l i a b l e d u r i n g t h e EXPECTED
S ERVICE LIFE of the ME E Q U I PMENT.
Compliance is checked by inspection of the ME E Q UIPMENT and if necessary inspection of the

RISK MANA GEMENT FILE.
8.6.4 I m ped a n ce and c u r rent-carrying capa b i lity
a) * P ROTECTIVE EARTH CONNECTIONS s h a l l be a b l e to ca rry fa u l t c u rre nts r e l i a bly and wit h o ut

excess ive voltage drop.
For PERMANE NTLY I NSTALLED ME EQUI PMENT, t h e i m pedance between t h e PROTECTIVE EARTH
TERM I NAL a n d any part that is PROTECTIVELY EARTHED s h a l l n ot exceed 1 00 mQ, except as
a l l owed by 8 . 6 . 4 b ) .
For ME EQUIPMENT w i t h a n APPLIANCE I NLET t h e i m pe d a n c e between t h e earth pi n i n t h e

APPLIANCE I N L E T a n d a ny part t h at is PROTECTIVELY EARTHE D s h a l l n ot exceed 1 0 0 m Q ,
except as a l l owed b y 8 . 6 . 4 b ) .
For ME EQUIPM ENT w i t h a n o n -DETACHABLE POWER SUPPLY C O R D t h e i m pe d a n ce betwee n t h e

protective e a rth pi n i n t h e M A I N S P L U G a n d a n y part that is PROTECTIVELY EARTHED s h a l l not
exceed 2 0 0 m Q , exce pt as a l l owed by 8 . 6 . 4 b) .
A current of 25 A or 1 , 5 tim es the highest RA TED current of the relevant circuit(s) ,

whichever is greater (:t 1 0 %), from a current source with a frequency of 50 Hz or 60 Hz
and with a no-load voltage not exceeding 6 V, is passed for 5 s to 1 0 s through the
PROTECTIVE EARTH TERMINAL or the protective earth contact in the APPLIANCE INLET or the
protective earth pin in the MAINS PLUG and each PRO TECT/ VEL Y EARTHED part.
The voltage drop b etween the parts describ ed is m easured and the impedance determined
from the current and voltage drop.
Where the product of the test current as specified above and the total impedance (i. e. the
impedance being m easured plus the impedance of the test leads and the contact
impedances) would exceed 6 V, the impedance is first m easured with a no-load voltage not
exceeding 6 V.
If the m easured impedance is within the permitted limit, either the impedance measure
ment is then repeated using a current source with a no-load voltage sufficient to deliver the
specified current into the total impedance, or the current-carrying ability of the relevant
protective earth conductor and protective earth connection is confirm ed by checking that
their cross sectional area is at least equal to that of the relevant current-carrying
conductors.
6060 1 - 1 © I EC : 20 0 5 - 1 65 -
b) * T h e i m p e d a n ce of PROTECTIVE EARTH CONNECTIONS is a l l owed to exceed t h e val ues

s pecifi ed above if t h e relevant circu its have l i m ited cu rrent c a p a b i l ity such t h at, i n case of
s h o rt circuit of relevant i ns u l ati o n , t h e a l l ow a b l e val u es of t h e TOUCH CURRENT a n d t h e
PAT I E NT LEAKAGE CURRENT i n S I NGLE FAULT CONDITI ON are not exceeded.
Compliance is checked by inspection and if necessary by m easurement of LEAKAGE

CURRENT in the relevant SINGLE FA ULT CONDITION. Transient currents occurring during the
first 50 ms following the short circuit are disregarded.
8.6.5 S u rface coat i n g s

C o n d u ctive e l e m e nts o f ME E Q U I P M E N T t h at h a v e s u rface co ati ngs of poorly c o n d u cti n g
m aterial s u c h a s pai nt, a n d betwee n w h i c h e l ectrical contact i s ess e nti a l t o a PROTECTIVE
EARTH CONNECTION, s h a l l h ave the co ati ngs re m ov e d at the poi nt of contact u n l ess a n
i nvesti gati o n o f t h e j o i nt constr u cti o n a n d t h e m a n ufact u ri n g PROCESS h a s d e m o nstrated t h at
t h e req u i re m e nts for i m pe d a n c e a n d c u rrent-ca rryi n g c a pa ci ty a re assu red wit h o ut t h e
r e m ov a l o f t h e s u rface coati n g .
8.6.6 P l u g s and sockets

Where the c o n n ecti o n between the S U PPLY MAI NS a n d ME EQUI PMENT o r betwe e n se pa rate
pa rts of ME EQUIPM ENT that can be operated by persons oth e r t h a n S E RVICE PERSONNEL is
m ade v i a a p l u g a n d soc ket dev i c e , the PROTECTIVE EARTH CONNECTION s h a l l be m a d e befo re
a n d i nterr u pted after t h e s u pply c o n n ecti o n s a re m ade o r i nterr u pted. T h i s appl i es also w h e re
i nterc h a n g e a b l e parts are PROTECTIVELY EARTHED.
8.6. 7 * POTE NTIAL EQUALIZATION CONDUCTOR

I f ME EQUIPM ENT is prov i d e d with a term i n al for t h e c o n n ecti o n of a POTENTIAL EQUALIZATION
CONDUCTO R , t h e fo l l owi n g re q u i re m e nts a pply.
T h e term i n al s h a l l be access i b l e to t h e OPERATO R with t h e ME EQUIPMENT in a n y pos i t i o n of
NORMAL USE.
T h e RISK of accide ntal d i s co n n ecti o n s h a l l be m i n i m ized in NOR MAL USE.
T h e term i n a l shall a l l ow t h e c o n d u ctor to be deta c h e d wit h o ut t h e use of a TOOL.
The term i n a l s h a l l n ot be used for a PROTECTIVE EARTH CONNECTI O N .
T h e term i n al s h a l l be m a rked w i t h sym bol I EC 6 0 4 1 7-502 1 ( 0 8 : 2 0 02 - 1 0) (see T a b l e 0 . 1 ,
symbol 8 ) .
T h e i nstru cti o n s f o r use s h a l l conta i n i nfo r m ati o n o n t h e fu n ct i o n a n d u s e o f t h e POTENTIAL
EQUALIZATION CON DUCTOR toget h e r with a refere nce to the req u i re m e nts of this sta n d a rd
for ME SYSTEMS.
T h e POWER SUPPLY CORD s h a l l n ot i n c o rporate a POTENTIAL EQUALIZATI ON CONDUCTOR.
8.6.8 FUNCTIONAL EARTH TERMI NAL

A FUNCTI ONAL EARTH TERMINAL of ME EQUIPMENT s h a l l n ot be u s e d to prov i d e a PROTECTIVE
EARTH CONNECTION.

6060 1 - 1 © I EC : 20 0 5 - 1 67 -
8.6.9 * CLASS I I M E EQU I P M E NT

If CLASS I I ME EQUIPMENT with isol ated i nt e r n a l screens is s u pp l i e d with a POWER S UPPLY CORD
havi n g three c o n d u ctors , the t h i rd c o n d u ctor ( c o n n ected to the protective earth co ntact of t h e
M A I N S P L U G ) s h a l l be used o n l y as t h e fu n cti o n a l e a rth co n n e ct i o n to a FUNCTI ONAL EARTH
TERM I NAL for th ese screens a n d s h a l l be col o u red g re e n a n d y e l l ow.
The i ns u l at i o n of s u c h i nt e r n a l screens and all i nternal wi r i n g c o n n ected to them s h a l l prov i d e

two MEANS OF PROTECTION. I n s u c h case, t h e re s h a l l be a n e x p l a n ati o n i n t h e tec h n ical
descri pti o n .
Compliance is checked b y inspection and m easurement. The insulation is tested a s describ ed

in 8. 8.
8. 7 LEAKAGE C U RRENTS a n d PAT I E NT AUXI LIARY CURRENTS
8.7. 1 General req u i re m ents
a) The e l ectrical i s o l ati o n prov i d i n g protect i o n agai nst el ectric s h ock s h a l l be of such q u a l ity
t h at c u rrents fl owi n g t h ro u g h it are l i m ited to t h e v a l ues s pe cifi ed in 8 . 7 . 3 .
b ) T h e specified v a l ues o f t h e EARTH LEAKAGE CURRENT, t h e TOUCH CURRENT, t h e PAT I E NT

LEAKAGE CURRENT a n d t h e PAT I E NT AUXI LIARY CURRENT a p p l y i n a n y c o m b i n at i o n of t h e
fol l owi n g c o n diti o n s :
a t o pe rati n g tem peratu r e a n d fo l l owi n g t h e h u m i dity preco n d iti o n i n g treat m e nt, a s
descri bed i n 5 . 7 ;
i n NORMAL CONDITION a n d i n t h e S I NG LE FAULT CONDITIONS s pe cifi ed i n 8 . 7 . 2 ;
- with ME EQUIPM ENT e n e rgized i n sta n d - by c o n diti o n a n d f u l l y o pe rati n g a n d with a n y
switch i n t h e MAINS PART i n a n y positi o n ;
- with t h e h i g h est RATE D s u pply freq u e n cy;
- with a s u pply e q u a l to 1 1 0 % of t h e h i g h est RATED MAINS VOLTAG E .
8 .7.2 * SINGLE F A U L T CONDITIONS

The a l l owa b l e v a l ues specifi ed in 8 . 7 . 3 a p ply in t h e S I NGLE FAULT CONDITIONS s pecifi e d i n
8 . 1 b ) except t h at:
- w h e re i ns u l at i o n is used i n c o nj u n cti o n with a PROTECTIVE EARTH CONNECT I O N , s h o rt circuit
of t h e i ns u l at i o n a p p l i es o n l y i n t h e c i r c u m sta n ces s pecifi ed i n 8 . 6 . 4 b ) ;
- t h e o n l y S I NGLE FAULT CONDI TION for t h e EARTH LEAKAG E CURRENT is t h e i nterrupti o n of o n e
s u pply c o n d u ctor a t a ti m e ;
LEAKAGE CURRE NTS a n d PAT I E NT AUXI LIARY CURRENT a r e n o t m eas u red i n t h e S I NGLE FAULT
CONDI TION of s h o rt ci rcuiti n g of one constituent part of DOUBLE I NS ULATION.
SI NGLE FAULT CONDITIONS shall n ot be applied at t h e same ti m e as t h e special test con diti o n s
o f MAXI MUM MAINS VOLTAGE o n APPLI ED PARTS ( 8 . 7 . 4 . 7 b)) a n d n o n-PROTECTI VELY EARTHED parts
of t h e E NCLOS URE ( 8 . 7 . 4 . 7 d ) ) .
8.7.3 * Allowable val u es
a) T h e a l l owa b l e v a l ues s pecifi ed i n 8 . 7 . 3 b ) , c) a n d d) a pply to c u rre nts fl owi n g t h r o u g h t h e

n etwo rk o f F i g u re 1 2 a) a n d m eas u re d as s h own i n this f i g u r e ( o r b y a device m e a s u r i n g
t h e fre q u e n cy co ntents o f t h e c u rre nts as defi n e d i n F i g u re 1 2 b ) ) . T h e v a l ues a p p l y to d . c .
a n d a . c. a n d c o m posite wavefo r m s . U n l ess state d oth e rwise t h ey m ay be d . c . o r r . m . s .
6060 1 - 1 © I EC : 20 0 5 - 1 69 -
b) T h e a l l owa b l e val u es of t h e PAT I E NT LEAKAGE CU RRENTS a n d PAT I E NT AUXILI ARY CURRENTS

are stated in T a b l e 3 and T a b l e 4. The v a l ues of a . c. a pply to cu rre nts h av i n g a fre q u e n cy
not l ess t h a n 0 , 1 Hz.
c) T h e a l l owa b l e v a l u es of t h e T O U C H CURRENT are 1 0 0 �-tA in N O R MAL CONDITION and 5 0 0 �-tA i n

S I NGLE FAULT CON D I TI O N .
d) T h e a l l owa b l e v a l u es of t h e EARTH LEAKAGE CURRENT a r e 5 m A i n NORMAL CONDITION a n d

1 0 m A i n S I NG L E FAULT CONDI T I O N . F o r PERMANE NTLY I NSTALLE D M E EQUI P M E NT co n n e cted to
a s u pply c i rc u it t h at s u p p l i es o n l y t h i s M E E Q U I P M E N T , a h i g h e r v a l u e of EARTH LEAKAGE
CURRENT is a l l owe d .
NOTE Local reg u lation c a n esta blish l i m its for protective e a rth currents o f t h e installati o n . S e e also
IEC 60364-7-7 1 0 [ 1 0] .
e) Additi o n a l l y , regardl ess o f wavefo rm a n d fre q u e n cy, n o LEAKAGE CURRENT s h a l l exceed

1 0 m A r. m . s . in NORMAL CON DITION o r in S I NGLE FAULT CONDI T I O N when m easu red with a
n o n-fre q u e n cy-wei g hted dev i c e .
18
+20
c�
,--------------, N�
Rt
I I N
��
0
Ol
I I
.Q
I I 0
N
I I
iri
�
I I Voltage -20
z "0
1 R2 Ct 1 measuring
instrument bJ o
I I Q)
I I
�Ci.
�
-40
I I
I I E
L _ _ _ _ _ _ _ _ _ _ _ _ _ _ � "'
Q)
> -60
Rt t O kQ ± 5 % '1 �
"
cr
R2 t kQ ± 5 % '1
Ct O.Ot 5 flF ± 5 % t o' t o' t o' t 05 t 06
Frequency f Hz
a) Measuring device b) Frequency characteristics

IEC 2395105
�
NOTE The network and voltage measuring instrument above are replaced by the symbol � in the
following figures.
a
) Non-inductive components
b) Resistance � 1 MQ and capacitance � 1 50 pF
c
) Z(f) is the transfer impedance of the network, i.e. Vout/lin, for a current of frequency f.
F ig u re 1 2 - Exa m ple of a meas u r i n g d evice and its freq u ency ch aracte ristics
(see 8 . 7 . 3 )
6060 1 - 1 © I EC : 20 0 5 - 1 71 -
Table 3 - * A l l owable val u es of PATIENT LEAKAG E CURRENTS a n d PATI ENT AUXILIARY

CURRENTS u n d e r NORMAL CONDITION a n d S I NGLE FAULT CONDITION
Current i n f.!A
TY P E B TY P E B F TY P E C F
APPLIED APPLIED APPLIED
PART PART PART
Cu rrent Description Reference Measuring NC SFC NC SFC NC SFC

C i rcuit
d.c. 10 50 10 50 10 50
PATIENT
AUXI LIARY 8. 7.4.8 Figure 1 9
CURRENT
a.c. 1 00 500 1 00 500 10 50
d.c. 10 50 10 50 10 50
From PAT I E N T
CON N ECT I O N to 8 . 7 . 4 . 7 a) Figure 1 5
earth
a.c. 1 00 500 1 00 500 10 50
PATIENT
LEAKAGE
CURRENT
d.c. 10 50 10 50 10 50
Caused by a n
exte rnal voltage 8 . 7 . 4 . 7 c) Figure 1 7
o n a S I P/SOP
a.c. 1 00 500 1 00 500 10 50
With the same d.c. 50 1 00 50 1 00 50 1 00

8.7.4.7 a) Figure 1 5
types of A P P L I E D
and and
PART con nected
8 . 7 . 4 . 7 h) Figure 20
Total together a.c. 500 1 000 500 1 000 50 1 00
PAT I E N T
LEAKAGE
CURRENT a d.c. 50 1 00 50 1 00 50 1 00
Caused by a n 8 . 7 . 4 . 7 c) Figure 1 7
exte rnal voltage and and
o n a S I P/SOP 8 . 7 . 4 . 7 h) Figure 20
a.c. 500 1 000 500 1 000 50 1 00
Key
NC = NORMAL CONDITION
SFC = S I N G L E FAU LT C O N D I T I O N
N O T E 1 For EARTH LEAKA G E C U R R E N T see 8 . 7 . 3 d) .

NOTE 2 For TOUCH C U R R E N T see 8. 7 . 3 c).
Total PATIENT LEAKAGE C U R R E N T va lues a re o n ly a p plicable to e q u i pm e nt having m u ltiple A P P L I E D PARTS . See

.
8 . 7 . 4 . 7 h). The i ndivi d u a l APPLIED PARTS shall com ply with the PAT I E N T LEAKAGE C U R RENT values.
6060 1 - 1 © I EC : 20 0 5 - 1 73 -
Table 4 - * A l l owable val u es of PATIENT LEAKAG E CURRENTS u n d e r the s pecial test

con d it i o n s iden tified in 8 . 7 . 4 . 7
Current i n f.!A
Cu rrent Description a Reference Meas uring TY P E B TY P E B F TY P E C F
C i rcuit APPLIED APPLIED APPLIED
PART PART PART
Caused by an
exte rnal voltage on
8.7.4.7 b) Figure 1 6 5 000 50
Not
the PATIENT
applicable
CON N ECT I O N of a n F-
PATIENT TYPE A P P L I E D PART
LEAKAGE
CURRENT Caused by a n
exte rnal voltage o n a
8.7.4.7 d ) Figure 1 8 500 500
metal ACC E S S I B L E -
'
PART not
PROTECT IVELY
EART H E D
Caused by a n
exte rnal voltage o n 8 . 7 . 4 . 7 b) Figure 1 6
5 000 1 00
Not
the PATIENT and and
8 . 7 . 4 . 7 h) Figure 20
applicable
CON N ECT I O N of an F-
Total TYPE A P P L I E D PART
PAT I E N T
LEAKAGE Caused by an
b
CURRENT
8 . 7 . 4 . 7 d) Figure 1 8
exte rnal voltage on a
1 000 1 000
metal ACC E S S I B L E -
'
and and
8 . 7 . 4 . 7 h) Figure 20
PART not
PROTECT IVELY
EART H E D
a
The condition referred to in Ta ble IV of the second edition as " M A I N S VOLTAGE on A P P L I E D PART", and treated
i n that edition as a S I N G L E FAU LT C O N D I T I O N , is treated i n this edition as a special test condition. The test with
MAXI M U M M A I N S VOLTAGE o n a non-P ROTECTIVELY EART H E D ACCESSI B L E PART is also a special test conditio n ,
but t h e a l lowable va lues a re t h e same as for S I N G L E FA U LT CONDITION . S e e also t h e rationales for 8 . 5 . 2 . 2 and
8 . 7 . 4 . 7 d) .
b
Total PATIENT LEAKAGE C U R R E N T va l ues are only applicable to equipment having m u ltiple A P P L I E D PARTS. See
8 . 7 . 4 . 7 h). The i ndivi d u a l A P P L I E D PARTS shall com ply with the PAT I E N T LEAKAGE C U R RENT values.
'
This condition is not tested with TYPE CF A P P L I E D PARTS because it is covered by the test with MAXI M U M M A I N S
VOLTAGE o n t h e A P P L I E D PART. See a l so the rationale f o r 8 . 7 . 4 . 7 d ) .
8.7.4 M eas u re m ents
8.7.4. 1 General
The LEAKAGE CURRENT and PATIENT A UXILIARY CURRENT test figures referenced in 8. 7. 4 . 5 to
8. 7. 4. 8 (Figure 13 to Figure 19 inclusive) show suitable test configurations for use in
conjunction with the test PRO CEDURES specified in these subclauses. It is recognized that
other test figures can yield accurate results. However if the test results are close to the
allowed values or if there is any doubt as to the validity of the test results, the applicable test
figure is to be used as the deciding factor.
a) The EARTH LEAKA GE CURRENT, the TOUCH CURRENT, the PATIENT LEAKAGE CURRENT and the
PATIENT A UXILIARY CURRENT are m easured after the ME EQUIPMENT has been brought up to
operating temperature in accordance with the requirements of 1 1 . 1 . 3 c) .
6060 1 - 1 © I EC : 20 0 5 - 1 75 -
b) Where examination of the circuit arrangem ent and the arrangement of components and
material of the ME EQUIPMENT shows no possibility of any HAZARDOUS S/ TUA TION, the number
of tests can be reduced.
(i)
0
Mains
PE
512 P1 I
f-- --- --e� ... � � � � � � _j
IEC 2396105

Key
Measure i n all poss ible combi nations of
positions of S5, S 1 0 and S 1 2 with:
S1 closed (NORMAL C O N D I T I O N ) , and
S, open (S I N G L E FA U LT C O N D I T I O N ) .
Ex a m pl e with t h e m eas u r i n g s u pply ci rcuit of F i g u re F . 1
F i g u re 1 3 - M eas u ri n g c i r c u i t fo r the EARTH LEAKAGE CURRENT of CLASS I M E EQUIPM ENT,

with or without APPL I E D PART
(see 8 . 7 . 4 . 5)
6060 1 - 1 © I EC : 20 0 5 - 1 77 -
0 Sg
Mains
Mains
FE
0
P1
f------� --+o PE
�------�� - -
87
IEC 2397105

Key
Measure (with S7 closed if CLASS 1 equipment) u nder all possible
combinations of positions of S 1 , S5, S9, S 1 0, and S 1 2 .
S, open is S I N G L E FA U LT CON DITI O N .
CLASS 1 equ ipment o n ly:
Measure with Sy open (S I N G L E FA U LT C O N D IT I O N) a n d with S, closed
under a l l possible com binations of S5, S9, S10 and S 1 2 .
For CLASS II e q u i pment, the PROTECT IVE EARTH CONN ECT I O N and Sy are
not used.
Transformer T2 is used if req u i red (see 8.1 a))
Ex a m pl e with the m eas u r i n g s u pply ci rcuit of F i g u re F . 1 .
F i g u re 1 4 - M eas u ri n g c i r c u i t fo r the TOUCH C U RRENT

(see 8 . 7 . 4 . 6)
6060 1 - 1 © I EC : 20 0 5 - 1 79 -
Mains
IEC 2398105

Key
Measure (with S7 closed if CLASS 1 ME EQU I P M ENT) under a l l possible
combinations of positions of S 1 , S5, S10 and S 1 3 .
S1 open is S I N G L E FA U LT CON DITI O N .
CLASS I M E EQU I P M ENT only:
Measure with Sy open (S I N G L E FA U LT C O N D IT I O N) a n d with S, closed under
a l l possible com binations of S5, S10 and S 1 3 .
For CLASS II M E EQU I PM E N T , the PROTECT IVE EARTH CONN ECTION and Sy are
not used.
Ex a m pl e with t h e m eas u r i n g s u pply ci rcuit of F i g u re F . 1 .
F i g u re 1 5 - M eas u ri n g c i r c u i t fo r the PATI ENT LEAKAG E C U RRENT from t h e

PAT I E NT CONNECTION t o earth
(see 8 . 7 . 4 . 7 a ) )
6060 1 - 1 © I EC : 20 0 5 - 1 81 -
Mains
L(N)
Mains
N(L)
0
IEC 2399,05

Key
Measure (with Sy close d , if CLASS I ME EQU I P M ENT ) WITH S1 closed under a l l
possible combinations of positions of S5, S9, S 1 0 and S 1 3 .
For CLASS II M E EQU I PM E N T , the PROTECT IVE EARTH CONN ECTION and Sy are
not used.
Ex a m pl e with the m eas u r i n g s u pply ci rcuit of F i g u re F . 1 .
F i g u re 1 6 - M eas u ri n g c i r c u i t fo r the PATI ENT LEAKAGE C U RRENT v i a t h e PAT I E NT

CONNECTION(s) of an F -TYPE APPL I E D PART to earth caused by an external voltage on the
PAT I E NT CONNECTION (S)
(see 8 . 7 . 4 . 7 b))
6060 1 - 1 © I EC : 20 0 5 - 1 83 -
0
Mains
Mains
!------.� � - -
P1
n----u ---+<J PE
o FE
�
1------., --
IEC 2400105

Key
Measure (with Sy close d , if CLASS 1 M E EQU I P M ENT) under a l l possible combinations of positi ons of s , , S5, Ss,
S10and S13 (S , open is S I N G L E FA U LT C O N D I T I O N ) .
Measure with Sy open (S I N G L E FA U LT C O N D IT I O N) a n d with s , closed under a l l poss ible combinations of S5,
Ss, S10 a n d s , 3 .
For CLASS I I M E EQU I PM E N T , t h e PROTECT IVE EARTH CONN ECTION and Sy a r e n o t used.
F i g u re 1 7 - M eas u ri n g c i r c u i t fo r the PATI ENT LEAKAGE C U RRENT from PATIENT

CONNECTION(S) to earth caused by an external voltage on a S IGNAL INPUT/OUTPUT PART
(see 8 . 7 . 4 . 7 c))
6060 1 - 1 © I EC : 20 0 5 - 1 85 -
0 Sg
Mains
Mains
r------.� �1 _ _
FE
� P_
r\ •1 _-+
1--------.. -------u o PE
IEC 2401105

Key
Measure with s , closed (a n d with Sy closed, if CLASS 1 M E EQU I P M ENT ) under a l l possible com binations of
positions of S5, Ss a n d S10
For CLASS I I M E EQU I PM E N T , t h e PROTECT IVE EARTH CONN ECTION and S7 a r e n o t used.
F i g u re 1 8 - M eas u ri n g c i r c u i t fo r the PATI ENT LEAKAGE C U RRENT from PATIENT

CONNECTION(s) to earth caused by an exte rnal voltage on a m etal ACCESS I B L E PART that is
not PROTECTIVELY EARTHED
(see 8 . 7 . 4 . 7 d ) )
6060 1 - 1 © I EC : 20 0 5 - 1 87 -
Mains
IEC 2402105

Key
Measure (with Sy closed if CLASS 1 ME EQU I P M ENT) under a l l possible com binations of
positions of S 1 , S5, and S 1 0 .
S, open is S I N G L E FA U LT CON DITI O N .
Measure with Sy open (S I N G L E FA U LT C O N D IT I O N) a n d with s , closed under a l l poss ible
combinations of positions of S5, and S10 .
For CLASS II M E EQU I PM E N T , the PROTECT IVE EARTH CONN ECTION and S7 are not used.
F i g u re 1 9 - M eas u ri n g c i r c u i t fo r the PATI ENT AUXILIARY C URRE NT

(see 8 . 7 . 4 . 8)
6060 1 - 1 © I EC : 20 0 5 - 1 89 -
See Figure 1 7
I
0 T1
TYPE CF
APPLIED PART
I
Mains I
TYPE CF
I
APPLIED PART
S1 I
0
TYPE BF
APPLIED PART
I
I
TYPE BF
I
APPLIED PART
I
TYPE B
APPLIED PART
-G-oP•1 _ ,
-G-oP•-1 ------------�
_________
These connections \\111

depend on the measurement
being made.
See Figure 15 through
Figure 18 (inclusive)
IEC 2403105

Key
For the position of S 1 , S5, S7 and S 1 0, see Figure 1 5 , Figure 1 6 , F i g u re 1 7 o r F i g u re 1 8
F i g u re 20 - M eas u r i n g c i rc u it for t h e total PATI ENT LEAKAGE C U RRENT with a l l PATI ENT
CONNECTIONS of a l l APPL I E D PARTS of t h e same type ( TYPE 8 APP L I E D PARTS, TYPE BF APPLI E D
PARTS o r TYPE CF APP L I E D PARTS ) co n n ected togeth er
(see 8 . 7 . 4 . 7 h))
6060 1 - 1 © I EC : 20 0 5 - 1 91 -
Table 5 - Leg e n d s of sym bo l s fo r F i g u re 9 to F i g u re 1 1 , F ig u re 1 3 to F i g u re 20,
CD
F ig u re A. 1 5, A n n exes E a n d F
®
ME EQU I P M ENT ENCLOS U R E
Separate power s u pply u n it o r other electrical e q u ipment i n a n M E SYSTEM that supplies power t o the
0
ME EQU I P M ENT (see 5 . 5 g) and Annex F)
0
S I G N A L I N PUT/OUTPUT PART short c i rc u ited o r loaded
®
PATIENT CON N ECTI O N S
0
M e t a l ACCESS I BLE PART n o t PROTECTIVELY EARTH ED
PATIENT c i rc u it
Vc1,2, 3 J
S i ngle- or polyphase isolation transformers with sufficient power rat i n g and adjustable output
T, , T 2
voltage (See also the rationale for 8 . 7 . 4 . 2 .)
Voltmeter ind icating r . m . s . value, using, if relevant a n d poss i b l e , o n e meter with a c o m m utator
switch
S i ngle-pole switches, s i m ulating the interruption of a power supply cond uctor (S I N G L E FA U LT
s , , s 2, s 3
CON D ITION) (See Annex F)
S 5 , Ss Comm utator switches to reverse the pola rity of the M A I N S VOLTAGE
S i ngle-pole switc h , s i m u lating the interruption of a single PROTECTIVE EARTH CON D U CTOR to the
ME EQUIPMENT (S I N G L E FA U LT C O N D ITION)
Single pole switch simulating the interruption of a single PROTECTIVE EARTH CONDUCTOR to a separate power
Sa s u pply u n it o r other e l ectrical equipment i n a n ME SYSTEM that supplies power to the ME E Q U I P M ENT
(S I N G L E FA U LT CONDITION) (see Figure F . 5)
Switch for con necting a F U NCTIONAL EARTH TERM I NA L to the e a rthed point of the measuring supply
system
s,2 Switch for con necting a PATIENT CON N ECTION to the e a rthed point of the measuring s u pply c i rc u it
s,3 Switch for con necting to earth a metal ACC ESS I B L E PART not PROTECTIVELY EART H E D
s ,. Switch to con nect/d isconn ect PAT I E N T C O N N ECTION to/from earth
P, Sockets, plugs o r terminals for the s u pply con nection of the ME EQU I PM E NT
Sockets , plugs o r terminals for the connection to a separate power s u pply o r other e lectrical
e q u i pm e nt i n a n ME SYSTEM that s u pplies power to the ME EQU I PM E N T (see F i g ure F . 5)
MD Measuring device (see F i g u re 1 2)
FE F U NCTIONAL EARTH T E R M I NAL
PE PROTECT IVE EARTH TERM I NA L
I m pedance to protect the c i rc u itry and the person performing the test, b u t low enough to accept
R
c u rrents higher than the a l lowable values of the LEAKAGE C U RRENT to be measure d
Optional con nection
Reference earth (for LEAKAGE C U RRENT and PATIENT AUXI L LARY C U R R EN T measure m e nts and for
testing of D E F I B R I LLATI O N -PROOF A P P L I E D PARTS, not conn ected to protective e a rth of the S U P P LY
MAI NS)
S U P P LY M A I N S voltage source
6060 1 - 1 © I EC : 20 0 5 - 1 93 -
8.7.4.2 * M eas u r i n g s u pp l y c i rcu its

ME E Q UIPMENT specified for connection to a SUPPL Y MAINS is connected to an appropriate
power source. For single-phase ME EQUIPMENT, the polarity of the supply is reversible and
tests are conducted at b oth polarities. INTERNALLY POWERED ME EQUIPMENT is tested without
any connection to a measuring supply circuit.
NOTE Figure F . 1 to F i g ure F . 5 (inclusive) show s o m e s u itable a rrangements but do not cover a l l possibilities, fo r
exa m p l e , d e lta-con nected 3-phase supplies.
8.7.4.3 * Con nection t o t h e m eas u ri n g s u pp l y c i rc u i t
a ) M E E Q UIPMENT provided with a POWER SUPPL Y CORD i s tested using this cord.
b) ME E Q UIPMENT provided with an APPLIANCE INLET is tested while connected to the m e asuring
supply circuit via a DE TA CHABLE POWER SUPPL Y CORD having a length of 3 m or a length and
type specified in the instructions for use.
c) PERMANENTLY INS TALLED ME EQUIPMENT is tested while connected to the measuring supply
circuit by the shortest possible connection.
d) Measuring arrangement
1 ) APPLIED PARTS, including PATIENT cables (when present), are placed on an insulating
surface with a dielectric constant of approxim ately 1 (for example, expanded
polystyrene) and approxim ately 200 mm above an earthed metal surface.
NOTE 1 The measuring s u pply c i rc u it and the measuring circuit s h o u l d be positioned as far as possible
away from unscreened power source leads. Placing the ME EQU I P M E N T o n o r near a l a rg e earthed metal
s u rface should be avoided.
NOTE 2 Where A P P L I E D PARTS are such that the test results can depend upon how they are placed o n the
insu lating s u rface , the test is repeated as necessary to determine the worst possible positi o n i n g .
2) If an isolating transform er is not used for LEAKAGE CURRENT m easurements (e.g. when
measuring LEAKAGE CURRENT for very high input power ME EQUIPMENT), the reference
earth of the m easuring circuits is connected to protective e arth of the SUPPL Y MAINS.
8.7.4.4 M eas u r i n g device ( M D)
a) The m easuring device loads the source of LEAKAGE CURRENT or PATIENT A UXILIARY CURRENT
with a resistive impedance of approxim ately 1 000 Q for d. c., a. c. and composite
waveforms with frequencies up to and including 1 MHz.
b) The evaluation of current or current components according to B. 7. 3 a) is obtained

autom atically if a m easuring device according to Figure 1 2 a) or a similar circuit with the
same frequency characteristic is used. This allows measurement of the total effect of all
frequencies with a single instrum ent.
If currents or current components with frequencies exceeding 1 kHz might exceed the
10 rnA limit specified in 8 . 7 . 3 e), these are m easured by other appropriate m eans such as
a 1 kil non-inductive resistor and suitable m e asuring instrum ent.
c) The voltage m easuring instrument as shown in Figure 1 2 a) has an input resistance of at

least 1 Mil and input capacitance of no more than 1 50 pF. It indicates the true r. m. s. value
of the voltage being d. c., a. c. or a composite waveform having components with
frequencies from 0, 1 Hz up to and including 1 MHz, with an indicating error not exceeding
± 5 % of the indicated value.
6060 1 - 1 © I EC : 20 0 5 - 1 95 -
The scale can indicate the current through the m easuring device including automatic
evaluation of components with frequencies above 1 kHz so a s to enable direct comparison
of the reading with the limit values specified in 8. 7. 3.
These requirements can be limited to a frequency range with an upper limit lower than
1 MHz if it can be proven (for example, by the use of an oscilloscope) that frequencies
above such an upper limit do not occur in the measured current.
8.7.4.5 * M eas u re m e n t o f the EARTH LEAKAG E CURRENT
a ) CLASS I ME EQUIPMENT is tested according to Figure 1 3.
b) If ME EQUIPMENT has m ore than one PROTECTI VE EARTH CONDUCTOR (for example, one
connected to the m ain ENCLOSURE and one to a separate power supply unit), then the
current to b e measured is the aggregate current that would flow into the protective earthing
system of the installation.
c) For FIXED ME EQUIPMENT that can have connections to earth through the building structure,
the MANUFA CTURER specifies a suitable test PRO CEDURE and configuration for m easurem ent
of EARTH LEAKAGE CURRENT.
8.7.4.6 * M eas u re m e n t o f the T O U C H C U RRENT
a ) ME E Q UIPMENT is tested according to Figure 1 4, using an appropriate m easuring supply

circuit.
Measure with MD b etween earth and each part of the ENCLOSURE(s) that is not
PROTECT/ VEL Y EARTHED.
Measure with MD between parts of the ENCLOSURE(S) that are not PROTECT/ VEL Y EARTHED.
In the SINGLE FA ULT CONDITION of interruption of any one PROTECTI VE EARTH CONDUCTOR
(when applicable, see 8. 1 b)), measure with MD b etween earth and any part of the
ENCLOSURE(S) that is normally PROTECT/ VEL Y EARTHED.
NOTE It is not necessary to m a ke separate measurements from m o re than one part that is PROTECTIVELY
EARTH E D .
INTERNALLY POWERED M E EQUIPMENT i s investigated for TOUCH CURRENT b ut only between

parts of the ENCLOSURE, not b etween the ENCLOSURE and earth unless 8. 7. 4. 6 c) applies.
b) If ME E Q UIPMENT has an ENCL OSURE or a part of the ENCLOSURE m ade of insulating m aterial,
metal foil of m aximum 20 em x 1 0 em is applied in intim ate contact with the ENCLOSURE or
relevant part of the ENCL OSURE.
The m etal foil is shifted, if possible, to determine the highest value of the TOUCH CURRENT.
The metal foil should not touch any metal parts of the ENCL OSURE that are possibly
PROTECT/ VEL Y EARTHED; howe ver, m etal parts of the ENCLOSURE that are not PROTECT/ VEL Y
EARTHED can be covered partly or totally by the m etal foil.
Where it is intended to measure the TOUCH CURRENT in the SINGLE FA ULT CONDITION of
interruption of a PRO TE C TIVE EARTH CONDUCTOR, the m etal foil is arranged to contact parts
of the ENCLOSURE that are normally PRO TECT/ VEL Y EARTHED.
Where the surface of the ENCLOSURE contacted by the PATIENT or OPERA TOR is larger than
20 em x 10 em, the size of the foil is increased corresponding to the area of contact.
6060 1 - 1 © I EC : 20 0 5 - 1 97 -
c) ME E Q UIPMENT with a SIGNAL INPUT/O UTPUT PART is, when required (see 8. 1 a)), additionally
tested using transform er T2.
The value of the voltage set at the transform er T2 is equal to 1 1 0 % of the MAXIMUM MAINS
VOLTAGE. The specific pin configuration used when applying the external voltage is
determined to be worst case b ased on testing or circuit analysis.
8.7.4.7 M eas u re m e n t o f the PATIENT LEAKAGE C U RRENT

See A n n ex K, w h i c h conta i n s si m pl ifi ed PAT I E NT LEAKAG E CURRENT d i a g r a m s , for s u ppl e m ental
ex p l a n atory deta i l .
a) M E E Q UIPMENT with a n APPLIED PART is tested according t o Figure 1 5.
An ENCLOSURE, other than an APPLIED PART, m a de of insulating m aterial is placed in any

position of NORMAL USE upon a flat m etal surface connected to earth with dim ensions at
least equal to the plan-projection of the ENCLOSURE.
b) * ME EQUIPMENT with an F-TYPE APPLIED PART is additionally tested according to Figure 1 6.
SIGNAL INPUT/O UTPUT PARTS are connected to earth, if not already permanently earthed in
the ME EQUIPMENT.
The value of the voltage to be set at the transformer T2 in Figure 1 6 is equal to 1 1 0 % of

the MAXIMUM MAINS VOLTAGE.
For this m easurement, non-PRO TECT/ VEL Y EARTHED m etal A CCESSIBLE PARTS including
PATIENT CONECTIONS of other APPLIED PARTS (if present) are connected to earth.
c) * ME E Q UIPMENT with an APPLIED PART and a SIGNAL INPUT/O UTPUT PART is, when required
(see 8. 1 a)) , additionally tested according to Figure 1 7.
The value of the voltage set at the transformer T2 is equal to 1 1 0 % of the MAXIMUM MAINS
VOLTAGE. The specific pin configuration used when applying the external voltage is to be
worst case b ased on testing or circuit analysis.
d) * ME EQUIPMENT with a PATIENT CONNECTION of a TYPE B APPLIED PART that is not

PROTECT/ VEL Y EARTHED or a TYPE BF APPLIED PART and with m etal A CCESSIBLE PARTS that are
not PRO TECT/ VEL Y EARTHED is additionally tested according to Figure 1 8.
The value of the voltage set at the transform er T2 is equal to 1 1 0 % of the MAXIMUM MAINS
VOLTAGE.
This test need not be conducted if it can be demonstrated that there is adequate
separation of the parts involved.
e) An APPLIED PART consisting of a surface made of insulating m aterial is tested using m etal
foil as m entioned under 8. 7. 4 . 6. Alternatively a 0, 9 % saline s olution is used in which the
APPLIED PART is immersed.
Where the surface of the APPLIED PART intended to contact the PATIENT is considerably
larger than that of a foil of 20 em x 1 0 em, the size of the foil is increased to correspond to
the area of contact.
Such m etal foil or saline solution is considered as the only PATIENT CONNECTION for the
APPLIED PART concerned.
6060 1 - 1 © I EC : 20 0 5 - 1 99 -
f) Where the PATIENT CONNECTION is form ed by a fluid which contacts the PATIENT, the fluid is
replaced by 0, 9 % saline solution, an electrode is placed in the saline solution and this
electrode is considered as the PATIENT CONNECTION for the APPLIED PART concerned.
g) The PATIENT LEAKAGE CURRENT is measured (see also Annex E) :

for TYPE 8 APPLIED PARTS and TYPE 8F APPLIED PARTS, from and to all PATIENT
CONNECTIONS of a single function either connected directly together or loaded as in
NORMAL USE;
- in TYPE CF APPLIED PARTS, from and to e very PATIENT CONNECTION in turn.
If the instructions for use specifies alternatives for a detachable part of the APPLIED PART
(for example, PATIENT leads and electrodes), the PATIENT LEAKAGE CURRENT m easurements
are made with the least favourable specified detachable part. See also 7. 9. 2. 1 4.
h) * The total PA TIENT LEAKA GE CURRENT is m easured from and to all PATIENT CONNECTIONS of
all APPLIED PARTS of the same type (TYPE 8 APPLIED PARTS, TYPE 8F APPLIED PARTS or TYPE
CF APPLIED PARTS) connected together. See Figure 20. If necessary, a functional earth m ay
be disconnected before conducting this test.
NOTE Measurement of total PAT I E N T LEAKAG E C U R R E N T of TYPE B A P P L I E D PARTS is only necessary if there are
two o r m o re PATIENT C O N N ECTION that belong to different functions and that a re not e l ectrically conn ected
d i rectly together.
i ) If the PATIENT CONNECTIONS of the APPLIED PART are loaded in NORMAL USE, the m easuring
device is connected to each PATIENT CONNECTION in turn.
8.7.4.8 M eas u re m e n t o f the PATIENT AUXILIARY C U RRENT

ME E Q UIPMENT with an APPLIED PART is tested according to Figure 1 9, using an appropriate
measuring supply circuit unless the ME EQUIPMENT has only a single PATIENT CONNECTION.
The PATIENT A UXILIARY CURRENT is m easured between any single PATIENT CONNECTION and all
other PATIENT CONNECTIONS, either connected directly together or loaded as in NORMAL USE
(see also Annex E) .
8.7.4.9 * M E EQU I P M E NT w i t h m u lt i p le PATI ENT CONNECTIONS

ME E Q U I PMENT with m u lti p l e PAT I E NT CONNECTI O N S i s i nvestigated to e n s u re t h at the PAT I E NT
LEAKAGE CURRENT a n d t h e PAT I E NT AUXI LIARY CURRENT do n ot exc e e d t h e a l l owa b l e v a l ues for
NORMAL CONDITION w h i l e o n e o r m o re PAT I E NT CONNECTIONS a r e :
disco n n ecte d f r o m t h e PAT I E N T ; a n d
disco n n ecte d f r o m t h e PAT I E N T a n d e a rt h e d .
Testing i s perform ed i f a n examination of the M E EQUIPMENT circuit indicates that the PATIENT
LEAKAGE CURRENT or the PATIENT A UXILIARY CURRENT can increase to excessive levels under
the above conditions. Actual m easurements should be limited to a representative number of
combinations.
6060 1 - 1 © I EC : 20 0 5 - 201 -
8.8 I ns u lation
8.8. 1 * Gen eral

O n l y t h e fol l owi n g i ns u l at i o n s h a l l be s u bj ect to testi n g :
i ns u l at i o n t h at i s r e l i e d u po n as a MEANS O F PROTECT I O N , i n cl u di n g R E I NFORCED I NS U LAT I O N ;
i ns u l at i o n betwe e n parts of o p posite p o l a rity of t h e MAINS PART o n t h e S U PPLY MAINS side of
a n y m ai ns fuse or OVER-CURRENT RELEAS E , w h i c h s h a l l be tested as o n e MEANS OF
PROTECT I O N .
I ns u l at i o n form i n g part of a c o m po n e n t i s ex e m pt prov i ded t h at the co m po n e nt c o m pl i es with

4.8.
I ns u l ati o n form i n g MEANS O F O P E RATOR PROTECT I O N i s exe m pt from t h e tests o f 8 . 8 i f i t

com pl i es with t h e re q u i re m e nts a n d tests o f I EC 6 0 9 5 0 - 1 for I NS U LATION CO-ORDI NAT I O N .
8.8.2 * D istance t h ro u g h s o l i d i n s u lation or use o f t h i n s h eet m aterial

S o l i d i ns u l at i o n which fo r m s S U P P L E M ENTARY I N S U LATI O N o r R E I NFORCED I NS U LATI O N for a PEAK
WORK I N G VOLTAGE g reate r than 71 V s h a l l either:
a) have a d i sta nce t h r o u g h i ns u l at i o n of at l east 0,4 m m , o r
b) not f o r m part o f a n E NCLOS URE a n d n ot be s u bj e ct to h a n d l i n g o r abrasi o n d u r i n g NORMAL

USE, and com prise:
at l e ast two l ayers of m ateri a l , each of w h i c h wi l l pass t h e appropriate d i e l ectric

stre n gth test; o r
- three l ayers of m ateri a l , for w h i c h a l l c o m b i n at i o n s of two l ayers toget h e r wi l l pass t h e
a p propriate d i e l ectric strength test.
The a ppro priate d i e l e ctric stre ngth test for the o n e or two l ayers i s the test for o n e MEANS O F
PROTECTION in t h e case of S U P P L E M ENTARY I NS U LAT I O N o r t h e test for two M E A N S O F PROTECTION
in the case of R E I NFORCED I NS U LATI O N , respecti vely.
NOTE 1 There is no m i n i m u m thickness req u i re m e nt fo r B A S I C I N S U LATI O N , n o r for insu lation operating a t WORKI N G
VOLTAGE u p to 7 1 V .
N O T E 2 T h e r e is no req u i re m e nt f o r a l l layers of insu lation to be of the same m ateri a l .
Compliance is checked by inspection, by m easurement of thickness and by the dielectric

strength test of 8. 8. 3.
For wo u n d co m po n e nts, where BAS I C I NS U LAT I O N , S U PPLEM ENTARY I NS U LATION o r R E I NFORCED

I NS ULAT I O N
is req u i red between wi n d i n g s , they s h a l l be s e p a rated by i nterleaved i ns u l ati o n
com ply i n g with a) o r b ) i m m ed i ately above, o r bot h , u n l ess o n e o f t h e fol l owi n g wi re
constructi o n s is u s e d :
c) wire t h at h as s o l i d i ns u l ati o n , oth e r t h a n s o l v e n t based e n a m el , c o m plyi n g w i t h a) above;
d) wire that has m u lti-layer extr u d e d o r s pi ra l l y wrapped i ns u l ati o n (where t h e l ayers c a n be

i n d i v i d u a l l y tested for d i e l ectric stre ngth) c o m plyi n g with b) a bove and passes t h e tests of
A n n ex L;
e) wire t h at h as m u lti - l ayer extruded o r s p i r a l l y wra pped i ns u l ati o n (where only t h e fi n i s h e d

wi re c a n be tested ) a n d passes t h e tests o f An n ex L . T h e m i n i m u m n u m be r of
constructi o n a l l ayers a pp l i e d to t h e c o n d u ctor s h a l l be as foll ows :
6060 1 - 1 © I EC : 20 0 5 - 203 -
BAS I C I NS U LAT I O N : two wra pped l ayers or o n e extr u d e d l ay e r ;

S U PPLEM ENTARY I NS U LAT I O N : two l ayers , wra pped o r ext r u d e d ;
R E I NFORCED I NS U LATI O N : three l ayers, wrapped o r extr u d e d .
I n both d) a n d e ) , f o r s pi ra l l y wrapped i ns u l ati o n where t h e C R E E PA G E D I S TANCES between

l ayers , as wrapped, are l ess t h a n those g i v e n in T a b l e 12 o r Tabl e 1 6 (for P o l l uti o n Degree 1 )
d e pe n d i n g o n t h e type of i ns u lati o n i n q u esti o n , t h e path betwe e n l ayers s h a l l be s e a l e d as for
a ce m e nted j o i n t in 8 . 9 . 3 . 3 a n d the test voltages of the TYPE TESTS in L . 3 a re i n creased to 1 , 6
times their normal values.
NOTE 3 O n e layer o f material wound with m o re than 5 0 % ove rlap is considered t o constitute two layers.
Where two i ns u l ated wi res o r o n e bare a n d o n e i ns u l ated wire are i n co ntact i ns i d e the wo u n d
co m po n e nt, c ross i n g each oth e r a t a n a n g l e betwee n 4 5 ° a n d g o o a n d s u bj ect t o wi n d i n g
tens i o n , protect i o n agai nst m ec h a n i ca l stress s h a l l be prov i d e d . T h i s protect i o n c a n be
ach i ev e d , for ex a m pl e , by p rovi d i n g physical s e pa rati o n in the form of i ns u l ati n g s l eev i n g or
s h e et m ateri a l , o r by usi n g d o u b l e the re q u i re d n u m be r of i ns u l ati o n l ayers.
The fi n i s h e d c o m po n e n t s h a l l pass rout i n e tests for d i e l ectric strength u s i n g the a p pro pri ate
test voltages i n 8 . 8 . 3 .
Compliance is checked b y inspection and m easurement and, if applicable, a s specified in

Annex L. However, the tests of Annex L are not repeated if the material data sheets confirm
compliance.
8.8.3 * D i e lectric stre n g th

T h e d i e l ectri c stre n gth of s o l i d el ectrical i ns u l ati o n of ME E Q U I P M ENT s h a l l be c a p a b l e of
withsta n d i n g t h e test v o ltages as s pecifi ed i n T a b l e 6. O n l y i n s u l at i o n with a safety fu n cti o n
n e e d be s u bj e ct t o testi n g (see 8 . 8 . 1 ) .
Compliance is checked b y applying the test voltage specified in Table 6 for 1 min:
imm e diately after the humidity preconditioning treatment (as described in 5. 7) with the
ME EQUIPMENT de-energized during the test, and
after any required sterilization PRO CEDURE (see 1 1 . 6. 7, 7. 9. 2. 1 2 and the instructions for
use) with the ME E Q UIPMENT de-energized, and
after reaching a temperature equivalent to the steady state operating temperature reached
during the heating test of 1 1 . 1. 1 .
Initially, not m ore than half the test voltage is applied, and then it is gradually raised over a
period of 1 0 s to the full value, which is m aintained for 1 min, after which it is gradually
lowered over a period of 1 0 s to less than half the full value.
The test conditions are as follows:
a) * The test voltage has a waveform and frequency such that the dielectric stress on the
insulation is at least equal to that occurring in NORMAL USE. The waveform and frequency of
the test voltage can differ from the voltage applied in NORMAL USE if it can be dem onstrated
that the dielectric stress on the insulation tested will not be diminished.
Where the voltage to which the relevant insulation is subjected in NORMAL USE is non
sinusoidal a. c. , the test may be perform ed using a sinusoidal 50 Hz or 60 Hz test voltage.
6060 1 - 1 © I EC : 20 0 5 - 205 -
Alternatively, a d. c. test voltage equal to the peak value of the a. c. test voltage m ay be
used.
The test voltage, for the WORKING VOLTAGE to which the insulation is subjected is greater
than or equal to the value specified in Table 6.
b) During the test, breakdown constitutes a failure. Insulation breakdown is considered to

have occurred when the current which flows as a result of the application of the test
voltage rapidly increases in an uncontrolled m anner, that is, the insulation does not restrict
the flow of the current. Corona discharge or a single m om entary flashover is not regarded
as insulation breakdown.
c) If it is not possible to test individual solid insulations, it is then necessary to test a large
part of the ME E Q UIPMENT or e ven the whole ME EQUIPMENT. In this case, it is important not
to overstress different types and levels of insulation and the following m ust b e taken into
account.
Where an ENCLOSURE or part of ENCLOSURE consists of non-conductive surfaces, m etal
foil is applied. Care is taken that the m etal foil is positioned in such a m anner that
flashover does not occur at the edges of insulation linings. If applicable, the metal foil
is m oved so as to test all parts of the surface.
The circuits on either side of the insulation under test should be connected or short
circuited such that components within these circuits do not get stressed during the
test. For example, the terminals of the MAINS PART, the SI GNAL INPUT/O UTPUT PART and
the PATIENT CONNECTION(s) (if applicable) respectively are short circuited during the
test.
Where there are capacitors across the insulation under test (e.g. radio-frequency filter
capacitors), they m ay be disconnected during the test, if they are certified to
IEC 60384- 1 4 .
6060 1 - 1 © I EC : 20 0 5 - 207 -
Table 6 - Test voltages for s o l i d i n s u l ation for m i ng a M EANS OF PROTECTION
A.C. test voltages i n V r. m.s.

M EANS O F O P E RATO R PROTECTION M EANS O F PAT I E N T PROTECTION
PEAK PEAK
WO R K I N G WO R K I N G Protection from Protection from Protection from Protection from
VOLTAGE VOLTAGE MAINS PART SECON DARY C I R C U ITS MAINS PART SECON DARY C I R C U ITS
(U ) (U )
One Two One Two One Two One Two
V peak V d.c. MOOP MOOP MOOP MOOP MOPP MOPP MOPP MOPP
u < 42,4 u < 60 1 000 2 000 No test No test 1 500 3 000 500 1 000
42,4 < u 60 < u See See

1 000 2 000 1 500 3 000 750 1 500
,; 71 ,; 71 Table 7 Table 7
71 < u ,; 7 1 < u ,; See See

1 000 2 000 1 500 3 000 1 000 2 000
1 84 1 84 Table 7 Table 7
1 84 < u 1 84 < u ,; See See

1 500 3 000 1 500 3 000 1 000 2 000
,; 2 1 2 212 Table 7 Table 7
212 < u 212 < u See See

1 500 3 000 1 500 4 000 1 500 3 000
,; 354 ,; 354 Table 7 Table 7
354 < u 354 < u See See See -!2 U 2 x (-J2 U -! 2 U 2 x (-J2 U
3 000
,; 848 ,; 848 Table 7 Table 7 Table 7 + 1 000 + 1 500) + 1 000 + 1 500)
848 < u 848 < u See See See -! 2 U + 2 x (-J2 U -! 2 U 2 x (-J2 U

3 000
,; 1 4 1 4 ,; 1 4 1 4 Table 7 Table 7 Table 7 1 000 + 1 500) + 1 000 + 1 500)
1 414 < u 1 414 < u See See See See Ul-!2 -! 2 U Ul-!2 -!2 U
,; 1 0 000 ,; 1 0 000 Table 7 Table 7 Table 7 Table 7 + 2 000 + 5 000 + 2 000 + 5 000
1 0 000 < 1 0 000 <

1 , 06 X 1 , 06 X 1 , 06 X 1 , 06 X Ul-!2 -! 2 U Ul-!2 -!2 U
u u
Ul-!2 Ul-!2 Ul-!2 Ul-!2 + 2 000 + 5 000 + 2 000 + 5 000
,; 1 4 1 40 ,; 1 4 1 40
U> U>
I f necessary, to be prescribed by particular standards
14 1 40 1 4 1 40
6060 1 - 1 © I EC : 20 0 5 - 209 -
Table 7 - Test voltages for M EANS OF OPERATOR PROTECTIO N
Test voltage i n V r . m . s .
PEAK PEAK PEAK

WO R K I N G WO R K I N G WORKING
VOLTAGE VOLTAGE VOLTAGE
(U ) (U ) (U )
V peak One Two V peak One Two V peak One Two
or V d . c . MOOP MOOP or V d . c . MOOP MOOP or V d . c . MOOP MOOP
34 500 800 250 1 261 2 018 1 750 3 257 3 257
35 507 81 1 260 1 285 2 055 1 800 3 320 3 320
36 513 821 270 1 307 2 092 1 900 3 444 3 444
38 526 842 280 1 330 2 1 27 2 000 3 566 3 566
40 539 863 290 1 351 2 1 62 2 1 00 3 685 3 685
42 551 882 300 1 373 2 1 96 2 200 3 803 3 803
44 564 902 310 1 394 2 230 2 300 3 920 3 920
46 575 920 320 1 414 2 263 2 400 4 034 4 034
48 587 939 330 1 435 2 296 2 500 4 1 47 4 1 47
50 598 957 340 1 455 2 328 2 600 4 259 4 259
52 609 974 350 1 474 2 359 2 700 4 369 4 369
54 620 991 360 1 494 2 390 2 800 4 478 4 478
56 630 1 008 380 1 532 2 451 2 900 4 586 4 586
58 641 1 025 400 1 569 2 510 3 000 4 693 4 693
60 651 1 041 420 1 605 2 567 3 1 00 4 798 4 798
62 661 1 057 440 1 640 2 623 3 200 4 902 4 902
64 670 1 073 460 1 674 2 678 3 300 5 006 5 006
66 680 1 088 480 1 707 2 731 3 400 5 1 08 5 1 08
68 690 1 1 03 500 1 740 2 784 3 500 5 209 5 209
70 699 1 118 520 1 772 2 835 3 600 5 309 5 309
72 708 1 1 33 540 1 803 2 885 3 800 5 507 5 507
74 71 7 1 1 47 560 1 834 2 934 4 000 5 702 5 702
76 726 1 1 62 580 1 864 2 982 4 200 5 894 5 894
78 735 1 1 76 588 1 875 3 000 4 400 6 082 6 082
80 744 1 1 90 600 1 893 3 000 4 600 6 268 6 268
85 765 1 224 620 1 922 3 000 4 800 6 452 6 452
90 785 1 257 640 1 951 3 000 5 000 6 633 6 633
95 805 1 288 660 1 979 3 000 5 200 6 81 1 6 81 1
1 00 825 1 319 680 2 006 3 000 5 400 6 987 6 987
1 05 844 1 350 700 2 034 3 000 5 600 7 1 62 7 1 62
110 862 1 379 720 2 060 3 000 5 800 7 334 7 334
115 880 1 408 740 2 087 3 000 6 000 7 504 7 504
1 20 897 1 436 760 2 113 3 000 6 200 7 673 7 673
1 25 915 1 463 780 2 1 38 3 000 6 400 7 840 7 840
1 30 931 1 490 800 2 1 64 3 000 6 600 8 005 8 005
1 35 948 1 51 7 850 2 225 3 000 6 800 8 1 68 8 1 68
1 40 964 1 542 900 2 285 3 000 7 000 8 330 8 330
1 45 980 1 568 950 2 343 3 000 7 200 8 491 8 491
1 50 995 1 593 1 000 2 399 3 000 7 400 8 650 8 650
1 52 1 000 1 600 1 050 2 454 3 000 7 600 8 807 8 807
1 55 1 000 1 61 7 1 1 00 2 508 3 000 7 800 8 964 8 964
1 60 1 000 1 641 1 1 50 2 560 3 000 8 000 9 119 9 119
1 65 1 000 1 664 1 200 2 61 1 3 000 8 200 9 273 9 273
1 70 1 000 1 688 1 250 2 661 3 000 8 400 9 425 9 425
1 75 1 000 1 71 1 1 300 2 710 3 000 8 600 9 577 9 577
1 80 1 000 1 733 1 350 2 758 3 000 8 800 9 727 9 727
1 84 1 000 1 751 1 400 2 805 3 000 9 000 9 876 9 876
1 85 1 097 1 755 1 410 2 814 3 000 9 200 1 0 024 1 0 024
1 90 1 111 1 777 1 450 2 868 3 000 9 400 10 1 7 1 1 0 1 71
200 1 1 37 1 820 1 500 2 934 3 000 9 600 1 0 31 7 1 0 31 7
210 1 1 63 1 861 1 550 3 000 3 000 9 800 10 463 10 463
220 1 1 89 1 902 1 600 3 065 3 065 10 000 1 0 607 1 0 607
230 1 214 1 942 1 650 3 1 30 3 1 30
240 1 238 1 980 1 700 3 1 94 3 1 94
6060 1 - 1 © I EC : 20 0 5 - 21 1 -
8.8.4 I ns u lation o t h e r than w i re i ns u lation
8.8.4. 1 * Mechan ical strength and res i stance to h eat

T h e resista nce to heat s h a l l be reta i n ed by a l l types of i ns u l ati o n , i n c l u d i n g i n s u l at i n g partit i o n
wa l l s , d u ri n g t h e EXPECTED S E RV I C E L I F E o f t h e M E E Q U I P M E NT .
Compliance is checked by inspection of the ME E Q UIPMENT and the RISK MANA GEMENT FILE and,
if necessary, in conjunction with the following tests:
resistance to moisture, etc. (see 1 1 . 6);
dielectric strength (see 8. 8. 3);
mechanical strength (see 1 5. 3) .
Resistance to heat is established by the following tests, which need not be perform ed if
satisfactory evidence of compliance is provided.
a) For parts of the ENCLOSURE and other external insulating parts, the deterioration of which
could result in an unacceptable RISK, by the ball-pressure test:
ENCLOSURES and other external parts of insulating m aterial, except the insulation of flexible
cords and parts of ceramic m aterial, are subjected to a b all-pressure test using the test
apparatus shown in Figure 2 1 . The surface of the part to be tested is placed in the
horizontal position and a steel b all of 5 mm diameter is pressed against the surface with a
force of 20 N. The test is perform ed in a heating cabinet at a temperature of 75 "C ± 2 oc
or the ambient temperature indicated in the technical description (see 7. 9. 3. 1) ± 2 "C plus
the temperature rise of the relevant part of insulating m aterial m easured during the test of
1 1 . 1 , whichever is the higher.
The ball is withdrawn after 1 h and the diam eter of the impression m ade by the b all is
measured. An impression greater than 2 mm in diameter constitutes a failure.
b) For parts of insulating material that support uninsulated p arts of the MAINS PART, the
deterioration of which could influence the safety of the ME EQUIPMENT, by the ball-pressure
test:
A test is perform ed as describ ed in a) above, b ut at a temperature of 1 25 oc ± 2 "C or at

the ambient temperature indicated in the technical description (see 7. 9. 3. 1) ± 2 "C plus the
temperature rise that was determined during the test of 1 1 . 1 of the relevant part, whichever
is the higher.
The test is not perform ed on parts of ceramic m aterial, insulating parts of comm utators,
brush-caps and the like, and on coil formers not used as REINFORCED INSULA TION.
NOTE For S U P P L E M ENTARY I N SU LATION and R E I N FORCED I N S U LATION of thermoplastic materials, see also
1 3. 1 .2.
8.8.4.2 Res istance t o e n v i ro n m ental stress

The i n s u l ati n g c h a racteristics a n d m ec h a n i ca l stre n gth of any M EANS O F PROTE CTI O N s h a l l be
so des i g n e d o r protected that it i s n ot l i ke l y to be i m pai red by envi r o n m ental stresses
i n cl u d i n g de pos iti o n of d i rt o r by dust res ulti n g from we a r of parts with i n the M E E Q U I P M ENT to
s u c h a n extent t h at CRE E PA G E D I S TANCES and AIR CLEARANCES are red u ced b e l ow the v a l ues
s pecifi ed in 8 . 9 .
6060 1 - 1 © I EC : 20 0 5 - 213 -
Cera m i c m aterial n ot t i g htly s i nte red, a n d t h e l i ke , a n d beads a l o n e s h a l l n ot be used as

S U PPLEM ENTARY I NS U LATI O N or R E I NFORCED I NS U LATI O N .
I ns u l ati n g m aterial in which h e ati n g c o n d u ctors are e m be d d e d m ay be cons i d e red as one

M E A N S O F PROTECTION but s h a l l not be used as two M E A N S O F PROTECT I O N .
Compliance is checked by inspection, by m easurement and for natural latex rubber by the
following test:
Parts of natural latex rubber are aged in an atmosphere of oxygen under pressure. The
samples are suspended freely in an oxygen cylinder, the effective capacity of the cylinder is at
least 1 0 tim es the volum e of the samples. The cylinder is filled with comm ercial oxygen not
less than 97 % pure, to a pressure of 2, 1 MPa ± 70 kPa.
The samples are kept in the cylinder at a temperature of 70 "C ± 2 oc for 96 h. Immediately
afterwards, they are taken out of the cylinder and left at room temperature for at least 1 6 h.
After the test, the samples are examined. Cracks visible to the naked eye constitute a failure.
R = 2,5 m m
Spherical Sample
IEC 2404105
F ig u re 2 1 - B a l l - p ress u re test a p pa ratus

(see 8 . 8 . 4 . 1 )
8.9 * C RE EPAG E DISTANCES a n d AIR CLEARANCES
8.9. 1 * Va l ues
8 . 9. 1 . 1 General
C R E E PAGE D I S TANCES a n d A I R CLEARANCES of M E E Q U I P M E NT s h a l l be e q u a l to o r g re ater t h a n
t h e val ues o f T a b l e 1 1 to T a b l e 1 6 ( i n c l usive) except as s pecifi e d i n 8 . 9 . 1 . 2 to 8 . 9 . 1 . 1 5 . S e e
also 8 . 9 . 2 t o 8 . 9 . 4 .
8.9. 1 . 2 C RE EPAG E DISTANCES a n d AIR CLEARANCES com p l y i n g with I EC 60950-1

The v a l ues of Table 1 1 to Table 1 6 ( i n c l usive) d o n ot a pply to CRE EPAGE DI STANCES and A I R
CLEARANCES form i n g MEANS OF O P E RATOR PROTECT I O N t h at c o m ply w i t h t h e req u i re m e nts of
I EC 6 0 9 5 0 - 1 fo r I NS U LATI O N co-O RDI NATI O N a n d are used i n t h e c o n diti o n s ( e . g . overvoltage
category, pol l ut i o n degree) u n der which co m pl i a n c e was tested .
8.9. 1 . 3 CREEPAG E DISTANCES across g lass, m ica, ceram ic a n d s i m i l a r materials

For CREEPAGE D I S TANCES across g l as s , m i ca , cera m i c and ot h e r i n o r g a n i c i ns u l ati n g m ateri a l s
w i t h s i m i l a r tracki n g c h a racte ri sti cs , t h e s pecifi e d m i n i m u m v a l u e o f A I R CLEARANCE s h a l l b e
a p p l i e d as t h e m i n i m u m CREEPAGE DI STANCE.
6060 1 - 1 © I EC : 20 0 5 - 215 -
8.9. 1 . 4 M i n i m u m CRE E PAG E DISTANCE

I f the m i n i m u m CREEPAGE DISTANCE d e rived from T a b l e 1 1 to T a b l e 1 6 ( i ncl usive) i s l ess t h a n
t h e a pp l i c a b l e m i n i m u m A I R CLEARANCE, t h a t v a l u e o f m i n i m u m A I R CLEARANCE s h a l l be a p p l i e d
as t h e m i n i m u m CREEPAGE DISTANCE .
8 . 9. 1 . 5 M E EQUIPMENT RAT E D for h ig h altitudes

U n l ess otherwise d e c l a red by t h e MANUFACTU R E R , ME E Q U I P M E N T is RATED to o p e rate at a n
altitude :s; 2 0 0 0 m . Where M E E Q U I P M E NT i s i nt e n d e d to be o pe rated i n a press u rized
e n v i r o n m ent, e . g . ai rcraft, t h e o p e rati n g altitude corres p o n d i n g to t h e air p ress u re c o n c e r n e d
s h a l l be used i n determ i n i n g m u lti pl icati o n factor f r o m T a b l e 8 . T h e A I R CLEARANCE i s t h e n
m u lti p l i e d b y t h i s factor. CRE EPAGE DISTANCES are not s u bj ect to t h e m u lti pl i cati o n factors b u t
s h a l l always be a t l east as l a rge as t h e res ulti n g val u e for A I R CLEARANCE .
Table 8 - M u lt i p l ication factors fo r AIR C LEARANCES

for altitudes u p to 5 000 m
M u ltipl ication M u ltipl ication

RATED operati ng Normal barometric factor factor
altitude ( a ) pressure for for
m kPa MOOP MOPP
a � 2 000 80,0 1 , 00 1 , 00
2 000 < a � 3 000 70,0 1 ,14 1 , 00
3 000 < a � 4 000 62,0 1 , 29 1 ,14
4 000 < a � 5 000 54,0 1 , 48 1 , 29
NOTE 1 The m u ltipl ication factors for M EA N S OF OPERATOR PROTECT I O N relate to

I E C 60950- 1 , which specifies AIR C L EARNACES for altitudes u p to 2 000 m .
NOTE 2 The m u ltiplication factors for M EA N S OF PAT I E N T PROTECTION relate to the second
edition of IEC 60601 - 1 , which specified spacing AIR C L EARA N C ES for altitudes u p to 3 000 m .
NOTE 3 The m u ltiplication factors for M OOPs (co l u m n 3) are d e rived from I EC 60664-
1 : 1 992 as amended.
8.9. 1 . 6 * I nterpolation
If t h e WORKI NG VOLTAGE has a v a l u e between those g i v e n i n Tabl e 1 1 to T a b l e 1 6 ( i n c l u s i v e ) :
f o r dete r m i n i n g CRE E PA G E DI STANC E S , l i n e a r i nterpolat i o n i s p e r m itted betwee n t h e n e a rest
two v a l u es , the c a l c u l ated s paci n g bei n g r o u n d e d to the n ext h i g h e r 0 , 1 mm i n crem ent;
for determ i n i n g A I R CLEARANCES for PEAK WORKI NG VOLTAGES a bove 2 8 0 0 V peak o r d . c. ,
l i n ea r i nterpolati o n is perm itted between t h e n e a rest two v a l u e s , t h e cal c u l ated s paci n g
be i n g r o u n d e d to t h e n ext h i g h e r 0 , 1 m m i n crem ent;
for determ i n i n g A I R CLEARANCES for PEAK WORKI NG VOLTAGE up to 2 800 V peak o r d . c. , t h e
h i g h e r o f t h e two v a l ues s h a l l be a p pl i e d .
6060 1 - 1 © I EC : 20 0 5 - 217 -
8.9. 1 . 7 M aterial g ro u ps c l ass ification

Material g r o u ps are cl ass ifi e d as s h own in Table 9.
Table 9 - M aterial g ro u p class ificat i o n
Material g ro u p Com parative tracking i n d ex (CTI)

I 600 ,; CTI
II 400 ,; CTI < 600
lila 1 75 ,; CTI < 400
Ilib 1 0 0 ,; CTI < 1 75
T h e m aterial g ro u p is v e rifi ed by eva l u at i o n of t h e test data for t h e m aterial accordi n g to

I EC 6 0 1 1 2 usi n g 50 d r o ps of s o l uti o n A.
If t h e m aterial g ro u p is n ot kn own , m aterial g r o u p I l i b s h a l l be ass u m e d .
8.9. 1 . 8 P o l l ution d eg ree c lass ification

P o l l ut i o n d e g rees are cl ass ifi e d as fo l l ows :
P ol l ut i o n degree 1 is used to descri be a m i cro-envi r o n m ent t h at is s e a l e d so as to excl u d e
dust a n d m oi stu re.
NOTE 1 A n exa m p l e o f such a m icro-e nviro n m e nt is a sealed o r potted c o m ponent o r assem bly.
P ol l ut i o n degree 2 is used to describe a m i cro-envi r o n m e n t w h e re o n l y n o n-co n d u ctive

p o l l u t i o n occurs except that occas i o n a l l y a tem po rary c o n d u ctivity caused by c o n d e n s ati o n
is t o b e expected.
P ol l ut i o n degree 3 i s used to descri be a m i c ro-envi ro n m e nt t h at i s s u bj ect to c o n d u ctive
p o l l u ti o n , o r to d ry n o n-co n d u ctive p o l l u t i o n t h at c o u l d beco m e c o n d u ctive due to expected
c o n d e nsati o n .
P o l l ut i o n d e g ree 4 i s u s e d t o descri be a m i cro-envi ro n m e n t wh ere co nti n u o u s c o n d u ctivity
occ u rs d u e to c o n d u ctive d ust, r a i n or oth e r wet con diti o n s .
NOTE 2 This type o f e nvironment c a n occur i nside co m m utating motors which generate carbon d u st from the
brushes.
P o l l ut i o n degree 4 i s not accepta b l e for i ns u l at i o n provi di n g a MEANS O F PROTECT I O N .

H owever, in t h e case w h e re i n s u lati o n betwe e n t h e MAINS PART and earth m i ght be
com pro m i s e d , it is n ecessary to prov i d e m easu res, such as pl a n n ed m a i nt e n a n c e , to e n s u re
t h at t h e m i c ro-envi ro n m ent is m iti gated to a l ower p o l l uti o n degree.
8.9. 1 . 9 Overvo ltage category c lass ification

T h e applicable value of t h e M A I N S TRANSI E NT VOLTAGE s h a l l be d ete r m i n e d from t h e
overvoltage cate gory accord i n g t o I E C 6 0664- 1 a n d t h e NOMI NAL a . c. M A I N S VOLTAGE u s i n g
Table 1 0.
8 . 9. 1 . 1 0 AIR CLEARANCE for MAINS PARTS

For MAINS PARTS operati n g on RATED MAINS VO LTAG ES up to 300 V, t h e re q u i red A I R CLEARANCE
s h a l l be t h e val u e in T a b l e 1 3 for t h e r . m . s . o r d . c . RATED MA I N S VOLTAGE p l u s the additi o n a l
A I R CLEARANCE i n T a b l e 1 4 f o r t h e PEAK WORKI NG VOLTAG E .
6060 1 - 1 © I EC : 20 0 5 - 219 -
8 . 9. 1 . 1 1 SUPPLY MAINS overvo ltage

T h i s sta n dard rel ates to overvoltage cate g o ry I I accord i n g to I E C 6 0664- 1 . I f M E E Q U I P M ENT is
i ntended to be used in l ocati o n s where t h e S U PPLY MAINS is overvoltage category I l l , the
v a l u es s pecifi ed i n Table 1 3 to Table 1 5 ( i n c l usive) wi l l be i n a d e q u ate for c l e a r a n c e .
T h e refo re t h e v a l ues g i v e n i n t h e n ext M A I N S TRANS I E NT VOLTA G E col u m n u pwards s h a l l be
u s e d . W h i l st it i s n ot envisaged t h at PAT I E NT protect i o n (Table 1 2) wi l l be req u i red for use of
M E E Q U I P M E N T o n overvoltage cate gory I l l S U PPLY MAI N S , s h o u l d t h i s be n ecess a ry, g u i da n c e is
g i v e n o n t h e val ues req u i red i n t h e rati o n a l e for S u bc l a u s e 8 . 9 .
Table 1 0 - M AINS TRANSIENT VOLTAG E
MAINS TRA N S I E N T VOLTAGE

NOMINAL a.c. S U P PLY MAI N S voltage V peak
l i ne-to-neutral Overvoltage Category
up to and i n c l u d i ng
V r. m.s. I II Ill IV
50 330 500 800 1 500
1 00 500 800 1 500 2 500
1 50 ' 800 1 500 2 500 4 000
300 b 1 500 2 500 4 000 6 000
600 ' 2 500 4 000 6 000 8 000
NOTE 1 I n Norway, d u e to the IT power distribution system used, the a . c S U P P LY M A I N S

voltage is considered t o b e equal t o t h e l i ne-to-line voltage, and wi l l re m a i n 2 3 0 V i n case
of a single e a rth fa ult.
NOTE 2 In Japan, the va l u e of the MAINS T RA N S I ENT VOLTAGES fo r the N O M I NAL a . c .
S U P PLY M A I N S voltage o f 1 00 V i s dete r m i ned from columns appl icable t o t h e N O M I NAL
a.c. S U P PLY MAINS voltage of 1 50 V .
I ncluding 1 20/208 or 1 20/240 V .

a
b
I ncluding 230/400 or 277/480 V .
I ncluding 400/690 V .
'
8 . 9. 1 . 1 2 SECONDARY C I RCUITS
A S ECONDARY C I RC U I T de rived from a S U PPLY MAINS wi l l n o r m a l l y be overvoltage cate gory I
accord i n g to I EC 6 0664- 1 if t h e MAINS PART is overvoltage cate g o ry I I ; t h e m axi m u m tra n s i e nts
for v a r i o u s S U PPLY MAINS voltages i n overvoltage cate gory I are s h own i n t h e col u m n h e a d i ngs
of T a b l e 1 5 .
Where t h e S ECONDARY CI RCUIT is eart h e d or t h e ME E Q U I P M E NT is I NTE RNALLY POWERED, T a b l e

1 5 applies.
W h e r e a S ECONDARY CI RCU I T is n ot eart h e d a n d i s de rived from a S U PPLY MA I N S , t h e ci rcuit

s h a l l be s u bj ected to t h e req u i re m e nts fo r pri m a ry circu its in Tabl e 1 3 and Table 1 4 .
If t h e S ECONDARY C I R C U I T is se parated from t h e MAINS PART by a f u n cti o n a l l y eart h e d o r

PROTECTIVELY EART H E D m etal screen o r transie nts i n t h e S ECONDARY C I RC U I T are b e l ow t h e
l evels expected f o r overvoltage cate gory I , ( f o r ex a m p i e d u e to be i n g atte n u ated by
con n ecti n g a c o m po n ent, s u c h as a ca pacito r , betwe e n t h e S ECONDARY C I RC U I T a n d e a rt h ) , t h e
v a l u es i n T a b l e 1 5 a p pl y .
6060 1 - 1 © I EC : 20 0 5 - 221 -
T h e col u m n for circu its n ot s u bj ect to tra n s i e nt ov e rvo ltages a p pl i es t o :

d . c . S ECONDARY CI RCUITS t h at are r e l i ably co n n ected to earth a n d have ca pacitive filte r i n g
w h i c h l i m its t h e pea k-to- peak ri p p l e t o 1 0 % o f t h e d . c . volta g e ; a n d
ci rcu its i n I NTE RNALLY POWE RED M E E Q U I P M ENT.
8 . 9. 1 . 1 3 P EAK WORKING VOLTAG ES above 1 400 V peak o r d . c .
T h e val u es i n T a b l e 1 5 f o r P E A K WORK I N G VO LTAG E S a bove 1 4 0 0 V peak o r d . c. d o n ot a pply if

a l l t h e fo l l owi n g c o n d iti o n s are s atisfi e d :
t h e A I R CLEARANCE i s at l east 5 m m ;
t h e i ns u l at i o n i nvolved passes a d i e l ectric stre ngth test accordi n g t o 8 . 8 . 3 usi n g :
a n a . c . test voltage whose r. m . s . v a l u e is e q u a l to 1 , 06 ti m es t h e PEAK WORKI NG
VOLTAGE or
a d . c . test voltage e q u a l to the peak v a l u e of the a . c . test v o ltage prescri bed above;
and
t h e A I R CLEARANCE path i s partly o r entirely t h r o u g h air o r a l o n g t h e s u rface of a n i ns u l ati n g
m aterial o f m aterial g ro u p I .
I f t h e A I R CLEARANCE path i s also partly a l o n g t h e s u rface o f a m ate r i a l t h a t is n ot m aterial

g ro u p I, t h e d i e l ectric str e n gth test i s c o n d u cted only ac ross th e part(s ) of t h e path t h at are
through air.
8.9. 1 . 1 4 M i n i m u m CRE E PAG E DISTANCES for two M EANS O F OPE RATOR PROTECTIO N
M i n i m u m CREEPAGE DI STANCES f o r two MEANS OF O P E RATOR P ROTECT I O N a r e o bta i n ed by

d o u b l i n g t h e val u es s h own i n T a b l e 1 6 for o n e MEANS O F O P E RATO R PROTECT I O N .
8 . 9. 1 . 1 5 * C RE EPAG E DISTANCES a n d AIR CLEARANCES fo r D E F I B RI L LATION-PROOF APPLIED

PARTS
C R E E PAGE DISTANCES a n d A I R CLEARANCES n e e d e d to s atisfy 8 . 5 . 5 . 1 for D E F I BRI LLATION- P ROOF
APPLI E D PARTS s h a l l n ot be l ess t h a n 4 m m .
NOTE I n Table 1 1 and Table 1 2 , which deta i l the spacing for PATIENT protect i o n , the C R E EPAGE D I STA N C E a n d A I R
C L EARAN C E a r e both related t o r . m . s . o r d . c . WORKI NG VOLTAGES. I n Ta ble 1 3 , Table 1 4 and Table 1 5 , w h i c h detail
the spacing for OPERATOR protection, the clearance i s related to peak o r d . c . WORKI N G VOLTAGE and the C R E EPAGE
D I STA N C E is related to r . m . s . o r d . c . WORK I N G VOLTAGE.
6060 1 - 1 © I EC : 20 0 5 - 223 -
Table 1 1 - M i n i m u m CRE E PAG E DISTANCES a n d AIR CLEARANCES between parts of o p posite

polarity of the MAINS PART
WORKING WO R K I N G
VOLTAGE VOLTAGE
V d.c. V r. m.s.
u p to and u p to and C R E E PAG E DISTANCE A I R C L EARAN C E
including including mm mm
17 12 0,8 0,4
43 30 1 0,5
85 60 1 ,3 0,7
1 77 1 25 2 1
354 250 3 1 ,6
566 400 4 2,4
707 500 5,5 3
934 660 7 4
1 061 750 8 4,5
1 414 1 000 11 6
6060 1 - 1 © I EC : 20 0 5 - 225 -
Table 1 2 - M i n i m u m CRE E PAG E DISTANCES a n d AIR CLEARANCES provid i n g

M EANS OF PATIENT PROTECTION
S pacing providing S pacing providing

WORKING WORKING one MEANS O F PATI E N T PROTECTION two MEANS O F PAT I E N T PROTECTION
VOLTAGE VOLTAGE
V d.c. V r. m.s. C R EEPAGE C R EEPAGE
u p to and u p to and DISTAN C E AIR CLEARA N C E DISTAN C E AIR CLEARA N C E
including including mm mm mm mm
17 12 1 ,7 0,8 3,4 1 ,6
43 30 2 1 4 2
85 60 2,3 1 ,2 4,6 2,4
1 77 1 25 3 1 ,6 6 3,2
354 250 4 2,5 8 5
566 400 6 3,5 12 7
707 500 8 4,5 16 9
934 660 1 0,5 6 21 12
1 061 750 12 6,5 24 13
1 414 1 000 16 9 32 18
1 768 1 250 20 1 1 ,4 40 22,8
2 263 1 600 25 1 4,3 50 28,6
2 828 2 000 32 1 8,3 64 36,6
3 535 2 500 40 22,9 80 45,8
4 525 3 200 50 28,6 1 00 57,2
5 656 4 000 63 36,0 1 26 72,0
7 070 5 000 80 45,7 1 60 91 ,4
8 909 6 300 1 00 57,1 200 1 1 4, 2
11 312 8 000 1 25 71 ,4 250 1 42 , 8
1 4 1 40 1 0 000 1 60 91 ,4 320 1 82 , 8
6060 1 - 1 © I EC : 20 0 5 - 227 -
Table 1 3 - M i n i m u m AIR CLEARANCES prov i d i n g M EANS OF OPERATOR PROTECTION from t h e

MAI NS PART
A I R C LEARA N C E i n m m
1 50 v< 300 v<

NOMINAL MAINS VOLTAGE NOMINAL MAI N S VOLTAGE NOMINAL MAINS VOLTAGE
::. 1 50 v ::. 300 v ::. 600 v
WORKING VOLTAGE ( M A I N S TRAN S I E N T (MAINS TRAN S I E N T ( M A I N S TRAN S I E N T
u p to and i n c l u d i ng VOLTAGE 1 500 V) VOLTAGE 2 500 V) VOLTAGE 4 000V)
Voltage
Voltage r.m.s Pollution Pollution Pollution Pollution
peak or d.c. (sin usoidal) d e g re e s 1 a n d 2 d e g re e 3 d e g re e s 1 , 2 a n d 3 d e g re e s 1 , 2 a n d 3
One T wo One T wo One T wo One T wo

v v MOOP MOOP MOO P MOOP MOOP MOOP MOOP MOOP
210 1 50 1 ,0 2,0 1 ,3 2,6 2,0 4,0 3,2 6,4
420 300 1 MOOP 2 , 0 2 MOOP 4 , 0 3,2 6,4
840 600 1 M O O P 3 , 2 2 MOOP 6 , 4
1 400 1 000 1 MOOP 4 , 2 2 MOOP 6 , 4
2 800 2 000 1 o r 2 MOOP 8 , 4
7 000 5 000 1 o r 2 MOOP 1 7 , 5
9 800 7 000 1 o r 2 MOOP 25
14 000 10 000 1 o r 2 MOOP 37
28 000 20 000 1 o r 2 MOOP 80
AIR C LEARANCES for WORKI NG VOLTAGES above 2 0 kV r . m . s . o r 28 kV d . c . can be prescribed by particular standards
if necessary.
NOTE AIR C L EARNACES are a function of peak voltage i n the c i rcuit. The r . m . s . voltage c o l u m n is provided for the
special case where the voltage has a s i n usoidal wavefo rm .
6060 1 - 1 © I EC : 20 0 5 - 229 -
Table 1 4 - Add it i o n a l AIR C L E ARANCES for i n s u lation i n MAINS PARTS with PEAK WORKING
VOLTAG E S excee d i n g the peak val u e of the N O M I NAL MAINS VOLTAGE
a
(see 8 . 9 . 1 . 1 0)
1 50 V r. m . s . or 2 1 0 V d e <
NOMINAL MAI N S VOLTAGE NOMINAL MAINS VOLTAGE Additional AIR C L EARAN C E
� 1 50 V r. m . s . or 2 1 0 V d . c . � 300 V r. m . s . or 4 2 0 V d . c. mm
Pol l u ti o n degrees Pol l u ti o n degree Pol l u ti o n degrees

1 and 2 3 1 , 2 an d 3
PEAK WO R K I N G VOLTAGE PEAK WO R K I N G VOLTAGE PEAK WO R K I N G VOLTAG E

One Two
v v v MOOP MOOP
210 210 420 0 0

298 294 493 0,1 0,2
386 379 567 0,2 0,4
474 463 640 0,3 0,6
562 547 713 0,4 0,8
650 632 787 0,5 1 ,0
738 715 860 0,6 1 ,2
826 800 933 0,7 1 ,4
914 1 006 0,8 1 ,6
1 002 1 080 0,9 1 ,8
1 090 1 1 53 1 ,0 2,0
1 226 1 ,1 2,2
1 300 1 ,2 2,4
" When using this table, select the appropriate c o l u m n for the RATED M A I N S VOLTAGE and pollution degree and
choose the row i n that c o l u m n which covers the actual PEAK WORKI N G VOLTAG E . R e a d the additional A I R
C L EARAN C E re q u ired from t h e relevant right h a n d c o l u m n (for one o r two M EA N S OF OPERATOR PROTECT I O N a n d a d d
t h i s t o t h e m i n i m u m A I R CLEARANCE from Table 1 3 t o give t h e total m i n i m u m A I R CLEARA N C E .
6060 1 - 1 © I EC : 20 0 5 - 231 -
Table 1 5 - M i n i m u m AIR C L EARANCES for M EANS OF O P E RATOR PROTECTION in S E C O N DARY

C I RC U I TS
(see 8 . 9 . 1 . 1 2)
A I R C LEARANCES in m m
Tran sient
val u e for
Tran sient value for SECON DARY
Tran sient value for
SECON DARY CIRCUIT CIRCUIT
SECON DARY CIRCUIT C i rc u i t not
WORKING VOLTAGE ::; 1 500 v ::; 2 500 v
up to and ::; 800 v s u bject to
including ( 1 50 v < (300 v < tra n s i e n t
( N O M I NAL MAINS VOLTAGE overvoltages
N O M I N A L MAINS VOLTAGE NOMINAL
::; 1 50 V)
::; 300 V) MAI NS
VOLTAGE
:>600 V)
Voltage Voltage Pol l u ti o n Pol l u ti o n Pol l u ti o n Pol l u ti o n

V peak V r. m . s . deg rees Pol l u ti o n deg rees Pollution deg rees deg rees
or (sinu- 1 and 2 degree 3 1 and 2 degree 3 1 , 2 an d 3 1 and 2 o n l y
V d.c. soidal)
One Two One Two One Two One Two One Two One Two
MOOP MOOP MOOP MOOP MOOP MOOP MOOP MOOP MOOP MOOP MOOP MOOP
71 50 0,7 1 ,4 1 ,3 2,6 1 ,0 2,0 1 ,3 2,6 2,0 4,0 0,4 0,8
1 40 1 00 0,7 1 ,4 1 ,3 2,6 1 ,0 2,0 1 ,3 2,6 2,0 4,0 0,7 1 ,4
210 1 50 0,9 1 ,8 1 ,3 2,6 1 ,0 2,0 1 ,3 2,6 2,0 4,0 0,7 1 ,4
280 200 One MOOP 1 ,4; two MOOP 2 , 8 2,0 4,0 1 ,1 2,2
420 300 One MOOP 1 ,9; two MOOP 3 , 8 2,0 4,0 1 ,4 2,8
700 500 One MOOP 2 , 5 ; two MOOP 5 , 0
840 600 One MOOP 3 , 2 ; two MOOP 5 , 0
1 400 1 000 One MOOP 4 , 2 ; two MOOP 5 , 0
2 800 2 000 One or two MOOP 8 , 4 , but see 8 . 9 . 1 . 1 3
7 000 5 000 One o r two MOOP 1 7 ,5, but see 8 . 9 . 1 . 1 3
9 800 7 000 One o r two MOOP 25, but see 8 . 9 . 1 . 1 3
1 4 000 1 0 000 One o r two MOOP 37, but see 8 . 9 . 1 . 1 3
2 8 000 20 000 One o r two MOOP 80, but see 8 . 9 . 1 . 1 3
42 000 30 000 One o r two MOOP 1 30 , but see 8 . 9 . 1 . 1 3
NOTE A I R C L EARNACES are a function of peak voltage i n the c i rcuit. The r . m . s voltage c o l u m n is provided for the
special case where the voltage has a s i n usoidal wavefo rm .
6060 1 - 1 © I EC : 20 0 5 - 233 -
Table 1 6 - M i n i m u m CRE E PAG E DISTANCES p rovi d i ng M EANS OF OPERATOR PROTECTION a
CREEPAGE D I STA N C E in m m
Spacing for o n e MEANS O F O P ERATO R PROTECTION
Pol l u ti o n
degree 1 P o l l u ti o n degree 2 P o l l u ti o n degree 3
WO R K I N G VOLTAGE
Material g ro u p Material g ro u p Material g ro u p
v
r. m . s or d . c . I , I I , l i la, l l l b I II lila or l l l b I II lila or l l l b
50 0,6 0,9 1 ,2 1 ,5 1 ,7 1 ,9
1 00 0,7 1 ,0 1 ,4 1 ,8 2,0 2,2

1 25 0,8 1 ,1 1 ,5 1 ,9 2,1 2,4
1 50 0,8 1 ,1 1 ,6 2,0 2,2 2,5

200 Use the 1 ,0 1 ,4 2,0 2,5 2,8 3,2
A I R C LEARA N C E
250 from the 1 ,3 1 ,8 2,5 3,2 3,6 4,0
appropriate
300 table 1 ,6 2,2 3,2 4,0 4,5 5,0
400 2,0 2,8 4,0 5,0 5,6 6,3
600 3,2 4,5 6,3 8,0 9,6 1 0,0
800 4.0 5,6 8,0 1 0,0 1 1 ,0 1 2 ,5
1 000 5,0 7,1 1 0,0 1 2 ,5 1 4,0 1 6,0
NOTE M i n i m u m C R EEPAGE D I STA N C E S for two M EA N S OF OPERATOR PROTECTION are obta ined by doubling the
va l ues i n this table.
CREEPAGE D I STA N C ES with i n this table apply to a l l situatio n s .

a
8.9.2 * Appl ication
a) * For i ns u l at i o n in t h e MAINS PART betwee n parts of o pposite pola rity, t h e m i n i m u m

CREEPAGE DISTANCES a n d A I R CLEARANCES are n ot req u i red i f s h o rt ci rcu iti n g of each s i n g l e
o n e o f t h e s e CRE E PA G E DI STANCES a n d A I R CLEARANCES i n t u r n does n o t res u lt i n a
HAZARDOUS S I TUATI O N .
b) T h e co ntri buti o n to t h e CRE E PA G E D I S TANCES o f a n y g ro ove o r a i r g a p l e s s t h a n 1 m m wi de

s h a l l be l i m ited to its width ( s e e F i g u re 23 to F i g u re 31 [ i n c l u s i v e ] ) .
c) I f A I R CLEARANCE prov i d e s a MEANS O F PROTECT I O N , t h e rel ati v e positi o n i n g s h a l l be s u c h

t h at t h e r e l ev a nt parts a re ri g i d a n d l ocated b y m o u l d i n g o r t h e des i g n s h a l l be oth e rwise
such that there i s n o reduct i o n of a distance b e l ow t h e s pecified v a l u e by d efo r m ati o n o r
m ov e m ent o f t h e parts .
Where l i m ited m ov e m ent of o n e of t h e relevant parts is n o r m a l or l i ke l y , t h i s s h a l l be ta k e n

i nto a c c o u nt when c o m puti n g t h e m i n i m u m A I R CLEARANCE .
8.9.3 * S paces f i l led b y i n s u lat i n g co m po u n d
8 . 9. 3 . 1 General
Where distances betwee n c o n d u ctive parts are fi l l e d with i ns u l ati n g c o m po u n d , i n cl u d i n g
w h e re i ns u l at i o n i s rel i a bly ce m e nted toget h e r with i ns u l ati n g c o m po u n d , s o that A I R
CLEARANCES a n d CREEPAGE DI STANCES do not exist, o n l y t h e re q u i re m e nts f o r s o l i d i ns u l at i o n
a p pl y .
6060 1 - 1 © I EC : 20 0 5 - 235 -
NOTE Examples of such treatment include pott i n g , encapsulation and vac u u m i m pregnat i o n , com ponents o r
s u basse m blies t h a t a r e treated w i t h a n insu lating c o m p o u n d t h a t fi lls voids; a n d i nternal insulation between
adjacent tracks o n one layer of a m u lti-layer printed board.
Compliance is checked by inspection, m easurement and test of samples. Requirements for

CREEPA GE DISTANCES and AIR CLEARANCES do not apply if samples pass the thermal cycling,
humidity preconditioning and dielectric strength tests specified in either 8. 9. 3. 2 and 8. 9. 3. 4 or
8. 9. 3. 3 and 8. 9. 3. 4.
8.9.3.2 I n s u lating co m po u n d for m i ng s o l i d i n s u lation between con d u ct ive parts

For situations where insulating compound forms solid insulation b etween conductive parts, a
single finished sample is tested. The sample is subjected to the thermal cycling PRO CEDURE as
specified in 8. 9. 3. 4, follo wed by humidity preconditioning according to 5. 7 except for 48 hours
only, follo wed by a dielectric strength test according to 8. 8. 3 except that the test voltage is
multiplied by 1, 6. The tests are followed by inspection, including sectioning, and
measurem ent. Cracks or voids in the insulating compound such as would affect the
homogeneity of the m aterial constitute a failure.
8.9.3.3 I n s u lating com po u n d fo r m i ng a cemented j o i n t with o t h e r i n s u lat i n g parts

For situations where insulating compound forms a cemented joint with other insulating parts,
the reliability of the joint is checked by testing three samples. If a winding of solvent-based
enam elled wire is used, it is replaced for the test by a m etal foil or by a few turns of bare wire,
placed close to the cemented joint. The three samples are then tested as follows.
One of the samples is subjected to the thermal cycling PROCEDURE as specified in 8. 9. 3. 4.
Immediately after the last period at highest temperature during thermal cycling it is
subjected to a dielectric strength test according to 8. 8. 3 except that the test voltage is
multiplied by 1 , 6;
The other two samples are subjected to humidity preconditioning according to 5. 7 except
for 48 hours only, follo wed by a dielectric strength test according to 8. 8. 3 except that the
test voltage is m ultiplied by 1 , 6.
8.9.3.4 T h e r m a l cyc l i n g
The sample is subjected 1 0 tim es t o the following sequence o f temperature cycles:
68 h at T1 ± 2 ·c;
1 h at 25 ·c ± 2 ·c;
2h at o ·c ± 2 ·c;
not less than 1 h at 25 ·c ± 2 ·c.
where T 1 is the higher of
10 ·c above the m aximum temperature of the relevant part as determined according to

1 1 . 1. 1; or
85 ·c.
However, the 1 0 ·c m argin is not added if the temperature is m easured by an embedded
thermocouple.
The period of tim e taken for the transition from one temperature to another is not specified,
but the transition is permitted to be gradual.
6060 1 - 1 © I EC : 20 0 5 - 237 -
*
8.9.4 M eas u re m e n t of CRE E PAG E DISTANCES AND AI R CLEARANCES
Compliance is checked by measurem ent taking into account the rules in Figure 22 to Figure
3 1 (inclusive) . In each figure, the dashed line ( - - -y repres ents A I R CLEARANCE and the
.... ....
shaded bar r· · · · · · ·)represents CREEPAGE DI STANCE.
Any corner with included angle less than 80 o is assumed to be bridged with an insulating link
of 1 mm m oved into the least favourable position (see Figure 25) .
Where the distance across the top of a groove i s 1 mm or m ore, no CREEPA GE DISTANCE exists
across the air space (see Figure 24).
CREEPA GE DIS TANCES and AIR CLEARANCES b etween parts m o ving relative to each other are
measured with the parts in their least favourable positions.
Computed CREEPA GE DIS TANCE is never less than m easured AIR CLEARANCE.
Coatings of varnish, enamel or oxide are ignored. Coverings of any insulating m aterial,
ho wever, are considered as insulation, if the covering is equivalent to a sheet of insulating
material of equal thickness with respect to its electrical, thermal and m echanical properties.
If CREEPA GE DIS TANCES or AIR CLEARANCES for one or two MEANS OF PROTECTION are interrupted
by one or more floating conductive parts, the minimum values specified in Table 1 1 to Table
1 6 (inclusive) apply to the sum of the sections, except that distances less than 1 mm are not
taken into consideration.
If there are grooves transverse to the CREEPA GE DISTANCE, the wall of the groove is counted
as CREEPA GE DISTANCE only if the width of the groove is m ore than 1 mm (see Figure 24). In
all other cases the groove is neglected.
In the case of a b arrier placed on the surface of insulation or held in a recess, the CREEPA GE
DISTANCES are m easured over the barrier only if the latter is so affixed that dust and m oisture
cannot penetrate into the joint or recess.
For ME E Q UIPMENT provided with an APPLIANCE INLET, the m easurements are m a de with an
appropriate connector inserted. For other ME EQUIPMENT incorporating POWER SUPPL Y CORDS,
they are m ade with supply conductors of the largest cross-sectional area specified by the
MANUFA CTURER and also without conductors.
Movable parts are placed in the least favourable position; nuts and screws with non-circular
heads are tightened in the least favourable position.
CREEPA GE DIS TANCES and AIR CLEARANCES through slots or openings in external parts are
measured to the standard test finger of Figure 6. If necessary, a force is applied to any point
on b are conductors and to the outside of m etal ENCLOSURES in an endeavour to reduce the
CREEPA GE DISTANCES and AIR CLEARANCES while taking the m easurements.
The force is applied by means of a standard test finger having a tip as shown in Figure 6 and
has a value of:
2N for b are conductors;
30 N for ENCLOSURES.
CREEPA GE DISTANCE and AIR CLEARANCES are measured after use of the test hook according to
5. 9. 2. 2, if relevant.
6060 1 - 1 © I EC : 20 0 5 - 239 -
Conditio n : Path under consideration is a

flat s u rface.
·�.-��-� , IEC 2405105 Rule: CREEPAGE D I STA N C E and AIR

C L EARAN C E are measured
d i rectly across the s u rfac e .
F i g u re 22 - CREEPAG E DI STANCE a n d AIR CLEARANC E - E xa m p l e 1
<1 mm Conditio n : Path under consideration
'�
includes a parallel- o r
converging-sided g roove o f
any depth w i t h a width less
than 1 m m .
IEC 2406105 Rule: CREEPAGE D I STA N C E a n d A I R
C L EARAN C E are measured
d i rectly across the groove as
shown.

Conditio n : Path under consideration
�1 mm includes a parallel-sided
groove of a ny depth and equal
�
to o r m o re than 1 m m .
Rule: A I R C LEARA N C E i s the "line of
sight" distance. CREEPAGE
D I STA N C E path follows the
contour of the groove .
IEC 2407
105
�
_;h
= 1 mm Conditio n : Path under consideration
.�
-- -�-- includes a V-shaped groove
I · · · . . . :r-1
. with a width greater than 1
.
·
·
· // mm and an i nternal angle of
less than 80'.
Rule: A I R C LEARA N C E is the "line of

IEC 2406105
contour of the groove but

"short circuits" the bottom of
the groove by a 1 mm l i n k .

includes a rib.
Rule: AIR C LEARA N C E is the s h o rtest
d i rect a i r path over the top of
the rib. CREEPAGE D I STAN C E
path follows the conto u r of t h e
rib.

6060 1 - 1 © I EC : 20 0 5 - 241 -

includes a n uncemented j o i nt
(see 8 . 9 . 3) with grooves less
than 1 m m wide o n each side.
Rule: CREEPAGE D I STA N C E and AIR
C L EARAN C E path a re the "line
of sight" distance shown.
IEC 24 10105

�1 mm includes a n uncemented j o i nt
(see 8 . 9 . 3) with grooves equal
to o r m o re that 1 m m wide o n
each s i d e .
Rule: A I R C LEARA N C E is the "line of

contour of the groove .
IEC 2411105

includes a n uncemented j o i nt
(see 8 . 9 . 3) with a groove o n
one side l e s s than 1 m m w i d e
and the g roove o n the other
side equal to o r m o re than
1 m m wide.
Rule: A I R C LEARA N C E and C R E EPAGE
D I STA N C E are as shown.
F i g u re 29 - CREEPAG E DI STANCE and AIR CLEARANC E - E xa m p l e 8
-�
>1 mm
___; -
Conditi o n : G a p betwe e n head of screw
and wall of recess wide
enough to be take n into
account.
Rule: The AIR CLEARNACE is the

shortest distance to any point
on the head of the screw.
CREEPAGE D I STA N C E path
follows the s u rfac e .

6060 1 - 1 © I EC : 20 0 5 - 243 -
= 1 mm
Conditi o n : G a p betwe e n h e a d of screw
and wall of recess too narrow
to be take n into account.
Rule: Measurement of C R E EPAGE
D I STA N C E is from screw to wa l l
a t a n y point where the
distance is equal to 1 m m .
The A I R CLEARNACE i s the
shortest distance to any point
on the head of the screw.
F i g u re 31 - CREEPAGE DI STANCE and AIR CLEARANCE - E xa m p l e 1 0
8. 1 0 Com pone nts and w i r i n g
8.1 0.1 * F i x i n g o f com po n e n ts

C o m p o n e nts of ME E Q U I PMENT, t h e u nwanted m ov e m e n t of w h i c h co u l d res u lt i n an
u n accepta b l e R I S K , s h a l l be m o u nted s e c u re l y to p revent s u c h m ov e m e nt.
Compliance is checked by inspection of the ME E Q UIPMENT and the RISK MANA GEMENT FILE.
8.1 0.2 * Fixing of wiring

C o n d u ctors a n d c o n n ectors of M E E Q U I P M ENT s h a l l be so s e c u r e d o r i ns u l ated t h at accide ntal
deta c h m ent s h a l l n ot res u l t in a HAZARDOUS S I TUAT I O N . They are not considered to be
a d e q u ately secu red if o n breaki n g free at t h e i r j o i nt and m ov i n g a bo u t t h e i r s u pport poi nt they
are capable of to u c h i n g ci rcuit poi nts res u lti n g in a HAZARDOUS S I TUAT I O N .
Breaki n g free of o n e means of m ec h a n i ca l restra i nt shall be c o n s i d e red a S I NG L E FAULT

CONDI T I O N .
Stra n d e d c o n d u ctors s h a l l not be s o l d e r-coated if they are affix e d by a n y c l a m pi n g means and

poor co ntact could res u lt i n a HAZARDOUS S I TUATI O N .
Compliance i s checked b y inspection of the M E E Q UIPMENT a n d the RISK MANA GEMENT FILE.
8.1 0.3 C o n n ecti o n s between d ifferent parts o f M E EQU I PM E NT
F l ex i bl e cords deta c h a b l e wit h o u t t h e u s e of a TOOL that are used for i nterco n n e ct i o n of

d iffe rent parts of M E E Q U I PMENT s h a l l be prov i ded with m e a n s for c o n n ecti o n s u c h t h at
com pl i a nce of m etal ACCESSI BLE PARTS with 8 . 4 is n ot c o m pro m ised w h e n a c o n n ect i o n is
l oo s e n e d o r broken due to t h e d i s e n g a g e m e n t of o n e of t h e co n n e cti n g m ea n s .
Compliance i s checked b y inspection and m easurement and, if necessary, b y a test with the
standard test finger according to 5. 9. 2. 1 .
6060 1 - 1 © I EC : 20 0 5 - 245 -
8.1 0.4 * Cord -co n n ected HAN D - H E L D parts a n d cord -co n n ected foot-ope rated control
devices (see also 1 5 . 4 . 7)
8 . 1 0.4. 1 L i m itation of operat i n g voltages
Cord-co n n ected HAND- H E L D a n d foot- operated c o ntrol devi ces of M E E Q U I P M E NT a n d t h e i r

ass ociated c o n n ecti o n cords s h a l l conta i n o n l y c o n d u ctors a n d c o m p o n e nts o p e rati n g a t
v o ltages n ot exceedi n g 4 2 , 4 V peak a . c . o r 60 V d . c . i n ci rcu its i s o l ated f r o m t h e MAINS PART
by two MEANS O F PROTECTION. T h e d . c . l i m it of 60 V a ppl i es to d . c. with n ot m o re t h a n 1 0 %
peak-to- peak r i p p l e . If t h e r i p p l e exceeds t h at a m o u nt, t h e 4 2 , 4 V peak l i m it a p p l i e s .
Compliance i s checked b y inspection and, i f necessary, voltage m easurements.
8 . 1 0.4.2 C o n n ection cords
The c o n n e ct i o n a n d a n c h o rage of a fl ex i bl e cord to a HAND- H E LD o r foot-operated control

device of M E E Q U I PMENT, at both e n ds of t h e cable to t h e co ntrol d ev i c e , s h a l l c o m pl y with t h e
req u i re m e nts s pe cifi ed f o r POWER S U PPLY CORDS i n 8 . 1 1 . 3 , if breaki n g free o r s h o rti n g betwe e n
t h e c o n d u ctors c o u l d res u l t i n a HAZARDOUS S I TUATI O N . T h i s re q u i re m e nt a l s o a pp l i e s to other
HAND- H E L D pa rts if distu rbance o r bre a ki n g of one o r m o re of the c o n n ecti o n s could res u l t in a
Compliance i s checked b y perform ance of the tests of B . 1 1 . 3.
8.1 0.5 * Mechan ical p rotection o f w i r i n g
a) I nt e r n a l c a b l es a n d wi ri n g s h a l l be a d e q u ately protected aga i n st contact with a m ov i n g part

or from fri cti o n at s h arp corn e rs a n d edges where d a m a g e to i ns u l at i o n c o u l d result i n a
b) M E E Q U I PMENT s h a l l be s o des i g n e d t h at wi ri n g , c o r d f o r m s o r co m po n e nts a r e n ot l i ke l y t o

be d a m ag e d d u ri n g ass e m bl y o r t h e o pe n i n g o r cl osi n g o f ACCESS COVERS w h e re s u c h
d a m a g e c o u l d r e s u l t i n a HAZARDOUS S I TUAT I O N .
Compliance is checked by inspection and, where appropriate, by m anual test or reference to

the RISK MANA GEMENT FILE.
8.1 0.6 G u i d i n g rol lers fo r i n s u lated cond uctors

G u i d i n g rol l e rs of i ns u l ated c o n d u ctors of M E E Q U I P M E NT s h a l l be c o n structed in s u c h a
m a n n e r t h at m ov a b l e i n s u l ated c o n d u ctors i n NORMAL U S E are n o t bent r o u n d a r a d i u s of less
than five ti m es t h e outer d i a m eter of t h e lead c o n c e r n e d .
Compliance i s checked b y inspection a n d m easurem ent of the relevant dimensions.
8.1 0.7 * I n s u lation o f i n ternal w i r i n g
a) I f i n s u l ati n g sl eevi n g is n e e d e d o n i nte r n a l wi r i n g o f M E E Q U I P M E NT , it s h a l l be adeq uately

secured. S l e evi n g t h at can only be rem oved by breaki n g o r c utti n g o r t h at i s s e c u red at
both e n ds m ay be used to s ati sfy t h i s re q u i re m e nt.
6060 1 - 1 © I EC : 20 0 5 - 247 -
b) I ns i d e ME EQUIPM ENT t h e s h e ath of a flex i b l e cord s h a l l n ot be used as a MEANS OF

PROTECTION if it i s s u bj e ct to m ec h a n ical o r thermal stresses outs i d e its RATED
c h a racte ristics.
c) I ns u l ated co n d u ctors of ME EQUIPM ENT t h at in NORMAL USE are s u bj e ct to tem peratu res
exceedi n g 70 oc s h a l l have i n s u lati o n of h eat- resistant m at e r i a l if c o m p l i a nce with t h i s
sta n dard is l i ke l y to be i m paired b y deteriorat i o n o f t h e i ns u l ati o n .
Compliance is checked b y inspection and, if necessary, b y special tests. Temperatures are

determined as indicated in 1 1 . 1 .
8. 1 1 M AINS PARTS, co m po n e n ts a n d l ayout
8. 1 1 . 1 Isolation from t h e S UPPLY MAINS
a) * M E EQUIPMENT s h a l l have m ea n s to i s o l ate its ci rcu its e l ectrical l y from t h e S U PPLY MAINS
o n all poles s i m u l t a n e o u s l y .
P E RMANE NTLY I NSTALLED ME EQUIPMENT c o n n ected to a polyphase S U PPLY M A I N S m ay be

prov i d e d with a device that does n ot i nterr u pt t h e n e utral c o n d u ctor, prov i d e d t h at l ocal
i nsta l l at i o n conditions a re such that in NORMAL CONDI TION t h e voltage o n t h e n e utral
c o n d u ctor can be ex pected n ot to exceed the l i m its specifi ed in 8 . 4 . 2 c ) .
b) M e a n s f o r i s o l at i o n e i t h e r s h a l l be i n c o rporated i n ME EQUIPM ENT or, if exte r n a l , s h a l l b e

descri bed i n t h e tec h n ical descripti o n (see 7 . 9 . 3 . 1 ) .
c) * A S U PPLY M A I N S switch that is used to c o m ply w i t h 8 . 1 1 . 1 a) s h a l l com ply w i t h t h e

CREEPAGE DISTANCES a n d A I R CLEARANCES as s pecifi e d i n I E C 6 1 0 5 8 - 1 fo r a MAINS
TRANS I E NT VOLTAGE of 4 kV.
NOTE Table 22 i n I EC 6 1 058- 1 : 2000 specifies different va lues for contact separation depending o n the MAINS
TRA N S I E N T VOLTAGE , which i s referred to i n that table as the "rated i m pulse withstand volta g e . "
d) A S U PPLY MAINS switch s h a l l n ot be i n corpo rated in a POW E R S UPPLY CORD o r a n y oth e r

exte rnal , fl ex i bl e l e a d .
e) T h e di recti o n o f m ov e m ent o f t h e actu ato r o f a S UPPLY MAI NS switch t h at i s u s e d t o com ply

with 8 . 1 1 . 1 a) s h a l l c o m ply with I EC 60447.
f) In n o n -PERMANENTLY I NSTALLED ME E Q U I PM E NT, a s u ita b l e p l u g device used to i s o l ate

ME EQUIPMENT from the S U PPLY MAINS s h a l l be c o n s i d e r e d as com plyi n g with t h e
req u i re m e nts o f 8 . 1 1 . 1 a ) . An APPLIANCE COUPLER o r a f l ex i b l e cord w i t h a M A I N S P L U G m ay
be u s e d .
g) A fuse o r a s e m i co n d u ctor d e v i c e s h a l l not be used as a n i s o l ati n g m e a n s i n t h e s e n s e of

t h i s s u bc l a u s e .
h ) * M E EQUIPMENT s h a l l not i n cl u d e a device t h at causes d i s co n n e cti o n o f t h e ME EQUIPMENT

from t h e S U PPLY MAINS by prod u c i n g a s h o rt circuit that res u lts i n o p e rati o n of an ov e r
cu rrent protect i o n device.
i ) * Any part wit h i n t h e E NCLOS URE of ME EQUIPMENT with a circuit voltage excee d i n g 42,4 V
peak a . c. or 60 V d . c . t h at c a n n ot be d i s co n n ected from its s u pply by a n exte r n a l switch o r
a p l u g d e v i c e that i s access i b l e a t a l l ti m es s h a l l be protected agai nst be i n g t o u c h e d eve n
after o pe n i n g o f t h e E NCLOS URE b y a n additi o n a l cove r i n g o r , i n t h e case o f a s pati a l l y
6060 1 - 1 © I EC : 20 0 5 - 249 -
separated arra n g e m e nt, s h a l l be m a rked clearly as exceedi n g t h e perm itted voltage for
pa rts that can be t o u c h e d . The use of the sym bol I SO 7000- 0434 (see T a b l e 0 . 1 , sym bol
1 0) is n ot s uffi c i ent. A wa r n i n g n otice o n t h e outs i d e of t h e M E E Q U I P M E NT m ay be u s e d .
For a part that cannot be disconnected from the supply by an external s witch or a plug device
that is accessible at all tim es, compliance is checked by inspection of the required cover or
warning notice (if present) and, if necessary, by application of the standard test finger of
Figure 6.
8. 1 1 . 2 * M ULTIPLE SOCKET-OUTLETS
M U LTI PLE SOCKET-OUTLETS t h at a re i nte gral with ME E Q U I PM E N T shall c o m ply with the
req u i re m e nts o f 1 6 . 2 d ) , s e c o n d das h , a n d 1 6 . 9 . 2 . 1 .
8. 1 1 . 3 POWE R S UPPLY CORDS
8. 1 1 . 3 . 1 Appl ication
T h e MAINS PLUG of M E E Q U I PMENT s h a l l n ot be fitted with m o re t h a n one P O W E R S U P P LY CORD.
8. 1 1 . 3 . 2 Types
Any POW E R S U PPLY CORD of M E E Q U I P M E NT s h a l l be n ot l ess ro bust t h a n ordi n a ry t o u g h r u bber
s h eathed fl exi b l e cord ( I E C 60245- 1 : 20 0 3 , A n n ex A, des i g n ati o n 5 3 ) or o r d i n a ry polyvi nyl
c h l o r i d e s h eathed f l ex i b l e cord ( I EC 60227- 1 : 1 99 3 , A n n ex A, des i g n ati o n 53) .
A polyvi nyl c h l o r i d e i ns u l ated POWER S U PPLY CORD s h a l l n ot be u s e d for ME E Q U I P M E NT havi n g

ext e r n a l m etal parts with a tem perature exceed i n g 7 5 oc a n d w h i c h c a n be t o u c h e d i n NORMAL
U S E by the cord, u n less it i s RATED for t h at tem perat u r e . See a l s o T a b l e 2 2 .
Compliance i s checked by inspection a n d m easurement.
8. 1 1 . 3 . 3 C ross-sectional a rea o f POWER SUPPLY C O R D co n d u ctors

T h e N O M I NAL c ross-secti o n a l area of co n d u ctors of a n y POW E R S U PPLY CORD of ME E Q U I PMENT
s h a l l be n ot l ess than that s h own in Table 1 7 .
6060 1 - 1 © I EC : 20 0 5 - 251 -
Table 1 7 - N O M I NAL cross-sect i o n a l area of co n d uctors of a POWER SUPPLY CORD
NoMINAL cross-s ecti onal

RAT E D cu rrent ( / ) of M E E Q U I P M E N T area
A m m Cu
2
I�6 0 , 75
6 < I � 10 1
1 0< I � 1 6 1 ,5
1 6< I � 25 2,5
25< I � 32 4
32< I � 40 6
40< I � 63 10
8. 1 1 . 3 . 4 * APPLIANCE COUPLERS
APPLIANCE COU P L E RS co m plyi n g with I EC 60320-1 are c o n s i d e red t o c o m pl y with 8 . 1 1 . 3 . 5 a n d
8. 1 1 . 3.6.
Compliance is checked b y inspection of the documentation demonstrating that the APPLIANCE

CO UPLER conforms to the requirements of IEC 60320- 1 .
8. 1 1 . 3 . 5 * Cord a n c h o rage
a) The c o n d u ctors of a POW E R S U PPLY CORD s h a l l be r e l i ev e d fro m stra i n , i n c l u d i n g twist i n g ,

a n d t h e i ns u l at i o n o f t h e c o n d u ctors s h a l l be protected from a bras i o n a t t h e poi nt o f e ntry
to M E E Q U I P M ENT o r a MAINS CONNECTOR by a cord a n c h o ra g e .
b) I f a total i ns u l ati o n fai l u re o f t h e POW E R S U P P LY CORD c o u l d c a u s e c o n d u ctive ACCESSI BLE

PARTS t h at are n ot PROTECTIVELY EART H E D to exceed the l i m its s pecifi e d in 8 . 4 , the cord
a n c h o rage of a POW E R S U P P LY CORD s h a l l be m a d e :
o f i n s u l ati n g m ateri a l , o r
of m eta l , i ns u l ated fro m c o n d u ctive ACCESSI BLE PARTS n ot PROTECTIVELY EARTHED b y a
MEANS OF PROTECT I O N , o r
o f m etal prov i d e d w i t h a n i ns u l ati n g l i n i n g , w h i c h s h a l l be affixed t o t h e c o r d

a n c h o ra g e , u n l ess it i s a flex i b l e b u s h i n g t h at forms part of t h e cord g u a r d s pecifi e d i n
8 . 1 1 . 3 . 6 , a n d w h i c h s h a l l com ply with t h e req u i re m e nts for o n e MEANS O F PROTECTI O N .
c) T h e cord a n c h o ra g e of a POW E R S U PPLY C O R D s h a l l be s o d e s i g n e d t h at t h e cord i s not

c l a m ped by a screw t h at bears d i rectly o n t h e cord i n s u lati o n .
d) Sc rews , if a ny, t h at h av e t o b e o p e rated w h e n repl a c i n g t h e POWER S U PPLY CORD s h a l l n ot

serve to fix a n y c o m po n ent other t h a n pa rts of t h e cord a n c h o r a g e .
e) C o n d u ctors o f t h e POW E R S U P P LY CORD s h a l l be s o arranged t h at if t h e cord a n c h o ra g e fai l s

t h e PROTECTIVE EARTH COND UCTOR i s n ot s u bj ect to stra i n as l o n g as t h e p h a s e co n d u ctors
are i n conta ct with t h e i r term i n al s .
6060 1 - 1 © I EC : 20 0 5 - 253 -
f) T h e cord a n c h o ra g e s h a l l prevent t h e POW E R S U P PLY CORD from be i n g p u s h e d i nto t h e

M E E Q U I P M E N T o r M A I N S CONNECTO R .
Compliance i s checked b y inspection a n d b y the follo wing tests:
ME EQ UIPMENT, if designed for a POWER SUPPL Y CORD, is tested with the cord supplied by the
MANUFA CTURER.
The POWER SUPPL Y CORD conductors are, if possible, disconnected from the terminals or from
the MAINS CONNECTOR.
The cord is subjected 25 tim es to a pull on the sheath of the value shown in Table 1 8. The
pulls are applied in the m ost unfavourable direction without jerks, each time for 1 s.
Immediately afterwards, the cord is subjected for 1 min to a torque of the value shown in
Table 1 8.
Table 1 8 - Tes t i n g of cord a n c h o rag es
Mass (m) of M E E Q U I P M E N T Pull Torq ue

kg N Nm
m ,s; 1 30 0,1
1 < m ,s; 4 60 0,25
m> 4 1 00 0 , 35
A cord anchorage that allows the cord sheath to be longitudinally displaced by m ore than
2 mm or the conductor ends to move over a distance of more than 1 mm from their normally
connected position is considered to fail.
CREEPA GE DISTANCES and AIR CLEARANCES that are reduced b elow the values specified in 8. 9
constitutes a failure.
Attempt to push the cord into the ME E Q UIPMENT or the MAINS CONNECTOR. If the cord can b e
pushed into the M E EQUIPMENT o r the MAINS CONNECTOR t o such a n extent that the cord or
internal parts are damaged, the cord anchorage is considered to fail.
8. 1 1 . 3 . 6 * Cord guards
POW E R S U PPLY CORDS of oth e r t h a n STAT I O NARY M E E Q U I P M E N T s h a l l be protected agai nst
excess ive be n d i n g at t h e i n l et o pe n i n g of t h e e q u i pm ent o r of t h e MAINS CON NECTOR by m e a n s
o f a c o r d g u ard o f i ns u l ati n g m ateri a l o r b y m ea n s o f a n a ppro p r i ately s h aped o pe n i n g i n t h e
M E E Q U I PMENT.
Compliance is checked by inspection and by either the test described in IEC 60335- 1 :200 1 ,
subclause 25. 1 4 or the following test. An arrangement that passes either test i s considered to
comply with the requirement.
ME E Q UIPMENT having a cord guard or opening is so placed tha t the axis of the cord guard,
where the cord leaves it, projects at an angle of 45 o when the cord is free from stress. A mass
2
equal to 1 0 x 0 gram is then attached to the free end of the cord, where 0 is the overall
diameter of, or for flat cords, the minor overall dimension of the POWER SUPPL Y CORD in
millim etres.
If the cord guard is of temperature-sensitive material, the test is made at 23 'C ± 2 'C.
6060 1 - 1 © I EC : 20 0 5 - 255 -
Flat cords are b ent in the plane of least resistance.
If the radius of curvature of the cord, immediately after the m ass has been attached, is
anywhere less than 1 , 5 x 0, the cord guard is considered to fail.
8. 1 1 . 4 M AINS TERMI NAL DEVICES
8. 1 1 . 4. 1 * Gen eral req u i re m e n ts fo r MAINS TERMI NAL DEVICES

P E RMANE NTLY I NSTALLED ME EQUIPMENT and ME EQUIPMENT h av i n g a n o n -DETACHABLE POWE R
S U PPLY CORD that is replaceable by S ERVICE PERSONNEL s h a l l be prov i d e d with MAINS TERMINAL
DEVICES t h at e n s u r e r e l i a b l e c o n n ecti o n .
R e l i a n c e s h a l l n ot be p l a ced u p o n t h e term i n al s a l o n e t o m a i ntai n t h e c o n d u ctors i n positi o n ,

u n l ess barri e rs are prov i d e d s u c h that CREEPAGE DI STANCES a n d A I R CLEARANCES t h at s e rve as
a MEANS OF PROTECTION c a n not be reduced to l ess t h a n the v a l ues s pe cifi ed in 8 . 9 , if a ny
co n d u ctor breaks away. See also 8 . 1 0 . 2 .
Term i n a l s o f co m po n e nts oth e r t h a n term i n a l bl ocks m ay b e u s e d as term i n a l s i ntended for

exte r n a l c o n d u ctors if t h ey com ply with the req u i re m e nts of t h i s s u bc l a u s e a n d are properly
m a rked accordi n g to 7 . 3 . 7 .
Screws a n d n uts t h at c l a m p exte r n a l c o n d u ctors s h a l l n o t s e rve t o fix a n y oth e r co m po n e nt,

except t h at t h ey m ay a l s o c l a m p i nte r n a l c o n d u ctors if th ese are so arranged that they are
u n l i ke l y to be d i s pl aced w h e n fitt i n g the s u pply c o n d u ctors .
8. 1 1 .4.2 Arrangement of MAINS TERMINAL DEVICES
a) * For ME EQUIPM ENT with rewi rable cords where term i n a l s a r e prov i d e d fo r t h e c o n n ecti o n
o f exte r n a l cords o r POWER S U PPLY CORDS , t h ese te r m i n a l s to geth e r with a n y PROTECTIVE
EARTH TERMINAL s h a l l be closely grou ped, s o as to prov i d e a c o nv e n i e nt m e a n s of
co n n ecti o n .
b) F o r det a i l s of PROTECTIVE EARTH CONDUCTOR co n n ecti o n s , s e e 8 . 6 .
c ) F o r m a rki n g o f MAINS TERMINAL DEVI CES, s e e 7 . 3 .
d) M A I NS TERMINAL DEVICES s h a l l n ot b e access i bl e wit h o u t t h e u s e o f a TOOL .
e) M A I NS TERMINAL DEVICES s h a l l be so l ocated or s h i el d e d t h at, if a wi re of a stra n d e d

co n d u ctor esca pes when t h e c o n d u ctors a r e fitted, s h o rt ci rcu iti n g a MEANS OF PROTECTION
is u n l i kely.
Compliance is checked by inspection and, if necessary, by the following test:
The end of a flexible conductor having the NOMINAL cross-sectional area specified in
Table 1 7 is stripped of its insulation for a length of 8 mm.
6060 1 - 1 © I EC : 20 0 5 - 257 -
A single wire of the stranded conductor is left free and the rest of the conductor is secured
to the terminal.
The free wire is bent in every possible direction without pulling b ack the insulating sheath
and without m aking sharp bends around partitions.
Contact between the free wire and any other part such that a MEANS OF PROTECTION is short
circuited constitutes a failure.
8. 1 1 .4.3 F ix i n g of m a i n s ter m i nals

Term i n a l s shall be F I X E D s u c h that, w h e n t h e means for cl a m pi n g t h e c o n d u ctors are tightened
o r l oo s e n e d , t h e i nternal wiri n g is n ot s u bj ected to stress a n d C R E E PA G E D I S TANCES and A I R
CLEARANCES are n ot reduced b e l ow t h e v a l ues s pecifi e d in 8 . 9 .
Compliance is checked b y inspection and b y m easurement after fastening and loosening a

conductor of the largest cross-sectional area specified 1 0 tim es.
*
8. 1 1 .4.4 Con nections to m a i n s te r m i na l s
Term i n a l s w i t h c l a m pi n g m ea n s f o r a rewi rable flex i b l e cord s h a l l n ot req u i re special
pre pa rati o n of t h e c o n d u ctors in o rd e r to effect co rrect co n n e cti o n , and t h ey shall be so
des i g n e d o r placed that t h e c o n d u ctors are n ot d a m a ged and c a n n ot s l i p o u t when t h e
cl a m pi n g m ea n s are t i g hte n e d . S e e a l s o 8 . 1 0 . 2 .
Compliance is checked b y inspection o f the terminals and o f the conductors after the test of
8. 1 1 . 3. 4.
8. 1 1 . 4 . 5 Access i bi l ity of t h e con nection

The s pace i n s i d e M E E Q U I PMENT des i g n e d fo r F I X E D wi ri n g o r a rewi rable POW E R S U P P LY CORD
s h a l l be a d e q u ate to a l l ow c o n d u ctors to be easily i ntroduced and c o n n ecte d , and covers, if
any, to be fitted wit h o ut d a m age to the co n d u ctors o r t h e i r i ns u l ati o n . It s h a l l be possi b l e to
c h e c k t h at the c o n d u ctors are co rrectly co n n ected a n d positi o n e d before the ACCESS COV E R is
fitted. S e e a l s o 8 . 1 0 . 5 .
Compliance i s checked b y inspection a n d by a n installation test.
*
8. 1 1 . 5 M a i n s fuses a n d OVE R-CURRENT RELEAS ES
A fuse o r OVER-CURRENT RELEASE s h a l l be prov i d e d in e a c h s u pply l e a d for CLASS I
ME E Q U I PMENT a n d fo r CLASS 1 1 ME E Q U I P M E NT h av i n g a fu n ct i o n a l e a rth c o n n e ct i o n accord i n g to
8 . 6 . 9 , a n d i n at l east o n e s u pply l ead for oth e r s i n g l e- p h ase CLASS 1 1 ME E Q U I P M E NT , except
t h at:
- for P E R MANE NTLY I NSTALLED ME E Q U I PM E NT , t h e n e utral c o n d u ctor s h a l l not be fused;
if ex a m i n at i o n s h ows t h at two MEANS O F PROTECTION are present between a l l parts of
o p posite p o l a rity with i n t h e M A I N S PART, a n d between a l l pa rts of t h e M A I N S PART a n d e a rt h ,
t h e n t h e fuses o r OVER-CURRENT RELEASES m ay be o m itted. T h ese i ns u l ati o n req u i re m e nts
s h a l l be co nti n u ed up to a n d with i n any c o m p o n e nt. T h e effect of s h o rt-ci rcuit fa u l t
conditions i n oth e r ci rcu its s h a l l be c o n s i d e red befo re e l i m i n ati n g f u s e s o r OVER-CURRENT
RELEA S E S .
A PROTECTIVE EARTH CONDUCTOR shall n ot i n c o r po rate a fuse o r OVER-CURRENT RE LEAS E .
Protective devi ces s h a l l have a d e q u ate breaki n g capacity t o i nterrupt t h e m ax i m u m fa u lt

cu rrent ( i n c l u d i n g s h o rt-circuit c u rre nt) w h i c h c a n flow.
6060 1 - 1 © I EC : 20 0 5 - 259 -
NOTE If fuses com plying with I E C 60 1 2 7 1 8) a re used and the prospe ctive short-c ircuit cu rrent exceeds 35 A o r
1 0 times the c u rrent rating of the f u s e , whi chever is greater, the fuses should have h i g h breaking capacity
(1 500 A) .
J ustifi cati o n for o m i s s i o n of fuses o r OVER-CU RRENT RE LEASES s h a l l be i n c l u d e d i n t h e R I S K

MANAG E M E NT F I L E .
8. 1 1 . 6 I nter n a l w i r i n g o f t h e MAI NS PART
a) I nt e r n a l wi r i n g in a MAINS PART between t h e MAINS TERM I N A L DEVICE a n d t h e protective

devices s h a l l have a c ross-secti o n a l area n ot l ess t h a n the m i n i m u m req u i red for t h e
POWER S U PPLY CORD as s pecifi e d i n 8 . 1 1 . 3 . 3 .
b) T h e cross-secti o n a l area of oth e r wi ri n g i n t h e MAINS PART a n d t h e sizes of tracks o n

pri nted wi r i n g ci rcu its o f M E E Q U I P M E N T s h a l l be s uffi ci e nt t o prevent fi re i n case o f possi b l e
fa u lt c u rre nts .
When necessary, compliance is checked by connecting the ME EQUIPMENT to a specified

SUPPL Y MAINS from which the most unfavourable short-circuit current expected can be
drawn in the event of a fault in the MAINS PART. Subsequently, a fault in a single insulation
in the MAINS PART is simulated so that the fault current is the least fa vourable. The
occurrence of any HAZARDOUS SITUATIONS listed in 1 3. 1 . 2 constitutes a failure.
9 * P rotect i o n a g a i nst M ECHAN ICAL HAZARDS of M E EQU I P M E N T a n d M E SYSTEMS
9.1 M ECHANICAL HAZARDS of M E EQUIPMENT

For g e n e ral req u i re m e nts on desi g n and m a n ufact u r e of M E E Q U I P M E N T , s e e C l a u s e 4 a n d
1 5.3.
T a b l e 1 9 i d e ntifies t h e s u bcl a u s es t h at a d d ress t h e M E CHANICA L HAZA RDS .
1 8) I EC 60 1 2 7 series, Miniature fuses

6060 1 - 1 © I EC : 20 0 5 - 261 -
Table 1 9 - M ECHANICAL HAZARDS covered by t h i s clause
M ECHAN ICAL HAZARD Covered by su bclause

Crus h i n g HAZARD 9.2, 9 . 4 a n d 9.8
S hearing HAZARD 9 . 2 a n d 9.8
Cutting o r severing HAZARD 9.2, 9 . 3 and 9 . 8
E ntanglement HAZARD 9.2
Trapping HAZARD 9.2
Stabbing or puncturing HAZARD 9 . 2 , 9 . 3 and 9 . 8
Friction o r a brasion HAZARD 9.2 and 9.3
Expelled parts HAZARD 9.5
High pressure fluid ejection HAZARD 9.7
Falling HAZARD 9.8
I nsta b i l ity HAZARD 9.4
I m pact HAZARD 9.2 and 9.8
Moving and positioning of PATIENT 9.2 and 9.4
V i bration a n d noise 9.6
9.2 * HAZARDS associated with movi n g parts
9.2. 1 * Gen eral

M E E Q U I PMENT with m ov i n g pa rts s h a l l be desi g n e d , b u i lt and laid o u t s o t h at, w h e n PROPE RLY
I NSTALLED a n d used as i n d i cated i n t h e ACCO MPANYI NG DOCUME NTS or u n de r reas o n a b l y
fores e e a b l e m is u s e , t h e R I S KS ass ociated w i t h t h ose m ov i n g pa rts a re reduced t o a n
accepta b l e l e v e l .
T h e R I S K from co ntact w i t h t h e m ovi n g pa rts s h a l l be reduced to a n accepta b l e l ev e l b y use of

protective m e asures, beari n g in m i n d t h e ease of access, t h e ME E Q U I PMENT ' s f u n cti o n , t h e
s h a pe o f t h e parts , t h e e n e rgy a n d speed o f t h e m ot i o n a n d t h e b e n efits to t h e PAT I E NT .
T h e RESI DUAL R I S K ass o c i ated with m ov i n g pa rts i s c o n s i dered accepta b l e if expos u re is

needed for t h e M E E Q U I P M ENT to perform its i nt e n d e d fu n cti o n . I f after a l l reas o n a b l e protective
m e as u res h ave b e e n i m pl e m e nted HAZARDS pers i st, wa r n i n g s s h al l be m a rked o n t h e

ME EQUIPMENT o r g i v e n i n t h e i nstruct i o n s f o r use.
NOTE Req u i re m e nts f o r pa rts s u bject t o w e a r a r e fo und i n 1 5 . 2 .
9.2.2 TRAPPING ZONE
9 . 2. 2 . 1 General
Where feas i bl e , M E E Q U I P M E NT with a TRA P P I N G ZONE s h a l l c o m ply with t h e req u i re m e nts of

o n e o r m o re of the fol l owi n g :
g a ps as s pecifi ed i n 9 . 2 . 2 . 2 ; o r
safe d i st a n ces as s pecifi ed i n 9 . 2 . 2 . 3 ; o r
G UARDS a n d protective m e as u res as s pecifi e d i n 9 . 2 . 2 . 4 ; o r
conti n u o u s a ctivati o n as s pecifi ed i n 9 . 2 . 2 . 5 .
6060 1 - 1 © I EC : 20 0 5 - 263 -
If i m pl e m e ntat i o n of t h e a bove protective m easu res wo u l d be i n c o n s istent with t h e I NTENDED

USE of t h e M E E Q U I P M E NT o r t h e M E SYS T E M , control of t h e r e l ev a nt m ot i o n s h a l l c o m ply with
9.2.2.6.
9.2.2.2 Gaps
A TRA P P I N G ZONE i s c o n s i dered n ot to pres e n t a M E CHANICA L HAZARD if t h e g a ps of the

TRAPPING ZONE c o m ply with the d i m e n s i o n s specified in Table 20.
NOTE In genera l the va l ues for adu lts should be used. However, i n the case of devices specifica lly designed for
use with children, the d i m e nsions given for c h i l d re n should be applied.
9.2.2.3 Safe d istan ces

A TRA P P I N G ZONE is c o n s i dered n ot to present a MECHANICAL HAZARD if t h e d i st a n ces
separat i n g the O P E RATO R , PAT I E NT a n d oth e r persons from the TRAPPING ZONES exceed t h e
v a l u es s pecifi ed i n I S O 1 38 5 2 . T h e d i st a n ces are m easu red fro m t h e ex pected pos itions of
t h e O P E RATO R , PAT I E NT a n d ot h e r pers o n s n e a r t h e M E E Q U I P M E N T in NORMAL USE or u n der
reas o n ably forese e a b l e m i s u s e .
9.2.2.4 * G UARDS and p rotective m easu res
9.2. 2.4. 1 Access to TRAPPING ZONES

A TRAPPING ZONE i s considered n ot to present a M ECHA N I CA L HAZARD if G UARDS and protective
m ea s u re s :
are o f rob ust constructi o n ;
a r e n ot e asy t o bypass o r render n o n - o p e rati o n a l ;
do n ot i ntroduce a n y additi o n a l u n acce pta b l e R I S K .
Compliance is checked by the applicable tests of 15.3 for ENCLOSURES.
9.2.2.4.2 FIXED G UARDS

F I X E D G UARDS s h a l l be s e c u r e l y h e l d i n place by syste m s t h at c a n n ot be d i s m antled wit h o ut
t h e u s e of a TOOL.

6060 1 - 1 © I EC : 20 0 5 - 265 -
Table 20 - Accepta ble g a ps a
Ad u l t C h i l d ren
gap a gap a
Part of body mm mm I l l ustration
Body >500 >500
}fA>
Head >300 o r < 1 20 >300 or <60
~
Leg > 1 80 > 1 80
j
Foot > 1 2 0 o r <35 > 1 2 0 o r <25
�
Toes >50 >50
~
Arm >120 >120
~
Hand , wrist, fist > 1 00 > 1 00
?�
Finger > 25 o r < 8 > 25 o r < 4
• The values in this table a re taken from I S O 1 3852 : 1 996.

~
6060 1 - 1 © I EC : 20 0 5 - 267 -
9.2.2.4.3 M ovable G UARDS

M o v a b l e G UARDS t h at c a n be o pe n e d wit h o ut t h e u s e of a TOOL:
s h a l l re m a i n attached to the M E E Q U I P M ENT w h e n the G UARD i s o p e n ;
s h a l l be ass ociated with a n i nterlock device t h at preve nts t h e relevant m ov i n g parts from
starti n g to m ov e wh i l e t h e TRA P P I N G Z O N E is access i b l e a n d stops m ov e m ent when the
G UARD i s o pe n e d ;
s h a l l be so desi g n e d t h at t h e a b s e n c e o r fai l u re o f o n e of t h e i r c o m p o n e nts p reve nts

start i n g , a n d stops m ov i n g parts.
Compliance is checked by conducting any applicable tests and inspection of the ME

EQUIPMENT and the RISK MANAGEMENT FILE.
9.2.2.4.4 P rotective m easu res
Protective m eas u res s h a l l be desi g n e d a n d i n co rporated i nto t h e c o ntrol system so t h at:

m ovi n g parts c a n not sta rt to m ove wh i l e they are in t h e reach of pers o n s ;
o n c e t h e M E E Q U I P M E NT has started to m ov e , t h e TRAPPING Z O N E c a n not be r e a c h e d , o r , i f
t h e TRA P P I N G Z O N E is r e a c h e d , system m ov e m ent m ust sto p. I n t h e later c a s e , n o HAZARD
or d a m age s h a l l resu lt;
if in a S I NGLE FAULT CONDITION of t h e protective m ea s u r e , an u n acce pta b l e R I S K co u l d
a r i s e , o n e o r m o re e m e rg e n cy stoppi n g device(s) i n t h e M E E Q U I P M ENT s h a l l be prov i ded
(see 9 . 2 . 4 ) .
Compliance is checked b y inspection of the ME E Q UIPMENT and the RISK MANA GEMENT FILE.
9.2.2.5 * C o n t i n u o u s activation
Where it i s i m practi cal to m a ke t h e TRA P P I N G ZONE i n access i bl e , a TRA P P I N G ZONE is not
c o n s i d ered to present a MECHANICAL HAZARD if:
a) t h e m ov e m e nt is in the O P E RATOR' s fi e l d of v i ew;
b) m ov e m e n t of t h e M E EQUI PMENT or its parts is poss i b l e o n l y by t h e co nti n u o u s activat i o n of

t h e control by t h e O P E RATOR as l o n g as t h e res ponse of t h e O P E RATOR to deactivate t h e
d e v i c e c a n be r e l i e d o n to prevent HARM;
NOTE Manua lly ope rated movements are also considered to com ply with this clause, as long as mass and
ve locity allow adequate control of positioning without causing a n unacceptable RISK.
c) i n a S I NGLE FAULT CONDI T I O N of t h e co nti n u o us activ ati o n system an u n acce pta b l e R I S K

co u l d arise, one o r m o re e m e rg e n cy sto ppi n g device(s) are prov i d e d in t h e M E E Q U I PMENT
(see 9 . 2 . 4 ) .
6060 1 - 1 © I EC : 20 0 5 - 269 -
9.2.2.6 * S peed o f move m ent(s)
The s pe e d of m ov e m e nt(s) that pos iti o n parts of t h e M E E Q U I P M ENT o r PAT I E NT , w h e re contact

with t h e ME E Q U I P M E N T c o u l d res u lt i n a HAZARDOUS S I TUATI O N , s h a l l be l i m ited SO that t h e
O P E RATOR wi l l have a d e q u ate c o n t r o l o f positi o n i n g wit h o ut res ulti n g i n a n u n accepta b l e R I S K .
T h e ove rtravel (stoppi n g d i s t a n c e ) o f s u c h m ov e m e nt, occurr i n g after o p e rati o n o f a co ntrol t o

sto p t h e m ov e m e nt, s h a l l n ot result i n a n u n accepta b l e R I S K .
Compliance i s checked b y inspection of the M E E Q UIPMENT a n d t h e RISK MANA GEMENT FILE.
9.2.3 * Other HAZARDS associated w i t h m ovi ng parts
9.2. 3 . 1 U n i n tended move m e n t

Co ntrols s h a l l be so positi o n e d , reces s e d , o r protected b y oth e r m ea n s s o t h at they c a n n ot be
accide nta l l y actuate d , res ulti n g in u n accepta b l e R I S K , u n l ess ergo n o m i c c o n s i derati o n s for the
i ntended PAT I E NT d i ctate oth e rwise ( e . g . PAT I E NT with speci a l n ee d s ) .
9.2.3.2 Overt ravel

T h e RISK d u e to overtravel ( past range l i m its ) of M E E Q U I P M E N T parts s h a l l be reduced to a n
accepta b l e l evel . E n d sto ps o r oth e r sto ppi n g m ea n s s h a l l be provi d e d to act a s t h e u l t i m ate
travel l i m iti n g m eas u re i n both NORMAL CONDITION a n d S I NGLE FAU LT CONDITI O N .
Such m ea n s s h a l l h ave t h e m ec h a n i ca l stre n gth to withsta n d t h e i nte n d e d l o a d i n g in NORMAL

USE a n d reas o n a bl y fo res e e a b l e m i s u s e .
Compliance i s checked b y inspection of the M E EQUIPMENT, the RISK MANAGEMENT FILE,

specifications of m aterials used and the processing specifications for these m aterials.
9.2.4 * E m ergency sto p p i n g devices

Where it is c o n s i dered n ecessary to have o n e or m o re e m e r g e n cy stoppi n g devi ce(s), t h e
e m e rg e n cy sto ppi n g device s h a l l c o m ply w i t h a l l t h e fo l l owi n g req u i re m ents.
a) T h e e m e rg e n cy stoppi n g dev i c e s h a l l r e d u ce t h e R I S K to a n accepta b l e l evel .
b) T h e prox i m ity a n d res ponse of t h e O P E RATOR to actu ate t h e e m e rg e n cy sto ppi n g device
can be relied o n to prevent HARM .
c) T h e e m e rg e n cy stoppi n g device actuator s h a l l be readily access i bl e to t h e O P E RATOR.
d) E m e rg e n cy stoppi n g device(s) shall n ot be part of t h e normal o pe rati o n of t h e

M E E Q U I PMENT.
e) O pe rati o n of an e m e rg e n cy switc h i n g o r stoppi n g m e a n s s h a l l neither i ntro d u c e a furt h e r

HAZARD n o r i nterfere with t h e com plete o perat i o n n ecessary t o rem ove t h e o r i g i n a l HAZA RD.
f) E m e rg e n cy sto ppi n g device(s) s h a l l be a b l e to break t h e f u l l l o a d of t h e relevant ci rcuit,

taki n g i nto acco u nt poss i b l e stal l e d m otor cu rre nts and t h e l i ke .
6060 1 - 1 © I EC : 20 0 5 - 271 -
g) M e a n s for stoppi n g of m ov e m e nts s h a l l operate as a res u l t of o n e s i n g l e acti o n .
h ) T h e e m e rg e n cy sto ppi n g device s h a l l have a n act u ator c o l o u red red desi g n e d t o be

d isti n ctive and easily i d e ntifi a b l e from that of oth e r c o ntro l s .
i ) An actuator t h a t i nterr u pts/o pens m ec h a n i cal m ov e m e nts s h a l l be m a rked o n , o r

i m m e d i ately a dj a c e nt to, t h e f a c e o f t h e actuator w i t h sym b o l I EC 604 1 7-5638 ( 0 8 : 2 0 02-
1 0) (see T a b l e 0 . 1 , sym bol 1 8) o r the word " ST O P " .
NOTE I f t h e actuator i s a switch that interrupts a l l power, compliance with t h e above m a rking re q u irement i s
not re quired.
j ) The e m e rg e n cy sto p p i n g device, once actu ate d , s h a l l m a i ntai n t h e M E E Q U I PMENT in t h e

d i s a b l e d c o n d iti o n u nt i l a d e l i be rate acti o n , d i ffe rent from t h a t used to actuate it, i s
perfo r m e d .
k) T h e e m e rg e n cy stoppi n g d e v i c e s h a l l be s h own to be s u itable for its a p pl i cati o n .
9.2. 5 * Release of PATIENT

Means shall be provi d e d to p e r m i t t h e release of t h e PAT I E NT q u i c kly and s afely in t h e event of
breakd own of t h e M E E Q U I PMENT o r fai l u re of t h e power s u pply (see 1 1 . 8 ) , activati o n of a
protective m eas u re or e m e rg e n cy stoppi n g . Special atte nti o n s h a l l be g i v e n to t h e fo l l owi n g .
U n c o ntro l l e d o r u n i nt e n d e d m ov e m e nt o f t h e M E E Q U I P M E N T t h at co u l d result i n a n
u n accepta b l e R I S K s h a l l b e preve nte d .
S i t u at i o n s w h e re t h e PAT I E NT i s s u bj ected to u n a cce pta b l e R I S KS d u e to t h e prox i m ity of
m ovi n g parts , r e m ov a l of n o r m a l exit ro utes , or oth e r HAZARDS , s h a l l be prev e nted.
- W h e n , after rem oval of c o u nte r b a l a n c e d parts , oth e r pa rts of t h e ME E Q U I P M ENT c a n m ove
in a h azardous way, m e a s u res s h a l l be prov i d e d to red u ce t h e R I S K to a n accepta b l e l evel .
9.3 * HAZARD assoc iated with s u rfaces, corn ers and edges
R o u g h s u rfaces, s h a r p corn e rs a n d e d g es of ME E Q U I P M E N T t h at co u l d res u lt i n an

u n accepta b l e R I S K s h a l l b e avoi d e d o r covered.
In parti c u l a r , attenti o n s h a l l be p a i d to fl a n g e o r fra m e e d ges a n d t h e removal of b u rrs .
9.4 * I nsta b i l ity HAZARDS
9.4. 1 General
M E E Q U I PMENT, other t h a n F I X E D M E E Q U I P M ENT and HAND- H E L D M E E Q U I P M E NT, i ntended to be

placed o n a s u rface s u c h as a fl oor o r a t a b l e s h a l l not ov e rb a l a n ce (ti p over) o r m ov e
u n ex pe ctedly, to t h e degree t h at it c o u l d present a n u n acce pta b l e R I S K to t h e PATI E NT,
O P E RATOR o r other pers o n .
NOTE The meaning of transport i n this subcla use is moving ME EQU I PM E NT from room to ro o m during N O R M A L
USE.
Compliance is checked by the tests in 9. 4. 2 to 9. 4 . 4 (inclusive) . Each test is performed

separately.
6060 1 - 1 © I EC : 2005 - 273 -
9.4.2 * I n stabil ity - overba lance
9 . 4. 2 . 1 I nsta b i l ity i n trans port pos ition

M E E Q U I PMENT o r its pa rts s h a l l n ot overba l a n c e w h e n placed i n a ny trans port positi o n of
NORMAL USE o n a pl a n e i n cl i n ed at a n a n g l e of 1 oo from t h e h o ri z o ntal pl a n e .
Compliance is checked b y the following test:
Prior to the test the ME E Q UIPMENT is prepared as indicated in th e A CCOMPANYING DOCUMENTS

(or, if not specified, as in 9. 4 . 2 . 2) . The ME E Q UIPMENT or its parts is placed on a plane inclined
at an angle 10 o from the horizontal plane. If the ME EQUIPMENT or its parts overbalances, it
constitutes a failure.
9.4.2.2 I nsta b i l ity exc l u d i ng tra n s po rt

M E E Q U I PMENT or its pa rts s h a l l not overbal a n ce w h e n placed i n a n y position of NORMAL U S E ,
excl u d i n g a n y trans port positi o n s , o n a p l a n e i n cl i n e d a t a n a n g l e o f 5o f r o m the h o rizo ntal
plane.
I f t h e M E E Q U I P M E NT o r i t s pa rts ov e r b a l a nces w h e n p l a c e d i n a ny pos iti o n o f NORMAL U S E ,

excl u d i n g a n y transpo rt positi o n s , o n a p l a n e i n cl i n e d a t a n a n g l e o f 1 0 ° f r o m the h o rizo ntal
pl a n e , it s h a l l ca rry a warn i n g notice stati n g that trans port s h o u l d o n l y be u n de rtaken in a
certai n c o n d iti o n that s h a l l be clearly descri bed i n t h e i n st r u cti o n s for u s e or m a rked on t h e
M E E Q U I P M E N T w i t h a n i n d i cati o n o f t h e RESI DUAL R I S K if t h e M E E Q U I PMENT o r i t s parts
ove r b a l a nces.
NOTE For warning notice re q u i re m e nts, s e e 7 . 9 . 2 . 2 .
Prior to conducting the test, the ME EQUIPMENT is prepared as follows:
a) ME E Q UIPMENT is provided with all specified connection leads, the POWER SUPPL Y CORD and
any interconnecting cords. It is provided with the least favourable combination of possible
detachable parts, A CCESSORIES and load as specified in NORMAL USE.
b) ME E Q UIPMENT having an APPLIANCE INLET is provided with the specified DE TA CHABLE POWER
SUPPL Y CORD.
c) The connection leads are laid down on the inclined plane in the position m ost unfavourable
for stability.
d) If castors/wheels are present, they are temporarily immobilized, if necessary by blocking,

in their most disadvantageous position.
e) Doors, drawers, shelves and the like are placed in the m ost disadvantageous position and
fully loaded or unloaded whiche ver represents "worst case " as specified in NORMAL USE
according to the A CCOMPANYING DOCUMENTS.
f) ME E Q UIPMENT having containers for liquids is tested with these containers completely or
partly filled or empty, whichever is least favourable.
g) The ME E Q UIPMENT is not connected to the SUPPL Y MAINS.
The test floor surface is to be hard and flat (e. g. concrete floor covered with 2 mm to 4 mm
thick vinyl flooring material) .
6060 1 - 1 © I EC : 2005 - 275 -
The ME EQUIPMENT or the ME EQUIPMENT parts is placed on a plane inclined at an angle of 1 0 o

from the horizontal plane, or, if a warning notice is present, compliance is checked by
inspection of the warning notice and the ME E Q UIPMENT or its parts is placed on a plane
inclined at an angle of 5 o from the horizontal plane. If the ME EQUIPMENT or its parts
overbalances, it constitutes a failure.
9.4.2.3 I nsta b i l ity f r o m h orizontal a n d vert i cal forces
a) ME E Q U I PMENT h av i n g a m ass of 25 kg o r m o re, oth e r t h a n F I X E D M E E Q U I PMENT t h at i s

i ntended to be used o n t h e fl o o r , s h a l l n ot overba l a n c e d u e to p u s h i n g , l e a n i n g , resti n g etc.
S u rfaces of the M E E Q U I PMENT where a RISK of overbal a n c i n g the M E E Q U I PMENT exi sts from
pus h i n g , l e a n i n g , resti n g etc . , s h a l l be perm a n e ntly m a rked with a CLEARLY LEG I B LE warn i n g
o f t h i s R I S K , e . g . by u s e o f s afety s i g n I S O 7 0 1 0- P 0 1 7 (see T a b l e 0 . 2 , s afety s i g n 5 ) .
Compliance is checked b y inspection and the following test:
Prior to the test, the ME EQUIPMENT is prepared as described in 9. 4. 2. 2. The ME EQUIPMENT

is placed on a horizontal plane and a force equal to 25 % of its weight, b ut not m ore than
220 N, is applied in any direction, except a direction having an upward component. Unless
otherwise marked, the force is applied at any point of the ME E Q UIPMENT but not exceeding
1 , 5 m from the floor. The ME EQUIPMENT is prevented from sliding on the floor by a
horizontal obstruction, not exceeding 20 mm height, which is fastened flat on the floor. If
the application of the test force results in lateral movement of the ME EQ UIPMENT, increase
the height of the obstruction to the minimum extent necessary to prevent lateral m o vement.
If the ME EQUIPMENT overbalances, it constitutes a failure.
b) M E E Q U I PM E N T , oth e r t h a n F I X E D ME E Q U I P M ENT, t h at is i nt e n d e d to be used o n t h e fl oor o r

o n a t a b l e , s h a l l n ot overba l a nce d u e to s i tti n g o r ste p p i n g u n l ess a l e g i b l e warn i n g o f t h i s
R I S K is prov i d e d o n t h e M E E Q U I P M E NT, e . g . b y u s e o f s afety s i g n s I S O 701 O-P0 1 8 o r
I S O 70 1 0- P0 1 9 as a p propriate (see T a b l e 0.2, s afety s i g n s 6 a n d 7).
NOTE Requirements for PATIENT s u pport s u rfaces are fo u n d i n 9 . 8 . 3 .
Compliance is checked by inspection and by the following test:
Prior to the test the ME EQUIPMENT is prepared as describ ed in 9. 4. 2. 2. The ME E Q UIPMENT

is placed on a horizontal plane and a constant down ward force of BOO N is applied at the
point of m aximum moment to any working surface, excluding PATIENT support surfaces,
offering an ob vious foothold or sitting surface of a minimum 20 em by 20 em area, and at a
height not exceeding 1 m from the floor. O verbalancing constitutes a failure.
9.4.2.4 * Castors and wheels
9 . 4 . 2 . 4. 1 Genera l
T h e m ea n s used fo r transportati o n o f M O B I L E M E E Q U I PM E N T , e . g . castors o r w h e e l s , s h a l l n ot
res u l t i n an u n acceptable R I S K w h e n t h e M O B I L E ME E Q U I P M E N T is m oved or parked i n NORMAL
USE.
9.4.2.4.2 Force fo r pro p u lsion

T h e force re q u i red for m ovi n g M O B I L E M E E Q U I P M E NT along a h a r d and fl at h o rizo ntal s u rface
s h a l l n ot exceed 200 N u n l ess the i n structi o n s fo r use state t h at m o re t h a n one person is
needed.
6060 1 - 1 © I EC : 2005 - 277 -
Compliance is checked by placing the ME E Q UIPMENT on a hard flat horizontal floor (e. g.
concrete floor covered with 2 mm to 4 mm thick vinyl flooring m a terial) and m easuring the
force needed to propel the ME E Q UIPMENT at a speed of 0, 4 m!s :t 0, 1 m!s. The force is applied
at a height of 1 m above the floor or at the highest point on the ME E Q UIPMENT if its height is
less than 1 m.
9.4.2.4.3 M ovement over a t h reshold

M O B I LE ME EQUIPMENT exceedi n g 45 kg shall be able to pass over a 20 mm th res h o l d . Passi n g
over a 20 m m thres h o l d s h a l l n ot res u lt i n a n u n accepta b l e RISK.
The ME E Q UIPMENT is configured in transport position with any SAFE WORKING LOAD in place as
indicated in the ACCOMPANYI NG DOCUMENTS. The ME E Q UIPMENT is m oved as in NORMAL USE 1 0
times in forward direction over (up and down) a solid vertical plane obstruction with a
rectangular cross-section, 20 mm high and 80 mm wide that is affixed flat on the floor. All
wheels and castors are to impact the obstruction at a speed of 0, 4 m!s :t 0, 1 m!s for manual
MOBILE ME E Q UIPMENT, or, for m otor driven MOBILE ME E Q UIPMENT, the m aximum speed capable
of being maintained.
It is unacceptable for ME E Q UIPMENT to be unable to go over (up) the obstruction (due to sm all
wheel diameter, for example). Overbalancing or any unacceptable RISK constitutes a failure.
Unacceptable RISK is determined by inspection of the ME E Q UIPMENT, its parts, and the RISK
MANA GEMENT FILE.
NOTE Examples of damage that can result i n u nacceptable R I S K incl ude the reduction of C R E EPAGE D I STA NCES
and A I R C L EARANCES below those specified i n 8 . 9 , access to parts which exceed l i m its i n 8 . 4 , o r access to moving
parts which could cause HAR M .
Assessment criteria that can b e useful i n determ i n i n g i f this test has resulted i n a n unacceptable R I S K include:
- those i n Clause 9 a n d 1 1 . 6 ;
- the dielectric strength test as specified i n 8 . 8 . 3 to evaluate the integrity of solid S U P P L E M ENTARY o r R E I N FORCED
I N S U LATI O N ; and
- measurement of C R E EPAGE D I STA NCES o r A I R C L EARANCES to com pare the values with the m i n i m u m distances
specified in 8.9. S m a l l c h i ps that do not adversely affect the protection agai nst electric shock o r m o isture can
normally be ignored.
9.4.3 I nsta b i l ity f r o m u nwanted lateral m ove m e n t ( i n c l u d i n g s l i d i ng )
9 . 4. 3 . 1 I nsta b i l ity i n trans port
a) B r a kes of power-driven MOBILE ME EQUI PMENT s h a l l be des i g n ed so t h at they a re n o r m a l l y

activated a n d c a n o n l y be released b y co nti n u o us actuati o n o f a contro l .
b) M O B I LE ME EQUIPMENt s h a l l be fitted with m ea n s ( s u c h as l oc ki n g devices) i ntended to

prevent any u nwanted m ov e m e n t of the ME EQUIPM ENT o r its p a rts in the trans port positi o n .
c) M O B I LE ME EQUIPMENT t h at is i ntended to be used on t h e fl oor s h a l l n ot result i n a n

u n accepta b l e RISK d u e t o u nwanted l ateral m ov e m e nt.
Prior to the test, the ME E Q UIPMENT is prepared as described in 9.4. 2.2. The MOBILE
ME E Q UIPMENT is placed in its transport position (or in the worst case NORMAL USE position)
with the SAFE WORKING LOAD in place, and the locking device (e. g. brakes) activated, on a
6060 1 - 1 © I EC : 2005 - 279 -
hard flat surface inclined at 1 0 o from the horizontal plane. If castors are incorporated, they
are positioned in their worst-case position. Follo wing the initial elastic m o vement, initial
creepage, and initial pivoting of castors, any further m o vement of the MOBILE ME EQUIPMENT
greater than 50 mm (in relation to the inclined plane) constitutes a failure. The RISK due to
any initial m o vement is assessed, taking into account the NORMAL USE of the ME EQ UIPMENT.
9.4.3.2 I nsta b i l ity exc l u d i ng tra n s po rt
a) M O B I LE ME E Q U I PMENT shall be prov i ded with wheel l ocks or with a braki ng system
appropriate to the i ntended m odes of use a n d suffi cient to e n s u re that u n i ntended
m ovem ent is prevented on a n i nc l i n e of 5°
Prior to the test, the ME EQUIPMENT is prepared as described in 9.4. 2.2. The MOBILE
ME EQUIPMENT with the SAFE WORKING LOAD in place is positioned on a hard flat surface
inclined at an angle of 5 ° from the horizontal plane with wheels locks on or braking system
activated. Following the initial elastic m o vement, initial creepage, and initial pivoting of
castors, any further m o vement of the ME E Q UIPMENT greater than 50 mm (in relation to the
inclined surface) constitutes a failure. The RISK due to any initial m o vement is assessed
taking into account the NORMAL USE of the ME EQ UIPMENT.
b) TRANSPORTABLE or STATIONARY ME E Q U I P M E NT that is i ntended to be used o n the floor shall

not res u lt i n a n u nacceptable R I S K d u e to u nwanted l ateral m ov e m e nt.
The ME EQUIPMENT is prepared as described in 9. 4. 2. 2. The ME EQUIPMENT is placed on a

horizontal plane with the SAFE WORKING LOAD in place, and the locking device (e. g. brakes)
activated. If castors are incorporated, they are positioned in their worst-case position. A
force equal to 25 % of the weight of the unit, but not m ore than 220 N, is applied in any
direction, except a direction having an upwards component, at the highest point of the
ME EQUIPMENT but not exceeding 1 , 5 m from the floor. Follo wing the initial elastic
m o vem ent, initial creepage, and initial pivoting of castors, any further movement of the
ME EQUIPMENT greater than 50 mm (in relation to the horizontal plane) constitutes a failure.
The RISK due to any initial m o vement is assessed, taking into account the NORMAL USE of
the ME EQUIPMENT.
9.4.4 G r i ps and o t h e r hand l i ng d ev ices
a) ME E Q U I PMENT other than PORTABLE M E E Q U I P M E NT or its part with a m ass of m ore than
20 kg that needs to be l ifted i n NORMAL U S E or trans port s hall either be provided with
s u itable h a n d l i n g devices (for exa m pl e h a n d l es, l ift i n g eyes , etc . ) or the ACCO MPANYI NG
DOCU M E NTS s h a l l i ndicate the poi nts where it can be lifted s afely, u n l ess the m ethod of
h a n d l i n g is o bvious a n d no HAZARDS can devel o p when this is done. If the m eans for l ifti ng
are h a n d l es, they shall be s u itably placed to enable the M E E Q U I P M E N T or its part to be
carried by two or m ore perso ns.
Compliance i s checked b y weighing (if necessary) and b y inspection of the M E E Q UIPMENT
or its part or the A CCOMPANYING DOCUMENTS.
6060 1 - 1 © I EC : 2005 - 281 -
b) M E E Q U I PMENT s pecifi ed by the MANUFACTU R E R as PORTABLE ME E Q U I P M E NT with a m ass of

m ore than 20 kg shall h ave o n e or m ore carryi n g-ha ndles s uitably placed to enable the
M E E Q U I P M E N T to be carried by two or m ore persons.
Compliance i s checked by carrying.
c) Carryi ng h a n dl es or gri ps furnished on PORTABLE M E E Q U I P M E NT shall withstan d loading as

descri bed in the fol l owi ng test:
The handles and their m eans of attachment are subjected to a force equal to four tim es the
weight of the ME EQUIPMENT in any direction of NORMAL USE and transport.
If more than one handle is furnished on PORTABLE ME EQUIPMENT, the force is distributed
between the handles. The distribution of forces is determined by m easuring the percentage
of the ME EQUIPMENT weight sustained by each handle with the ME EQUIPMENT in the normal
carrying position. If the ME EQUIPMENT is furnished with more than one handle but is so
designed that it can readily be carried by only one handle, then each handle is to b e
capable of sustaining the total force .
The force i s applied uniformly over a 7 e m length of the han dle at the centre, starting a t
zero a n d gradually increasing so that the test value will b e attained in 5 s t o 1 0 s and
maintained for a period of 1 min.
Handles that break loose from the ME E Q UIPMENT or exhibit any permanent distortion,
cracking or other evidence of breakdown constitutes a failure.
9.5 * Expel led parts HAZARD
9 . 5. 1 P rotective means
Where ex pel led parts could res u lt in an u nacceptable RISK, the ME EQUIPMENT shall be
provided with a means for protecti n g agai nst such R I S K .
Compliance is checked by assessment of the suitability of the protective m eans and by
inspection of the RISK MANA GEMENT FILE.
9.5.2 Cat hode ray tu bes

Any cath ode ray t u be shall com ply with the applicable req u i r e m e nts of I EC 60065: 200 1 ,
C l a use 1 8 ; or I EC 6 1 965.
Compliance is checked by inspection of a certificate of compliance or by the relevant tests of
IEC 60065:200 1 , Clause 1 8.
9.6 Acoustic e n e r g y ( i n c l u d i ng i nfra- and u l t rasou n d ) a n d v i b ration
9.6. 1 * Gen eral

ME E Q U I PMENT s h a l l be des i g ned so that h u m a n expos u re to aco usti c e nergy and vi brati on
shall not res ult i n a n u n acceptable R I S K .
Compliance is checked by inspection of the RISK MANAGEMENT FILE (taking into account the
audibility of auditory alarm signals and PATIENT sensitivity) and the tests indicated in 9 . 6 . 2 and
9. 6. 3.
6060 1 - 1 © I EC : 2005 - 283 -
9.6.2 * Acoustic energ y
9.6. 2 . 1 A u d i ble acoustic e n e rgy

I n NORMAL U S E , the PATI E NT, O P E RATO R and other persons s h a l l not be exposed to acoustic
en ergy from M E E Q U I P M E NT , except s o u n d from auditory alarm s i g n als, exceedi ng the l evels
specifi ed below.
80 dBA for a c u m u l ative exposu re of 24 h ove r a 24 h peri od; an offset of 3 dBA is to be
added to this value when halvi ng the cu m ulative ex pos u re ti m e ove r a 24 h period ( e . g .
83 d B A for 1 2 h over a 2 4 h period);
1 40 dB u n-we i g hted sou n d pressure level for i m pulsive or i m pact acoustic energy ( n oise).
NOTE 1 I nterpolation o r extrapolation is a l lowed for exposure times i n accordance with t h e fo llowing form u l a ,
80 - 1 0* log1 D(h/24) , i n dBA, where h is c u m u lative exposure time over a 24 h period.
NOTE 2 S i nce PAT I E NTS m ight have a higher sens itivity to acoustic e n e rgy (noise), a lower level could be m o re
appropriate. Consideration should also be give n to perception of a u d itory a larm signals. The World Health
Organization has recom m e nded a maximum impulse o r i m pact acoustic energy (no ise) level for c h i ldren of 1 20 d B .
NOTE 3 I f t h e A-we i g hted s o u n d pressure leve l exceeds 8 0 d B (A), n o i s e protection measure should be
considered.
Compliance is checked by measuring the maximum A-weighted sound pressure level at the
minimum distances of PA TIENT, OPERA TOR and other persons from the source of acoustic
en ergy ( noise) in NORMAL USE, and if necessary, calculating the A-weighted sound pressure
level produced by the ME EQUIPMENT in accordance with ISO 3 74 6, ISO 9 6 1 4- 1 or
IEC 6 1 6 72- 1 . The following conditions apply.
a) The ME E Q UIPMENT is operated under worst-case NORMAL CONDITION.
b) Any protective means provided or called for in A CCOMPANYING DOCUMENTS are to be in

place during sound measurement.
c) Sound level meters used in the m easurement conform to IEC 6 1 672- 1 and IEC 6 1 6 72-2.
d) The test room is semi-reverb erant with a hard reflecting floor. The distance between any
wall or other object and the surface of the ME E Q UIPMENT is not less than 3 m.
9.6.2.2 l nfras o u n d a n d u ltraso u n d energy

When applicable, the MANUFACTU R E R shall address the R I S KS associ ated with i nfras o u n d or
u ltraso u n d in the R I S K MANAG E M E N T PROCE S S .
9.6.3 * H a n d -tra n s m itted v i b ration

Except for vi brations di rectly req u i red to carry out the I NT E N D E D U S E of the M E E Q U I P M E N T ,
means shall be provi ded to protect the PAT I E NT , O P E RATOR and other persons if in NORMAL U S E
the h a n d-transm itted frequency-we i g hted r. m . s . accel erati on generated by the M E E Q U I P M E NT
exceeds the value below:
2,5 m/s 2 for a c u m u l ative ti m e of 8 h d u r i n g a 24 h period.
Allowable accel erations for different ti m es are i nversely proportional to the squ are root of
the t i m e ( e . g . the a l l owable accelerati on for 2 h wou l d be 5 , 0 m!s\
NOTE I nterpolation o r extrapolation is a l lowed for a l lowable acce l e ratio n i n accordance with the fo llowing
2
form u l a , 2,5 x -1(8 I t) , i n m/s , where t is the c u m u lative time over a 24 h period.
Compliance is checked by m easurements at points of equipment in hand contact with PATIENT,

OPERA TOR or other persons. Measurements are m ade in accordance with ISO 5349- 1 .
6060 1 - 1 © I EC : 2005 - 285 -
9.7 * P ress u re vessels a n d parts s u bj ect t o pneu m atic a n d h yd rau l ic press u re
9. 7 . 1 General
The req u i rem ents of this s u bc l a use apply to vessels and pa rts of M E E Q U I PMENT s u bject to
press ure, the rupture of which could resu lt in an u nacceptable R I S K .
The parts of a p n e u m atic or hydra u l i c system that are used as a su pport system shall
additi onally com ply with the req u i rem ents i n 9 . 8 .
9.7.2 P n e u matic a n d h yd rau l ic parts
P n e u m atic and hydrau l i c parts of M E E Q U I P M E NT or ACCES SORI E S s h a l l be so designed that:

no u nacceptable R I S K resu lts from l oss of pressure or loss of vac u u m ;
no u nacceptable R I S K res ults from a fl u i d j e t caused b y l eakage or a com ponent fai l ure;
elements of the M E E Q U I PMENT or an ACCESSORY , a n d especi a l ly pi pes a n d h oses, that can
lead to an u n acceptable R I S K shall be protected agai nst harmful external effects ;
reservoirs and s i m i l a r vessels ( e . g . hydro- p n e u m atic acc u m u l ators) that can l ead to a n
u n accepta ble R I S K are automatically depress u rized w h e n t h e M E E Q U I P M ENT is isolated
from its power s u pply ( e . g . p u l l i n g o ut the p n e u m ati c p l u g at the co n n ector m o u nted on the
facil ity wal l ) . If this is n ot poss i bl e , means shall be prov i ded fo r the isolation ( e . g . cutti ng
off from the peri pheral circuit) , or l ocal de press u rizi ng of reservoirs a n d similar vessels,
a n d pressure i ndicati o n ;
all elements that c a n rem ai n u nder press u re after isolation o f t h e M E E Q U I P M E N T or an
ACCESSORY from its power s u pply a n d that co u l d res ult i n a n u nacceptable R I S K shall be
provided with clearly ide ntifi ed ex ha ust devices, a n d a war n i n g l abel drawi n g attenti on to
the n ecessity of depressu rizi n g these e l e m e nts before any s etti ng or m a i ntenance activity
on the M E E Q U I P M E NT or ACCE SSORI E S .
Compliance i s checked b y inspection a n d examination of RISK MANA GEMENT FILE.
9.7.3 Maxi m u m p ress u re
The m axi m u m pressu re to which a part of ME E Q U I P M E NT can be s u bjected i n NORMAL

CONDI T I O N a n d S I NGLE FAULT CONDI T I O N s h a l l be consi dered to be whichever is the h i g h est of
the fol l owi n g :
a) the RATED m ax i m u m su pply pressure from a n external sou rce;
b) the pressure setti n g of a press u re-rel i ef device provided as part of the ass e m bly;
c) the m axi m u m pressu re that can be devel o ped by a source of press u re that is part of the
assem bly, u n l ess the pressure is l i m ited by a pressure-re l i ef device.
9.7.4 P ress u re rat i n g o f M E E QU I P M E NT parts

The m axi m u m pressure to which a part of ME E Q U I P M E N T can be s u bj ected i n NORMAL
CONDI T I O N
a n d S I NG L E FAULT CONDI T I O N shall n ot exceed the MAXI M U M P E R M I S S I BLE WORKI NG
PRESS URE for the part, except as all owed fo r pressure rel i ef devices in 9 . 7 . 7 .
6060 1 - 1 © I EC : 2005 - 287 -
Compliance is checked by inspection of the MANUFA CTURER 's data for the component,
inspection of the ME EQ UIPMENT, inspection of the RISK MA NAGEMENT FILE, and where
necessary, by functional test.
9.7.5 * P ress u re vessels

A press u re vessel shall withstan d a HYDRA U L I C TEST PRESSURE if both the fol l owi ng con diti ons
are m et:
- the press u re is greate r than 50 kPa; and
- the product of press u re a n d vol u m e is greater than 200 kPa · I .
Compliance is checked by the following tests:
The HYDRA ULIC TEST PRESSURE is the MAXIMUM PERMISSIBLE WORKING PRESSURE multiplied by a
factor ob tained from Figure 32.
The pressure is raised gradually to the specified test value and is held at that value for 1 min.
A sample that bursts or suffers from permanent (plastic) deformation or leaks constitutes a
failure. Leakage at a gasket during this test is not considered to constitute failure unless it
occurs at a pressure b elow 40 % of the required test value, or belo w the MAXIMUM PERMISSIBLE
WORKING PRESSURE, whichever is greater.
No leakage is allowed for pressure vessels intended for toxic, flammable or otherwise
hazardous substances. For other pressure vessels, no leakage is allowed that will otherwise
result in an unacceptable RISK (e.g. high pressure fluid jet) .
Where unm arked pressure vessels a n d pipes cannot be hydraulically tested, integrity is
verified by other suitable tests, e . g. pneum atic using suitable media, at the same test
pressure as for the hydraulic test.
6060 1 - 1 © I EC : 2005 - 289 -
0
t5 3,0
.E
c
0
�
,g 2,5
a.
�
::2:
2,0
1 ,5
1 ,3
5 10 15 20 25 30
MAXI M U M PERMISSIBLE WORKING PRESSURE MPa
IEC 24 15105
F i g u re 32 - Ratio between HYDRAULIC TEST P RESSURE

and MAXI M U M PERMISSIBLE WORKING PRESS URE
(see 9 . 7 . 5 )
9.7.6 P ress u re-con trol d ev ice

I n M E E Q U I PMENT for wh i c h 9 . 7 . 7 req u i res a press u re-rel i ef device, any pressu re-co ntrol device
responsible for reg u l ati ng the press u re shall be capa ble of perform i n g u nder RATED load for
1 00 000 cycl es of operati on and shall prevent the pressure from exceeding 90 % of the setti n g
o f the press u re-re l i ef device u n d e r a n y conditi o n o f NORMAL U S E .
Compliance i s checked b y inspection of the MANUFA CTURER 's data for the component,
inspection of the ME EQ UIPMENT, inspection of the RISK MA NAGEMENT FILE, and where
9.7.7 P ressu re-relief d evice

ME E Q U I PMENT shall i ncorporate pressu re-rel i ef device(s) where the MAXI M U M P E R M I S S I BLE
WORK I N G PRESSURE cou l d otherwise be exceeded.
A press u re-re l i ef device shall co m ply with all of the fol l owi ng req u i re m e nts :
a) it shall be con nected as close as reasonably practical to the press u re vessel or parts of the
system that it is i ntended to protect;
b) it shall be so i nstalled that it is readily access i bl e for i n specti o n , m a i nten a n ce and repair;
c) it shall not be capable of bei n g adj usted or rendered i n o pe rative without the use of a TOOL;
d) it s h a l l h ave its discharge o pen i n g so located a n d di rected that the rel eased m aterial is not
di rected towards any pers o n ;
e) it shall h a v e its discharge open i n g so l o cated a n d di rected that operatio n o f the device wi l l
n o t deposit m ateri al o n parts that c o u l d result i n a n u n acceptab l e R I S K ;
6060 1 - 1 © I EC : 2005 - 291 -
f) it shall be of adequate discharge capacity to ensure that the pressure wi l l not exceed the
MAXI M U M P E R M I S S I BLE WORKING PRESSURE of the system to which it is con nected by more
than 1 0 % i n the event of a fai l u re in the control of the s u pply pressure;
g) there shall be no s h ut-off valve between a pressure-re l i ef d evice and the parts that it is
i ntended to protect;
h) the m i n i m u m n u m ber of cycl es of o peratio n s h a l l be 1 00 000, except for on e-ti m e use

devices such as bu rsti ng disks .
Compliance is checked b y inspection o f the MANUFA CTURER 's data for the component,
inspection of the ME EQ UIPMENT, inspection of the RISK MANA GEMENT FILE, and where
9.7.8 RAT E D m axi m u m s u p p l y press u re

See 7 . 2 . 1 8.
9.8 * HAZARDS assoc iated with s u pport syste m s
9.8. 1 General
Where M E E Q U I P M ENT parts are designed to s u pport l oads or to provide actu ati ng forces, the
fol l owi ng req u i re m e nts shall be a pplied if a m echanical fa ult co u l d constitute an u nacceptable
RISK.
The constructi o n of the s u p port, suspens i o n or actuati o n system shall be desi gned based
upon Table 21 and the TOTAL LOA D .
Means of attachment of ACCES SORI E S shall be designed s u ch that any poss i bi l ity of
i ncorrect attachm ent that could res ult i n an u n a cceptable R I S K is avoided.
The R I S K ANALY S I S of su pport systems s h a l l consider HAZARDS aris i n g from static, dyn a m i c ,
vi brati o n , i m pact and pressure l oadi n g , fo u n d ation and oth e r m ovements, tem perature,
environm enta l , m a n ufacture and service conditi ons.
- All l i kely fai l u re effects shall be consi dered i n the R I S K ANALYS I S . These i nclude excessive
deflecti o n , pl astic deformati o n , d u ctile or brittle fracture, fati g u e fracture, i nstability
( buckl i n g ) , stress-assisted corrosi o n cracki ng, wear, m ateri al creep, m aterial deteriorati on
a n d residual stresses res ulti ng from the m a n ufacturi ng P ROCES S E S , e . g . m achi n i n g ,
ass e m b l i n g , wel d i n g , heat treat m e nt or s u rface coati ng.
The ACCO MPANYI NG DOCUME NTS s h a l l co ntai n i nstructi ons on attachment of structu res to a
fl oor, wal l , cei l i n g , etc. m aki n g adequate a l l owances for q u al ity of the m aterials used to
m ake the co n n ectio n and shall l i st the req u i red m aterials. Additi onally there shall be
advice o n checki n g the adequacy of the surface of the structure to wh ich the parts wi l l be
attached.
9.8.2 T E N S I L E SAFETY FACTOR

S u pport systems shall m a i ntai n structural i ntegrity d u r i n g the EXPECTED S E RV I C E LIFE of the M E
E Q U I P M E NT . T E N S I LE SAFETY FACTORS shall not be l ess than those s h own in Table 2 1 u nless an
alternative m ethod d e m o nstrates structural i ntegrity thro u g h o ut the EXPECTED S E RV I C E L I F E of
the M E E Q U I P M ENT, or the s u pport is a foot rest. The req u i re m ents fo r foot rests are i n
9.8.3.2 a).
6060 1 - 1 © I EC : 2005 - 293 -
Table 21 - Dete r m i nation of T E N S I L E SAF E T Y FACTOR
S ituation M i n i m u m TENSILE
SAFETY FACTOR a
No. System Part E l o ngation A

"
B'
1 S u pport system parts not Metallic material d having a 2,5 4

i m pa i red by wear specific elon gation at break
equal to o r g reater than 5 %
2 S u pport system parts not Metallic material d having a 4 6

i m pa i red by wear specific elon gation at break of
less than 5 %
3 S u pport system parts Metallic material d having a 5 8

i m pa i red by wear • and no specific elon gation at break
M EC HA N I CA L PROTECTIVE equal to o r g reater than 5 %
D EV I C E

i m pa i red by wear • and no specific elon gation at break of
M EC HA N I CA L PROTECTIVE less than 5 %
D EV I C E
5 S u pport system parts Metallic material d having a 2,5 4

i m pa i red by wear • and with specific elon gation at break
M EC HA N I CA L PROTECTIVE equal to o r g reater than 5 %
D EV I C E (o r primary system of
m u ltiple s u pport syste ms)

i m pa i red by wear • and with specific elon gation at break of
M EC HA N I CA L PROTECTIVE less than 5 %
D EV I C E (o r primary system of
m u ltiple s u pport syste ms)
7 M E C H A N I CA L PROTECT IVE 2,5 4

D EV I C E (o r back-up system of
m u ltiple s u pport system)
• The T E N S I L E SAFETY FACTORS are intended to take account of conditi o n s defined in 1 5 . 3 . 7 ( i . e .

enviro n m e ntal effects, i m pairing effects o f wear, corrosi o n , material fatigue o r ageing).
Case A = The material T E N S I L E ST R E N GTH and a l l external forces to be expected a re qua ntifiable
b
and known accurately.
' Case 8 = Other than case A; specifica lly, the material T E N S I L E STRENGTH and all external forces to
be expected are known approximately, but not with sufficient accuracy to justify the T E N S I L E
SAFETY FACTOR f o r c a s e A .
d For non-metallic materials, particular standards can prescribe adeq uate T E N S I L E SAFETY FACTORS
(see rationale i n An nex A, S u bclause 9.8).
• Components considered i m pa i red by wear include: chains, cables (wire ro pe) , belts , jack screw
nuts, springs, pneumatic o r hydra u l i c hoses, gaskets o r rings of pneumatic o r hyd raulic pistons.
Compliance with 9. 8. 1 and 9. 8. 2 is checked by inspection of the ME EQ UIPMENT, the RISK

MANA GEMENT FILE, the specifications of m aterials used and the processing specifications for
these materials.
When test results are part of relevant inform ation, testing consists of gradually applying a test
load to the support assembly under test equal to the TO TAL LOAD tim es the required TENSILE
SAFE TY FA CTOR. The support assembly under test is to be in equilibrium after 1 min, or
otherwise not result in an unacceptable RISK.
NOTE 1 It m ight be necessary to support asse m blies that a re con nected to the assem bly u nder test but do not
req u ire such a h i g h safety factor, e . g . assem bly under test req u i res T E N S I L E SAFETY FACTOR = 8 a n d assem bly
s u pporting it is designed with a T E N S I L E SAFETY FACTOR = 4 . Use of additio n a l s u pport should be explained i n the
test report.
NOTE 2 The 1 min time period m ig ht need to be longer for materials which m i g ht have creep type problems, such
as plastics o r other non-meta l l i c materials.
6060 1 - 1 © I EC : 2005 - 295 -
9.8.3 * Stre n g t h o f PAT I E N T o r O P E RATOR s u p po rt o r s us p e n s i o n system s
9 . 8. 3 . 1 General
M E E Q U I PMENTparts servi ng for s u pport or i m m obil izati on of PAT I E NTS shall be designed and
m a n ufactured so as to m i n i m ize the R I S K of physical i nj u ri es and of accidental l oose n i n g of
fixi ngs.
The S A F E WORK I N G LOAD of M E E Q U I P M ENT or its parts servi n g for su pport or s uspensi o n of
PAT I E NTS or O P E RATORS shall be the s u m of the m ass of the PAT I E NTS or the m ass of the
O P E RATORS plus the m ass of ACCES SORI E S i ntended by MANUFACTURERS to be s u p ported o r
suspended b y the M E E Q U I PMENT or M E E Q U I P M E NT parts .
U n l ess otherwise stated by the MANUFACTU RER, su pporti ng a n d suspending parts for adult
h u m a n PAT I E NTS or O P E RATORS shall be desi gned for a PATI E N T or O P E RATOR havi ng a
m i n i m u m m ass of 1 35 kg a n d ACCESSORIES havi ng a m i n i m u m m ass of 1 5 kg.
Where a MANUFACTU R E R specifies parti cular appl i cati ons ( e . g . paediatric use) , the m axi m u m
m ass of t h e PAT I E NT i ncluded i n t h e SAFE WORKING LOAD of t h e M E EQUI PMENT or its parts
servi ng fo r su pport or s us pension of PAT I E NTS m ay be adapted. When the m axi m um a l l owable
value of the m ass of the PAT I E NT is l ess than 1 35 kg, that val u e shall be marked on the
M E E Q U I P M E N T a n d descri bed in ACCO MPANYI NG DOC U M E NTS . When the m ax i m u m a l l owable
value of the m ass of the PAT I E NT is m ore than 1 35 kg, that v a l u e shall be described i n
ACCOMPANY I NG DOCUM ENTS .
Compliance is checked by inspection of m arkings, A CCOMPANYING DO CUMENTS, and the RISK

MANA GEMENT FILE.
9.8.3.2 * Static forces d u e t o load i n g from perso ns

In analyzi n g loading forces and torq u es on s u pport ass e m bl i es , the part of the SAFE WO RKING
LOAD representi ng the m ass of the PAT I E NTS or O P E RATORS is distri buted on the
s u p port/s uspension s u rface i n a m anner representi n g the h u m an body (see the exa m pl e in
F i g u re A. 1 9) .
NOTE The position o f the h u m a n body varies depending o n the configuration o f the support/s uspe nsion system
and the refore the load acti ng on d iffe rent sections will vary and should be taken into account.
I n analyzi n g loading forces and torq u es on s u pport ass e m bl i es , t h e part of the SAFE WO RKING
LOAD representi n g the m ass of ACCES SORI E S shall be de ployed as in NORMAL U S E or, if n ot
defi ned, at the worst case positio n perm itted by the confi gurati on or ACCESSORI E S attachm ent
on the s u pport/suspension parts .
a) For a foot rest that is i ntended to tem porarily su pport a sta n d i n g PAT I E NT or O P E RATO R , the
whole m ass of the PAT I E NT or O P E RATOR is distri buted over an area of 0, 1 m 2
Compliance is checked by inspection of the ME E Q U I PM ENT, the R I S K MANAG E M E N T F I L E , the
specifications of m aterials used and the processing specifications for these m aterials, and
the following test:
Prior to performing these tests, the PATIENT support/suspension system is positioned

horizontally in its m ost disadvantageous position in NORMAL usE.
6060 1 - 1 © I EC : 2005 - 297 -
A m ass equal to two tim es 1 35 kg or two tim es the intended person load, whichever is
greater is applied to the foot rest over an area of 0, 1 m 2 for 1 m in. A fter the test, a foot rest
and its fixings that shows any damage or deflection that could result in an unacceptable
RISK constitutes a failure.
b) For an area of su pport/s uspension where a PAT I E NT or OPE RATOR can sit, deflecti on of a
support s u rface from PAT I E NT or O P E RATO R loadi n g shall not result i n an u n acceptable R I S K .
Compliance is checked by inspection of the ME EQ UIPMENT, the RISK MANAGEMENT FILE, the
specifications of m aterials used and the processing specifications for these m aterials, and
the following test:
Prior to performing these tests, the PATIENT support/suspension system is positioned

horizontally in its m ost disadvantageous position in NORMAL usE.
A m ass of 60 % of the part of the SAFE WORKING LOAD representing the PATIENT or
OPERA TOR, as defined in the instructions for use, or at a minimum 80 kg, is placed on the
support/suspension system with the centre of the load 60 mm from the outer edge of the
support/suspension system for a tim e of at least one minute. Any deflection of the
support/suspension system that could result in an unacceptable RISK constitutes a failure.
9.8.3.3 * Dynam ic forces d u e t o load i n g f r o m persons

Where dyn a m i c forces ( d u e to sitti ng down , sta n d i n g up, PATI E NT h a n d l i n g PROCESS o r the
l i ke) can be exerted on equi pment parts i ntended to su pport or suspend a PAT I E NT or
O P E RATOR in NORMAL U S E , they shall not res ult in an u n acceptab l e R I S K .
Compliance i s checked b y t h e following test:
Prior to performing this test, the PATIENT support/suspension system is positioned horizontally
in its most disadvantageous position in NORMAL USE.
For the area of support/suspension where a PATIENT or OPERA TOR can sit, a mass (as defined
in Figure 33) equivalent to the SAFE WORKING LOAD representing the PATIENT or OPERA TOR as
defined in the instructions for use is dropped from a distance of 1 50 mm above the seat area.
Any loss of function or structural damage that could result in an unacceptable RISK constitutes
a failure .
9.8.4 * Syste m s w i t h M ECHANICAL PROTECTIVE DEVICES
9.8.4. 1 General
a) A M E CHANICA L PROTECTIVE D E V I C E shall be provided when a s u pport system or any of its

parts i m paired by wear have a T E NS I LE SAFETY FACTOR greate r than or equal to the val ues
specifi ed in rows 5 and 6 but less than th ose i n rows 3 and 4 of Table 2 1 .
b) The M E CHANICA L PROTECTIVE DEVICE s h a l l :
b e desi gned on the basis o f TOTAL LOA D , w h i c h shall i n c l u de the effects o f the SAFE
WORK I N G LOAD when a pplicable;
have T E NS I LE SAFETY FACTORS for all parts not l ess than those in row 7 of Table 2 1 ;
6060 1 - 1 © I EC : 2005 - 299 -
activate before travel ( m ovement) produces a n u n acceptable RISK;
take i nto acco u nt 9 . 2 . 5 and 9 . 8 . 4 . 3 .

Compliance is checked b y inspection o f the ME EQUIPMENT, the RISK MANAGEMENT FILE, the
specifications of m aterials used and the processing specifications for these m aterials.
14 -1
Dimensions i n m i l l i metres
300
��
0
0
C')
IEC 2416105
NOTE The upper carriage of the h u m a n body test mass apparatus i s formed of wood or a s i m i l a r materi a l . The
bottom portion is foa m . The resi l i e ncy o r spring factor of the foam (ILD o r I FD ratings) is not specified, as with a
large mass being dropped, the foam properties a re l i kely i nconseque ntia l . The foam is cyl i n d rical, rather than
spherica l .
F i g u re 33 - H u m an b o d y test mass
(see 9 . 8 . 3 . 3)
9.8.4.2 U se after activation of a M ECHANICAL PROTECTIVE DEVICE

If M E E Q U I P M ENT can sti l l be used after fai l u re of the suspension or actuati on means a n d
activation o f a M E CHANICA L PROTECTIVE DEVICE s u ch a s a seco n d a ry c a b l e (wi re rope) , it shall
becom e obvious to the O P E RATOR that the M E CHANICA L PROTECT I V E DEVICE h as been activated.
The M E CHANICA L PROTECTIVE D E V I C E shall req u i re the use of a TOOL to be reset or replaced.
Compliance is checked by inspection of the ME EQ UIPMENT.
9.8.4.3 M ECHANICAL PROTECTIVE DEVICE i n tended fo r s i n g le activation
If a M E CHANICA L PROTECTIVE D E V I C E is i ntended to fu nctio n only once, the fol l owi n g

req uirem ents s h a l l b e fulfi lled:
Further use of the M E E Q U I P M E NT shall be i m possible u ntil the M E CHANICA L PROTECTIVE
DEVICE has been replaced.
6060 1 - 1 © I EC : 2005 - 301 -
The ACCOMPANY I NG DOCU M E NTS shall i nstruct that once the M E CHA N I CA L PROTECTIVE DEVICE
has been activated, S E RVICE PERSONNEL are to be cal l e d , a n d the M E CHANICA L PROTECTIVE
DEVICE m ust be replaced before the M E E Q U I P M E NT can be used agai n .
The M E E Q U I P M ENT s h a l l b e perm a n e ntly marked with safety s i g n 7 0 1 O-W00 1 (see

Table 0.2, safety sign 2).
The m arki ng shall be adjacent to the M E CHANICA L PROTECTIVE DEVICE or S O l ocated that its
relation to the M E CHANICA L PROTECTIVE DEVICE is obvious to the person perfo r m i n g service
or repai r.
NOTE See also 1 5 . 3 . 7 .
Compliance is checked as follows:

by inspection of the ME EQUIPMENT, the A CCOMPANYING DO CUMENTS, the RISK MANA GEMENT
FILE, specifications of m aterials used and the processing specifications for these m aterials;
a chain, cable (wire rope), b and, spring, belt, jack screw nut, pneum atic or hydraulic hose,
structural part or the like, employed to support a load, is defeated (to test the MECHANICAL
PROTECTIVE DEVICE) by any convenient m e ans, thereby causing the m aximum normal load
to fall from the most adverse position permitted by the construction of the ME EQUIPMENT. If
the system supports a PATIENT or OPERA TOR, the load is to include the SAFE WORKING LOAD
defined in 9. 8.3. 1 .
Any evidence o f damage to a MECHANICAL PROTECTI VE DEVICE that would affect its ability to
perform its intended function constitutes a failure.
9.8. 5 System s without M ECHANICAL PROTECTIVE DEVICES

A M E CHANICA L PROTECTIVE D E V I C E is not req u i red if:
- the s u pport system parts are n ot i m paired by wear a n d h ave T E NS I LE SAFETY FACTORS
greater than or equal to the val u es s pecified i n rows 1 and 2 of Table 2 1 ; o r
- the support system parts are i m paired by wear but have T E N S I LE SAFETY FACTORS greater
than or equal to the val u es s pecified in rows 3 and 4 of Table 2 1 .
Compliance is checked by inspection of the ME EQ UIPMENT and the RISK MANA GEMENT FILE.
1 0 * P rotect i o n a g a i nst u nwanted a n d excess ive rad iati o n HAZARDS
10.1 X- Rad iation
10.1.1 * M E EQUIPMENT n ot i ntended to p ro d u ce d iag nostic o r t h e rapeutic X-radiation

For M E E Q U I P M E NT not i ntended to prod uce X-radi ati on for diagnosti c or therapeutic pu rposes,
but which m i ght produce i onizi n g radiati o n , the dose-rate shall n ot exceed 36 pA/kg (5 � Sv/h)
( 0 , 5 m R/h) at a dista nce of 5 em fro m a s u rface of the M E EQUI P M ENT taki n g acco u nt of the
background radiati o n .
NOTE 1 The dose-rate value appears i n I CRP 6 0 [39] .
NOTE 2 I n the m e m be r cou ntries of C E N E L E C , the a m o unt of ionizing radiation is regulated by E u ropean Council
Directive 96/29/Euratom of 1 3 May 1 996. This Di rective req u i res that at any point 10 em from the surface of the
equi pment, the dose-rate s h a l l not exceed 1 �Sv/h (0, 1 m R/h) taking acco u nt of the background leve l .
Compliance i s checked by following test:

6060 1 - 1 © I EC : 2005 - 303 -
The amount of radiation is determined by means of a radiation m onitor of the ionizing

2
chamber type with an effective area of 1 0 cm or by m easuring equipment of other types
giving equivalent results.
The ME EQUIPMENT is operated at the m ost unfavourable RA TED MAINS VOLTAGE and with any
controls adjusted so as to give maximum radiation whilst m aintaining the ME EQUIPMENT in
NORMAL USE.
Internal preset controls not intended to be adjusted during the EXPECTED SERVICE LIFE of the
ME EQUIPMENT are not considered.
Measurements are made at a distance of 5 em from any surface to which OPERA TORS other
than SERVICE PERSONNEL:
can gain access without the use of a TOOL;
is delib erately provided with the m eans of access; or
is instructed to enter regardless of whether or not a TOOL is n eeded to gain access.
Any measurement exceeding 36 pA!kg (5 fJS vlh) (0, 5 m R!h) adjusted for the level of
background radiation constitutes a failure.
NOTE 3 This test PROC E D U R E is equivalent to that in A n n ex H of I E C 60950- 1 :2001 .
1 0 . 1 .2 M E E Q U I P M E N T I nte n d ed to p rod uce d i ag nostic or therapeutic X-rad iation

The MANUFACTURER shall address in the R I S K MANAG E M E NT PROCESS the R I S K from u n i ntended
X-radi ati o n from M E E Q U I P M E NT desi gned to prod uce X-radiati on for diagnostic a n d therapeutic
purposes. See I EC 6060 1 - 1 -3 and also see 1 . 3.
1 0.2 A l p ha, beta, g a m ma, n e utron and oth e r particle rad iation
When applicable, the MANUFACTURER shall address in the R I S K MANAG E M E N T PROCESS the
R I S KS associ ated with a l ph a , beta, gam m a , n e utron and other particle radi ati o n .
Compliance is checked b y inspection of the RISK MANA GEMENT FILE.
1 0.3 M icrowave rad iation

R I S KS associ ated with m i crowave radiati o n .
1 0.4 * Lasers a n d l i g h t em itt i n g d iodes ( L E Ds)

The relevant req u i rem ents of I EC 60825- 1 : 1 993 a pply. If laser l i g ht barri ers o r s i m i l a r
products a r e u s e d with i n equi pment, they s h a l l c o m ply with the requirements o f I EC 60825-
1 : 1 993.
Compliance i s checked b y following the relevant PRO CEDURES of I E C 60825- 1 : 1 993.
10.5 Other v i s i ble electromag netic rad iation

R I S KS associated with visible el ectrom agnetic radiati o n , other than that produced by l asers
a n d l i ght em itti ng di odes (see 1 0. 4 ) .
6060 1 - 1 © I EC : 2005 - 305 -
1 0.6 I nfrared rad iation

When applicable, the MANUFACTURER shall address in the RISK MANAG E M E N T PROCESS the
R I S KS associated with i nfrared radiati o n , other t h a n that produced by lasers and l i g ht em itti ng
diodes (see 1 0. 4 ) .
1 0.7 U lt raviolet rad iation

R I S KS associated with ultraviolet radi ati o n , other than that produced by l asers and l i ght
em itti ng diodes (see 1 0 . 4 ) .
11 P rotect i o n agai nst excess ive tem p e rat u res a n d oth e r HAZARDS
1 1 .1 * Excess ive tem peratu res i n ME EQU I P M E NT
1 1 .1.1 * M axi m u m tem perat u re d u ri n g NORMAL USE
When M E E Q U I P M ENT is ope rated in wo rst-case NORMAL USE i ncl u d i n g the m axi m u m am bient
operati n g tem perature s pecifi ed i n the tech n i cal descriptio n (see 7 . 9 . 3. 1 ) :
M E E Q U I P M E N T parts s h a l l not reach tem peratures exceedi ng the val ues given i n Table 22
a n d Table 23;
the M E E Q U I P M ENT
shall n ot cause the surfaces of the test corner to exceed 90 oc; and
THERMAL CUT-OUTS shall not o perate i n NORMAL CONDI T I O N .
Table 22 - Al lowable m ax i m u m tem peratu res of parts
Parts Maxi m u m Temperature

'C
I ns u latio n , including winding i n su l ation a
- of Class A Mate rial 1 05
- of Class E Mate rial 1 20
- of Class B Mate rial 1 30
- of Class F Material 1 55
- of Class H Mate rial 1 80
Parts with T m a rking Tb

'
Other com ponents and materials
Parts in contact with fla m m able liquid with fl ash-po i nt of T ' C T-25
Wood 90
a The classification of insu lating materials i s i n accordance with I EC 60085. Any incompatibil ity of the materials of
a n i nsu lating system that could reduce the maxi m u m temperature l i m it of the system below the l i m its of the
individual materials shall be co nsidered.
b T m a rking refers to the m a rked maxi m u m operating tem perature .
For each material a n d com ponent, account shall be take n of the temperature ratings for each material o r
'
c o m ponent to determine t h e a ppropriate maxi m u m tem perature. Each com ponent shall be u s e d i n accordance
with its tem perature rat i n g . Where doubt exists, the ball pressure test of 8 . 8 . 4 . 1 should be perfo rmed.
6060 1 - 1 © I EC : 2005 - 307 -
Table 23 - Al lowable m ax i m u m tem peratu res for M E EQU I P M E NT parts

that are l i kely to be to u ched
Maxi m u m temperature a
'C
M E EQUIPMENT and its parts M o u lded

materi a l ,
Metal G l ass, porcelai n , p l astic, rub ber,
and l i q u i d s vitreous m aterial wood
t< 1 s 74 80 86
External s u rfaces of 1 s � t < 10 s 56 66 71

ME EQU I P M ENT that are
l i kely to be touched for
a time " t " 10 s � t < 1 m i n 51 56 60
1 min � t 48 48 48
a These tem perature l i m it va lues are appl icable for touching the healthy skin of adults. They are not applicable
when l a rg e areas of the skin (1 0 % of total body surface o r m o re) c a n be i n c o ntact with a hot surface. This also
applies i n the case of skin contact with over 1 0 % of the head surface. Where this is the case, appropriate l i m its
shall be dete rmined a n d documented in the R I S K M A N A G E M E N T F I L E .
Table 24 - Al lowable m ax i m u m tem peratu res for skin contact

with ME EQUIPMENT APPLIED PARTS
Maxi m u m temperature a
0
'C
APPLIED PARTS of M E EQU I P M E N T M o u lded

materi a l ,
Metal G l ass, porcelai n , p l astic, rub ber,
and l i q u i d s vitreous m aterial wood
t < 1 min 51 56 60
A P P L I E D PART having
contact with the 1 m i n � t < 10 m i n 48 48 48
PAT I E N T f o r a t i m e "I "
1 0 min � t 43 43 43
a These tem perature l i m it values are appl icable for the healthy skin of a d ults. They are not a pplicable when l a rge
areas of the skin (1 0 % of total body s u rface o r m o re) can be i n contact with a hot s u rface. They a re not
appl icable i n the case of skin contact with over 1 0 % of the head s u rface. Where this is the case, appro p riate
l i m its shall be determi ned and documented in the R I S K M A N A G E M E N T F I L E .
Where it is necessary for A P P L I E D PARTS to exceed the tem perature l i m its of Table 24 in order to provide clin ical
b
benefit, the RISK M A N A G E M E N T FILE shall contain docum entation showing t h at the resulting benefit exceeds any
associated increase i n R I S K .
1 1 . 1 .2 * Tem perat u re of APPL I E D PARTS
1 1 . 1 .2.1 APPLIED PARTS i ntended to s u pply h eat to a PATI ENT

The tem perature ( hot or cold s u rfaces) or (where a ppropriate) the c l i n i cal effects s h a l l be
determi ned and docum ented in the RISK MANAG E M E N T F I L E . T h e tem peratures a n d c l i n ical
effects s h a l l be disclosed in the i nstructi ons for use.
1 1 . 1 .2.2 * APPL I E D PARTS not i nte n d ed t o s u pply heat t o a PATIENT

The l i m its of Table 24 shall a pply. If the s u rface temperature of an APPLI E D PART exceeds
4 1 o c , the m ax i m u m tem perature s h a l l be disclosed in the i nstructions for use and the cl i n i cal
effects with respect to characteristics such as body s u rface , m atu rity of PAT I E NTS , m edicati ons
bei n g taken or s u rface pressu re shall be determi ned and docu m e nted i n the R I S K MANA G E M E N T
F I L E . Where 4 1 o c is not exceeded, n o j ustificati o n is req u i red.
6060 1 - 1 © I EC : 2005 - 309 -
S u rfaces of APPLI E D PARTS that are cooled below a m bi ent tem peratures can also result i n
HAZARD a n d s h a l l b e eva l u ated a s part o f the R I S K MANAG E M E NT P ROCESS.
1 1 . 1 .3 * M ea s u re m e nts
Where e n g i n eeri n g j udgem ent by the MANUFACTU R E R i n dicates that tem perature l i m its cannot
be exceeded, no m eas u rem ent is req u i red. Where such j u d g e m e nts i n dicate that the test
corner wi l l not i m pact the m easure m e nts , it m ay be om itted. H owever, the rati onale for such
judgement s h a l l be docum ented i n the R I S K MANAG E M E N T F I L E . I f the test corner is used, its
surfaces s h a l l n ot exceed 90 o c .
For M E E Q U I P M E NT parts that are li kely to be touched a n d for A P P L I E D PARTS , the probabil ity of
occurrence of co ntact and of the d u rati on of contact is determi ned and docum ented in the
R I S K MANAG E M E NT F I L E .
Compliance with t h e requirements of 1 1 . 1 . 1 a n d 1 1 . 1 . 2 i s checked b y inspection of the RISK

MANA GEMENT FILE and the instructions for use, operation of ME EQUIPMENT and temperature
measurem ents as follows:
a) Positioning
1) ME E Q UIPMENT is tested in the position (s) of NORMAL USE.
2) ME E Q UIPMENT is placed in a test corner. The test corner consists of two walls at right
angles, a floor and, if necessary, a ceiling, all of dull black painted plywood of 20 mm
thickness. The linear dim ensions of the test corner are at least 1 1 5 % of the linear
dim ensions of the ME E Q UIPMENT under test.
The ME E Q UIPMENT is positioned in the test corner as follows:

ME E Q UIPMENT normally used on a floor or a table is placed as near to the walls as
is likely to occur in NORMAL USE.
ME E Q UIPMENT norm ally affixed to a wall is m ounted on one of the walls, as near to
the other wall and to the floor or ceiling as is likely to occur in NORMAL USE.
ME E Q UIPMENT norm ally affixed to a ceiling is mounted on the ceiling as near to the
walls as is likely to occur in NORMAL USE.
3) HAND-HELD ME EQUIPMENT is suspended in its normal position, in still air.
4) ME E Q UIPMENT intended for installation in a cabinet or wall is built in as required by the

technical description (see 7. 9. 3. 1), using dull black painted plywood walls, 10 mm thick
when representing cabinet walls if the technical description so specify and 20 mm thick
when representing building walls.
b) Supply
ME E Q UIPMENT having heating elements is operated as in NORMAL USE, with all heating
elements energized unless prevented by switching interlocks, the supply voltage being
equal to 1 1 0 % of the m aximum RA TED voltage.
Motor operated ME EQUIPMENT is operated under normal load and normal DUTY CYCLE
and the least favourable voltage b e tween 90 % of the minimum RA TED voltage and
1 1 0 % of the m aximum RA TED voltage.
6060 1 - 1 © I EC : 2005 - 31 1 -
Combined heating and m otor operated and other ME EQUIPMENT is tested both at 1 1 0 %
of the maximum RA TED voltage and at 90 % of the minim um RA TED voltage.
When modules are tested separately, the configuration for testing simulates the worst
case conditions of NORMAL USE that might affect the test result.
c) Therm al stabilization
For ME EQUIPMENT intended for non-CONTINUOUS OPERA TION:
After operating in standby/quiescent mode until THERMAL S TABILI TY is reached, the
ME EQUIPMENT is operated in NORMAL USE over consecutive cycles until THERMAL
S TABILITY is again achieved, or for 7 h, whichever is shorter. The "on " and "off" periods
for each cycle are the RA TED "on " and "off" periods;
For ME EQUIPMENT for CONTINUOUS OPERA TION:
The ME E Q UIPMENT is operated until THERMAL S TABILITY is reached.
d) Temperature m easurement
Resistance m ethod (for windings) :
The value of the temperature rise of a copper winding is calculated from the form ula:
wh ere:
LlT is the temperature rise in oc;
R1 is the resistance at the beginning of th e test in il;
R2 is the resistance at the end of the test in il;
T1 is the room temperature at the beginning of the test in OC;
T2 is the room temperature at the end of the test in °C.
At th e beginning of th e test, windings are to b e at room temperature.

NOTE When the resistance method is used, it is reco m m ended that the resistance of windings at the
end of the test be dete r m i ned by taking measure m e nts as soon as possible after switching off, and then at
short intervals so that a c u rve of resistance agai nst time can be plotted fo r ascerta i n i n g the va l u e at the
instant of switc hing off.
Thermocouple and other m ethods (for all m easurements):

Measurement is made by devices or sensors so chosen and positioned that they have
a n egligible effect on the temperature of the part under test.
When thermocouples are used to determine th e temperature of windings, the

temperature limits of Table 22 are to be reduced by 1 0 OC.
Th e temperature of electrical insulation, other than that of windings, is determin ed on

the surface of the insulation at places where failure could cause a sh ort circuit,
bridging of a MEANS OF PROTECTION, bridging of insulation or reduction of CREEPA GE
DISTANCES or AIR CLEARANCES below th e values specified for the insulation type in B. 9.
6060 1 - 1 © I EC : 2005 - 313 -
Th e point of separation of cores of a m ulticore cord and where insulated wires enter
lamph olders are examples of places where temperatures migh t be m easured.
e) Test criteria
During th e test THERMAL CUT-OUTS are not de-activated.
Th e m aximum temperature of a part is determin ed by m e asuring the temperature rise of

the part under test and adding it to the m aximum allowed ambient temperature specified in
the technical description (see 7. 9. 3. 1). Where thermal regulatory devices make this method
inappropriate, alternative methods for measurement are justified in the RISK MANAGEMENT FILE.
1 1 . 1 .4 G UARDS
GUARDS intended to p revent contact with h ot or cold accessible s u rfaces of M E E Q U I P M ENT
shall be remova ble o n ly with the aid of a TOOL.
1 1 .2 * F i re prevention
1 1 .2.1 * Stre n g t h a n d rig id ity req u i red t o preve nt f i re i n M E EQUIPMENT

ENCLOS URES shall have the strength and rigid ity necessary to avo id a fire that could occ u r as
a res u lt of a total o r partial colla pse caused by reasonably foreseeable misuse.
Compliance i s checked by the mech anical strength tests for ENCLO S URES (see 1 5. 3).
1 1 .2.2 * M E EQU I P M E NT a n d M E SYSTEMS used i n conj u n ction w i t h OXYG EN RICH

E NVI RO N M E NTS
1 1 .2.2. 1 RISK of f i re in an OXYG E N RICH E NVI RONM ENT

In M E E Q U I P M E NT and M E SYS T E M S , the R I S K of fire in an OXY G E N R I C H E NV I RO N M E N T shall be
red uced as far as poss i b le u nder N O R M A L CONDI T I O N o r S I NG L E FAULT C O N D I T I O N S (as identified
in 1 1 . 2 . 3). An u n acceptable R I S K of fire is considered to exist in an OXY G E N RICH E NV I R O N M E N T
when a source of i g n ition is i n contact with i g n itable material and there is no means that wou l d
l i m it the spread o f a fi re.
NOTE 1 For oxygen concentrations u p to 25 % at one atmosphere o r partial pressures u p to 2 7 , 5 kPa for higher
atmospheric pressures, the requirements i n 1 3 . 1 . 1 are considered to be sufficient.
a) * A source of i g n ition is considered to exist in an OXY G E N RICH E NV I R O N M E N T when any of

the fol lowi ng conditions exist i n N O R M A L CONDI T I O N and S I N G L E FAULT CONDITI ONS ( i n c l u d i n g
voltage and cu rrent):
1 ) the temperature of the material is ra ised to its i g n ition tempe rat u re;
2) temperatu res could affect solder o r solder j o i nts causing loose n i n g , short circuiting o r
oth e r fa i l u res that c o u l d res u lt i n sparking o r raising the tem peratu re o f the material to
its i g n ition temperature;
6060 1 - 1 © I EC : 2005 - 315 -
3) parts affecting safety crack o r change t h e i r outer shape exposi ng temperatu res
exceeding 300 c or sparks (see 4) and 5) below) due to overheating;
o
4) temperatu res of parts o r compone nts could exceed 300 o c;
5) sparks p rovide adequate energy for i g n ition by exceeding the l i mits of F i g u re 35 to

F i g u re 37 ( i nclusive).
Items 4) and 5) add ress the wo rst case where the atmosp here is 1 00 % oxyg e n , the
contact material (for item 5) is solder and the fuel is cotto n . Ava i l a b l e fuels and oxyg en
conce ntrations s h o u ld be take n i nto consideration wh e n applying these specific
req u i reme nts. Where deviations from these worst case l i m its are made ( based on lower
oxygen conce ntrations o r less flammable fu els) they shall be j u stified and documented in
the R I S K MANAG E M E NT F I L E .
As an alternative t o 1 1 . 2. 2. 1 a) 5), th e following test m ay be u s e d t o determine whether a
source of ignition exists.
First, the place(s) within the ME EQ UIPMENT where sparking might cause ignition are
identified. Then the m a terial(s) of the parts between which sparks can occur is identified.
Samples of the same m aterial are then used to construct the contact pins for th e test
apparatus (see Figure 34).
Other parameters for the test are: oxygen concentration, fuel, electrical parameters
(current, voltage, capacitance, inductance or resistance). These parameters are ch osen
such th at they represent the worst case for the ME EQ UIPMENT.
NOTE 2 For M E EQU I P M ENT that includes a c i rc u it not addressed in F i g u re 35 to F i g u re 37 (inclusive) , either the
test voltage o r current may be set at three times the worst case va lues with the other parameter set at the worst
case value fo r determ i n i n g whether i g nition can occur.
Two contact pins made of the m aterial to b e considered are placed in opposition (see
Figure 34). One pin has a diameter of 1 mm, th e other of 3 m m . Th e electrical source is
connected to the pins as shown in Figure 35 to Figure 37. A piece of cotton is placed close
to the contact surfaces of the two pins. The contacts are constantly flushed by oxygen with
a speed of less than 0, 5 mls via a tube. The cathode is m oved to the anode to close the
contacts and pulled b ack to open them again. A minimum of 300 trials has to be performed
before it can b e decided that th e sparks do not ignite. If th e sparks get smaller because of
bad surfaces of the electrodes, th e electrodes are cleaned with a file. If the cotton gets
black b ecause it b ecame oxidized then it is replaced. In Figure 36 and Figure 37, the
resistance used to control current flowing into the inductor and the time constant for
charging th e capacitor is chosen such that it has minimal impact on the energy of the
spark. This is tested by visual inspection with out the capacitor in place or with the inductor
shorted.
Th e situation with th e highest voltage or current respectively and no ignition defines the
upper limit. A safe upper limit is given by dividing the upper limit of voltage or current
respectively with the safety margin factor of three.
NOTE 3 The safety margin factor is considere d to cover the uncertai nty of sparking experiments and the
va ria bility of the u nderlying param eters l i ke pressure , q u a l ity of cotton o r of the contact materials.
6060 1 - 1 © I EC : 2005 - 317 -
�======�==��----
02
Pin 1 Pin 2
3 mm diameter 1 mm diameter
material material
(+) (-)
IEC 2417105
F i g u re 34 - Spark i g n ition test a p pa ratus

(see 1 1 .2 . 2 . 1 )
Resistive load
2
I I I I I I
� R
�9
-
-
r-
<( "' -
" u -
" -
Pin 2
0,5 "' -
"
""
-
"""'
['-._
""
�
0,2
0,1 "'
"'
"
0,05
10 20 50 1 00
u v -�
IEC 24 18105
F i g u re 35 - M axi m u m a l lowable c u rrent I as a f u n ction of t h e m axi m u m al lowable

voltage U m easu red i n a p u re l y res istive c i rcu it i n a n OXYG E N RICH E NVI RO N M E NT
(see 1 1 .2 . 2 . 1 )
6060 1 - 1 © I EC : 2005 - 319 -
Capacitive load
40
I I I I I
�
R
""'" U l-
�9
35
T
>
:::>
30 C
Pin 2
25 �
�
20 �
�['.._
'�
15
�
10
0
0,5 10 1 00 1 000 2 000
C f.!F -
IEC 2419105
F ig u re 36 - M axi m u m a l lowable voltage U as a fu nction of t h e capacita nce C

m eas u red i n a capac itive c i rc u i t u sed i n an OXYGEN RICH E NVI RO N M E NT
(see 1 1 .2 . 2 . 1 )
I nductive load
0,7
0,6
<(
0,5
0,4
0,3
R L
0,2 u
0,1
0,0
0 2 4 6 8 10 12
L mH -
IEC 2420105
F i g u re 37 - M axi m u m a l lowable c u rrent I as a f u n ction of t h e i n d uctance L

m eas u red i n an i n d uctive c i r c u i t in an OXYGE N RICH ENVIRO N M E NT
(see 1 1 .2 . 2 . 1 )
6060 1 - 1 © I EC : 2005 - 321 -
b) The fol lowing configu rations, alone o r i n combi nation as appropriate (as determ ined by the
a p p l ication of the R I S K MANAG E M ENT PROCESS ) , are considered to p rovide an acce ptable
RESI DUAL R I S K of fire in a n OXY G E N R I C H E NV I RO N M E NT.
1) Electrical components i n a compartment with a n OXY G E N RICH ENVIRONMENT shall h ave

power suppl ies with li mited energy leve ls. Th ose energy l evels shall be less than th ose
which are considered to be sufficient for i g n ition (see 1 1 . 2 . 2 . 1 a ) ) .
Compliance is checked b y inspection o f the design a n d m easurement o r calculation of
po wer, en ergy and temperature values in NORMAL CONDITION and SINGLE FA ULT
CONDITION (as identified in 1 1 . 2. 3).
or
2) * Compartments that contai n parts o r compo n e nts that can be a source of i g n ition (as
defi n ed i n 1 1 . 2 . 2 . 1 a)) only under S I NG L E FAULT CONDITI O N (as identified i n 1 1 . 2 . 3 ) and
that can be pen etrated by oxyg en (e.g. because of an u n d etected leak) shall be
venti lated such that the oxygen conce ntration will not exceed 2 5 % .
Compliance i s checked b y the following test:
Th e oxygen concen tration is m easured for such a period that th e high est possible
concentration of oxygen occurs. Th e least favourable control settings are selected.
Th e leaking condition s of oxygen are selected such tha t they provide the minimum
leak that could be detected by the OPERA TOR (e. g. b ecause of a failure of the function
of the device). If the concen tration of oxygen exceeds 25 % in th e presence of parts or
components that could be a source of ignition including at th e m oment energy is
applied, it constitutes a failure.
or
3) * A compartment that contains parts o r compon ents that can be a source of i g n ition
(as defi n ed i n 1 1 . 2 . 2 . 1 a ) ) o n ly under S I NG LE FAULT CONDITION (as ide ntified i n 1 1 . 2 . 3 )
I S separated from a n other compartment that contains an OXYG E N RICH E NV I RO N M E N T b y
sea l i n g a l l jo ints and any h o l e s f o r cables, sh afts o r fo r other p u rpose. The effect of
poss i b le leaks and fai l u res u n d e r S I NG L E FAULT CONDI T I O N (as identified in 1 1 . 2 . 3 ) that
cou l d cause i g n ition shall be eva l u ated using a R I S K A S S E S S M E N T to determi n e the
appropriate m a i ntenance i ntervals.
Compliance i s checked by visual inspection o f the documentation provided b y the
MANUFA CTURER including the RISK MANA GEMENT FILE.
or
4) Electrical compon ents i n a compartment conta i n i n g a n OXYG E N R I C H E NV I RO N M E N T that
can become a source of i g n ition (as defi n ed i n 1 1 . 2 . 2 . 1 a)) o n l y u n d e r S I NG L E FAULT
CONDITIONS (as identified in 1 1 . 2 . 3 ) shall be enclosed in such a way that s h o u ld
i g n ition occ u r with in the E NCLO S U R E , the fire wou l d se lf-extingu ish ra pidly and n o
hazardous amount o f toxic gases wo uld reach t h e PATI E N T .
Compliance shall be checked by starting a fire in the ENCLOSURE. If it is not evident
that toxic gases cannot reach the PA TIENT, the gas that could reach th e PATIENT is
an alyzed.
6060 1 - 1 © I EC : 20 0 5 - 323 -
1 1 .2.2.2 * Exte rnal exhaust out lets fo r OXYGEN RICH ENVIRO N M E NT
Exte r n a l exh a u st outlets of an OXY G E N RICH E NV I RO N M E N T s h a l l n ot be located so that R I S K of

i g n it i o n o c c u rs because of a n y e lectrical c o m p o n e n t (wh i c h c o u l d c a u s e a s park i n NORMAL
U S E or S I NGLE FAULT CONDITI O N as i d e ntified in 1 1 . 2 . 3 ) m o u nted o n the outside of t h e
M E E Q U I PMENT o r a n M E SYST E M . R I S K of i g n it i o n is c o n s id e red to b e s u ffi c i e nt l y l ow if oxyg e n
c o n c e ntrat i o n i n t h e i m m e d i ate s u rro u n d i n g s of t h e e l ectrical c o m p o n e nt d o es not exceed
25 % u n d e r t h e l e ast favo u r a b l e c o n d it i o n s of o p e rat i o n .
1 1 .2.2.3 E lect rical co n n ections i n OXYG E N R I C H ENVIRO N M E NTS

E lectrical c o n n ecti o n s with i n a c o m p a rtment conta i n i n g a n OXY G E N RICH E NV I RO N M E N T u n d e r
NORMAL U S E s h a l l not p r o d u ce s p a rks because of loose n i n g o r b r e a k i n g u n less they are l i m ited
in powe r and e n e rgy to the va l u e s i d e ntified i n 1 1 . 2 . 2 . 1 a ) 5 ) .
Preve ntion o f loos e n i n g o r b r e a k i n g is acc o m p l i s h e d by t h e fo l l owi ng o r e q u iva l e n t methods.

Sc rew-attachme nts s h a l l be p rotected aga i n st loos e n i n g d u ri n g use by m eth ods s u c h as
varn i s h i n g , t h e u se of spring was h e rs o r a p p l icat i o n of a d e q u ate torq u e s .
S o l d ered, c r i m ped a n d p i n-and-socket c o n n e ct i o n s of c a b l e s that e x i t t h e E NCLOS URE s h a l l
i n c l u d e a d d it i o n a l m e c h a n ical fix i n g .
Compliance i s checked by visual inspection.
1 1 .2.3 S I N G L E FAULT CONDITIONS related t o OXYGE N R I C H E NVI RONME NTS i n conj u n ction w i t h
M E EQUIPMENT a n d M E SYSTEMS
F a i l u re of a ve n t i l at i o n system constructed in accord a n c e with 1 1 . 2 . 2 . 1 b ) 2 ) .
F a i l u re of a b a r r i e r constructed i n acco rda n ce with 1 1 . 2 . 2 . 1 b ) 3 ) .
F a i l u re of a c o m p o n ent t h a t creates a s o u rce of i g n it i o n ( a s defi n e d i n 1 1 . 2 . 2 . 1 a ) ) .
F a i l u re of i n s u l at i o n (whether solid material o r spacing) p rovid i n g t h e e q u iv a l e nt of a t l east
o n e MEANS O F PATI ENT PROTECTI O N b ut less t h a n two MEANS O F PAT I E NT PROTECTI O N ( a s
d e s c r i b e d i n 8 . 8 a n d 8 . 9 ) that c o u l d create a s o u rce of i g n it i o n (as d efi ned i n 1 1 . 2 . 2 . 1 a ) ) .
F a i l u re of a p n e u matic c o m p o n e n t t h at resu lts i n l e akage of oxyge n-e n r i c h e d gas.
1 1 .3 * Constructional req u i rements for f i re E NCLOSURES of M E EQU I P M E NT

T h i s su b c l a u s e p rovides an altern ative m e a n s of c o m p l i a n c e with se lected HAZARDOUS
S I TUATI O NS and fa u lt co n d it i o n s as i d e ntified in 1 3 . 1 . 2 . In d o i n g so, the fo l l owi n g constructi o n a l
req u i re m e nts s h a l l be met o r s p ecifi c a l l y a n a l yzed i n t h e R I S K MANAG E M E N T F I LE a n d if n o t m et,
spec ific j u st ificat i o n s h a l l a l so be g ive n .
a ) I n s u l ated wire with i n t h e fire E NCLOS URE s h a l l h ave a fl a m m a b i l ity c l assificat i o n e q u iva l e nt
FV- 1 , o r b etter, accord i n g to t h e a p p r o p riate p a rts of t h e I E C 60695 series. C o n n ect o rs ,
pri nted c i rcu it b o a rds a n d i n s u lati ng mate r i a l o n w h i c h c o m p o n e nts a r e m o u nted s h a l l h ave
a fl a m m a b i l ity c l ass ifi cat i o n FV-2, o r better, acco rd i n g to I E C 6 0695-1 1 - 1 0 .
6060 1 - 1 © I EC : 20 0 5 - 325 -
Compliance is checked by inspection of data on materials, or by performing the F V tests

specified in IEC 60695- 1 1 - 1 0 on three samples of the rele van t parts b eing tested. Th e
samples can be any of th e following:
1) complete parts; or
2) sections of a part, including th e area with the least wall thickn ess and any ven tilation
openings.
C o m p o n e nts c e rtified in accorda nce with I E C 60695- 1 1 - 1 0 n e e d n ot be teste d .
b ) T h e fire E NCLOS URE s h a l l m e e t t h e fo l l owi n g re q u i re m e nts:
1 ) T h e b otto m s h a l l h ave n o o p e n i n g s or, to t h e extent s p ecified in F i g u re 39, s h a l l be

constructed with b affl es as s p e c ified in F i g u re 3 8 , o r be made of meta l , p e rfo rated as
spe cified i n T a b l e 25, or be a meta l screen with a mesh n ot exce e d i n g 2 m m x 2 mm
centre to ce ntre a n d a w i re d i a mete r of at least 0 , 45 mm.
2 ) T h e sides s h a l l h ave n o o p e n i ngs with i n t h e area t h at is i n c l u d ed wit h i n t h e i n c l i ned

l i n e C i n F i g u re 39.
3 ) T h e E NCLO S U R E , a n d any baffle o r fl a m e b a rr i e r, s h a l l b e made of metal ( except

m a g n e s i u m ) o r of n o n-meta l l i c mate r i a l s , exce pt fo r constructions accord i n g to T a b l e 2 5
a n d construct i o n s w i t h a m e s h , h avi ng a fl a m m a b i l ity class ificat i o n of FV-2 ( o r bette r)
fo r TRANSPORTABLE M E E Q U I P M E NT a n d FV- 1 (or b etter) fo r F I X E D M E E Q U I P M E NT or
STAT I O NARY M E E Q U I P M E N T in accord a n c e with I EC 60695- 1 1 - 1 0 .
T h e E NCLOS U R E , a n d a n y baffle o r flame barrier, s h a l l h ave a d e q u ate r i g i d ity.
Conformity is checked by inspection. In case of doubt, th e flam mability classification of

requirement b) 3) is checked as in a).
Table 25 - Accepta ble pe rforat ion of t h e bottom of an E NCLOSURE
M i n i m u m spaci n g of h o l es
M i n i m u m thickness Maxi m u m diam eter of h o l es centre to centre
mm mm mm
1 ,14 1 , 70 (233 hol es/645 m m )

2
0 , 66
0 , 66 1 ,19 2 , 36
0 , 76 1 .15 1 , 70
0 , 76 1 ,19 2 , 36
3 , 1 8 ( 7 2 hol es/645 m m )
2
0,81 1 ,91
0 , 89 1 , 90 3,18
0,91 1 , 60 2 , 77
0,91 1 , 98 3,18
1 , 00 1 , 60 2 , 77
1 , 00 2 , 00 3 , 00
6060 1 - 1 © I EC : 20 0 5 - 327 -
IEC 2421105
(2)
Y = twice X but never less than 25 m m
0
Baffle plates (may b e below t h e bottom o f t h e E N C L OS U R E)
Bottom of the ENCLOSURE
F i g u re 38 - Baffle
(see 1 1 . 3 )
IEC 2422105
Key
A Part o r co m ponent of the M E EQU I PM E NT that is co nsidere d to be a source of fire. This consists of an entire
c o m ponent o r part of the ME EQU I P M ENT if it i s not otherwise shielded, or the u nshielded portion of a
c o m ponent that is partially shielded by its cas i n g .
B Projection of the o u t l i n e of A o n the horizontal plane.
C I nc l i ned l i n e that traces out the minimum area of the bottom and sides to be constructed as specified i n
1 1 . 3 b ) 1 ) a n d 1 1 . 3 b ) 2). This line projects at a s· angle from the vertical at every point a r o u n d t h e
perimeter of A and i s o riented so as to trace out the maxi m u m a r e a .
D M i n i m u m a r e a of the bottom to be constructed as specified i n 1 1 . 3 b ) 1 ) .
F i g u re 39 - Area of t h e bottom o f an E NC L O S U RE a s s pecified i n 1 1 . 3 b ) 1 )

(see 1 1 . 3 )
6060 1 - 1 © I EC : 20 0 5 - 329 -
1 1 .4 * M E EQU I P M E NT a n d ME SYSTEMS i ntended fo r use with flam m a ble an aesth etics

M E E Q U I PMENT, ME SYSTEMS o r t h e i r pa rts described i n t h e ACCO M PANYI N G DOC U E M NTS fo r u s e
a n aesthetics (CATEGORY A P ) o r fl a m m a b l e a n aesthetics w i t h oxidants
w i t h fla m m a b l e
(CATEGORY APG ) s h a l l m eet t h e a p p l ic a b l e req u i r e m e nts of A n n e x G .
1 1 .5 * M E EQU I P M E NT a n d ME SYSTEMS i ntended fo r use i n conj u nction with f l a m m a b l e

agents
The MANUFACTU R E R ' S RISK MANAG E M E N T PROCESS s h a l l a d d ress t h e poss i b i l ity of fire a n d
associated mitigat i o n s .
Compliance i s determin ed by inspection of the RISK MANAGEMENT FILE.
1 1 .6 Overflow, s p i l lage, leakage, i n g ress of water or particu late matter, c lean i n g ,

d i s i nfecti o n , ste r i l ization a n d com pat i b i l ity with s u bsta nces u sed w i t h t h e
M E EQUIPMENT
1 1 .6.1 General
T h e constru cti o n of M E E Q U I P M E NT a n d M E S Y S T E M S shall e n s u re a s uffi c i e nt d eg ree of
p rotect i o n a g a i n st ove rfl ow, s p i l l a g e , l e akage, i n g ress of water or p a rticu late matter, c l e a n i n g ,
d isi nfect i o n a n d ste r i l ization a s we l l a s c o m p at i b i l ity with s u bsta nces u s e d with t h e
M E E Q U I PMENT.
1 1 .6.2 * Overflow i n M E EQUIPMENT

I f M E E Q U I P M ENT i n c o r p o rates a rese rvo i r o r l i q u id sto rage c h a m b e r that is l i a b le to be
ove rf i l l e d o r to ove rflow i n N O R M A L U S E , l i q u i d ove rflowi n g from t h e res e rvo i r o r c h a m b e r s h a l l
n o t wet a n y MEANS O F PROTECTION t h at is l i a b l e t o be adve rse ly affected b y s u c h a l i q u i d , n o r
s h a l l a n u n acce pta b l e R I S K be created . U n less restri cted by a marking o r by t h e i n struct i o n s
fo r u s e , n o HAZARDOUS S I TUATION (as s pe c ified h e r e i n ) o r u n a cc e pt a b l e R I S K d u e t o overflow
s h a l l deve l o p if TRANSPORTABLE M E E Q U I P M E NT is ti lted throug h an a n g l e of 1 5° .
Compliance i s checked b y filling th e liquid reservoir completely and subsequently adding a

further quantity equal to 1 5 % of the capacity of the reservoir, which is poured in steadily over
a period of 1 min.
TRANSPORTABLE ME E Q UIPMENT is subsequently tilted through an angle of 1 5 o in the least

favourable direction (s) (if n ecessary with refilling) starting from the position of NORMAL usE.
After th ese PRO CEDURES, the ME E Q UIPMENT is to pass the appropriate dielectric strength and
LEAKAGE CURRENT tests and is to show no signs of wetting of uninsulated electrical parts or
electrical insulation of parts that could result in a HAZARDOUS SITUA TION.
1 1 .6.3 * S p i l lage on M E EQU I P M E NT a n d M E SYSTEM

ME E Q U I PMENT and M E SYSTEMS re q u i ri n g t h e h a n d l i n g of l i q u i d s in NORMAL USE s h a l l b e SO
constructed t h at s p i l lage does n ot wet p a rts t h at co u l d res u lt i n a HAZARDOUS S I TUAT I O N .

6060 1 - 1 © I EC : 20 0 5 - 331 -
Th e ME EQUIPMENT is positioned according to 5. 4 a). A quantity of liquid is poured steadily on

a point on the top of the ME EQUIPMENT. Th e type of liquid, volum e, duration of the spill, and
location (point) are determined through application of the RISK MANAGEMENT PROCESS. All test
con ditions are identified through inspection of the RISK MANA GEMENT FILE.
After th ese PRO CEDURES, the ME E Q UIPMENT is to pass the appropriate dielectric strength and
LEAKAGE CURRENT tests and is to show no signs of wetting of uninsulated electrical parts or
electrical insulation of parts that could result in a HAZARDOUS SITUATION.
1 1 .6.4 * Leakage
See 1 3 . 2 . 6 .
1 1 .6.5 * I n g ress o f water or part i c u l ate matter i nto M E EQU I P M E NT a n d M E SYSTEMS
ENCLOS URES of M E E Q U I PMENT and M E SYSTEMS d es i g n ed to g ive a spec ified deg ree of
p rotect i o n a g a i n st h a rmfu l i n g ress of water or p a rti c u l ate matter s h a l l p rovi de t h i s p rotect i o n
i n accorda nce w i t h t h e cl assificat i o n of I E C 60529. See a l so 7 . 2 . 9 .
Compliance is checked b y the tests o f IEC 60529 with th e ME E Q UIPMENT placed in the least
favourable position of NORMAL USE and by inspection.
After th ese PRO CEDURES, the ME EQUIPMENT is to show no signs of bridging of insulation (or
electrical components) that could result in a HAZA RDOUS SITUA TION in NORMAL CONDITION or in
combination with a SINGLE FA ULT CONDITION (based on a visual inspection) followed by the
appropriate dielectric strength and LEAKAGE CURRENT tests.
1 1 .6.6 C l ea n i n g and d i s i nfecti o n of ME EQU I P M E NT and ME SYSTEMS

ME E Q U I P M E NT , M E SYSTEMS and t h e i r p a rts, i n c l u d i n g APPLI E D PARTS a n d ACCESSORI E S , s h a l l
be c a p a b l e o f with sta n d i n g , with out d a m age o r d eterioration o f safety p rovis i o n s , t h e c l e a n i n g
o r d is i nfect i o n PROCESSES sp ecified i n t h e i n struct i o n s fo r u s e . S e e a l s o 7 . 9 . 2 . 1 2 .
T h e MANUFACTURER s h a l l eva l u ate t h e effects of m u lt i p l e clea n i ng s/d i s i n fect i o n s d u ri n g t h e

EXPECTED S E RV I C E L I F E of t h e M E E Q U I PMENT, M E SYS T E M , t h e i r pa rts a n d ACCES S O R I E S a n d
ass u re t h at n o u n acce pta b l e R I S K wi l l o c c u r . T h e resu lts of t h e eva l u at i o n s h a l l be
docu mented i n t h e R I S K MANAG E M E N T F I L E .
Where compliance with this standard could be affected by cleaning o r disinfecting th e

ME EQUIPMENT, ME S YS TEM and their parts and A CCESSORIES, they are cleaned or disin fected
once in accordance with the m ethods specified including any cooling or drying period. After
these PROCEDURES, the ME EQUIPMENT, ME E Q UIPMENT parts or A CCESSORIES are to show no
signs of deterioration that could result in an unacceptable RISK (visual inspection) followed by
the appropriate dielectric strength and LEAKAGE CURRENT tests. The RISK MANA GEMENT FILE is
inspected to verify that the MANUFA CTURER has evaluated the affects of m ultiple cleanings.
1 1 . 6. 7 Steri l ization of ME EQU I P M E NT and ME SYSTEMS

ME E Q U I PMENT, M E SYSTEMS and th e i r p a rts o r ACCESSORIES i ntended to be ste r i l ized s h a l l be
assessed and docu mented accord i n g to ISO 1 1 1 34 , ISO 1 1 1 35 or I S O 1 1 1 3 7 as a p p r o p ri ate .
S e e a lso 7 . 9 . 2 . 1 2 .
After th ese PROCEDURES, the ME EQ UIPMENT, ME S YSTEM and their parts or A CCESSORIES are to
show no signs of deterioration that could result in an unacceptable RISK (visual inspection)
followed by the appropriate dielectric strength and LEAKAGE CURRENT tests and by inspection
of th e RISK MANA GEMENT FILE.
6060 1 - 1 © I EC : 20 0 5 - 333 -
1 1 .6.8 * Com pati b i l ity w i t h s u bstan ces used with t h e M E EQUIPMENT

When a p p l ic a b l e , t h e MANUFACTURER s h a l l add ress i n t h e R I S K MANAG E M E N T PROCESS t h e
R I S KS associated w i t h c o m pati b i l ity w i t h s u bsta nces used w i t h t h e M E E Q U I P M E N T .
1 1 .7 B ioco m pat i b i l ity of ME EQU I P M E NT a n d ME SYSTEMS

ME E Q U I PMENT, M E SYSTEM and t h e i r pa rts o r ACCESSORI E S i nt e n d e d to come i nto d i rect o r
i n d i re ct contact with b i o l o g i c a l tissues, c e l l s o r body fl u i d s s h a l l b e assessed a n d docu mented
accord i n g to the g u i d a n c e and p r i n c i p l e s g iven in t h e ISO 1 09 9 3 s e r ies of sta n d ards.
Compliance is checked by inspection of the in formation provided by th e MANUFA CTURER.
1 1 .8 * I nte r r u ption of the power s u p p l y I S UPPLY MAINS to ME EQUIPMENT

ME E Q U I PMENT s h a l l be so d es i g n ed t h at an i nterruption and resto rat i o n of t h e p ower s u p p l y
s h a l l n ot res u lt i n a HAZARDOUS S I TUATION oth e r t h a n interru pt i o n of its intended fu n cti o n .
NOTE This can re q u i re testing at several d u rations and ME EQU I PM E NT state s .
Compliance is checked by in terruption and restoration of relevant power supplies.
1 2 * A c c u racy of co ntro l s a n d i nstru m e nts a n d p rotect i o n a g a i n st h azard o u s

o ut p uts
12.1 Accu racy of co n t ro l s and i nstru m en ts

R I S KS associated w i t h accu racy of c o n t r o l s a n d i n strume nts.
1 2.2 U SABILITY
The MANUFACTURER s h a l l a d d ress in a USAB I L I TY E N G I N E E R I N G PROCESS the R I S K of p o o r
USAB I L I TY , i n c l u d i n g
t h o s e associated with i d e ntificat i o n , m a r k i n g a n d d o c u m e nts (see 7 . 1 . 1
a n d 1 6 . 2 ) . S e e I E C 6060 1 - 1 -6 a n d a lso see 1 . 3 .
Compliance i s checked b y inspection of the results of the USABILI TY ENGINEERING PROCESS.
1 2.3 Alarm system s

When a p p l ic a b l e , t h e MANUFACTURER s h a l l a d d ress i n t h e R I S K MANA G E M E NT PROCESS t h e n e e d
fo r a l a r m syste ms as a m e a n s of R I S K CONTROL a n d add ress a n y R I S KS associated with t h e
o p erat i o n o r fa i l u re of t h e a larm syste m . S e e I EC 6060 1 - 1 -8 a n d a lso see 1 . 3 .
Compliance i s checked by inspection of the RISK MANA GEMENT FILE.
1 2.4 P rotect ion ag ai nst hazard o u s o u t p u t
1 2 .4. 1 * I nte ntional exceed i n g of safety l i m its

When a p p l ic a b l e , the MANUFACTURER s h a l l add ress in the RISK MANAG E M E N T PROCESS t h e
R I S KS associated w i t h h az a rd o u s o utput a r i s i n g f r o m t h e i ntenti o n a l exceed i n g of safety l i m its.

6060 1 - 1 © I EC : 20 0 5 - 335 -
1 2 .4.2 I nd ication of parameters relevant to safety

When a p p l ic a b l e , t h e MANUFACTURER s h a l l a d d ress in t h e R I S K MANA G E M E NT PROCESS t h e need
fo r t h e i n d ication of parameters that are associated with hazard o u s output.
EXAMPLE P r i o r t o t h e delivery o f e n e rgy o r s u bstances t o a PATIENT t h e energy, rate o r vo l u m e s h o u l d be
ind icated q u a ntitively.
1 2 .4.3 * Accidental selection of excess ive o u t p u t va l u es

Where ME E Q U I P M ENT is a m u lti-purpose u n it d e s i g n e d fo r prov i d i n g both low- i n te n s ity a n d
h ig h - i nt e n s ity o u t p uts fo r d i ffe rent treatments, t h e MANUFACTU R E R s h a l l a d d ress i n t h e R I S K
MANAG E M E NT PROCESS t h e R I S KS associated w i t h accidental s e l ecti o n of excess ive o u t p ut
va l u es.
1 2 .4.4 I ncorrect output

R I S KS associated w i t h i n c o rrect o utput.
EXAMPLE T h e R I S KS associated with incorrect del ivery o f e n e rgy o r s u bsta nces t o a PAT I E N T c a n b e addressed
by providing a n a l a rm to alert the OPERATOR to any significant departure from the set level of delivery.
1 2.4.5 D i ag nostic or th erapeutic rad iation
1 2 . 4 . 5. 1 L i m its
F o r M E E Q U I PMENT d es ig n ed to p rod uce radiation for d i a g n ostic or t h e r a p e ut i c p u r poses,
a d e q u ate p rovis i o n s shall b e made to p rotect PAT I E NTS , O P E RATORS , oth e r persons a n d
sens itive d evices i n t h e v i c i n ity, f r o m u nwanted o r excessive ra d i ati o n e m itted by t h e
M E E Q U I PMENT.
NOTE Radiation from M E EQU I PM E NT intended for application to PAT I E NTS fo r diag nostic o r therapeutic purpose
under medical supervision could exceed l i m its n o rm a l ly acceptable for the population as a whole.
As a p p r o p riate, p a rtic u l a r sta n d a rds s h a l l s p e c ify re q u i re m e nts, l i m its and c o m p l i a n c e tests to

e n s u re radiation safety.
1 2.4.5.2 D iag n ostic X- ray eq u i p m e n t

R I S KS associated w i t h d i a g n ostic X-rays. S e e I EC 6060 1 - 1 -3 a n d a lso see 1 . 3 .
1 2.4.5.3 Rad iotherapy eq u i pm ent

R I S KS associated w i t h ra d i otherapy.

6060 1 - 1 © I EC : 20 0 5 - 337 -
1 2 .4.5.4 Other ME EQU I P M E NT p rod u c i n g d iag nostic or therapeutic rad iation

When a p p l ic a b l e , t h e MANUFACTURER s h a l l add ress in t h e R I S K MANAG E M E N T PROCESS the
R I S KS associated with M E E Q U I P M E NT p rod u c i n g d i a g n ostic o r t h e ra pe ut i c radiat i o n oth e r t h a n
fo r d i a g n ostic X-rays a n d ra d i ot h e ra p y (see 1 2 . 4 . 5 . 2 a n d 1 2 . 4 . 5 . 3 ) .
1 2 .4.6 Diag nostic or th erapeutic acoustic p ress u re

R I S KS associated w i t h d i a g n ostic o r t h e ra p e ut i c acoust i c p ress u re .
1 3 * HAZARDOUS SITUATIONS a n d fa u lt c o n d it i o n s
13.1 S pecific HAZARDO US SITUATIONS
13.1.1 * General
When a p p l y i n g t h e S I NG L E FAULT C O N D I T I O N S as described i n 4 . 7 a n d l isted i n 1 3 . 2 , o n e at a
t i m e , n o n e of t h e HAZARDOUS S I TUATIONS in 1 3 . 1 . 2 to 1 3 . 1 . 4 ( i n c l u s ive) s h a l l occ u r i n t h e
M E E Q U I PMENT.
The fa i l u re of any one c o m p o n ent at a time, which co u l d res u lt in a HAZA RDO US S I TUATI O N , is
described i n 4 . 7.
1 3 . 1 .2 * E m issions, deformation of E NCLOSURE or exceed i n g maxi m u m tem peratu re

T h e fo l l owi ng HAZARDOUS S I TUATIONS s h a l l n ot occur:
e m i s s i o n of fla m e s , m o lten meta l , p o i s o n o u s o r i g n it a b l e s u bsta n c e i n hazard o u s
q u a ntities;
deformat i o n of E NCLOS URES to s u c h a n extent t h at c o m p l i a n c e with 1 5 . 3 . 1 is i m p a i r e d ;
- tempe ratu res of APPLI E D PARTS exce e d i n g t h e a l lowed va l u e s i d e ntified i n T a b l e 24 w h e n
measu red as described i n 1 1 . 1 . 3 ;
- tempe ratu res of M E E Q U I PMENT pa rts t h a t a r e n ot APPLI E D PARTS b ut a re l i ke l y to b e
t o u c h e d , exceed i n g t h e a l l ow a b l e va l u e s i n T a b l e 2 3 w h e n measu red a n d adj u sted a s
described i n 1 1 . 1 . 3 ;
exce e d i n g t h e a l lowa b l e va l u e s fo r " ot h e r c o m p o n e nts a n d m ate r i a l s " i d e ntified i n T a b l e 2 2
t i m e s 1 , 5 m i n u s 1 2 , 5 a c . L i m its fo r w i n d i n g s are fo u n d i n T a b l e 2 6 , T a b l e 27 a n d T a b l e 3 1 .
I n a l l oth e r cases, t h e a l l ow a b l e va l u e s of T a b l e 22 a p p ly.
T e m p e ratu res s h a l l b e measu red using t h e method d escri bed i n 1 1 . 1 . 3 .
T h e S I NGLE FAULT CONDITIONS i n 4 . 7, 8 . 1 b ) , 8 . 7 . 2 a n d 1 3 . 2 . 2 , w i t h reg a rd to t h e e m ission o f

fl ames, m o l t e n m eta l o r i g n it a b l e s u bsta nces, s h a l l n ot b e a p p l i ed to pa rts a n d c o m p o n e nts
where:
T h e construction o r t h e s u p p l y c i r c u it l i m its t h e p o w e r d i s s i p ati o n i n S I NGLE FAULT
CONDI T I O N to less t h a n 1 5 W or the e n e rgy d issi pation to less t h a n 900 J .
6060 1 - 1 © I EC : 20 0 5 - 339 -
Compliance is checked by drawing 1 5 W from the supply circuit for 1 min. If, after 1 min.
the supply circuit can not supply 1 5 W, the circuit shall be considered to limit power
dissipation to less than 1 5 W The related design documentation is also reviewed.
or
T h e y a r e c o m p l etely conta i n e d with i n a fire E NCLOS U R E .
Compliance is checked by inspection and evaluation of the design documentation to
assure that the ENCLOSURE is con structed in accordance with 1 1 . 3.
NOTE The tests according to this s u bclause should be pe rfo rmed i n the seque nce i n d icated i n A n n ex B.
After the tests of this clause, THERMAL CUT-OUTS and O VER-CURRENT RELEA SES are inspected to
determine th at their setting has not changed (by heating, vibration or other causes)
sufficiently to affect their safety function.
1 3 . 1 .3 Exceed i n g LEAKAG E CURRE N T or voltage l i m its

T h e fo l l owi ng HAZARDOUS S I TUATIONS s h a l l n ot occur:
exce e d i n g t h e l i m its for LEAKA G E CURRENT i n S I NG L E FAULT C O N D I T I O N as i n d i cated i n 8 . 7 . 3 ;
exce e d i n g t h e voltage l i m its fo r t h e ACCESSI BLE PARTS i n c l u d i n g APPLI E D PARTS i n d icated i n
8.4.2.
1 3 . 1 .4 S pecific M ECHANICAL HAZARDS

F o r s pec ific M E CHANICA L HAZARDS , see 9 . 1 to 9 . 8 ( i n c l u s ive ) .
1 3.2 S I N G L E FAULT CONDITIONS
1 3.2.1 General
D u r i n g t h e a p p l ication of t h e S I NGLE F A U L T C O N D I T I O N S l i sted i n 1 3 . 2 . 2 to 1 3 . 2 . 1 3 ( i n c l u s ive ) ,
t h e NORMAL CONDITIONS i d e ntified i n 8 . 1 a ) s h a l l a l so be a p p l ied i n t h e l e ast favo u ra b l e
co m b i n at i o n .
1 3.2.2 E lectrical S I NG L E FAULT CONDITION

R e q u i r e m e nts a n d tests r e l at i n g to this S I NGLE FAULT CON DITION a re fo u n d in 8 . 1 .
1 3.2.3 Overheat i n g of t ra n sfo rm ers i n M E EQU I P M E NT

R e q u i r e m e nts a n d tests r e l at i n g to this S I NGLE FAULT CON DITION a re fo u n d i n 1 5 . 5 .
1 3.2.4 Fai l u re of THERMOSTATS

R e q u i re m e nts a n d tests re l ati ng to t h i s S I NGLE FAULT CONDI T I O N are fo u n d in 1 3 . 2 . 1 3 a n d
1 5 . 4 . 2 fo r ove r l o ad i n g s ituati o n s .
T H E RMOSTATS are s h o rt circu ited o r i nterrupted, w h i c h ever is l e s s favo u r a b l e .
1 3.2.5 Fai l u re o f tem peratu re l i m it i n g devices

R e q u i re m e nts and tests re l ati ng to t h i s S I NGLE FAULT CONDI T I O N are fo u n d in 1 3 . 2 . 1 3 a n d
1 5 . 4 . 2 fo r ove r l o ad i n g s ituati o n s .
6060 1 - 1 © I EC : 20 0 5 - 341 -
T H E RMOSTATS are s h o rt circu ited o r i nterrupted, w h i c h ever is less favo u r a b l e .
1 3.2.6 Leakage o f l iq u id
M E E Q U I PMENT s h a l l be so constructed that l i q u i d t h at m i g ht escape i n a S I NG L E FAULT
CONDI T I O N d o es not res u lt in a n u n acce pta b l e R I S K .
Since o n l y small a m o u nts of l i q u i d will escape w h e n t h e y leak, s ea l e d re c h a r g e a b l e batte ries

are exem pted fro m t h i s req u i re m ent.
A R I S K MANAG E M E NT P R O C E S S s h a l l b e used to d eterm i n e t h e a p p r o p ri ate test c o n d it i o n s fo r

t h e ME E Q U I P M ENT.
1 3.2.7 I m pai rment of coo l i ng t h at co u l d res u lt in a HAZARD

ME E Q U I PMENT s h a l l be S O desig n ed t h at it rema i n s S I NG LE FAULT SAFE d u ri n g t h e fa i l u re of
coo l i n g systems to o p e rate as i n t e n d e d .
Impairments of cooling th at can occur are simulated, for example:

single ventilation fans are locked consecutively;
ven tilation through openings in top and sides is impaired by covering of openings in the
top of the ENCLOSURE or positioning of ME E Q UIPMENT against walls;
blocking of filters is simulated;
the flo w of a cooling agent is interrupted.
Temperatures that exceed th e limits set in 1 3. 1 . 2 constitute a failure.
Compliance is checked utilizing the test m ethods of 1 1 . 1, which are applied as far as
possible.
1 3.2.8 Loc k i n g of moving parts

ME E Q U I PMENT s h a l l be SO d es i g n ed t h at it re m a i n s S I NG LE FAULT SAFE w h e n m ovi ng pa rts
become j a m m e d .
Moving parts are locked i f M E EQ UIPMENT:

has m o ving A CCESSIBLE PARTS including APPLIED PARTS liable to be jammed, or
- is liable to be operated while unattended (this includes ME E Q UIPMENT that is automatically
or remotely controlled), or
has one or m ore motors with a locked rotor torque smaller th an th e full load torque.
If ME E Q UIPMENT has more than one m o ving part as described above, only one part at a time is
locked. If a SINGLE FA ULT CONDITION can lock m ultiple motors, then all motors are locked
simultan eously. For further test criteria see 1 3. 2. 1 0.
1 3.2.9 * I n te r r u ption a n d s h ort c i rcu i t i n g o f m otor capacitors

ME E Q U I PMENT s h a l l be so desig ned that it re m a i n s S I NG L E FAULT SAFE d u ri n g the s h o rt c i rc u it
a n d o p e n c i r c u it of moto r capacitors.
6060 1 - 1 © I EC : 20 0 5 - 343 -
Compliance is checked by performing the following test:
Motors with a capacitor in the circuit of an auxiliary winding are operated according to 1 3. 2. 1 0
with a locked rotor, with th e capacitor short circuited or open circuited in turn. Capacitor
voltages are measured with one side disconnected (open circuit). A measured voltage th at
exceeds th e RA TED value constitutes a failure.
Th e test with a short-circuited capacitor is not performed if the m otor is provided with a
capacitor complying with IEC 60252-1 and th e ME EQUIPMENT is not intended for unattended
use (including automatic or remote control).
For additional test criteria, see 1 3. 2. 1 0.
1 3 . 2. 1 0 * Ad d itional test criteria fo r m otor ope rated ME EQU I P M E NT

For every test in the SINGLE FA ULT CONDITION of 1 3. 2. 8 and 1 3 . 2. 9, taking into account the
exemptions stated in 1 3. 1 . 2, motor-operated ME EQUIPMENT is operated starting from cow
CONDITION, at RA TED voltage or at the upper limit of the RA TED voltage range for the following
periods of time:
a) 30 s for:
HAND-HELD ME EQUIPMENT;
ME EQUIPMENT that has to be kept switched on by hand;
ME EQUIPMENT that has to be kept under physical load by hand;
b) 5 min for other ME E Q UIPMENT intended only for attended use (attended use excludes
automated or remotely con trolled ME EQUIPMENT that could operate when the OPERA TOR is
not present);
c) for the maximum period of a timer, if such a device termin ates the operation, for
ME EQUIPMENT not listed under a) or b);
d) as long as necessary to establish THERMAL S TABILITY for all the remaining ME EQUIPMENT.
Temperatures of windings are determined at the end of the specified test periods or at the
instant of operation of fuses, THERMAL CUT-O UTS, motor protective devices and the like.
Temperatures are measured as specified in 1 1 . 1 . 3 d) .
Temperatures th at exceed th e limits of Table 26 constitute a failure.
1 3 . 2. 1 1 Fai l u res of co m po n e n ts i n M E EQU I P M E NT u sed i n conj u n ction with OXYGEN RICH

E NVI RO N M E NTS
R e q u i r e m e nts and tests r e l at i n g to these S I NG L E FAULT CONDITI O N S are fo u n d in 1 1 . 2 . 2 .
1 3 . 2. 1 2 Fai l u re of pa rts t h at m i g ht res u lt i n a M ECHANICAL HAZARD

R e q u i re m e nts a n d tests re lati n g to these S I NGLE FAULT CONDI T I O N S are fo u n d in C l a use 9 a n d
1 5.3.
6060 1 - 1 © I EC : 20 0 5 - 345 -
Table 26 - * Tem perat u re l i m its of m otor w i n d i n g s
Tem perature i n ' C
I n s u lation cl ass
Type of M E EQU I P M E N T C l ass A Class 8 Class E C l ass F C l ass H
M E EQU I P M ENT provided with a timer and not 200 225 215 240 260
intended for u natte nded use a n d M E EQU I P M ENT to
be operated for 30 s o r 5 m i n
Other M E EQU I P M ENT
- if i m pedance-protected, maxi m u m va l u e 1 50 1 75 1 65 1 90 210
- if protected by protection devices that operate 200 225 215 240 260
during the first hour, maxi m u m va lue
- after the first hour, maxi m u m va l u e 1 75 200 1 90 215 235
- after the first hour, arithmetic average 1 50 1 75 1 65 1 90 210
NOTE The tem perature l i m its i n this table were derived from I E C 6 1 0 1 0- 1 :2001 [22] .
1 3 . 2. 1 3 * Overload
1 3 . 2. 1 3 . 1 * Gen eral overload test con d itions

Aft e r t h e tests o f 1 3 . 2 . 1 3 . 2 t o 1 3 . 2 . 1 3 . 4 ( i n c l u s ive ) , M E EQUI P M E N T , when cooled down to
a p p roxi mately ro o m te m perature, s h a l l re m a i n safe.
Compliance is determined by inspection of the ME EQUIPMENT or the appropriate tests (such as

dielectric strength of m otor insulation according to 8. 8. 3).
For insulation of thermoplastic materials that is relied upon as a MEANS OF PROTECTION (see
8. 8), the ball-pressure test specified in 8. 8. 4. 1 a) is performed at a temperature 25 oc higher
than th e temperature of the insulation m easured during the tests of 1 3. 2. 1 3. 2 to 1 3. 2. 1 3. 4
(inclusive).
1 3.2. 1 3.2 M E EQUIPMENT w i t h heat i n g elem ents
a) ME E Q UIPMENT having heating elements is checked for compliance as follows:

1) for thermostatically controlled ME EQUIPMENT having heating elements th at is intended
for b uilt-in or for unattended operation or th at has a capacitor not protected by a fuse
or the like connected in parallel with the contacts of the THERMOS TA r : by the tests of
1 3 . 2. 1 3 . 2 b) and 1 3. 2. 1 3. 2 c);
2) for ME E Q UIPMENT h a ving heating elements RA TED for non-CONTINUOUS OPERA TION: by
the tests of 1 3. 2. 1 3. 2 b) and 1 3. 2. 1 3. 2 c);
3) for other ME EQUIPMENT h a ving heating elements: by th e test of 1 3 . 2. 1 3. 2 b) .
If m ore than one of th e tests is applicable to the same ME EQUIPMENT, these tests are
performed consecutively.
6060 1 - 1 © I EC : 20 0 5 - 347 -
If, in any of the tests, a non-SELF-RESE TTING THERMAL CUT-OUT operates, a heating element
or an intention ally weak part ruptures, or if th e current is o therwise in terrupted before
THERMAL STABILITY is establish ed without the possibility of automatic restoration, th e
heating period is ended. However, if the interruption is due to th e rupture of a heating
element or of an intentionally weak part, the test is repeated on a second sample. Open
circuiting of a heating element or of an intention ally weak part in the second sample does
not in itself entail a failure to comply. Ho wever, if either sample fails to comply with the
con ditions specified in 1 3. 1. 2, it constitutes a failure.
b) ME E Q UIPMENT h a ving h eating elements is tested under the conditions specified in 1 1 . 1, but
without adequate h eat discharge, the supply voltage being 9 0 % or 1 1 0 % of the RA TED
supply voltage, whiche ver is the least favourable.
If a non-SELF-RESE TTING THERMAL CUT-OUT operates, or if the current is oth erwise

interrupted without the possibility of automatic restoration before THERMAL S TABILI TY is
establish ed, th e operating period is ended. If interruption of th e current does not occur,
ME EQUIPMENT is switch ed off as soon as THERMAL S TABILI TY is establish ed and is allowed to
cool to approximately room temperature.
For ME EQUIPMENT RA TED for non-CONTINUOUS OPERA TION, the duration of th e test is equal to
the RA TED operating time.
c) Heating parts of ME E Q UIPMENT are tested with the ME E Q UIPMENT operated in NORMAL
CONDITION, at a supply voltage 1 1 0 % of the RA TED supply voltage and as specified in 1 1 . 1 .
Th e following test con ditions are met.
1) Any con trol that serves to limit th e temperature in NORMAL CONDITION, except a THERMAL
CUT-OUT, is disabled.
2) If the ME EQUIPMENT is provided with m ore than one con trol, they are disabled in turn.
3) The ME EQUIPMENT is operated at th e RA TED DUTY CYCLE until THERMAL S TABILI TY is
achieved, irrespective of th e RA TED operating time.
1 3.2. 1 3.3 M E EQUIPMENT with m otors
a) ME E Q UIPMENT having motors is checked for compliance as follows:
1) For th e motor part of the ME EQUIPMENT, compliance is checked by th e tests of 1 3. 2. 8 to

1 3 . 2. 1 0 (inclusive), 1 3 . 2. 1 3 . 3 b), 1 3. 2. 1 3. 3 c) and 1 3. 2. 1 3. 4, as applicable. For motors
located in circuits with a voltage not exceeding 42, 4 V peak a. c. or 60 V d. c. and where
difficulty is experienced in obtaining accurate temperature m easurements due to the
small size or design of the m otor, it is permitted to use th e following test instead of
temperature m easurement in order to determine compliance with 1 3. 2. 9 and 1 3. 2. 1 0.
Th e m otor is covered with a single layer of ch eesecloth with th e following

characteristics:
bleached cotton material;
2
26-28 m per kg m ass; and
13 threads per em in one direction and 1 1 threads per em in th e oth er.
6060 1 - 1 © I EC : 20 0 5 - 349 -
Ignition of the cheesecloth during the test or at its conclusion constitutes a failure.
2) For ME E Q UIPMENT that also con tains h eating parts, th e tests are performed at the
prescribed voltage, with the m otor part and th e h eating part operated simultan eously so
as to produce the least fa vourable condition.
3) If m ore than one of the tests is applicable for the same ME EQ UIPMENT, these tests are
performed consecutively.
b) Motors are checked for running o verload protection if they are:

1) intended to be remotely controlled or automatically controlled (by a single control
device without redundant protection), or
2) likely to be subjected to CONTINUOUS OPERA TION whilst unattended.
Compliance is determined by operating th e ME E Q UIPMENT under n ormal load conditions at

RA TED voltage or at the maximum of the RA TED voltage range, until THERMAL S TABILI TY is
achieved (see 1 1 . 1 . 3) .
Th e load i s then increased so that th e current i s increased i n appropriate steps, the supply
voltage b eing m aintain ed at its original value.
When THERMAL S TABILI TY is established, the load is again increased. The load is thus
progressively increased in appropriate steps un til the overload protection operates, or until
no further temperature rise is n oted.
Th e m otor win ding temperature is determined during each steady period. If the m aximum
value recorded exceeds the value in Table 27, it constitutes a failure.
Table 27 - M axi m u m m otor w i n d i ng steady-state tem peratu re
Maxi m u m temperature
I n s u lation cl ass 'C
A 1 40
B 1 65
E 1 55
F 1 80
H 200
If the load cannot be changed in appropriate steps in ME EQUIPMENT, the m o tor is removed
from the ME EQUIPMENT in order to perform th e test.
Th e running overload test for m otors located in circuits with a voltage not exceeding
42, 4 V peak a. c. or 60 V d. c. is performed only if a possibility of an overload occurring is
determined by inspection or by review of the design. Th e test need not be performed, for
example, where electronic drive circuits m aintain a substantially constant drive current.
6060 1 - 1 © I EC : 20 0 5 - 351 -
c) ME E Q UIPMENT with three-phase motors is operated with norma/ load, connected to a three
phase (SUPPL Y MAINS) with one phase disconnected. Periods of operation are according to
1 3 . 2. 1 0.
1 3 . 2 . 1 3 . 4 * M E EQU I P M E NT RAT E D fo r n o n -CONTINUOUS OPERATION

ME E Q UIPMENT RA TED for non-CONTINUOUS OPERA TION other th an:
HAND-HELD ME EQUIPMENT;
ME EQUIPMENT that has to be kept switched on manually;
ME EQUIPMENT that has to b e kept under physical load by hand;
ME EQUIPMENT with a timer and a back-up timer system
is operated under normal load and at RA TED voltage or at the upper limit of the RA TED voltage
range un til the peak temperature does not increase by m ore than 5 "C in one hour, or un til
any protective device operates.
Motor win ding temperatures are determined when THERMAL S TABILI TY is established or
immediately before the operation of the protective device. Motor winding temperatures that
exceed the values specified in 1 3. 2. 1 0 constitute a failure.
If in NORMAL USE a load-reducing device in the ME EQUIPMENT operates, th e test is contin ued
with the ME EQUIPMENT running idle.
1 4 * P ROGRA M MABLE E LECTRICAL M E DICAL SYSTEMS (PEMS)
14.1 * Gen eral
The re q u i re m e nts of this c l a u s e s h a l l a p p l y to P E M S u n less:

t h e PESS p rovi des n o BAS I C SAFETY o r E S S E NTIAL P E RFORMA N C E ; or
t h e a p p l icat i o n of ISO 1 4 9 7 1 d e m o nstrates t h at t h e fa i l u re of t h e PESS d oes n ot lead to a n
u n accepta b l e R I S K .
N O T E 1 T h i s clause requires that a PROC ESS b e followed throughout t h e P E M S D EV E L O P M E N T L I FE-CYCLE a n d that a
RECORD of that PROC ESS be produced. The co ncepts of R I S K MANAG E M EN T and a P E M S D EV E L O P M E N T L I FE-CYC L E are
the basis of such a PROCESS. However, because a RISK MANAG E M E N T PROC ESS i s a l ready require d by this sta ndard,
this clause will defi n e the m i n i m u m elements of the P E M S D EV E L O P M E N T L I FE-CYC L E and o n ly the additional e l e m ents
for the PEMS that needs to be considered as part of the RISK M A N A G E M E N T PROCESS (see 4 . 2 ) .
N O T E 2 I t is recognized t h a t the M A N U FACT U R E R m ight n o t be able to follow a l l the PROCESSES ide ntified i n Cla use
1 4 fo r each co nstituent com ponent of the P E M S , such as off-the-shelf (OTS) s oftwa re , s u bsyste m s of non-medical
origin, and legacy devices. In this case, the M A N U FACT U R E R should take special account of the need for additional
R I S K CONTROL measure s .
Compliance is determin ed by application of the requirements in 1 4. 2 to 1 4. 1 3 (inclusive), by

inspection of th e RISK MANA GEMENT FILE, and assessment of PROCESSES cited in this clause.
NOTE 3 This assessment could be performed by internal a u d it .
1 4. 2 * Doc u m entation
In addition to t h e RECORDS and d o c u m e nts req u i red by ISO 1 4 97 1 , t h e d o c u m e nts prod uced
from a p p l icati o n of C l a u s e 14 s h a l l b e m a i nta i n ed a n d s h a l l fo rm p a rt of t h e R I S K MANAG E M E NT
FILE.
NOTE See Figure H.3 as g u idance.
6060 1 - 1 © I EC : 20 0 5 - 353 -
T h e docu ments req u i red by C l a u s e 1 4 s h a l l be reviewed , a p p rove d , issued a n d c h a n g ed i n

accord a n c e with a fo rmal d oc u m ent control PROCEDU RE .
1 4. 3 * RISK MANAG E MENT plan

T h e R I S K MANAG E M E N T plan req u i red by 3.5 of ISO 1 4 9 7 1 shall a l s o include a refe rence to the
PEMS VALI DAT I O N plan ( se e 1 4 . 1 1 ) .
1 4. 4 * PEMS DEVE LOPMENT L I F E -CYCLE

A PEMS DEVELO P M E N T L I F E-CYCLE s h a l l be d o c u mented.
NOTE 1 Clause H . 2 explains P E M S DEVELOP M E NT L I FE-CYC L E i n m o re deta i l .
NOTE 2 I E C 62304 [26] defines general req u i re m e nts f o r additional PROCESSES a n d activities specific t o software
deve lopment.
The P E M S DEVELO P M E N T L I F E-CYCLE s h a l l i n c l u d e a set of d efi n e d m i l esto n e s .
At each m i l esto n e , t h e activities to be c o m p l eted a n d t h e VERI F I CATI O N methods to b e a p p l ied

to th ose activities s h a l l be defi n e d .
E a c h activity s h a l l b e defi n ed i n c l u d i n g its i n p uts a n d outputs.
Each m i lesto n e s h a l l i d e ntify t h e R I S K MANAG E M E NT activities t h at m u st b e c o m p l eted before

t h at m i l esto n e .
T h e PEMS DEVELOPMENT L I F E-CYCLE s h a l l b e t a i l o red fo r a spec ific d eve l o p m e n t by m a k i n g

p l a n s w h i c h d eta i l act ivities, m i lesto nes a n d s c h e d u les.
T h e P E M S DEVELO P M E N T L I F E-CYCLE shall i n c l u d e d o c u m e ntat i o n req u i re m e nts.
1 4. 5 * Problem reso l ution

Where a p p r o p r i at e , a docu mented syste m fo r problem re s o l u t i o n wit h i n a n d betwe e n a l l
p h ases a n d activit ies o f t h e PEMS DEVELO P M E N T L I F E-CYCLE s h a l l be d eveloped a n d
m a i nta i n e d .
D e p e n d i n g o n t h e type o f p r o d u ct, t h e p r o b l e m res o l ut i o n syst e m may:

be docu mented as a p a rt of t h e P E M S DEVELO P M E N T L I F E-CYC L E ;
a l l ow t h e r e p o rt i n g of pote nti a l o r exist i n g p ro b l e ms affect i n g BAS I C SAFETY o r ESS ENTIAL
P E RFORMANCE ;
i n c l u d e an assessment of e a c h p r o b l e m fo r associated R I S KS ;
i d e ntify t h e criteria t h at m u st b e met fo r t h e i s s u e t o be c l osed ;
i d e ntify t h e act i o n to be taken to reso lve e a c h p r o b l e m .
1 4. 6 RISK MANAG E MENT PROCESS
1 4. 6 . 1 * I d e n t ification of known a n d foreseeable HAZARDS

When co m p i l i n g t h e l ist of k n own or fo resee a b l e HAZARDS , t h e MAN UFACTURER s h a l l c o n s i d e r
t h o s e HAZARDS assoc iated with software a n d h a rdwa re a s pects of t h e P E M S i n c l u d i n g those
assoc iated with N E TWORK/DATA COUPLI N G , c o m p o n e nts of t h i rd-party orig i n a n d legacy
su bsyste m s .
NOTE I n addition t o the material g iven i n A n n ex D o f I S O 1 497 1 , t h e l i st o f poss ible causes f o r HAZARDS
associated with P E M S should include:
- fa i l u re of the N ETWORK/DATA cou P L I N G to provide the characteristics necessary for the P E M S to achieve its BASIC
SAFETY o r ESSENTIAL P E R F O R M A N C E ;
- undesired fee d back [physical and data] (possi bilities include: unsol icited i n put, out of ra nge o r i nco nsistent
i n put, and i n put originating from electro m agnetic interfe rence) ;
6060 1 - 1 © I EC : 20 0 5 - 355 -
- unava i lable data;

- lack of i ntegrity of data ;
- inco rrect data;
- inco rrect timing of data .
- u n intended i nteractions within and among PEss;
- u n known aspects or quality of third-party softwa re ;
- u n known aspects or quality of third-party PEss;
- lack of data sec u rity, parti cu larly vulnerabil ity to tamperi n g , u n intended interaction with other programs and
viruses.
1 4. 6 . 2 * RISK CO NTROL
The fo l l owi ng req u i re m e nts fo r PEMS s u p p l e m e n t S u bc l a use 6 . 1 of I S O 1 49 7 1 .
S u it a b l y v a l i d ated tools a n d PROCEDURES s h a l l be s e l ected a n d i d e ntifi ed to i m p l e m e nt each

R I S K CONTROL m e a s u r e . T h e s e to o l s a n d PROC E D U RES shall b e a p p r o p ri ate to ass u re t h at each
R I S K CONTROL measure satisfacto r i l y red u ces t h e i d e ntified R I S K ( s ) .
1 4. 7 * Req u i re m e n t s pecification
F o r t h e PEMS a n d each of its su bsystems ( e . g . fo r a PESS ) t h e re shall be a d o c u m e nted
req u i re m e nt s pec ificati o n .
NOTE Example structures o f a P E M S are given i n H . 1 .
T h e req u i re m e nt s p ecificat i o n fo r a system o r s u bsystem s h a l l i n c l u d e a n d d isti n g u i s h a n y

ESSENTIAL PE RFORMANCE a n d a n y R I S K CONTROL measu res i m p l e m ented by that system o r
su bsystem.
1 4. 8 * Arc h itect u re
F o r t h e P E M S a n d each of its s u bsystems, a n arch itect u re s h a l l be spec ified t h at s h a l l sati sfy
t h e re q u i re ment s pecificat i o n .
Where a p p r o p ri ate , t o re d u ce t h e R I S K to a n accept a b l e leve l , t h e arch itect u r e sp ecificat i o n

s h a l l m a ke u s e of:
a ) COMPONE NTS WITH H I G H-I NTEGRITY CHARACT E R I ST I CS ;
b) fa i l-safe fu n cti o n s ;
c) red u n d a n cy;
d) d ivers ity;
e ) * p a rtit i o n i n g of fu n cti o n a l ity;
f) defe ns ive desig n , e . g . l i m its on pote nti a l l y hazardous effects by restrict i n g t h e ava i l a b l e
o u t p ut p ower o r by i ntrod u c i n g m e a n s t o l i mit t h e travel o f a ct u ators .
T h e arch itect u re sp ecificat i o n s h a l l take i nto c o n s i d e rati o n :

g ) * a l l ocat i o n o f R I S K CONTROL measu res t o su bsystems a n d c o m p o n e nts o f t h e PEMS ;
NOTE S u bsyste m s and components include sensors, actuators, PESS and interfaces.
h) fa i l u re modes of c o m p o n e nts a n d t h e i r effects;

i) common c a u s e fa i l u re s ;
j) systematic fa i l u re s ;
6060 1 - 1 © I EC : 20 0 5 - 357 -
k) test i nterval d u ration a n d d i a g n ostic coverag e ;

I) m a i nta i n a b i l ity;
m ) p rotect i o n from reaso n a b l y fores e e a b l e m is u s e ;
n ) t h e N E TWORK/DATA COUPLING sp ecificatio n , if a p p l i c a b l e .
1 4. 9 * Des i g n a n d i m p l e m en tation
Where a p p r o p ri ate , t h e d e s i g n s h a l l be decom posed i nto su bsyste m s , each h avi n g b oth a
d e s i g n a n d test spe cificat i o n .
Descri ptive data reg a rd i n g t h e desig n envi ro n m e nt s h a l l be i n c l u d ed i n t h e R I S K MANAG E M E N T

FILE.
NOTE See H.3 for examples of design enviro n m e nt elements.
1 4 . 1 0 * VERIFI CATION
V E R I F I CATION is re q u i red fo r all fu n cti o n s t h at i m p l e m e nt BAS I C SAFETY , ESSENTIAL
P E RFORMANCE o r R I S K CONTROL m e a s u re s .
A VERI F I CATI O N p l a n s h a l l be p rod u ced to s h ow how these functions s h a l l be verifi e d . T h e p l a n

shall include:
a t w h i c h m i l esto n e ( s ) V E R I F I CATION i s t o b e p e rformed fo r e a c h fu n ct i o n ;
- t h e se lect i o n a n d d o c u m e ntat i o n of VERI F I CATION strate g i es, a ctivities, tech n i q u e s , a n d t h e
a p p r o p ri ate leve l of i n d e pe n d e n ce of t h e p e rs o n n e l p e rfo r m i n g t h e VERI F I CATION;
- t h e se lection a n d ut i l izat i o n of VERI F I CATI O N tools;
cove rage crite r i a fo r VERI F I CATI O N .
NOTE Examples o f methods a n d tech niques are:
- walkthro u g h s ;
- inspectio n s ;
- static analys is;
- dyn a m i c analysis;
- white box testing;
- black box testing;
- statistical testing.
The VERI F I CATI O N s h a l l be p e rfo rmed accord i n g to the VERI F I CATION p l a n . The resu lts of the
VERI F I CATI O N
activiti es s h a l l be d ocu mented.
1 4. 1 1 * PEMS VALI DATION

A PEMS VALI DAT I O N plan s h a l l i n c l u d e t h e v a l i d ati o n of BAS I C SAFETY a n d E S S E N T I A L
P E RFORMANCE , a n d s h a l l req u i re ch ecks fo r u n i ntended fu n ctio n i n g of t h e P E M S .
T h e PEMS VALI DAT I O N shall be p e rfo rmed accord i n g to t h e PEMS VALI DAT I O N plan. T h e resu lts of
PEMS VAL I DATION activities shall be docu mented.
T h e p e rs o n h avi ng t h e ove ra l l respo n s i b i l ity fo r t h e PEMS VA L I DATION s h a l l be i n d e p e n d e nt of

t h e design team. T h e MANUFACTU R E R s h a l l docu ment t h e rat i o n a l e fo r t h e l eve l of
independence.
N o m e m b e r of a d e s i g n team s h a l l be res p o n s i b l e fo r t h e P E M S VALI DATION of t h e i r o w n d es ig n .

6060 1 - 1 © I EC : 20 0 5 - 359 -
A l l p rofess i o n a l relatio n s h i p s of t h e m e m b e rs of t h e P E M S VALI DAT I O N team with m e m b e rs of

t h e d es ig n team s h a l l be d o c u m e nted i n t h e R I S K MANAG E M E N T F I L E .
A refe re n c e to t h e methods a n d resu lts of t h e P E M S VAL I DATION s h a l l be i n c l u d ed i n t h e R I S K

MANAG E M E NT F I L E .
1 4 . 1 2 * Mod ificat ion

I f a n y o r all of a d es ig n resu lts from a mod ificat i o n of a n e a r l i e r design then either all of this
clause a p p l ies as if it were a n ew design o r t h e conti n u ed va l i d ity of a n y p revi o u s d es i g n
docu mentat i o n s h a l l b e assessed u n d e r a d o c u m e nted mod ificati o n/ch a n g e PROC E D U R E .
1 4 . 1 3 * Con nection of PEMS by NETWORK/DATA COUPLING to other eq u i pm e n t

I f t h e P E M S is i ntended to be co n n e cted by N E TWORK/DATA COUPLING to ot h e r e q u i p m e nt t h at is
outside t h e control of t h e PEMS MANUFACTURER, t h e tec h n ical d es c r i pt i o n s h a l l :
a ) sp ecify t h e c h a racte ristics o f t h e N E TWORK/DATA COU P L I N G necessary f o r t h e PEMS to

ach i eve its I NTENDED U S E ;
b ) l i st t h e HAZARDOUS S I TUATIONS res u lt i n g from a fa i l u re of the N E TWORK/DATA COUPLING to

p rovide t h e s p ecified c h a racte ristics;
c) i n st r u ct t h e RESPONSIBLE ORGANIZATI O N that:

c o n n ect i o n of t h e PEMS to a N E TWORK/DATA COUPLING that i n c l u d e s oth e r e q u i p m ent
co u l d res u lt i n p revi o u s l y u n id e ntifi e d R I S KS to PAT I E NTS , O P E RATORS o r t h i rd p a rt i e s ;
- t h e RESPONSIBLE ORGANIZATI O N s h o u ld i d e nt ify, a n a lyz e , eva l u ate a n d control these
R I S KS ;
s u bseq u e nt c h a n g e s to t h e N E TWORK/DATA COUPLING co u l d i ntro d u c e n ew R I S KS a n d

req u i re a d d iti o n a l a n a l ys i s ; a n d
c h a n g es to t h e N E TWORK/DATA COUPLI NG i n c l u d e :
c h a n g e s i n N E TWORK/DATA COUPLI N G confi g u rat i o n ;
co n n ect i o n of a d d itio n a l ite ms to t h e N E TWORK/DATA COUPLI N G ;
d isco n n ecti n g i t e m s f r o m t h e N E TWORK/DATA COUPLI N G ;
u p date of e q u i p m e nt co n n ected to t h e N E TWORK/DATA COUPLI N G ;
u p g ra d e of e q u i p ment c o n n ected to t h e N E TWORK/DATA COUPLI N G .
1 5 Construction of M E EQUI PMENT
1 5. 1 * Arra n g e m e n ts of controls and i n d icators of M E EQU I P M E NT

R I S KS associated w i t h t h e a r r a n g e m e n t of c o n t r o l s a n d i n d i cato rs of M E EQUI P M E N T .
1 5. 2 * Servi cea b i l ity

P a rts of M E E Q U I P M ENT s u bj ect to m e c h a n ical wear, e lectrical and e nviron mental deg radat i o n
o r a g e i n g t h at c o u l d res u lt i n a n u n acce pta b l e R I S K if a l l owed t o conti n u e u n c h ecked fo r t o o
l o n g a p e riod s h a l l b e access i b l e fo r i n s pecti o n , re p l acement a n d m a i n t e n a n c e .
6060 1 - 1 © I EC : 20 0 5 - 361 -
P a rts of ME E Q U I P M E NT that are l i ke l y to be re p laced o r adj u sted s h a l l be so l ocated a n d

s e c u red as to permit i n s p ecti o n , s e rvi c i n g , re p l acement a n d adj u stment wit h o ut d a m age t o , o r
i nterfe r e n c e wit h , adj a ce nt pa rts o r wi r i n g .
Compliance i s checked b y inspection of th e parts mentioned above i n this subclause a n d of

their location.
1 5. 3 M echan ical strength
1 5. 3 . 1 General
M E E Q U I PMENT or its pa rts s h a l l h ave a d e q u ate mech a n i c a l stre n gth a n d s h a l l not resu lt i n a n
u n accepta b l e R I S K d u e to m o u l d i n g stress o r w h e n s u bj ected to m e c h a n i c a l stress c a u s e d by
p u s h i n g , i m pact, d r o p p i n g , a n d ro u g h h a n d l i n g .
Compliance is checked b y application of the tests in Table 28. The tests are n o t applied to
handles, le vers, knobs, the face of cathode ray tub es (see 9. 5. 2), or to transparent or
translucent covers of indicating or m easuring devices unless with th e handle, lever, knob, or
cover removed there is an unacceptable RISK of electric shock.
NOTE Examples of damage that can result i n unacceptable R I S K include the re duction of C R E EPAGE D I STANCES
and AIR C L EARANCES below those specified i n 8 . 9 , access to parts which exceed l i m its i n 8 . 4 , o r access to moving
parts which could cause HAR M .
Assessment criteria that can b e useful i n determ ining i f the tests i n Table 2 8 have resulted i n a n unacceptable R I S K
include:
- those i n Clause 8 and 1 1 .6;
- the die lectric strength test as specified i n 8 . 8 . 3 to evaluate the integrity of solid S U P P L E M ENTARY o r R E I N FORCED
I N S U LATI O N ; and
- measure m e nt of C R E EPAGE D I STA N C ES o r A I R C L EA RA N C ES to com pare the va l ues with the m i n i m um distances
specified i n 8.9. Small chips that do not adversely affect the protection agai nst electric shock o r m o i sture can
normally be ignored.
Table 28 - M echan ical strength test a p p l i cabi l ity
ME E Q U I P M E N T type Test
Push ( 1 5 . 3 .2)
HAND-HELD Dro p (1 5 . 3 . 4 . 1 )
Moulding stress relief (1 5 . 3 . 6)
Push ( 1 5 . 3 .2)
I m pact (1 5 . 3 . 3)
PORTABLE
Dro p (1 5 . 3 . 4 . 2)
Push ( 1 5 . 3 .2)
I m pact (1 5 . 3 . 3)
MOBI L E
Rough handling ( 1 5 . 3 . 5)
Push ( 1 5 . 3 .2)
FIXED o r STATIONARY I m pact (1 5 . 3 . 3)

6060 1 - 1 © I EC : 2005 - 363 -
1 5. 3 . 2 * P u s h test
ENCLOS URES of M E E Q U I P M E NT s h a l l h ave suffic i e nt r i g i d ity to p rotect a g a i n st u n acce pta b l e
RISK.
Compliance is checked by the following test.
External parts of an ENCLOSURE are subject to a steady force of 250 N ± 1 0 N for a period of
5 s, applied by m eans of a suitable test tool providing contact o ver a circular plane surface
30 mm in diameter. However, this test is not applied to the bottom of an ENCLOSURE of ME
EQUIPMENT having a mass of m ore than 1 8 kg.
After the test, any damage sustained th at results in an unacceptable RISK, as determined by
inspection of th e RISK MANA GEMENT FILE, constitutes a failure.
1 5. 3 . 3 * I m pact test
ENCLOS URES of M E E Q U I P M E NT s h a l l h ave s uffi c i e n t res i sta n c e to i m pact to protect a g a i n st
u n accepta b l e R I S K .
Compliance is checked by the following test.
Except for HAND-HELD ME EQUIPMENT and ME E Q UIPMENT parts tha t are HAND-HELD, ENCLOSURES
and other external insulating parts, the deterioration of which could result in unacceptable
RISK, are tested as indicated b elow.
A sample consisting of the complete ENCLOSURE, or a portion thereof representing th e largest

unreinforced area, is supported in its normal position. A solid smooth steel ball, approximately
50 mm in diameter and with a mass of 500 g ± 25 g, is permitted to fall freely from a 1 , 3 m
height once onto each relevant part of the test sample.
To test vertical surfaces, the steel b all is suspended by a cord and allowed to s wing like a
pendulum in order to apply a horizontal impact, dropping though a vertical distance of 1 , 3 m
once against each relevant part of the test sample.
Th e test is not applied to flat panel displays, to th e platen glass of ME EQ UIPMENT (for example
film scann ers), or to cathode ray tubes (see 9. 5. 2).
After the test, any damage sustained th at results in an unacceptable RISK, as determined by
inspection of th e RISK MANA GEMENT FILE, constitutes a failure.
1 5. 3 . 4 * D ro p test
1 5. 3 . 4. 1 H AN D-HELD ME EQU I P M E NT
H A N D- H E L D ME E Q U I P M E N T a n d ME E Q U I PMENT pa rts t h at are HAND-HELD s h a l l n ot result i n a n
u n accepta b l e R I S K as a res u lt of a free fa l l .
Compliance i s checked b y the following test.
Th e sample to be tested, with any SAFE WORKING LOAD in place, is allowed to fall freely once
from each of three different starting orientations encountered during NORMAL USE from the
height at which the ME EQUIPMENT is used (as specified in the A CCOMPANYING DO CUMENTS), or
from a h eight of 1 m, whichever is greater, onto a 50 mm ± 5 mm thick hardwood b o ard
3
(hardwood > 600 kglm ) lying flat on a concrete or a similar rigid b ase.
After the test, the HAND-HELD ME E Q UIPMENT and ME EQUIPMENT p arts that are HAND-HELD shall
not result in an unacceptable RISK.
6060 1 - 1 © I EC : 20 0 5 - 365 -
1 5. 3 . 4 . 2 * PORTAB LE M E EQUIPMENT
PORTABLE ME E Q U I P M E NTa n d ME E Q U I P M ENT p a rts t h at a re PORTA B L E s h a l l withsta nd t h e stress
caused by a free fa l l from t h e h e i g ht i n d icated in T a b l e 29 o nto a h a rd s u rfac e .
Compliance i s checked by t h e following test.
Th e sample to be tested, with th e SAFE WORKING LOAD in place, is lifted to a height as

indicated in Table 29 above a 50 m m ± 5 m m thick hardwood b oard (for example,
> 600 kglm3) th at lies flat on a concrete floor or a similar rigid b ase. Th e dim ensions of the
board are at least th ose of the sample tested. The sample is dropped three times from each
orien tation in which it can be placed during NORMAL usE.
Table 29 - D ro p h e i g h t
Mass ( m) of PORTABLE M E E Q U I P M E N T
o r i t s parts Drop h e i g h t
kg em
m � 10 5
1 0 < m �50 3
m > 50 2
After the test, any damage sustained that results in a unacceptable RISK, as determin ed by
inspection of the RISK MANA GEMENT FILE and inspection of th e ME EQ UIPMENT or th e
ME EQUIPMENT parts that are PORTABLE, constitutes a failure.
1 5. 3 . 5 * Ro u g h hand l i n g test
M O B I LE M E E Q U I P M ENT and M E E Q U I P M ENT p a rts t h at are M O B I L E s h a l l with sta n d the stress
caused by r o u g h h a n d l i n g a n d move m e n t a n d s h a l l n ot res u lt in a n u n accept a b l e R I S K .
Compliance is checked by the following tests.
Th e sample is tested in transport position with any SAFE WORKING LOAD in place and in th e
most adverse condition permitted in NORMAL USE.
a) Ascending step shock
Th e sample is pushed three times in its normal direction of travel at a speed of

0, 4 m/s ± 0, 1 mls against an ascending h ardwood step obstruction with vertical face of
40 mm th at is rigidly attached to an oth erwise flat floor. Th e direction of m o vement is
perpendicular to the face of the obstacle. Th e sample need not go over th e 40 mm
obstruction.
b) Descending step shock
Th e sample is pushed three times in its normal direction of travel at a speed of

0, 4 m/s ± 0, 1 mls in order to fall over a vertical step h a ving a height of 40 mm affixed flat
on a rigid base (e. g. con crete) . Th e direction of movement is perpendicular to the face of
the descending step.
During performance of the descending step shock test, if a part other than the castor
comes in contact with the obstruction before the castor touches the ground, the ME
EQUIPMENT con tinues to be pushed un til it has fully descended.
6060 1 - 1 © I EC : 2005 - 367 -
c) Door frame shock
Th e sample is moved three times in its norm al direction of travel at a speed of

0, 4 mls ± 0, 1 m!s, or, for m otor driven MOBILE ME EQUIPMENT, the m aximum speed capable
of b eing m aintain ed, against a hardwood vertical obstacle h a ving a width and thickness of
40 m m affixed to a vertical rigid support (e. g. concrete). The h eight of the vertical obstacle
must be higher than th e ME EQUIPMENT contact point(s). Th e direction of m ovement is
perpen dicular to the face of the obstacle.
After each test, any damage sustained that results in an unacceptable RISK, as determined by
inspection of the RISK MANA GEMENT FILE and inspection of the ME EQ/UPMENT or th e
ME EQUIPMENT parts that are MOBILE, constitutes a failure.
*
1 5. 3 . 6 M o u ld stress rel ief test
ENCLOS URES of m o u lded or fo rmed t h e r m o p l astic m ate r i a ls s h a l l be so constructed that a n y
s h r i n ka g e o r d i stort i o n of t h e mate r i a l d u e to re lease of i nt e r n a l stresses c a u s e d by t h e
m o u l d i n g o r fo r m i n g o p e rat i o n d o es n ot res u lt i n a n u n acce pta b l e R I S K .
Compliance is checked by inspection of the construction and a vailable data were appropriate
or by the following test.
One sample consisting of the complete ME EQUIPMENT, or of th e ENCLOSURE together with any
supporting fram e work, is placed in a circulating air oven at a temperature 1 0 oc higher than
the m aximum temperature observed on the ENCLOSURE during th e test of 1 1 . 1 . 3, but not less
than 70 OC, for a period of 7 h, then permitted to cool to room temperature.
NOTE Relative h u m i dity need not be m a intained at a specific value during this conditi o n i n g .
For large ME E Q UIPMENT where it is not practical to condition a complete ENCLOSURE, it is

permitted to use a portion of the ENCLOSURE represen tative of th e complete assembly with
regard to thickn ess and shape, including any mechanical support m embers.
Any damage that results in an unacceptable RISK constitutes a failure.
*
1 5. 3 . 7 E n v i ro n m ental i nflue nces
The se l e ct i o n and treatment of mate rials used in the c o n structi o n of M E E Q U I PMENT s h a l l take
acco u nt of the I NTENDED U S E , the EXPECTED S E RVICE LIFE and the conditions fo r tra n s p o rt a n d
sto rage.
T h e M E E Q U I P M E NT shall be S O d es ig n ed a n d constructed t h at d u ri n g its EXPECTED S E RVICE L I F E

a n y corros i o n , a g e i n g , mechanical we ar, o r d e g ra d at i o n of b i o l o g i c a l mate rials d u e to t h e
i nfl u e nce of bacte r i a , p l a nts, a n i mals a n d t h e l i ke, s h a l l not reduce i t s m e c h a n ical p r o p e rties
i n a way t h at resu lts i n a n u n acce pta b l e R I S K . S e e a lso 1 5 . 2 .
Compliance i s checked b y inspection:
of the ME EQUIPMENT, of th e A CCOMPANYING DOCUMENTS and of the MANUFA CTURER 'S
specifications of materials used and of the processing specifications for th ese materials;
of th e MANUFA CTURER 's relevant tests or calculation s.
6060 1 - 1 © I EC : 20 0 5 - 369 -
1 5. 4 M E EQUIPMENT co m po n e nts a n d g e n eral assem b l y
1 5.4. 1 Construction of co n n ectors

D e s i g n a n d const r u ct i o n of e l ectrica l , h yd r a u l i c , p n e u matic a n d gas co n n e ct i o n te r m i n a l s a n d
co n n ectors of ME EQUI P M E NT s h a l l be s u c h t h a t i n co rrect c o n n ecti o n of access i b l e c o n n ectors ,
remova b l e with out t h e u se of a TOOL, s h a l l be p reve nted w h e re a n u n acce pta b l e RISK wo u l d
oth e rwise exist. I n p a rtic u la r :
a ) P l u g s for co n n ect i o n of PAT I E NT leads s h a l l be so d e s i g n e d t h at they c a n n ot b e co n n ected

to other o utlets on t h e same ME EQUIPMENT i nte nded for ot h e r functions, u n less it can be
p rove n that no u n acce pta b l e RISK can res u lt.
b ) M ed ic a l gas c o n n ecti o n s o n ME EQUIPM ENT fo r d i ffe rent gases to b e o p e rated i n NORMAL

USE s h a l l n ot b e i nterc h a n g e a b l e . See a l so I S O 407 [27].
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
1 5.4.2 Tem peratu re and overload control d ev ices
1 5.4.2. 1 Appl ication
a ) THE RMAL CUT-OUTS a n d OVER-CURRENT RELEAS ES with automatic resett i n g s h a l l n ot be used

i n ME EQUIPMENT if t h e i r u se could resu lt i n a HAZARDOUS SI TUATION by s u c h resett i n g .
b) THE RMAL CUT-OUTS with a safety f u n ct i o n t h at h ave to be reset by a s o l d e r i n g o peration t h at

can affect t h e o perating va l u e s h a l l n ot be fitted i n ME EQUIPMENT.
Compliance is checked by inspection of th e design documen tation and the RISK

MANA GEMENT FILE.
c) I n ME EQUI PMENT, w h e re a fa i l u re of a THERMOSTAT co u l d c o n stitute a HAZARD a n

i n d e p e n d e nt n o n-SELF-RESETTING THERMAL CUT-OUT s h a l l ad d iti o n a l ly be prov i d e d . T h e
tempe rat u re of o p e rati o n of t h e a d d itio n a l device s h a l l be o utside t h at atta i n a b l e a t t h e
extreme sett i n g of t h e n o r m a l control d evice b ut s h a l l be with i n t h e safe t e m p e rat u re l i m it
fo r its i nte nded fu n ct i o n .
Compliance i s checked b y inspection o f the design documentation a n d the RISK

MANA GEMENT FILE.
d) loss of f u n ct i o n of t h e ME EQUIPMENT caused by o p erat i o n of a THE RMAL CUT-OUT or OVER

CURRENT RELEASE s h a l l n ot res u lt in a HAZARDOUS S I TUATION.
Compliance is checked by inspection of th e design documen tation and the RISK

MANA GEMENT FILE.
e) C a p acitors or other s p a rk-s u p p ress i o n devices of ME EQUI P M ENT s h a l l n ot be co n n ected

betwe e n the co ntacts of THERMAL CUT-OUTS .

6060 1 - 1 © I EC : 20 0 5 - 371 -
f) T h e use of a THERMAL CUT-OUT o r OVER-CURRENT RELEASE in t h e d e s i g n s h a l l n ot affect t h e

safety of t h e ME EQUI P M E NT.
Compliance is checked by inspection and, if applicable, by th e following tests.
Verify compliance of positive temperature coefficient devices (PTC 's) with IEC 60730- 1 :
1 999, clauses 1 5, 1 7, J . 1 5 and J . 1 7 a s applicable.
THERMAL CUT-OUTS and O VER-CURRENT RELEASES are tested by operating the ME EQUIPMENT
under th e conditions describ ed in Clause 1 3.
SELF-RESE TTING THERMAL CUT-OUTS and self-resetting O VER-CURRENT RELEA SES including
circuits that perform equivalent functions (other than PTC 's) are caused to operate 200
times unless approved to the appropriate IEC component stan dard.
Manual reset THERMAL CUT-OUTS and O VER-CURRENT RELEA SES are caused to operate 1 0
times, if they are not approved to the appropriate IEC compon ent standard (see 4 . 5) or the
MANUFA CTURER has not provided adequate data to demonstrate the reliability of th e
component to perform its safety-related function.
Th ermal protection devices can be tested separately from ME EQUIPMENT where

engineering judgem ent indicates that doing so would not impact the test results.
g) ME EQUI PMENT t h at i n co r p o rates a fl u i d fi l l e d conta i n e r h av i n g h eati n g fac i l ities s h a l l be

p rovided with a p rotect i o n device to safeg u a rd aga i n st ove r h eati n g in t h e eve nt of t h e
h e ater b e i n g switch e d o n w i t h t h e conta i n e r e m pty. An u n a c ce pta b l e RISK s h a l l n ot occur
from ove r h e ati n g .
Compliance is checked b y operating the relevant ME EQUIPMENT with a n empty container

un til th e protection device activates.
h) ME EQUI PMENT that i n c o r p o rates tu b u l a r h e at i n g e l e m e nts s h a l l h ave p rotect i o n a g a i n st

ove r h e ati ng i n both leads w h e re a c o n d u ct ive co n n ect i o n to e a rth c o u l d resu lt i n
ove r h e ati n g .
Compliance i s checked b y inspection o f th e design documen tation and the RISK

MANA GEMENT FILE.
1 5. 4 . 2 . 2 Tem perat u re sett i n g s

W h e r e m e a n s are p rovided fo r va ryi n g t h e t e m p e rat u re sett i n g of THERMOSTATS in
ME EQUI PMENT, t h e t e m p e rat u re sett i n g s h a l l be clearly i n d icate d .
Compliance i s checked by inspection.
1 5.4.3 * Batteries
1 5.4.3. 1 Housing
I n ME EQUIPM ENT, h o u s i n g s conta i n i n g batte ries f r o m w h i c h g ases t h at are l i kely to res u lt i n a
HAZARD c a n escape d u ri n g c h a r g i n g o r d is c h a rg i n g s h a l l be ve nti l ated to m i n i mize t h e RISK of
acc u m u lation a n d i g n it i o n .
B attery c o m p a rtments of ME EQUIPMENT s h a l l be des i g n ed to p reve nt accide ntal s h o rt

c i r c u it i n g of t h e battery w h e re s u c h s h o rt circu its c o u l d res u lt in a HAZARDOUS S I TUATION.
Compliance is checked by inspection of the design documentation and the RISK MANAGEMENT
FILE.
6060 1 - 1 © I EC : 20 0 5 - 373 -
1 5. 4 . 3 . 2 Con nection
If a HAZARDOUS S I TUAT I O N m i g ht deve l o p by t h e i n c o rrect c o n n e ct i o n o r re p l ac e m e nt of a
batt e ry, ME E Q U I P M ENT s h a l l be fitted with a m e a n s of p reve nti ng i n c o rrect p o l a rity of
co n n e ct i o n . S e e a l so 7 . 3 . 3 a n d 8 . 2 . 2 .
1 5. 4 . 3 . 3 P rotection ag ai nst ove rcharg i n g

Where ove rc h a r g i n g of a n y battery of M E E Q U I P M E NT co u l d resu lt i n a n u n a ccepta b l e R I S K , t h e
d e s i g n s h a l l p reve nt overc h a rg i n g .
Compliance i s checked b y inspection of the design documen tation.
1 5. 4 . 3 . 4 Lith i u m batter ies

L ith i u m b atte ries used in M E E Q U I P M E NT t h at c o u l d become a HAZARD s h a l l c o m p l y with t h e
req u i re m e nts of I EC 6 0 0 86-4 . S e e also 7 . 3 . 3 .
Compliance is checked b y inspection o f th e battery design documen tation o r by performance

of th e tests iden tified in IEC 60086-4.
1 5. 4 . 3 . 5 Excess ive c u rrent and voltage p rotection

An I NTE RNAL ELECTRI CAL POW E R SOURCE i n M E E Q U I P M E NT s h a l l b e p rovi d ed with an
a p prop ri ate l y RATED device fo r p rotect i o n a g a i n st fire caused by excess ive cu rre nts if t h e
cros s-s ect i o n a l area a n d l a y o u t of t h e i nt e rn a l w i r i n g o r t h e rat i n g of co n n ected c o m p o n e nts
can g ive rise to a fire in case of a s h o rt c i rcu it. P rotective d evices s h a l l h ave a d e q u ate
breaking capacity to interru pt the maxi m u m fa u lt c u rrent ( i n c l u d i n g s h o rt-c i rcu it c u r rent) w h i c h
can flow. J u stificat i o n fo r o m is s i o n of fuses o r OVER-CURRENT R E LEASES s h a l l be i n c l uded i n
t h e R I S K MANAG E M E NT F I L E .
Compliance i s checked by inspection for t h e presence of protective means, and i f necessary,

by inspection of the design documen tation and the RISK MANA GEMENT FILE.
1 5.4.4 * I n d i cators
U n less it is otherwise a p parent to the O P E RATO R from the n o r m a l o p e rati n g posit i o n , i n d icator
l i g hts s h a l l be p rovi ded to i n d i cate t h at M E EQUI P M E NT is ready fo r NORMAL U S E . The marking of
7 . 4 . 1 is not s uffi c i e nt fo r t h i s p u rpose.
I f e q u i pped with a sta nd-by state or a warm- u p state whose d u rati o n exceeds 1 5 s, the
M E E Q U I PMENT s h a l l be p rovi d ed with a n a d d iti o n a l i n d icator l i g ht u n less it is ot h e rwise
a p parent to the O P E RATO R from t h e n o r m a l o p e rati n g posit i o n .
I n d icator l i g hts s h a l l be p rovided o n M E E Q U I P M E NT i n corporati ng n o n -l u m i n o u s h e aters to

i n d icate t h at t h e h e aters are o p e ratio n a l , if a HAZARDOUS S I TUATI O N c o u l d exist u n less it is
oth e rwise a p parent to the O P E RATOR from the n o rm a l o p erat i n g p o s iti o n .
NOTE This does not a p ply to heated styl us-pens for rec o rding purposes.
I n d icator l i g hts s h a l l be p rovided on M E EQUI P M E NT to i n d icate t h at a n o utput exists where an

accide ntal or p r o l o n ged o p e rati o n of the o u t p ut c i rc u it c o u l d constitute a HAZARDOUS
S I TUATI O N .
C o l o u rs of i n d icator l i g hts are d e s c r i b e d i n 7 . 8 . 1 .

6060 1 - 1 © I EC : 20 0 5 - 375 -
I n ME EQUIPMENT i n c o r p o rati n g a m e a n s for c h a r g i n g an I NTERNAL ELECTRICAL POWER SOURCE ,

t h e c h a rg i ng mode s h a l l be visi b l y i n d i cated to t h e OPERATO R .
Compliance i s checked by inspection of th e presence and function of in dicating m eans visible

from the position of NORMAL USE.
1 5. 4 . 5 P re-set controls
When a p p l ic a b l e , t h e MANUFACTURER s h a l l add ress i n t h e RISK MANAG EMENT PROCESS t h e
RISKS associated w i t h p re-set controls.
1 5.4.6 Act u at i n g parts of controls of M E EQUI P M E N T
1 5.4.6. 1 F i x i n g , preve ntion of m aladj ustment
a ) A l l a ctuati ng p a rts of ME EQUIPMENT s h a l l be so secu red t h at they c a n not be p u l led off or

work loose d u ri n g NORMAL USE.
b ) C o ntrols, t h e adj u st m e nt of w h i c h can resu lt i n a HAZARDOUS S I TUATION fo r t h e PAT I E NT or

OPERATOR wh i l e ME EQUI PMENT is i n u s e , shall be so secured that t h e i n d ication of a n y
scale a lways corre s p o n d s with t h e position o f t h e c o ntro l .
T h e i n d icat i o n i n t h i s case refers t o " o n " o r " off" positio n , sca l e markings o r ot h e r
i n d icat i o n s o f posit i o n .
c) I n co rrect c o n n ect i o n of t h e i n d icat i n g device to t h e relevant c o m p o n e nt s h a l l be p reve nted

by a n a d e q u ate construct i o n , if it can be s e p a rated wit h o u t the use of a TOOL.
Compliance is checked by inspection and tests. For rotating controls, the torques as shown in
Table 30 are applied between the control knob and the shaft for not less than 2 s in each
direction alternately. The test is repeated 1 0 times.
A knob that rotates with respect to th e shaft constitutes a failure.
If an axial pull is required in NORMAL USE, compliance is checked by applying for 1 min an
axial force of 60 N for electrical components and 1 00 N for other components.
6060 1 - 1 © I EC : 20 0 5 - 377 -
Table 30 - Test torq ues fo r rotat i n g controls
G r i p p i n g d i a m eter ( d ) of
control knob Torq u e
mm " Nm
1 0 � d < 23 1 ,0
23 � d < 3 1 2,0
31 � d < 41 3,0
4 1 � d < 56 4,0
56 � d � 7 0 5,0
d > 70 6,0
• The g ripping diameter (d) is the maxi m u m w i d t h of a

control knob regardless of its shape (e . g . control knob
with poi nter).
1 5. 4 . 6 . 2 L i m itation o f movement
Sto ps of a d e q u ate m e c h a n ical stre ngth s h a l l be p rovi ded on rotat i n g o r mova b l e pa rts of
controls of ME EQUIPM ENT, wh ere n ecessary to p reve nt a n u n exp e cted c h a n g e from max i m u m
t o m i n i m u m , o r vice-ve rsa, o f t h e c o ntro l l e d p a r a m eter w h e re t h i s c o u l d p rod u c e a HAZARDOUS
S ITUATI O N .
Compliance i s checked by inspection and m an ual tests. For rotating con trols, t h e torques a s
shown in Table 30 are applied for not less than 2 s in each direction alternately. The test is
repeated 1 0 times.
I f an axial p u l l is l i kely to be a p p l ied to the rotati n g o r mova b l e p a rts of controls of

ME EQUI PMENT in NORMAL U S E , n o u n acce pta b l e RISK s h a l l deve l o p .
Compliance i s checked b y applying for 1 min a n axial force of 6 0 N for electrical components
and 1 00 N for other components.
1 5.4. 7 Cord-co n n ected HAN D - H E L D a n d foot-ope rated control d ev ices (see a lso 8 . 1 0 . 4 )
1 5.4. 7 . 1 M echan ical strength
a ) HAND-HELD control devices of ME EQUIPM ENT shall c o m p l y with 1 5 . 3 . 4 . 1 .
b ) F o ot-o pe rated control devices of ME EQUI PMENT s h a l l be a b l e to s u p p o rt t h e we i g ht of a n

a d u lt h u m a n b e i n g .
Compliance is checked by application t o the foot-operated control device, in its position of

NORMAL USE, of an actuating force of 1 350 N for 1 min. The force is applied over an area of
30 mm diameter. Th ere shall be no damage to the device resulting in an unacceptable
RISK.
6060 1 - 1 © I EC : 20 0 5 - 379 -
1 5.4. 7 . 2 Acc i d e n tal o peration of ME EQUIPMENT

HAND-HELD a n d foot-o pe rated control devices s h a l l not res u lt in a n u n acce pta b l e RISK by
c h a n g i n g t h e i r control sett i n g when accidentally p laced i n a n a b n o rm a l posit i o n .
Compliance i s checked by turning th e control device i n all possible abnormal positions and
placing it on a flat surface. Any inadvertent change of control setting resulting in an
unacceptable RISK constitutes a failure.
1 5. 4 . 7 . 3 * Entry of l i q u ids
a ) F o ot-o pe rated control d evices of ME EQUI PMENT s h a l l be at l e ast I PX 1 accord i n g to

I EC 60529.
Compliance i s checked by t h e tests of I E C 60529.
b) I n ME E Q U I PMENT, E NCLOSURES of foot operated control devices t h at conta i n e l ectrical

ci rcu its s h a l l be c l assified at l east I PX6 accord i n g to IEC 6 0529 if they a re i ntended fo r
NORMAL USE i n areas w h e re l i q u ids are l i kely to be fo u n d ( s u c h as e m e rg e n cy rooms a n d
o p erat i n g t h eatres ) . T h e p ro b a b i l ity of occurre n c e s h a l l be estimated as p a rt of t h e R I S K
MANAG E M E NT PROCESS.
Compliance is determined by inspection of the A CCOMPANYING DO CUMENTS, the design

documen tation, the RISK MANAGEMENT FILE and by performing the appropriate tests of
IEC 60529.
1 5.4.8 I nte rnal w i r i n g of ME EQU I P M E NT

2
A l u m i n i u m wi res of less t h a n 1 6 m m cross-sect i o n s h a l l n ot be used i n ME EQUIPMENT.
1 5.4.9 Oil conta i n e rs
a) O i l conta i n e rs i n PORTABLE ME EQUIPMENT s h a l l be a d e q u ately sea led to p reve nt loss of o i l

i n a n y posit i o n . T h e conta i n e r d es ig n s h a l l a l l ow for t h e expa n s i o n o f t h e o i l .
b ) O i l conta i n e rs i n MOBILE ME EQUIPMENT s h a l l b e s e a l ed t o p reve nt t h e loss o f o i l d u ri n g

transport b ut m a y be fitted with a p ress u re-re lease device t h a t c a n o p e rate d u ri n g NORMAL
USE.
c) P a rt i a l l y sealed o i l-fi lled ME EQUIPMENT or its pa rts shall b e p rovided with m e a n s fo r

c h e c ki n g t h e o i l l eve l so that leakage c a n be d etected (see 7 . 9 . 3 . 1 ) .
Compliance i s checked by inspection of th e M E EQUIPMENT, t h e technical description, a n d b y

man ual test.
1 5. 5 * MAINS S UPPLY TRANS FORM E RS of M E EQUIPMENT a n d tra n sfo rmers p rov i d i ng

separation i n acco rdance with 8 . 5
1 5. 5 . 1 Overheat i n g
1 5. 5. 1 . 1 * T ra nsform ers
Transfo r m e rs of ME EQUI PMENT s h a l l b e protected aga i n st ove r h e ati n g in the eve nt of s h o rt
c i r c u it o r ove rload of a n y output wi n d i n g .
6060 1 - 1 © I EC : 20 0 5 - 381 -
Compliance is checked by the tests of 1 5. 5. 1 . 2 and 1 5. 5. 1 . 3 as appropriate under th e

following conditions.
Each winding is tested, in turn, with the follo wing parameters at the most adverse value:
- primary voltage m aintained b etween 90 % to 1 1 0 % of RA TED voltage
RA TED input frequency
- loads on other win dings between no load and their NORMAL USE load
Short circuit or resistive load, as appropriate, is applied at the ends of the windings or at th e
first point that can be sh ort circuited under SINGLE FA ULT CONDITION.
Components intended to pre vent overheating of th e transformer during sh ort circuit and
overload conditions are included as part of th e tests of 1 5. 5. 1 . 2 and 1 5. 5. 1. 3 provided that it is
unlikely that a short circuit or overload condition could arise for which they would not provide
protection. Failure of such circuits to provide protection are considered unlikely to occur where
insulation (including spacing) is equal to at least one MEANS OF OPERA TOR PROTECTION as defined
in Clause 8 and COMPONENTS WI TH HIGH-INTEGRITY CHARA CTERISTICS are used.
During th e tests, no win ding are to open, no HAZARDOUS SI TUA TION occurs, and th e maximum
temperatures of windings are not to exceed th e values in Table 3 1 . After the sh ort circuit and
overload tests, the transformer is to pass the dielectric strength test (as describ ed in 8. 8. 3)
between primary and secon dary win dings, between the primary windings and th e frame and
between the secondary windings and th e frame. The tests are performed under the conditions
specified in 1 1 . 1, either in the ME EQUIPMENT or under simulated conditions on the b ench.
Table 3 1 - M axi m u m al lowable tem peratu res of transfo r m e r w i n d i n g s u nd e r ove rload

and s h o rt-c i rc u it con d itions at 25 o c (± 5 °C} a m b i e n t tem perat u re
Maxi m u m
Parts tern peratu re
'C
Windings and core lam inations in

contact therewit h , if the winding
insu lation i s :
-
of Class A material 1 50
-
of Class B material 1 75
-
of Class E material 1 65
-
of Class F material 1 90
-
of Class H material 210
1 5. 5. 1 . 2 S h o rt-c i r c u i t test
Th e output winding under test is short circuited. The test i s continued until th e protective
device operates or THERMAL STABILITY is achieved. For transformers not tested according to
the 5X frequency and 5X voltage test of 1 5. 5. 2, th e sh ort circuit is applied directly across th e
output win dings.
6060 1 - 1 © I EC : 20 0 5 - 383 -
1 5. 5. 1 . 3 Overload test
Windings with m ore than one protective device could require m ultiple overload tests in order
to fully evaluate worst-case NORMAL USE loading and fusing.
If the short-circuit test is completed without operation of a protective device (such as a current
limiting circuit), the overload test is not required.
a) This test (a) is performed if the current at which the protective device operates cannot b e
determined based on a review of the provided protective devices a n d their performance
data; oth erwise test b) is performed.
Th e winding under test is loaded to its NORMAL USE load until THERMAL S TABILI TY is reached.
Th e load is then progressively adjusted in appropriate steps to approach the minimum
current at which the protective device operates. Each adjustment of the load is followed by
a sufficient time to reach THERMAL S TABILI TY, and th e load current and temperature are to
be noted.
Following operation of a protective device, b) is performed.
b) If the protective device that operated in a) is external to the transformer, it is shunted. The
win ding under test is loaded b ased on the type of protective device as follows.
Fuse in accordance with IEC 601 27- 1 :
3 0 min at the appropriate test current determined from Table 32.
Table 32 - Test cu rrent for transfo r m e rs
Marked val u e of RAT E D cu rrent Ratio between test cu rrent

(I ) of protecti n g fuse-l i n k a n d RAT E D cu rrent o f the
A fuse-l i n k
I�4 2,1
4 < 1 .5' 1 0 1 ,9
1 0 < I � 25 1 , 75
I > 25 1 ,6
Fuses not in accordance with IEC 6 0 1 2 7- 1 :

3 0 min a t the current according t o th e ch aracteristics supplied by the fuse
manufacturer, specifically th e 30 min clearing-time current. If no 30 min clearing-time
current data is available, the test current from Table 32 is used un til THERMAL STABILITY
is achieved.
Other protective device:
un til THERMAL S TABILI TY at a current just below that which caused th e device to operate
in a).
This portion of the overload test is concluded at the specified time or when a second
protective device opens.
1 5. 5. 2 * D i e lectric stre n g t h
M E EQUI PMENT tra nsfo rmer w i n d i n g s s h a l l h ave a d e q u ate i n s u lation to p reve nt i nt e r n a l s h o rt
ci rcu its t h at co u l d cause overh eati n g w h e re s u c h ove r h e at i n g c o u ld resu lt in a HAZARDOUS
S ITUATI O N .
6060 1 - 1 © I EC : 20 0 5 - 385 -
T h e d ie l e ctric stre ngth of t h e e l ectrical i n s u l at i o n betwe e n t u r n s a n d layers of each wi n d i n g of

a tra nsfo rm e r of ME EQUI PMENT w h e re fa i l u re of t h e transformer c o u l d res u lt i n a HAZARDOUS
S ITUATION s h a l l be s u c h t h at after the h u m i d ity preco n d it i o n i n g treatment ( see 5 . 7 ) it passes
t h e fo l l owi n g tests.
a ) Transformer windings having a RA TED voltage :0: 500 V or RA TED frequency :0: 6 0 Hz are
tested with a voltage across th e winding of five times the RA TED voltage or five times the
upper limit of the RA TED voltage range of th at winding and a frequency not less than five
times the RA TED frequency (where RA TED frequency is the n ormal operating frequency of
the transformer input voltage).
b) Transformer windings h a ving a RA TED voltage exceeding 500 V or RA TED frequency

exceeding 60 Hz are tested with a voltage across that winding of twice the RA TED voltage
or twice the upper limit of the RA TED voltage range of that win ding and a frequency not less
than twice the RA TED frequency (where RA TED frequency is th e normal operating frequency
of th e transformer input voltage) .
In th e two cases abo ve, however, the stress on th e turn and layer insulation of any winding of
the transformer is to be such that th e test voltage appearing at the winding with th e high est
RA TED voltage does not exceed the test voltage specified in Table 6, for one MEANS OF
PROTECTION, if th e RA TED voltage of such a winding is considered as the WORKING VOLTAGE. If
this should occur, the test voltage on the primary winding is reduced accordingly. The test
frequency can be adapted to produce in the core approximately th e m agnetic induction
present in NORMAL usE. Where the core of th e transformer is isolated from all external
con ductive conn ections (such as in m ost toroidal transformers), connections to the core
describ ed below m ay be omitted.
Three-phase transformers can be tested by m eans of a three-phase testing device or by
three consecutive tests using a single-phase testing device.
Th e value of th e test voltage with respect to the core and to any screen b etween primary
and secondary win dings is in accordance with th e specification of the relevant transformer.
If th e primary winding has an iden tified conn ection point for the n eutral of th e SUPPL Y
MAINS such a point is connected to the core (and screen if present) unless the core (and
screen) are specified for connection to an unearthed part of the circuit. To simulate this,
the core (and screen) are connected to a source with an appropriate voltage and
frequency with respect to the identified connection point.
If such a connection point has not been identified, each side of the primary win ding in turn
is connected to the core (and screen if present) unless the core (and screen) are specified
for connection to an unearth ed part of th e circuit.
To simulate this, the core (and screen) are connected to a source with an appropriate
voltage and frequency with respect to each side of the primary winding in turn.
During the test, all win dings not intended for conn ection to the SUPPL Y MAINS are left
unloaded (open circuit) . Windings intended to be earthed at a point or to be operated with
a point nearly at earth potential are to h a ve such a point connected to the core, unless the
core is specified for connection to an unearth ed part of the circuit.
To simulate this, the core is connected to a source with an appropriate voltage and
frequency with respect to such win dings.
6060 1 - 1 © I EC : 20 0 5 - 387 -
Initially not more than half th e prescribed voltage is applied, then, it is raised over a period
of 1 0 s to the full value, which is then m aintain ed for 1 min, after which the voltage is
reduced gradually and switched off.
Tests are not conducted at resonant frequencies.
Compliance is checked by the following:
During th e test, any flashover or breakdown of any part of the in sulation constitutes a failure.
Th ere is to be no detectable deterioration of the transformer after the test.
Slight corona discharges are neglected, provided that they cease wh en the test voltage is
temporarily dropped to a lower value, that this value is higher th an th e WORKING VOLTAGE and
that th e discharges do not provoke a drop in test voltage.
1 5. 5. 3 * Construction o f transfo r m e rs u sed t o prov i d e separation a s req u i red by 8 . 5

Transfo r m e rs o f ME EQUI PMENT that fo rm MEANS OF PROTECTION a s re q u i red by 8 . 5 s h a l l c o m p l y
w i t h I E C 6 1 5 5 8- 1 : 1 997, S u bc l a u s e 5 . 1 2 .
Compliance is checked as specified in IEC 6 1 558- 1 .
16 * M E SYST E M S
16.1 * Gen eral req u i rements fo r t h e M E SYSTEMS

After i n st a l lation o r s u bs e q u e n t mod ificat i o n , an ME SYSTEM s h a l l n ot res u lt in a n u n accepta b l e
RISK.
O n l y HAZARDS arising from co m b i n i n g various e q u i p m e n t to c o n stitute a n ME SYSTEM s h a l l b e

c o n s i d e red .
NOTE RESPO N S I B L E ORGAN IZAT I O N S are re m i nded that the assem bly of M E SYSTEMS and modifications d u ring the
actual service life req u i re eva l uation to the req u i re m e nts of this sta ndard.
An ME SYSTEM s h a l l prov i d e :
- wit h i n t h e PAT I E NT E NV I RONMENT, t h e l eve l of safety e q u iva l e n t to ME EQUI PMENT c o m p l y i n g
w i t h this sta n d a rd ; a n d
outside t h e PAT I E NT E NV I RONMENT, t h e l eve l of safety e q u iva l e nt to e q u i p m e nt c o m p l y i n g
w i t h th e i r respective I E C o r I S O safety sta n d ards.
Tests s h a l l be p e rfo r m e d :
i n NORMAL CONDITION u n less ot h e rwise s pecified, a n d
u n d e r t h e o p erating co n d it i o n s s pe c ified by t h e MANUFACTURE R of t h e ME SYSTEM.
S afety tests t h at h ave a l ready b e e n p e rformed o n i n d iv i d u a l e q u i p m e nt of t h e ME SYSTEM

accord i n g to rel eva nt sta n d a rds s h a l l n ot b e repeate d .
T h e MANUFACTU RER of a n ME SYSTEM t h a t is ( r e )confi g u r a b l e by t h e RESPONSIBLE ORGANIZATION

o r OPERATOR may u s e RISK MANAG E M E NT methods to dete r m i n e which confi g u rat i o n s constitute
the h i g h est RISKS and w h i c h m e a s u res are n e eded to e n s u re t h at the ME SYSTEM in a n y
poss i b le configu rat i o n d o es n ot present a n u n acce pta b l e RISK.
6060 1 - 1 © I EC : 20 0 5 - 389 -
N o n-ME EQUI PMENT, w h e n used i n a n ME SYSTEM, s h a l l c o m p l y with I EC o r I S O safety

sta n d a rds that are rel evant to t h at e q u i p m ent.
E q u i p m e nt i n which p rotect i o n aga i n st e l ectric shock re l i e s o n ly o n BAS I C I NS ULATION s h a l l not

be used i n a n ME SYSTE M .
Compliance i s checked by inspection o f appropriate documents o r certificates.
1 6.2 * ACCOMPANYING DOCUMENTS o f an M E SYSTEM

An ME SYSTEM, ( i n c l u d i n g a mod ified ME SYSTE M ) , s h a l l b e a c c o m p a n ied by d o c u m e nts
conta i n i n g a l l the data necessary fo r the ME SYSTEM to be used as i ntended by t h e
MANUFACTURER, a n d a n add ress to w h i c h t h e RESPONSIBLE O RGANIZATI ON c a n refe r. T h e
ACCOMPANYI NG DOCUM ENTS s h a l l be reg a rd ed a s a p a rt o f t h e ME SYSTE M .
NOTE AccoMPANYING DOCUM ENTS c a n b e provided electro n i ca l ly, e . g . electronic file format o r CD-RO M , for a n
M E SYSTEM capable of d i splaying o r printing those documents.
T h ese d o c u m e nts s h a l l i n c l u d e :
a ) t h e ACCOMPANYI NG DOCUME NTS fo r e a c h item o f ME E Q U I PM ENT t h a t is p rovi d ed by t h e

MANUFACTURER ( s e e 7 . 8 . 2 ) ;
b ) t h e ACCOMPANYI NG DOCUME NTS fo r each ite m of n o n-ME E Q U I P M E NT t h at is p rovi ded by t h e

MANUFACTURER;
c) the fo l l owi ng i nfo rmati o n :

- t h e s pe c ificat i o n of t h e ME SYSTEM, i n c l u d i n g t h e u s e as i nt e n d e d by t h e MANUFACTURER
a n d a l i st i n g of all of t h e items fo rm i n g t h e ME SYSTEM;
i n struct i o n s for t h e i n sta l lati o n , asse m b l y a n d mod ification of t h e ME SYSTEM to e n s u re
conti n u ed c o m p l i a n c e with this sta n d a rd ;
i n struct i o n s fo r c l e a n i n g a n d , w h e n a p p l i c a b l e , d i si nfect i n g a n d ste r i l i z i n g each i t e m o f
e q u i p m e nt o r e q u i p m e nt p a rt fo r m i n g p a rt of t h e M E SYSTEM (see 1 1 . 6 . 6 a n d 1 1 . 6 . 7 ) ;
a d d iti o n a l safety measu res that s h o u l d be a p p l ie d , d u ri n g i n st a l lation of t h e ME SYSTEM;
w h i c h p a rts of t h e ME SYSTEM are s u ita b l e fo r use wit h i n t h e PAT I E NT E NV I RONMENT;
a d d iti o n a l measu res t h at s h o u l d be a p p l ied d u ri n g p reventive m a i nte n a n c e ;
if a M ULTI PLE SOCKET-OUTLET is p r e s e n t a n d it is a s e p a rate ite m , a warn i n g that i t s h a l l
n o t be p laced o n t h e fl o o r ;
a wa r n i n g t h at a n a d d iti o n a l M U LTIPLE SOCKET-OUTLET o r exte n s i o n cord s h a l l n ot b e
co n n e cted to t h e ME SYSTEM;
a wa r n i n g to co n n ect o n ly items that h ave been spec ified as p a rt of t h e M E SYSTEM or
t h at h ave b e e n s pe c ified as being c o m pati b l e with t h e ME SYSTE M ;
t h e maxi m u m p e r m itted load fo r a n y M ULTI PLE SOCKET-OUTLET(s) u s e d with t h e
ME SYSTEM;
a n i n st r u ct i o n t h at M U LTIPLE SOCKET-OUTLETS p rovi ded with t h e ME SYSTEM shall o n ly be
used fo r s u p p l y i n g powe r to e q u i p m e nt t h at is intended to form p a rt of t h e ME SYSTEM;
6060 1 - 1 © I EC : 20 0 5 - 391 -
an exp l a n at i o n of t h e RISKS of c o n n ect i n g n o n -ME EQUI P M E NT that h a s b e e n s u p p l ied as

a p a rt of t h e ME SYSTEM d i rect l y to t h e w a l l o ut l et w h e n t h e n o n-ME EQUIPMENT is
i ntended to be s u p p l i e d via a M ULTIPLE SOCKET-OUTLET with a s e p a rat i n g tra nsformer;
a n exp l a nation of t h e RISKS of c o n n e ct i n g any e q u i p m e nt t h at has n ot b e e n s u p p l ied as
a p a rt of t h e ME SYSTEM to t h e M ULTIPLE SOCKET-OUTLET;
the p e rmiss i b l e environ mental c o n d i t i o n s of use of the ME SYSTEM i n c l u d i n g conditions
fo r transport a n d sto rage; and
i n struct i o n s to t h e OPERATOR not to t o u c h pa rts refe rred to i n 1 6 . 4 a n d t h e PAT I E NT
s i m u lt a n e o u s ly.
d ) advice to t h e RESPONSIBLE ORGANIZATION:

- to ca rry out a l l adj u stment c l ea n i n g , ste r i l ization a n d d i s i n fect i o n PROCEDURES sp ecified
t h e re i n ; a n d
- t h at t h e asse m b l y of M E SYSTEMS a n d mod ifi cat i o n s d u ri n g t h e act u a l service l ife
req u i re eva l u at i o n to t h e req u i re m e nts of t h i s sta n d a r d .
1 6.3 * Power s u pply

I f ME EQUIPMENT is i ntended to rece ive its p ower from oth e r e q u i p m e nt i n a n ME SYSTEM, t h e
i n st r u ct i o n s fo r u s e s h a l l s pe c ify t h e ot h e r e q u i p m e nt s u ffi c i e n t l y to e n s u re c o m p l i a n c e with
t h e re q u i reme nts of this sta n d a rd (see 4 . 1 0 . 1 , 5 . 5 f) and 7 . 9 . 2 . 3 ) . S e e a lso F i g u re F . 5 .
1 6.4 ENCLOSURES
P a rts of n o n-ME EQUIPMENT i n t h e PAT I E NT E NV I RONMENT t h at c a n be contacted by t h e
OPERATOR d u ri n g rout i n e m a i n te n a n c e , c a l i b rati o n , e t c . after re m ova l of cove rs , co n n ectors,
etc. , wit h o ut t h e u s e of a TOOL s h a l l o p e rate at a voltage n ot exceed i n g the voltage sp ecifi e d
i n 8 . 4 . 2 c ) s u p p l ied f r o m a s o u rce t h at is s e p a rated f r o m t h e S U PPLY MAI NS by two MEANS O F
OPERATOR PROTECTION (see 8 . 5 . 1 ) .
16.5 * SE PARATIO N DEVICES

When FUNCTI ONAL CONNECTION betwe e n ME EQUIPMENT and ot h e r items of e q u i p m e nt of a n
ME SYSTEM o r other syste ms c a n c a u s e t h e a l l owa b l e va l u e s o f LEAKAGE CURRENT t o b e
exc e e d e d , th e n safety m e a s u res i n co r p o rati n g a S E PARATION DEVICE s h a l l be a p p l i e d .
T h e S E PARATION DEVICE s h a l l h ave t h e d i e l ectric stre n gt h , CRE EPAGE DI STANCES a n d A I R

CLEARANCES req u i red fo r o n e MEANS OF OPERATOR PROTECTION a p p r o p ri ate fo r t h e h i g hest
voltage o c c u r r i n g ac ross t h e S E PARATION DEVICE d u ri n g a fa u lt c o n d itio n .
T h e WORKI NG VOLTAGE s h a l l be t h e h i g h est voltage ac ross t h e S E PARATION DEVICE d u ri n g a

fa u lt c o n d i t i o n , b ut n ot less t h a n t h e MAXI M U M MAI NS VOLTAGE.
NOTE 1 For CLASS 1 e q u i pment, potential d iffe rences can occ u r between t h e protective e a rth o f t h e M E EQU I P M ENT
and the protective e a rth of other parts of the ME SYSTEM i n the absence of a common protective earth.
6060 1 - 1 © I EC : 20 0 5 - 393 -
NOTE 2 S ituations that can require a SEPARATION DEVICE i nclude F U N CT I O NAL C O N N ECTIONS to an e m e rg e ncy
calling system o r a data processing syste m .
Compliance i s checked b y the tests in 8. 8 and 8. 9.
1 6.6 * LEAKAGE CURRENTS
1 6.6.1 TOUCH CURRENT

In NORMAL CO NDITI O N , the TOUCH CURRE NT from or betwe e n p a rts of the M E SYSTEM with i n t h e
PAT I E NT ENVIRONMENT s h a l l n ot exceed 1 00 JlA.
I n the event of the interru pt i o n of a n y n o n-PE RMANE NTLY I NSTALLED PROTECTIVE EARTH
CONDUCTO R , the TOUCH CURRENT from or b etwee n pa rts of an ME SYSTEM wit h i n t h e PAT I E NT
E NV I RONMENT s h a l l n ot exceed 5 0 0 JlA.
NOTE For the purposes of this clause, the LEAKAGE C U R R ENT from accessible o uter s u rfaces of e q u i p m e nt is also
considered to be TOUCH C U R R E N T .
1 6.6.2 EARTH LEAKAGE CURRE NT o f MULTIPLE SOCKET -OUTLET

I f t h e ME SYSTEM o r p a rt of t h e ME SYSTEM is s u p p l ied from a MULTI PLE S OCKET-OUTLET, t h e n
t h e cu rrent i n t h e PROTECTIVE EARTH CON DUCTOR of t h e M U LTI PLE SOCKET-OUTLET s h a l l n o t
exceed 5 mA.
1 6.6.3 * PATIENT LEAKAGE CURRENT

The PAT I E NT LEAKAGE CURRENT and tot a l PAT I E NT LEAKAG E CURRENT of a n ME SYSTEM in NORMAL
CONDI TION s h a l l not exceed t h e va l u e s s p ecified fo r ME EQUI P M E NT, as g iven i n T a b l e 3 a n d
T a b l e 4 (see a lso 8 . 7 . 3 a n d 1 6 . 1 ) .
T h e tot a l PAT I E NT LEAKAGE CURRENT may be measu red at i n st a l l ati o n .
Compliance with th e requirements o f 1 6. 6. 1 , 1 6. 6. 2 and 1 6. 6. 3 i s checked b y inspection and

measurement using a m e asuring device as specified in 8. 7. 4. 4.
1 6.6.4 M eas u re m ents
1 6 . 6 . 4. 1 General con d itions for ME SYSTEMS
a ) Th e TOUCH CURRENT, the PATIENT LEAKAGE CURRENT and the total EARTH LEAKA GE CURRENT
of any MUL TIPLE SOCKET-OUTLET are measured after the ME S YS TEM has been brought up to
operating temperature as follows:
Th e ME S YS TEM is operated:
For ME S YS TEMS intended for n on-CONTINUOUS OPERA TION;
After operating in standby/quiescent m ode un til THERMAL S TABILI TY is reached, the
ME S YS TEM is operated in NORMAL USE over consecutive cycles un til THERMAL S TABILI TY
is again achieved, or for seven hours, whichever is shorter. Th e "on " and "off" periods
for each cycle are th e RA TED "on " and "off" periods;
For ME S YS TEMS intended for CONTINUOUS OPERA TION;
Th e ME S YS TEM is operated until THERMAL S TABILI TY is reached.
b) Th e ME S YS TEM is connected to a supply with a voltage equal to the highest RA TED MAINS
VOLTAGE. When the characteristics of an ME SYSTEM can only be m easured properly after it
has b een installed at the site of the RESPONSIBLE ORGANIZA TION, prior to its clinical use, th e
ME S YS TEM is connected to th e local SUPPL Y MAINS.
6060 1 - 1 © I EC : 20 0 5 - 395 -
NOTE Where exa m i nation of the circuit arrangement and the arrangement of com ponents a n d material of the
ME SYSTEM shows n o poss i b i l ity of any HAZA R D , the n u m be r of tests could be red uced.
1 6.6.4.2 Con nection o f t h e M E S Y S T E M t o the meas u r i n g s u p p l y c i rcu it
a) The ME S YS TEM is tested after being assembled according to its A CCOMPANYING DOCUMENTS.
b) Measuring arrangement
If an isolating transformer is not used for LEAKA GE CURRENT m easurements (e. g. when
measuring LEAKAGE CURRENT for very high input power ME S YS TEMS) , the reference earth of
the measuring circuits is connected to th e protective earth of th e SUPPL Y MAINS.
NOTE 1 I t is recom m e nded to position the measuring circuit as far a s possible away from unscreened power
s u pply leads and (unless specified otherwise i n the fo l lowing s u bclauses) to avoid placing the ME SYSTEM o n or
near a large earthed metal s u rfac e .
N O T E 2 However, A P P L I E D PARTS , i ncluding PATIENT c a b l e s (when prese nt) , should be p l a c e d o n a n insu lating
s u rface with a diel ectric constant of approximately 1 (for exa m p l e , expa nded polystyrene) and approximately
200 m m above a n earthed metal surface.
1 6.7 * P rotection aga i nst M ECHANICAL HAZARDS

If a M E CHANICA L HAZARD exists, t h e M E SYSTEM s h a l l c o m p l y with t h e a p p l i c a b l e re q u i re m e nts
of C l a u s e 9 .
Compliance i s checked by inspection o r applicable tests.
1 6.8 I nte rru ption of the power s u p p l y to parts of an ME SYSTEM

An M E SYSTEM s h a l l be so des i g n ed that a n i nterruption and restorat i o n of t h e p ower to t h e
M E SYSTEM as a w h o l e , o r a n y p a rt of t h e M E SYS T E M , s h a l l not res u lt i n a HAZARDOUS
S I TUAT I O N oth e r t h a n i nterrupt i o n of its i ntended fu n ct i o n .
Compliance i s checked by interruption a n d restoration of relevant power connections o n e at a

time and all connections simultaneously.
1 6.9 M E SYSTEM con n ections a n d w i r i n g
1 6.9.1 C o n n ection te r m i na l s a n d co n n ectors

D e s i g n a n d const r u ct i o n of e l ectrica l , h yd r a u l i c , p n e u matic a n d gas co n n e ct i o n te r m i n a l s a n d
co n n e ctors s h a l l be s u c h t h a t i n co r rect c o n n e ct i o n of access i b le co n n ectors, re mova b l e
wit h o ut t h e u s e of a TOOL, s h a l l be p revented w h e re a HAZARDOUS S I TUAT I O N co u l d oth e rwise
exist.
C o n n ecto rs s h a l l comply with 1 5 . 4 . 1 .
P l u g s fo r c o n n e ct i o n of PAT I E NT leads s h a l l b e so desig ned t h at t h e y c a n not b e c o n n ected
to oth e r o u t l ets of t h e same M E SYSTEM that a re l i kely to be located in the PAT I E NT
E NV I RO N M E N T u n less it c a n be p rove d that no HAZA RDO US S I TUAT I O N c a n res u lt.
Compliance is checked by inspection and, if possible, by interchanging connectors.

6060 1 - 1 © I EC : 20 0 5 - 397 -
1 6.9.2 M AINS PARTS, co m po n e n ts a n d l ayout
1 6.9.2. 1 * M ULTIPLE SOCKET-OUTLET
a ) A M ULTIPLE SOCKET-OUTLET s h a l l :
o n l y a l low co n n ect i o n by u s i n g a TOOL ( s e e F i g u re 1 . 1 ) , o r
be o f a type that c a n not accept MAINS PLUGS o f a n y o f t h e k i n d s specifi ed i n
I EC/TR 6 0 0 8 3 , o r
be s u p p l ied v i a a se parating tra nsfo r m e r ( s e e 1 6 . 9 . 2 . 1 d ) a n d An n ex 1 ) .
b ) A M ULTIPLE SOCKET -OUTLET:

s h a l l be ma rked with safety s i g n I S O 7 0 1 0-W00 1 (see T a b l e 0 . 2 , safety sign 2 ) s u c h
t h at i t is v i s i b l e i n NORMAL USE; a n d :
s h a l l be m a rked e i t h e r i n d iv i d u a l l y o r i n c o m b i n at i o n s , w i t h t h e maxi m u m a l l owed
conti n u o u s output in a m p e res or vo lt-a m peres, o r
s h a l l be m a rked t o i n d i cate w h i c h e q u i p m ent o r e q u i p m e nt p a rts m a y be safe ly
atta c h e d .
m a y be a s e p a rate item o r a n i ntegral p a rt of ME E Q U I P M E N T o r n o n-ME EQUI PMENT.
NOTE Each outlet d o e s not have t o be m a rked .
c) T h e M U LTIPLE SOCKET-OUTLET shall comply with IEC 6 0884-1 and the fo l l owi n g
req u i re m e nts.
CRE EPAGE DI STANCES and AIR CLEARANCES s h a l l c o m p l y with 8 . 9 .
I t s h a l l b e o f CLASS I construct i o n a n d t h e PROTECTIVE EARTH CONDUCTOR s h a l l b e
co n n ected t o t h e e a rt h i n g co ntacts i n t h e socket-o utlets.
- * PROTECTIVE EARTH TERMINALS a n d PROTECTIVE EARTH CONNECTIONS s h a l l c o m p l y with
8 . 6 , except t h at the total i m pe d a n c e of the p rotective e a rth p ath fo r a n ME SYSTEM may
be up to 400 mQ, or h ig h e r if the c o n d it i o n s of 8 . 6 . 4 b ) are satisfi e d .
ENCLOS URES s h a l l c o m p l y w i t h 8 . 4 . 2 d ) .
M A I N S TERMINAL DEVICES a n d w i r i n g s h a l l c o m p l y w i t h 8 . 1 1 . 4 , if a p p l ic a b l e .
RATI NGS of c o m p o n e nts s h a l l n ot co nfl ict with t h e c o n d it i o n s of use (see 4 . 8 ) .
D e s i g n a n d const r u ct i o n o f e l ectrical co n n ect i o n term i n a l s a n d co n n ectors o f MULTIPLE
SOCKET-OUTLETS s h a l l p reve nt t h e i n c o rrect c o n n ect i o n of access i b l e co n n ectors that
are re mova b l e wit h o ut t h e u s e of a TOOL.
Req u i re m e nts fo r the POWER SUPPLY CORD as described in 8 . 1 1 . 3 s h a l l be fulfi l le d .
d ) * If t h e M U LTIPLE SOCKET-OUTLET is co m b i n e d with a s e p a rati n g tra nsfo r m e r, t h e fo l l owi n g

a d d iti o n a l re q u i re m e nts a p p ly.
- The se parating tra nsfo r m e r s h a l l c o m p l y with t h e re q u i re m e nts of I EC 6 1 5 58-2- 1 ,
except t h e re q u i re m e nts of maxi m u m RATED o u t p ut p owe r of 1 kVA a n d deg ree of
p rotect i o n I PX4 do n ot a p p l y.
6060 1 - 1 © I EC : 20 0 5 - 399 -
NOTE 1 As a separating transformer is not a M A I N S S U P P LY TRANSFO R M E R , it does not req u i re m o re than

BAS I C I N S U LATI O N .
NOTE 2 Lim itation o f output power is n o t explained i n I E C 61 558-2-1 a n d the RATED output power i s
defi ned b y t h e fuse i n t h e i n stallation a n d b y t h e a l lowable power s u pply cable u s e d . However, the
characteristics of the separating transformer need to be carefully selected, taking into acco u nt the
va riations i n the load c u rrent of the ME SYSTEM to ensure that the voltage su pplied to the va rious ite m s of
the ME SYSTEM remains with i n the l i m its specified for the equi pment.
NOTE 3 IEC 61 558-2-1 should be used with the ge neral standard I E C 61 558- 1 .
T h e s e p a rati n g transformer a s s e m b l y s h a l l be of CLASS 1 c o n structi o n .

T h e d e g ree o f p rotect i o n a g a i n st i n g ress o f wate r a s g iven i n I EC 60529 s h a l l b e
specifi e d .
T h e s e p a rati n g transformer asse m b l y s h a l l be m a rked acc o r d i n g t o t h e req u i reme nts of
7.2 and 7.3.
T h e M U LTI PLE SOCKET-OUTLET s h a l l be p e r m a n e ntly c o n n ected t o t h e s e parating
transformer o r t h e socket-o utlet of t h e s e p a rati n g transfo rm e r asse m b l y s h a l l b e of a
type t h at c a n not accept MAINS PLUGS of a n y of t h e k i n d s i d e ntifi e d i n I E C/TR 60083
(see F i g u re 1 . 1 and F i g u re 1 . 2 ) .
Compliance i s checked by inspection a n d as describ ed i n the relevant subclauses of this

standard.
*
1 6.9.2.2 P ROTECTIVE EARTH CON NECTIONS in ME SYSTEMS
PROTECTIVE EARTH CONNECTIONS s h a l l b e made S O t h at t h e removal of any s i n g l e item of
e q u i p m e nt in the M E SYSTEM wi l l not i nterrupt the p rotective e a rt h i n g of any other p a rt of t h e
M E SYS T E M , wit h o ut a t t h e same t i m e d isco n n ecti n g t h e e l ectrical s u p p l y to t h at p a rt.
Additi o n a l PROTECTIVE EARTH CON DUCTORS s h a l l o n ly be d etac h a b l e by use of a TOOL.
1 6.9.2.3 P rotect ion o f cond uctors

C o n d u ctors t h at c o n n ect d iffe rent items of e q u i p m e nt with i n a n M E SYSTEM s h a l l b e p rotected
a g a i n st m e c h a n ical d a m a g e .
1 7 * E l e ctromag netic com pati b i l ity of M E EQU I PM E N T and M E SYST EMS
T h e MANUFACTURER shall add ress I n t h e R I S K MANAG E M E N T PROCESS t h e R I S KS asso c i ated wit h :

t h e e l ectro mag netic p h e n o m e n a exist i n g a t t h e locat i o n s w h e re t h e M E E Q U I P M E NT o r
M E SYSTEM is i ntended t o be u sed a s i n d i cated i n t h e ACCOMPANYING DOC U M E NTS; a n d
t h e i ntrod u ct i o n by t h e M E E Q U I P M E NT o r M E SYSTEM o f e l ectro mag n et i c p h e n o m e n a i nto t h e

e n vi r o n m e nt t h at m i g ht d eg rade t h e p e rfo rmance of oth e r d evices, e l ectrical e q u i p m e n t
a n d systems.
S e e IEC 6060 1 - 1 -2 a n d a lso see 1 . 3 .

6060 1 - 1 © I EC : 20 0 5 - 401 -
A nnex A
(info rmative)
G eneral g uid ance and rationale
A.1 G e n e ra l g u i d a n c e
T h e req u i re m e nts for M E EQUIPMENT a n d ME SYSTEMS d iffer fro m those fo r other k i n d s of

e lectrical e q u i p m e nt because of t h e p a rt i c u l a r re l ati o n s h i p of M E EQUIPMENT o r ME SYSTEM to
t h e PAT I E NT, t h e OPERATO R a n d t h e s u rro u n d i n g s . T h e fo l l owi n g a s p e cts p lay a n i m p o rtant r o l e
i n t h i s re l ati o n s h i p :
a ) t h e i n a b i l ity o f t h e PAT I E NT o r OPERATOR t o d etect t h e presence of certa i n HAZARDS, s u c h
a s i o n i z i n g a n d n o n - i o n i z i n g radiat i o n ;
b ) a b s e n ce o f n o rmal react i o n s o f t h e PAT I E NT w h o c a n be i l l , u n c o n s c i o u s , a n aesthetiz e d ,
i m m o b i l iz e d , etc. ;
'
c) a b s e n ce of n o rmal p rotect i o n to c u rre nts p rovi ded by t h e PAT I E NT s s k i n , if this is
p e n etrated o r t reated to obta i n a low ski n-resista nce;
d ) s u p p o rt o r re p la c e m e nt of vital body fu n ct i o n s , w h i c h d e pe n d s o n t h e re l i a b i l ity of
ME EQUIPMENT o r ME SYSTEM;
e ) t h e s i m u lt a n e o u s c o n nection to t h e PAT I E NT of more than o n e piece of ME E Q U I PMENT;
f) co m b i n at i o n of h i g h-power ME EQUIPM ENT a n d sens itive l ow-s i g n a l ME EQUI PMENT oft e n i n
a d h o c c o m b i n at i o n s ;
g ) t h e a p p l ication of e l ectri c a l c i rcu its d i rectly to t h e h u m a n b o d y, e i t h e r t h r o u g h co ntacts t o
t h e s k i n o r t h r o u g h t h e i n s e rt i o n of p r o b e s i n t o i nt e r n a l o rg a n s ;
h ) c o n d i t i o n s , p a rt i c u l a r l y i n o p e rati n g t h e atres, t h a t c a n present a co m b i n at i o n o f h u m id ity,
moistu re or fire or e x p l o s i o n HAZARDS caused by a i r, oxyg e n or n it ro u s oxide.
When ME EQUIPM ENT is combined with a n o t h e r e lectrical e q u i p me n t to fo rm a n ME SYSTEM,
a d d iti o n a l re q u i re m e nts a p p l y. T h ese are g ive n i n Clause 1 6 . In s o m e i n sta nces, refe re nce to
oth e r pa rts of this sta n d a rd is m a d e . If a c l a use o r su b c l a u s e i s s pe cific a l l y i ntended to b e
a p p l i c a b l e to ME EQUIPMENT o n ly, t h e t i t l e a n d content of t h at c l a u s e o r s u bc l a use wi l l s a y s o .
I f that is not t h e case, t h e c l a u s e o r s u bc l a u s e c o u l d b e a p p l ic a b l e to ME SYSTEMS as we l l a s
to ME EQUIPM ENT.
A.2 Safety o f M E EQU I PM E N T a n d M E SYSTEMS
BASI C SAFETY and ESSE NTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS, as described i n
I EC/TR 605 1 3 [ 1 2 ] , are p a rt o f t h e tota l safety s it u ati o n , c o m p r i s i n g safety o f ME EQUIPMENT,
safety of the i n sta l l ati o n to w h i c h the ME EQUIPMENT or ME SYSTEM is co n n e cted and safety of
a p p l icat i o n .
BASI C SAFETY a n d ESSE NTIAL PE RFORMANCE o f ME EQUIPMENT a n d ME SYSTEMS a r e req u i red fo r

NORMAL USE a n d fo r reaso n a b l y fores e e a b l e m i s u se a n d in NORMAL CONDITION a n d S I NGLE
FAULT CONDITI ONS . R e l i a b i l ity of f u n cti o n i n g is re g a rded as a safety a s p ect fo r l ife-s u p porting
ME EQUIPMENT a n d where i nterrupt i o n of a n exa m i nation o r treatment is c o n s i d e red as a
HAZARD fo r t h e PAT I E NT.
6060 1 - 1 © I EC : 20 0 5 - 403 -
Adeq u ate construct i o n , l ay-o ut a n d ACCOMPANYI NG DOCUME NTS that s e rve to p reve nt use
e rr o rs are reg a rd ed as safety aspects.
S afety precautions are cons i d e red accepta b l e if they provide a d e q u ate p rotect i o n wit h o ut a n
u n d e s i r a b l e restrict i o n of n o r m a l f u n cti o n .
G e n e ra l ly, i t is pres u m ed t h at ME EQUIPM ENT a n d ME SYSTEMS a r e o p e rated u n d e r t h e

j u risdict i o n o f q u a l ified o r l icensed p e rs o n s a n d t h at t h e OPERATOR h a s t h e s k i l l re q u i red fo r a
p a rtic u l a r m e d i c a l a p p l icat i o n a n d acts acco rd i n g to t h e i n struct i o n s fo r u s e .
T h e tot a l safety of ME EQUI PMENT c a n consist of:

i n h erent safety by d es ig n ;
p rotective measu res i n co r p o rated i nto t h e M E EQUIPMENT o r a d d iti o n a l p rotective
m e a s u re s , s u c h as t h e u se of s h i e l ds or p rotective cloth i n g ; a n d
i nfo rmat i o n for safety, s u c h as restrict i o n s i n t h e i n struct i o n s for use concern i n g t r a n s p o rt,
m o u nt i n g or positi o n i n g , c o n n ecti o n , putt i n g i nto s e rvice, o p e ration and the position of t h e
OPERATOR a n d h is/h e r assista nts i n re lation t o t h e ME EQUIPMENT d u ri n g u s e .
A.3 G u i d a n c e to the t h i rd e d it i o n
I n this e d it i o n , a n u m b e r of c l a uses a n d s u bc l a u s es from t h e s e c o n d e d it i o n h ave b e e n

de leted, e . g . w h e n t h e c l a use o r s u b c l a u s e w a s i n d i cated as " N ot u s e d . " H oweve r , t h o s e
clauses o r su b c l a u s es f r o m t h e s e c o n d e d i t i o n t h at stated " N o ge n e r a l req u i rement" h ave
b e e n reta i n e d so t h at p a rtic u l a r or c o l lateral sta n d a rds c a n refe r to t h e m . T h e statement, " N o
ge n e r a l re q u i re m e nt " , has b e e n replaced with a refe re n c e to t h e RISK MANAG EMENT PROCESS
because the " g e n e r a l req u i re m e nt" is t h at, i n the a b s e n ce of a p a rtic u l a r or c o l late ra l
sta n d a r d , these issues are d ealt with t h r o u g h t h e a p p l icat i o n of R I S K MANAG EMENT.
While p r e p a r i n g t h e th ird e d it i o n , basic safety sta n d a rds a n d I SO/I EC g u id es h ave b e e n take n

i nto c o n s i d e rat i o n to t h e extent possi b l e c o n sistent with t h e p a rticu l a r relati o n s h i p of
ME EQUIPMENT o r ME SYSTEM to t h e PATI E NT, t h e OPERATOR a n d t h e s u rro u n d i n g s .
T h e fo rmat of t h e t h i rd e d i t i o n h a s b e e n a l ig n ed w i t h t h e basic req u i re m e nts of P a rt 2 of t h e

I SO/I EC D i rective s. A l l t h e sect i o n s exce pt S ecti o n 1 of t h e second edition h ave b e e n
converted i nto maj o r c l a uses. T h i s c h a n g e was i m p le m e nted b e c a u s e secti o n s are n o l o n g e r
a l l owed u n d e r t h e d raft i n g r u l e s a n d t h e n e w n u m be r i n g system wi l l a l l ow future c h a n g es to
mod ify a c l a u s e wit h o u t affect i n g the n u m b e r of oth e r p a rts of the sta n d a rd .
T h e n o rmative refe re nces h ave b e e n m oved from A p p e n d ix L o f t h e second e d i t i o n to

C l a use 2. I nfo rm ative refe re nces a re l i sted in t h e B i b l i o g ra p hy.
T h e d efi n it i o n s i n C l a u se 3 h ave been re a r ra n g e d i nto a s i n g le a l p h a beti c a l l isting as

o rg a n iz i n g the d efi n it i o n s by cate g o ry was b e co m i n g i n creasi n g l y d iffi c u lt and the res u lt less
i ntu itive. The i n d ex has b e e n expanded to i d e ntify each page w h e re a term is used in the body
of t h e sta n d a rd . A n u m b e r of n ew defi n e d terms h ave b e e n i ntrodu ced i n s u p p o rt of n ew or
expanded req u i re m e nts.
A g e n e r a l re q u i re m e nt fo r a RISK MANAG E M E NT PROCESS has been i ntrodu ced in 4 . 2 .

6060 1 - 1 © I EC : 20 0 5 - 405 -
C l a use 8 h a s b e e n exte n s ive ly rest r u ctu red to b r i n g toget h e r in o n e c l a use t h e req u i re m e nts
re lati n g to e l ectrical safety. T h e re q u i re m e nts i n C l a u s e 8 h ave b e e n reviewed a g a i n st t h e
safety req u i reme nts fo r i nfo rmat i o n tec h n o l o g y ( I T ) e q u i p ment i n I EC 6 0 9 5 0 - 1 a n d
harmo n ized w h e re a p p ro p riate g ive n t h e p a rt i c u l a r relati o n s h i p of ME EQUIPMENT to t h e
PAT I E NT, t h e OPERATOR a n d t h e s u rro u n d i n g s .
C l a use 9 o n p rotect i o n a g a i n st MECHANICAL HAZARDS has b e e n s u bstanti a l l y revi sed to d e a l

w i t h a wide ra n g e of t h e HAZARDS t h at ME EQUIPM ENT c o u l d pose to t h e OPERATOR o r PAT I E NT.
R e q u i r e m e nts r e l at i n g to t h e mech a n i c a l stre ngth of t h e ME EQUI P M ENT when s u bj ected to the
stresses caused by p u s h i n g , i m p act, d r o p p i n g , a n d ro u g h h a n d l i n g a re i n 1 5 . 3 .
T h e sta n d a rd n o w d e a ls with USAB I L I TY i n 1 2 . 2 a s o p p osed t o " u s e r o r h u m a n e r ro rs . "
S e ct i o n s ix o f t h e second e d i t i o n o n p rotect i o n aga i n st t h e HAZARDS o f i g n it i o n o f fl a m m a b l e

a n aest h et i c m ix t u res h a s b e e n moved to a n o rmative a n n ex . W h i l e this a n n ex w a s o r i g i n a l ly
i ntended to be i nfo rmative because t h e use of such a n a e sthetics is ra re, c o m m e nts from
Nati o n a l C o m m itte es i n d i cated t h at some MANUFACTURERS m ig h t sti l l want to offer
ME EQUIPMENT fo r s u c h a p p l i cati o n s .
T h e s u rface te m p e rature l i m it i n 1 1 . 1 . 2 . 2 fo r APPLI E D PARTS t h at a r e i n co ntact with t h e

PAT I E NT fo r 1 0 m i n o r m o re has b e e n i n creased from 4 1 o c to 43 ° C . H oweve r, t h e
MANUFACTURER is to d isc lose i n t h e ACCOMPANYING DOCUME NTS if t h e s u rfa ce tempe rat u re o f
a n APPLI ED PART exceeds 4 1 ° C .
T h e req u i re m e nts of I E C 6060 1 - 1 -4 [ 1 4] fo r PROG RAM MABLE ELECTRICAL MEDICAL SYSTE MS, as
refe rred to in 5 2 . 1 of the second e d i t i o n , h ave b e e n i n corpo rated i nto the body of this
sta n d a rd i n a n ew C l a use 1 4 .
T h e req u i re m e nts of I EC 6060 1 - 1 - 1 [ 1 3] fo r ME SYSTEMS h ave b e e n i n c o r p o rated i nto t h e body

of t h i s sta n d a rd i n a n ew Clause 1 6 .
A.4 Rat i o n a l e fo r part i c u l a r c la u ses a n d s u b c la uses
The fo l l owi ng are rati o n a l e s fo r s pe c ific clauses a n d su b c l a u s e in this sta n d a rd , with c l a u s e

a n d su b c l a u se n u m be rs p a r a l l e l to t h o s e i n t h e body of t h e d o c u m e nt.
S u bclause 1 . 1 - Scope
The scope of this sta n d a rd is esta b l i s h e d by the refe re n ce to t h e d efi n it i o n s of ME EQUIPMENT

a n d ME SYSTEMS. T h i s is to clearly defi n e t h e scope of t h i s sta n d a rd as c o m p a red with
req u i re m e nts fo r oth e r types of e l ectrical e q u i p ment.
Labo rato ry e q u i p m e nt with i n t h e scope of IEC 6 1 0 1 0- 1 [22] is not cove re d by t h i s sta n d a rd

except w h e n a MANUFACTURER i n corporates s u c h l a b o ratory e q u i p me n t i nto an ME SYSTEM.
T h i s sta n d a rd d o es n ot apply to active i m p l a nt a b l e m e d i c a l d evices cove red by t h e I S O

1 4 708-1 [3 1 ] except where t h e I S O 1 4 708-1 re q u i res c o m p l ia n ce with I EC 606 0 1 - 1 .
T h i s sta n d a rd d o es n ot a p p l y to a n y oth e r e l e ctrical e q u i p m e nt u n less it fa l l s u n d e r t h e

defi n it i o n of ME EQUIPM ENT o r ME SYSTEMS.
6060 1 - 1 © I EC : 20 0 5 - 407 -
S u bclause 1 .3 - Co l l ateral standards
C o l l ateral sta n d a rds are a ve h i c l e deve l o ped by T e c h n ical C o m m ittee 62 as a way of

exte n d i n g the g e n e r a l sta n d a rd . C o l l ateral sta n d ards fa l l i nto two cate g o r i e s :
- sta n d a rds t h at add ress add itio n a l BAS I C SAFETY a n d E S S E NTIAL P E RFORMANCE req u i re m e nts
t h at are c o m m o n to a s u b g ro u p of M E E Q U I P M ENT. F o r exa m p l e , S u bco m m ittee 6 2 8
deve l o p e d I EC 6060 1 - 1 -3 to p rovi de g e n e ra l req u i re m e nts fo r p rotect i o n a g a i n st i o n iz i n g
rad iation i n m e d i c a l d i ag n ostic X-ray e q u i p m e nt i n o r d e r t h at t h e d o s e e q u iva l e n t to t h e
PAT I E NT , t h e O P E RATOR a n d o t h e r staff can be k e p t as low as reas o n a b l y a c h ieva b l e ; o r
- sta n d a rds that add ress a d d it i o n a l BAS I C SAFETY o r E S S E NTIAL P E RFORMANCE req u i re m e nts
t h at d e a l with c h a racte ristic of M E E Q U I P M E NT or M E SYSTEMS t h at a re n ot fu l l y cove red by
the g e n e r a l sta n d a rd . At t h e t i m e of p u b l icat i o n , t h ree co l l ateral sta n d ards in t h i s category
h ave been p u b l i s h e d by S u b c o m m ittee 62A: EMC ( I EC 6060 1 - 1 -2 ) , U sa b i l ity ( I E C 6060 1 -
1 -6 ) a n d Alarm systems ( I EC 6060 1 - 1 -8 ) .
T h e editions o f I EC 6060 1 - 1 -2 , I E C 6060 1 - 1 -3 , I E C 6060 1 - 1 -6 a n d I EC 6060 1 - 1 -8 exist i n g at
t h e t i m e of p u b l icat i o n of t h i s t h i rd e d it i o n of t h e ge n e r a l sta n d a rd were a l l d eveloped i n
re lation t o t h e second e d iti o n o f t h e g e n e r a l sta n d a rd ( I E C 6060 1 - 1 : 1 98 8 ) . I t i s i ntended t h at
revised editions of these c o l l ateral sta n d ards, re l ati ng s pecifica l l y to t h i s t h i rd e d i t i o n , wi l l be
deve l o p e d a n d p u b l i s h e d as s o o n as possi b l e . As stated i n 1 . 3 , these wi l l become n o rmative
at the date of t h e i r p u b l icat i o n and s h a l l a p p l y toget h e r with th is sta n d a rd .
U nt i l s u c h n ew e d iti o n s of t h e s e c o l lateral sta n d ards a r e p u b l i s h e d , u s e rs of t h i s sta n d a rd

s h o u l d a p p l y t h e exist i n g e d it i o n s as fa r as poss i b l e w h e n they a re r e l evant to t h e
M E E Q U I P M E N T o r M E SYSTEM c o n c e r n e d . H oweve r some req u i re m e nts of t h e s e c o l late ra l
sta n d a rds m i g h t n ot be c o m p at i b l e with t h i s sta n d a rd .
T h e req u i reme nts fro m two o f t h e co l l ateral sta n d a rds deve l o p e d fo r t h e second edition of
I EC 6060 1 - 1 h ave b e e n i n co r p o rated into the body of t h i s sta n d a rd . T h e y are:
I EC 6060 1 - 1 - 1 : 20 0 0 , Medical electrical equipment - Gen eral requirements for safety -
Collateral standard: Safety requirements for medical electrical systems
I EC 606 0 1 - 1 -4 : 1 996, Medical electrical equipment - Part 1: General requirements for
safety - 4. Collateral stan dard: Program mable electrical medical systems a n d its
A m e n d m e nt 1 ( 1 9 9 9 ) 1 9)
_
W h i l e b oth sta n d a rds wi l l re m a i n active u nt i l a l l t h e p a rtic u l a r sta n d a rds based o n t h e second

e d i t i o n of I EC 6060 1 - 1 h ave been a l i g n ed with t h i s sta n d a rd , they are n ot a p p l i c a b l e when
a p p l y i n g t h i s sta n d a r d .
Additi o n a l c o l late ra l sta n d a rds c a n be p u b l i s h e d f r o m t i m e t o time as needs are i d e ntifi e d .

W h i l e t h o s e sta n d ards w i l l n ot be m e n t i o n e d i n t h i s sta n d a rd , t h e y sti l l esta b l is h ge n e r a l
req u i re m e nts t h at need to b e consid ered w h e n a p p l i c a b l e . R e a d e rs are e n co u raged to c o n s u lt
t h e reg iste rs of cu rrently va l i d I nternati o n a l Sta n d a rds m a i n ta i n e d by t h e i r natio n a l sta n d a rds
body to see what a p p l i c a b l e co l l ateral sta n d a rds h ave b e e n p u b l is h e d .
S u bclause 1 .4 - Part i c u l a r sta n d a rd s
A p a rt i c u l a r sta n d a rd c a n specify:
- c l a u ses o r su b c l a u s es of this sta n d ard that a p p l y wit h o ut a m e n d m e nt;
- clauses o r su bcla uses ( o r p a rts of t h e m ) of t h i s sta n d a rd t h at d o n ot a p p l y;
1 9) There exists a conso lidated edition 1 . 1 (2000) i ncluding I E C 6060 1 - 1 -4 ( 1 996) and its Ame ndment 1 ( 1 999).
6060 1 - 1 © I EC : 20 0 5 - 409 -
clauses o r su b c l a u s es ( o r p a rts of t h e m ) of t h i s sta n d a rd t h at are re p l aced by c l a uses o r

s u b c l a uses i n t h e p a rticu l a r sta n d a rd ; o r
a d d it i o n a l c l a u s es o r s u b c l a u s es.
A p a rt i c u l a r sta n d ard c a n co nta i n :

a ) req u i re m e nts t h at res u lt i n a n i n crease o f BAS I C SAFETY o r ESS E NTIAL PE RFORMANCE ;
b) req u i re m e nts that c a n be less stri n g e nt t h a n t h e req u i re m e nts i n t h i s sta n d a rd , if t h e l atte r
can not be m a i nt a i n e d because of, for exa m p l e , t h e power o u t p ut of ME EQUIPMENT;
c) req u i re m e nts c o n ce r n i n g p e rfo r m a n c e , re l i a b i l ity, i nt e rfaces, etc. ;
d) accu racy of wo rki ng d at a ; o r
e ) ext e n s i o n a n d l i m itat i o n o f e nviron mental c o n d it i o n s .
C l a use 2 - N o r m ative referen ces
T h i s c l a u s e p rovides a l i st of the d o c u m e nts cited in oth e r n o r m ative pa rts of t h i s sta n d ard i n

s u c h a way a s t o make t h e m i n d is p e n s a b l e fo r t h e a p p l ication o f t h e docu ment. H oweve r,
confo r m a n ce with t h e d o c u m e nts in this l ist is req u i red o n ly to the exte nt that they are
refe renced in a n o rmative re q u i re m e nt i n this sta n d a r d . For exa m p l e , if a refe re n c e is made to
a s pe c ific c l a u s e , s u bc l a u s e , table o r fig u re, then the user of this standard is o n ly req u i red to
conform to the req u i rements i n that c l a u s e , su b c l a u s e , table or fig u re in order to satisfy the
req u i rement in this standard.
U n dated refe re nces are made o n ly to a c o m p l ete docu ment o r to a m aj o r p a rt t h e reof and o n l y
i f i t is a cc e pted t h a t i t w i l l be poss i b l e t o u s e a l l futu re c h a n g e s o f t h e refe re nced docu ment
fo r t h e p u rposes of this sta n d a rd . For exa m p l e , a n u n d ated refe re nce is made to I EC 60529
because it is i ntended t h at t h e MANUFACTURER wi l l a lways u s e t h e l atest e d it i o n of that
sta n d a rd w h e n ass i g n i n g IP Codes to E NCLOS URES.
U n dated refe re nces are u n d e rstood to i n c l u d e all a m e n d m e nts to a n d revi s i o n s of t h e

refe renced d o c u m e nt.
Dated references are made when the req u irements of a particular edition are to be used to satisfy a
req u i rement of this standard. S u bseq uent amendments to, or revisions of, dated references will need
to be i ncorporated by amendment of this standard. For example, a dated reference is made to
IEC 60825-1 because relevant parts of that standard are applied to light emitting diodes (LEOs) and
I EC/TC 76 was in t h e early stages of deve l o p i n g a t h i rd e d i t i o n of IEC 60825-1 and was
c o n s i d e r i n g re movi n g t h e req u i re m e nts for L E O s .
References t o specific clauses, su bclauses, tables a n d figures o f another docu ment are always dated.
Cla use 3 - Te rm i n o l o g y a n d defi n itions
This clause contains definitions for terms that are necessary for t h e understanding o f t h e req u i rements
in this standard. M a n y of these terms are i n h e r ited from t h e second e d it i o n . H oweve r , a n u m b e r
o f terms h ave b e e n added d u ri n g t h e c o u rse o f deve l o p i n g n ew o r modified re q u i re m e nts.
Where pos s i b l e , exist i n g defi n it i o n s in oth e r sta n d a rds h ave been c o p i e d or a d a pted.
Except w h e n u sed to su p p o rt other defi n ed terms, a defi n it i o n is o n ly p rovi ded if t h e term is

used m o re t h a n o n ce i n t h e text of t h e sta n d ard.
6060 1 - 1 © I EC : 20 0 5 - 41 1 -
Defi n e d terms are p r i nted i n S MALL CAPITALS to assist t h e re a d e r i n i d e ntify i n g t h e m in t h e

body of t h e sta n d a rd . When n o r m a l c a s e is u se d , t h e words h ave t h e i r n o r m a l E n g l i s h
mea n i n g . T h e c o m m ittee m a d e a n effort to avo id u s i n g t h e s a m e word b oth as a d efi ned term
and in its n o rmal E n g l is h m e a n i n g . At times this h a s n ot been possi b l e . F o r exa m p l e , the word
" p roc e d u re" is used as a defi n e d term in Start- u p PROCE DURE , s pe c ifi c a l l y m e a n i n g a " s pec ific
way to p e rfo rm a n activity" of start i n g up the ME EQUIPMENT or ME SYSTE M. It is also used i n t h e
defi n it i o n of PAT I E NT accord i n g to i t s g e n e r a l E n g l i s h m e a n i n g , i . e . " Livi n g b e i n g ( pe rs o n o r
a n i m a l ) u n d e rgo i n g a m e d i c a l , s u rg i c a l o r d e ntal p roced u r e . "
S u bclause 3 . 8 - APPL I E D PART
P a rts t h at co ntact PAT I E NTS c a n present g reater HAZARDS t h a n o t h e r pa rts of t h e E NCLOS URE,
a n d t h ese APPLI ED PARTS are t h e refo re s u bj e ct to m o re stri n g e n t re q u i re me nts, fo r exa m p l e ,
fo r t e m p e ratu re l i m its a n d ( accord i n g t o clas sificati o n B/BF/CF) fo r LEAKAGE CURRENT.
NOTE S o m e other ACCESS I B L E PARTS of the E N C L O S U R ES of ME EQU I PM E NT a re s u bject to tests that a re m o re
demanding than those for ENCLOS U R ES of oth e r kinds of e q u i pment, because the PAT I E N T can touch t h e m , or the
OPERATOR can to uch them and the PATIENT s i m u ltaneously.
In o rd e r to d eterm i n e w h i c h req u i re m e nts a p p ly, it is necessary to d ist i n g u i s h b etwe e n

APPLI ED PARTS a n d pa rts that are s i m p l y c o n s i d e red as t h e E NCLOSURE.
Thus, typ i c a l l y:
an i nfrared therapy l a m p d oes not h ave a n APPLI E D PART b e c a u s e it does n ot need to be
brought i nto d i rect co ntact with t h e PAT I E NT;
- t h e o n l y p a rt of an X-ray t a b l e t h at is an APPLI ED PART is t h e t o p on w h i c h t h e PAT I E NT l i es;
l i kewise, i n a n M R I s c a n n e r , t h e o n ly APPLI E D PART is t h e ta b l e s u p p o rt i n g t h e PATI E NT.
H oweve r , a p a rt t h at u n i ntenti o n a l ly comes i nto contact with a n u n c o n s c i o u s , a n a esthetized o r

i n capa citated PAT I E NT c a n present t h e s a m e RISKS a s a n APPLI ED PART that necess a r i l y h a s to
contact t h e PAT I E NT. On t h e oth e r h a n d , a p a rt t h at an active PATI ENT c a n reach o u t a n d t o u c h
m i g ht pres e nt n o m o re RISK t o t h at PAT I E NT t h a n it prese nts to a n OPERATOR.
The d efi n it i o n in the fi rst and second editions of t h i s sta n d a rd fa i l e d to a d d ress t h i s p r o b l e m .

T h e s e c o n d a m e n d m e nt to t h e second e d i t i o n exte nded t h e d efi n it i o n to i n c l u d e p a rts t h at c a n
be b r o u g ht i nto co ntact w i t h t h e PATI E NT, b u t t h e n ew defi n it i o n co nti n u ed to c a u se d iffi c u lties.
In t h i s e d it i o n , su b c l a u se 4.6 req u i res t h e RISK MANAG EMENT PROCESS to i d e ntify w h i c h p a rts,

oth e r than APPLI ED PARTS , are s u bj ect to t h e same req u i reme nts as APPLI ED PARTS. These can
i n c l u d e p a rts of n o n-ME EQUIPMENT i n a n ME SYSTEM.
P a rtic u la r sta n d a rds s h o u ld s pe c ifica l l y i d e ntify t h e APPLI ED PART(s) i n p a rticu l a r types of

ME EQUI PMENT.
In o rd e r to assess which p a rts are APPLI ED PARTS and w h at are the PAT I E NT CONNECTI ONS, the
fo l l owi ng PROCESS is e m p loyed in t h e o rd e r s h own .
a) D ete r m i n e whether t h e ME EQUIPMENT h a s a n APPLI ED PART , a n d if it h as, i d e ntify t h e extent

of t h e APPLI ED PART (these d ec i s i o n s being based o n n o n-elect r i c a l cons i d e rat i o n s ) .
b ) I f t h e re is n o APPLI E D PART, there a r e n o PAT I E NT CONNECTI O N ( S ) .
c) I f there is a n APPLI ED PART, there c a n b e o n e o r m o re PATI E N T CONNECTION(S). Eve n if t h e

APPLI ED PART has n o accessi b l e c o n d u ctive p a rts, fo i l a p p l ied i n accord a n c e with 8 . 7 . 4 . 7 i s
reg a rd ed as o n e PAT I E NT CONNECTI ON.
6060 1 - 1 © I EC : 20 0 5 - 413 -
d) Where a co n d u ctive p a rt of t h e APPLI E D PART is n ot i n d i rect c o ntact with t h e PAT I E NT , but is

not s e p a rated a n d cu rrent c a n flow t h ro u g h s u c h a p a rt to o r from t h e PAT I E NT , it is to b e
treated as a n i n d iv i d u a l PAT I E NT CONNECTI O N .
NOTE Relevant separation req u i re m e nts are those that relate to M EA N S OF PAT I E N T PROTECTION .
An APPLI E D PART c a n i n c l u d e o n e o r m o re fu n ct i o n s . Each fu n ct i o n c a n i n cl u d e o n e o r more

PAT I E NT CONN ECTI O N S . A PAT I E NT CONNECTI O N c a n be a n e l e ctrode t h at is i n te n d e d to ca rry
c u r rent; or the e l ectrical c o n n ect i o n can b e i n c i d ental to the p u rp o s e , for exa m p l e with a n
i nt ra-vas c u l a r f l u i d l i n e o r a PAT I E NT s u p p o rt.
S e e a lso t h e rati o n a l e fo r 3 . 7 8 .
F i g u re A. 1 to F i g u re A . 7 ( i n c l u s ive) p rovide examples of t h e way i n w h i c h APPLI E D PARTS a n d

PAT I E NT CONNECTIONS are i d e ntified i n o r d e r to a p p l y t h e re q u i r e m e nts fo r PAT I E NT LEAKAGE
CURRENT a n d PAT I E NT AUXI LIARY CURRENT in various M E E Q U I P M E NT a n d M E SYSTE M S .
F i g u re A. 1 a n d F i g u re A . 2 s h ows a n E C G m o n itor t h at i n c l u d e s t h e E C G mo n itor, t h e PAT I E NT

c a b l e , PAT I E NT leads a n d t h e E C G e l ectrodes. I n F i g u re A. 1 a n d F i g u re A. 2 :
T h e APPLI E D PART i n c l udes t h e e l ectrodes a n d th ose p a rts of t h e PAT I E NT l e a d s t h at n eed to
p h ys i ca l l y contact t h e PAT I E N T i n N O R M A L U S E .
- A p p l icat i o n of R I S K MANAG E M E N T m i g ht i d e ntify ot h e r p a rts of t h e PAT I E NT c a b l e h ave to b e
treated as APPLI E D PARTS because of t h e p ro b a b i l ity t h e y w i l l come i n contact w i t h t h e
PAT I E NT .
T h e PAT I E NT CONNECTIONS consist of the E C G e l e ctrod es, w h i c h are all p a rt of t h e same
�, -,�
fu nction of t h e APPLI E D PART.
M E_
EO
__
U IP M E N T
____
________________ ______________
APPLIED PART and parts

that have to be treated as
APPLIED PARTS
ECG PATIENT cable ECG electrodes
ECG monitor
.
'
///
i
d.t�
/
/ i
•
'
ECG electrode detail
APPLIED PART y � PATIENT CONN ECTION

IEC 2423105
F i g u re A. 1 - I d e n t ification of M E EQU I P M E NT, APPLI E D PARTS a n d PATI ENT CONNECTIONS

in an ECG m o n itor
F i g u re A . 2 s h ows t h e re q u i red F-TYPE APPLI E D PART i n s u l at i o n . The pa rts with i n the d otted l i n e
a r e t h e PAT I E NT c i rc u it.
6060 1 - 1 © I EC : 20 0 5 - 415 -
I n F i g u re A . 2 t h e req u i red APPLI ED PART i n s u lation i s :

,
o n e MEANS OF PATIENT PROTECTION between e a rth a n d p a rts with i n t h e dotted l i n e b a s e d o n

t h e MAINS VOLTAGE;
- two MEANS OF PATIENT PROTECTION betwe e n e a rth a n d p a rts wit h i n t h e dotted l i n e based o n
t h e voltage carried by these p a rts; a n d
��---------------M_E_E_OU__I PM_E_NT
- two MEANS OF PATIENT PROTECTION between l ive pa rts ( i n c l u d i n g m a i n s ) a n d t h e pa rts
��
wit h i n t h e dotted l i n e .
______________

APPLIED PARTS
IEC 2424105
F i g u re A.2 - Exam p l e of the i ns u lation of an F -TYPE APPLI E D PART

with the i ns u lation i n corporated in the ME EQUIPMENT
F i g u re A. 3 sh ows a n F-TYPE APPLI E D PART with t h e i n s u l at i o n i n c o r p o rated i n a transd ucer. The

pa rts wit h i n t h e dotted l i n e are t h e PAT I E NT c i rcu it. T h e re are p a rts o utside t h e dotted l i n e that
are s u bj e ct to t h e req u i re m e nts fo r APPLI ED PARTS as d eterm i n e d t h r o u g h t h e RISK
MANAG E M E NT PROCES S .
6060 1 - 1 © I EC : 20 0 5 - 417 -
��--------------_M_E _EO_U_IP_M_E_NT ______________

��
APPLIED PARTS
PATIENT monitor
I nvasive pressure Pressure monitoring

Pressure transducer line with electrically PATIENT CONN ECTION
conducting fluid
IEC 2425105
F i g u re A.3 - I d e n t ification of M E EQU I P M E NT, APPLI E D PARTS a n d PATI ENT CONNECTIONS

in a PATIENT m o n itor with i nvasive p ress u re m o n ito r i n g fac i l ity
F i g u re A. 4 s h ows a PAT I E NT m o n it o r with ECG and i nvas ive press u re m o n itoring fa c i l ities. I n
t h i s exa m p l e :
T h e ME EQUIPMENT i n c l u d es t h e E C G m o n itor; t h e E C G PATI E NT c a b l e a n d its e lectrodes;
a n d t h e p ress u re transd u ce r a n d its fl u i d fi l l e d l i n e .
T h e APPLI ED PART(s) i n c l u d e t h e E C G e l ectrodes a n d those p a rts o f t h e PAT I E NT c a b l e that
need to p h ys i ca l l y contact t h e PAT I E NT i n NORMAL usE; and t h e fl u i d fi l l e d p ress u re
m o n it o r i n g l i n e .
- A p p l icat i o n of RISK MANAG EMENT m i g h t i d e ntify other p a rts of t h e E C G PAT I E NT c a b l e o r t h e
p ress u r e tra n s d u c e r t h at h ave to be treated as APPLI E D PARTS beca u s e of t h e proba b i l ity
they wi l l come in co ntact with t h e PAT I E NT.
T h e E C G PAT I E NT CONNECTIONS cons ist of t h e E C G e l ectro des.
T h e p ress u re m o n itoring PAT I E NT CONNECTI ON cons ists of t h e e l ectrica l l y c o n d u ct i n g fl u i d in
t h e p ress u re l i n e . F o r t h e m e a s u r e m e nt of PAT I E NT LEAKAGE CURRENT a n d PAT I E NT
AUXILIARY CURRENT, an e l ectrode is p l aced i n t h e e l ectrica l l y c o n d u cti ng fl u id a n d treated
as a s i n g le PAT I E NT CONNECTI O N .
I f t h e PAT I E NT CON NECTI ONS assoc iated w i t h t h e E C G fu n ct i o n a re not e l ectr i c a l l y s e p a rated
from the PAT I E NT CONNECTION associated with the p ress u r e m o n it o r i n g fu n ct i o n , t h ese are
treated as two fu n cti o n s of the s a m e APPLI ED PART.
I f the PAT I E NT CONNECTIONS assoc iated with the ECG fu n ct i o n are e lectrica l l y s e p a rated
from the PAT I E NT CONNECTION associated with the p ress u r e m o n it o r i n g fu n ct i o n , t h ese are
treated as s e p a rate APPLI E D PARTs.
��--------------M_E_E_O_U_IP_M_E_N T
6060 1 - 1 © I EC : 20 0 5 - 419 -
______________
__ �
APPLIED PARTS
ECG PATIENT lead
PATIENT monitor
I nvasive pressure Pressure monitoring

Pressure transducer line with electrically PATIENT CONNECTION
conducting fluid
IEC 2426105
F i g u re A.4 - I d e n t ification of M E EQU I P M E NT, APPLI E D PARTS a n d PATI ENT CONNECTIONS

in a m u ltifu nction PATIENT m o n i tor with i nvas ive p res s u r e m o n ito r i n g fac i l ities
F i g u re A. 5 sh ows a n X-ray M E SYSTEM in w h i c h :

T h e M E SYSTEM i n c l u d es t h e X-ray t u b e assembly, t h e X-ray t a b l e a n d t h e w a l l sta n d ,
w h i c h a r e a l l ite m s o f M E E Q U I P M E NT. Oth e r p a rts o f t h e M E SYSTEM s u c h a s t h e X-ray
g e n e rator and O P E RATOR c o n s o l e are n ot s h own .
T h e APPLI E D PART ( s ) i n c l u d e t h e t o p of t h e ta b l e a n d t h e fro nt of t h e w a l l sta n d , as th ese
pa rts need to p h ys i ca l ly contact t h e PAT I E NT in NORMAL U S E .
T h e a p p l ication of R I S K MANAG E M E NT m i g ht i d e ntify some pa rts of t h e t u b e assembly a n d
some oth e r p a rts of t h e t a b l e a n d t h e wa l l sta n d h ave t o b e treated as APPLI E D PARTS
because of t h e p r o b a b i l ity t h e y w i l l come in contact with t h e PAT I E NT .
T h e PAT I E NT CO N N ECTI ONS consist of t h e co n d u ctive p a rts of these APPLI E D PARTS that
e lectri c a l l y co ntact t h e PAT I E N T .
T h e MANUFACTU RER c a n spec ify t h at t h e table a n d t h e wa l l sta nd are d iffe rent f u n ct i o n s of
t h e same APPLI E D PART.
- Alte r n ative ly, t h e MANUFACTU RER c a n s pec ify that t h e t a b l e a n d t h e wa l l stand are d i ffe rent
APPLI E D PARTS .
6060 1 - 1 © I EC : 20 0 5 - 421 -
�, ________________
E S ST E
M___ Y___ M________________ �
Wall stand
APPLIED PARTS
X-ray source
assembly -
n
U
PATIENT support
IEC 2427105
F i g u re A . 5 - I d e n t ification of APPL I E D PARTS a n d PAT I E NT CONNECTIONS

in an X-ray M E SYSTEM
F i g u re A. 6 s h ows a transcuta n e o u s e l ectro n i c n e rve sti m u l ator ( T E N S ) t h at is i ntended to be

' '
wo r n on t h e PAT I E NT s b e lt and c o n n ected to e l ectrod es a p p l ied to the PAT I E NT s u p pe r arm. I n
t h i s case:
T h e ME EQUIPMENT i n c l u d es t h e TENS st i m u l ator, t h e e l ectrod e cable a n d t h e e l e ctrod es.
T h e APPLI ED PART i n c l u d e s t h e e lectrodes a n d those p a rts of t h e e l ectrode leads that
p h ys i ca l l y need to contact t h e PAT I E NT i n NORMAL USE.
T h e a p p l icat i o n of RISK MANAG E M E NT might i d e ntify that t h e case of t h e sti m u l at o r a n d its
b e lt c l i p a l s o h ave to be treated as APPLI ED PARTS because of t h e p ro b a b i l ity t h e y wi l l come
i n co ntact with t h e PAT I E NT.
T h e PAT I E NT CONNECTIONS consist of t h e e l ectro des, which are all p a rt of t h e same fu n ct i o n
of t h i s APPLI ED PART.
Skin electrodes
lT
IH
APPLIED PARTS
¥
�
TENS
I
with belt clip
IEC 2428105
F i g u re A.6 - I d e n t ification of M E EQU I P M E NT, APPLI E D PARTS a n d PATI ENT CONNECTIONS i n a

transcutaneous e l ectro n i c n e rve st i m u lator ( T E N S) i n tended to be worn on the PATIENT's
belt and co n n ected to e l ectrodes a p p l ied to t h e PATI ENT's u p per arm
6060 1 - 1 © I EC : 20 0 5 - 423 -
F i g u re A . 7 sh ows an E C G p rocess i n g ME EQUIPMENT I ME SYSTEM i n w h i c h :

T h e ME SYSTEM i n c l u d es t h e E C G mod u l e , PAT I E NT c a b l e a n d e l ectro des, a n d t h e p e rs o n a l
com puter a n d a n y of its ACCESSORIES ( n ot s h own ) .
T h e MANUFACTURER c a n c h oose t o s pe c ify o n e o f t h e fo l l owi n g s ituati o n s :
T h e E C G m o d u l e a n d its PAT I E NT c a b l e a n d e l e ctrodes a r e a n item of M E EQUIPMENT;
a n d t h e p e rso n a l c o m p uter is n ot a n item of ME EQUIPMENT. T h i s w o u l d b e a n
ME SYSTEM.
T h e E C G module a n d its PAT I E NT c a b l e a n d e l ectrodes a r e one item of ME EQUIPMENT;
a n d t h e p e rs o n a l c o m p ut e r is a s e p a rate item of ME EQUI PMENT. T h i s w o u l d a lso be an
ME SYSTEM.
T h e E C G module a n d its PAT I E NT c a b l e a n d e l ectrodes toget h e r with t h e p e rs o n a l
com puter is a s i n g l e ite m of ME EQUIPMENT a n d n ot a n ME SYSTE M .
T h e APPLI ED PART i n c l udes t h e e l ectrodes a n d t h o s e p a rts of t h e PAT I E NT c a b l e t h a t need t o
p h ys i ca l l y contact t h e PATIENT i n NORMAL U S E .
- A p p l icat i o n of RISK MANAG EMENT m i g ht i d e ntify ot h e r p a rts of t h e PAT I E NT c a b l e h ave to b e
treated as APPLI E D PARTS because of t h e p ro b a b i l ity t h e y w i l l come i n contact w i t h t h e
PAT I E NT.
T h e PAT I E NT CONNECTIONS consist of the E C G e l e ctrod es, w h i c h are all p a rt of t h e same
fu nction of t h e APPLI ED PART.
Personal computer
ECG electrodes
APPLIED PART
and parts
that have to be
treated as
APPLIED PARTS
� /
ECG mod"O /
ECG PATIENT cable
IEC 2429105
F i g u re A.7 - I d e n t ification of M E EQUIPMENT o r M E SYSTEM, APPL I E D PARTS a n d PATI ENT

CONNECTIONS i n a personal com p u ter with a n ECG m od u le
S u bclause 3 . 9 - BAS IC INS ULATION
T h i s defi n it i o n d o es n ot i n c l u d e i n s u l ati o n used exclu sive ly for fu n cti o n a l p u r poses.
S u bclause 3 . 1 0 - BAS IC SAFETY
BASI C SAFETY relates to a device not h a r m i n g the PATIENT i n c i d e n t a l to its o p e rati o n .
BASI C SAFETY is often a passive fo rm o f p rotect i o n ( s u c h a s radiation s h i e l d i n g o r e l ectrical

g ro u n d i n g ) .
6060 1 - 1 © I EC : 20 0 5 - 425 -
ESSENTIAL PERFORMANCE g e n e ra l l y re l ates to ME EQUIPMENT o r ME SYSTERMS o perating as

i ntended wit h o ut creat i n g a HAZARD. A fa i l u re of ESSE NTIAL PE RFORMANCE c a n be e it h e r a lack
of p e rfo rm a n c e ( s u c h as l ife s u p po rt i n g p e rfo r m a n ce ) o r i n c o rrect p e rfo rmance ( s u c h as
d e l ivering a n i n c o rrect dose to t h e PAT I E NT).
In ge n e r a l , BAS I C SAFETY re l ates to p r o d u ct p r o p e rties t h at a re n ot d evice s pe c ific and

ESSE NTIAL PERFORMANCE re l ates to a c l ass of p r o d u cts (such as a defi b r i l l at o rs being able to
d e l iver the correct e l ectri c a l s h ock).
W h i l e t h e terms BAS I C SAFETY a n d ESSE NTIAL PE RFORMANCE are g e n e r a l l y cons i d e red to b e

mutu a l ly exc l u s ive, t h e re are s o m e HAZARDS t h at m a y r e l ate to b o t h BAS I C SAFETY a n d
ESSENTIAL PE RFORMANCE c o n c u rrently.
S u bclause 3 . 1 7 - COMPONENT WITH HIGH-INTE G RITY CHARACTERISITCS
The c o n c e pt of h i g h - i ntegrity refers o n ly to s pecific c h a racte rist i cs of the c o m p o n e nt. T h e s e

characteristics are re l i e d u p o n to e n s u re safety of t h e p rod u ct. S u c h a COMPONENT W I T H H I G H
I NTEGRITY CHARACTE RISTICS s h o u l d be i d e ntified in t h e ACCOM PANY I NG DOCU MENTS by t h e
MANUFACTURER ( e . g . fo r m a i n te n a n c e ) . S e e a lso t h e rati o n a l e fo r 4 . 9 .
S u bclause 3 . 1 8 - CONTINUOUS OPERATION
While t h e terms CONTI N UOUS OPERATION o r n o n -CONTI NUOUS OPERATION are used with regard to
the ME EQUIPMENT, p a rts of the ME EQUIPMENT can b e RATED d iffere ntly. For exa m p l e , an
e lectro s u r g i c a l g e n e rator m i g ht b e RATED fo r CONTI NUOUS OPERATION wh i l e the APPLI ED PART is
RATED fo r n o n-CONTI NUOUS OPERATI O N .
S u bclause 3.20 - D E F I B RI L LATION-PROOF A P P L I E D PART
A DEFIBRI LLATI ON-PROOF APPLI ED PART is protected o n ly aga i n st d isch arges of d efi b r i l l ators
c o m p l y i n g with I EC 6060 1 -2-4 [ 1 5 ] . H i g h e r voltage d efi b r i l l ators c o u l d d a mage DEFIBRI LLATION
PROOF APPLI ED PARTS .
S u bclause 3 . 2 1 - DETAC HABLE POWER S UPPLY CORD
Cord sets are covered by I EC 60320- 1 .
S u bclause 3.22 - DIRECT CARDIAC APPLICATI ON
A d isti n ct i o n is made b etwe e n u se of APPLI ED PARTS t h at m ig h t c o m e i n d i rect co ntact with t h e

'
PAT I E NT s h e a rt a n d a l l other circu msta nces of contact w i t h t h e PAT I E NT. Ventricu l a r f i b r i l lation
can be caused by a m u c h smaller c u rrent flowi n g through a small co ntact area where a wire
o r cat h eter makes d i rect contact with t h e h e a rt t h a n a cu rrent flowi n g t h r o u g h any oth e r p o i nt
'
of co ntact on o r i n t h e PAT I E NT s body.
S u bclause 3.23 - DOUBLE INS ULATION
BASI C I NS U LATI ON a n d SUPPLEME NTARY I NS U LATI ON can, if req u i red, be tested s e p a rately.
Where m u lt i p l e l aye rs of i n s u lation c a n n ot b e tested s e p a rately, t h e i n s u lat i o n system is
c o n s i d e red as REI NFORCED I NS U LATI O N .
S u bclause 3.24 - DUTY CYCLE
The terms " o n t i m e " and " off t i m e " are cons i d e red to i n c l u d e " b u rsts" of o p e ration a n d
de activation as we l l as CONTI NUOUS OPERATI O N .
6060 1 - 1 © I EC : 20 0 5 - 427 -
S u bclause 3.26 - E NCLOSURE
T h e E NCLOSURE of ME EQUI PMENT o r ME EQUIPMENT p a rts i n c l u d es a l l ACCESS I BLE PARTS , k n o b s ,

g ri p s , c a b l e s , c o n n ectors a n d t h e l i ke . T h i s i n c l u d e s a n y ACCESSIBLE PARTS of exte r n a l
co n n e ct i o n s betwe e n ot h e r s e p a rate p a rts.
S u bclause 3.27 - ESSENTIAL PERFORAM NCE
It has l o n g been recogn ized t h at ME EQUIPMENT t h at d oes n ot p e rfo rm properly c o u l d res u lt i n

u n accepta b l e RISK fo r PATIENTS, OPERATORS, o r oth e rs. A l l featu res o r fu n cti o n s that m u st
p e rform p ro p e r l y to p reve nt HARM to t h e PAT I E NT, OPERATOR o r oth e rs are i m p o rtant, b u t n ot
eve ry feat u r e o r fu n ct i o n of ME EQUIPMENT is ESSE NTIAL PERFORMANCE. When a fa i l u re to
p e rform wo u l d res u lt i n u n accept a b l e RISK fo r t h e PAT I E NT, OPE RATOR or others, then th ose
feat u res o r fu n cti o n s are, fo r t h e p u r poses of this sta n d a r d , seen as ESSE NTIAL PERFORMANCE .
Assessment of t h i s RISK is made on t h e assu mption t h at t h e pe rformance as pect i n q u est i o n

has b e e n lost o r d e g r a d e d , a n d takes acco u nt of t h e p ro b a b i l ity t h at HARM wo u l d t h e n occ u r
(wh i c h i n some i n stances co u l d b e 1 00 %) a n d t h e S EVERITY o f that HARM. A p p l icat i o n o f t h e
RISK MANAGEMENT PROCESS t h e n e n s u res t h at t h e p ro b a b i l ity o f loss o f t h e p e rfo r m a n ce as pect
is l ow e n o u g h to make t h e RESI DUAL RISK accept a b l e .
A p r o b l e m with ESSE NTIAL PERFORMANCE exists w h e n t h e feat u r e o r fu n ct i o n i n q u est i o n i s

e it h e r a b s e nt o r its c h a ra cte ristics are d e g raded to a p o i n t t h at t h e ME EQUIPMENT o r
ME SYSTEM is n o l o n g e r s u it a b l e fo r its I NTENDED USE.
Examples of ESSE NTIAL PERFORMANCE a r e :

accu racy of a l ife-s u p p o rt i n g fu n ct i o n o r correct a d m i n istrat i o n of a d ru g by a syri n g e p u m p
w h e re i n accu racy/i n c o r rect a d m i n i strat i o n wo u l d cause a n u n accept a b l e R I S K t o t h e
PAT I E NT;
- t h e a b i l ity of an e l ectro c a rd i o g ra p h/mon ito r to recove r from t h e effects of t h e d isch arge of
a defi b r i l l ato r w h e re t h e fa i l u re to recove r co u l d lead to a n i n correct response by t h e
m e d i c a l staff that wo u l d pres e nt a n u n a ccepta b l e RISK to t h e PAT I E NT;
correct o p e rati o n of a n a larm in a n i nt e n s ive care or o p erat i n g ro o m m o n ito r i n g system
w h e re an i n correct/m issing a l a r m c o u l d lead to an i n c o rrect r e s p o n s e by the m e d i c a l staff
t h at wo u l d pres e nt an u n a cce pta b l e RISK to t h e PATI E NT; o r
correct output o f d i ag n ostic i nformat i o n from ME EQUIPMENT t h at is l i kely t o be re l i e d u po n
to dete r m i n e treatment, w h e re i n co rrect i nfo rmat i o n c o u l d lead to a n i n a p p ro p ri ate
treat m e nt that wo u l d present a n u n accepta b l e RISK to t h e PATI E NT.
EssENTIAL PERFORMANCE is i d e ntified wit h o ut taking i nto acco u nt the p ro b a b i l ity of occu rre nce
of factors that could re s u lt i n a loss of fu n cti o n a l ity. Th ese factors are taken into acco u nt i n
t h e RISK MANAG E M E NT PROCESS .
P a rtic u la r a n d c o l l ateral sta n d a rds i n t h e I E C 6 0 6 0 1 fa m i l y a r e expected to i d e ntify s p ecific

ESSENTIAL PE RFORMANCE .
S u bclause 3.33 - F UNCTIONAL CONNECTION
The defi n ed term FUNCTIONAL CONNECTION is used to fac i l itate the d efi n it i o n of an ME SYSTEM.
T h e FUNCTIONAL CONNECTION is a co u p l i n g between ite ms of a n ME SYSTEM, i n c l u d i n g t h e
poss i b i l ity of s u p p ly i n g p ower.
6060 1 - 1 © I EC : 20 0 5 - 429 -
T h e p h rase " o r oth e rwise" c o u l d i n c l u d e mech a n i c a l , o ptical o r wi re less c o n n ecti o n s fo r

exa m p l e .
S u bclause 3 . 3 5 - F UNCTIONAL EARTH TERMINAL
I n ME E Q U I PME NT, fu n cti o n a l e a rt h c o n n ecti o n s c a n be made by m e a n s of a FUNCTIONAL EARTH

TERM I NAL t h at is accessi b l e to the OPERATOR. Alte r n ative ly t h is sta n d a rd a l so a l lows a
fu n cti o n a l e a rth co n n ecti o n fo r CLASS 1 1 ME EQUIPMENT via a g re e n a n d ye l low c o n d u cto r i n a
POWER S U PPLY CORD. I n t h i s case t h e p a rts to w h i c h t h i s c o n d u ctor is c o n n ected ca n n ot be
ACCESSI BLE PARTS (see 8 . 6 . 9 ) , a n d h ave to b e i n s u l ated from ACCESSIBLE PARTS .
S u bclause 3.38 - HARM
T h e defi n it i o n of HARM is based on t h e defi n it i o n in I S O 1 49 7 1 mod ifi ed to i n c l u d e a n i ma l s .

T h i s c h a n g e w a s made s i n ce t h e s c o p e of t h e I EC 6060 1 - 1 i n c l udes t h e safety of a n i m a l s .
S u bclause 3.40 - HAZARDOUS SITUATI O N
A s used i n th is sta n d a rd , a HAZARD ca n n ot re s u lt i n HARM u nt i l s u c h t i m e as a seq u e nce o f

eve nts o r oth e r circu mstances ( i n c l u d i n g NORMAL USE ) lead to a HAZARDOUS S I TUATI O N . A s a
res u lt of t h e RISK MANAG EMENT PROCESS, t h e r e l ated RISK accepta b i l ity c a n be assessed by
est i m at i n g both S EVERITY a n d proba b i l ity of occurrence of t h e HARM t h at co u l d res u lt from this
HAZARDOUS S ITUATION (see F i g u re A. 8 ada pted fro m t h e d raft text of t h e 2 "d edition of t h e
ISO 1 4971 ).
"'
c HAZARD
�
0
Q) l- Exposure (P1) -
u
c
Q)
::J
0" HAZARDOUS
Q)
(/) SITUATION
p2
HARM
'
SEVERITY of Probability of
the HARM occurrence
of HARM
P1 X P2
IEC 2430105
NOTE P1 is the probability of a HAZARDOUS SITUATION occu rri ng.

P2 is the probability of a HAZARDOUS SITUATION leading to a HA R M .
F i g u re A.B - P icto rial re presentation of t h e relatio n s h i p o f HAZARD, seq uence of even ts,
HAZARDOUS SI TUATION a n d HARM
6060 1 - 1 © I EC : 20 0 5 - 431 -
S u bclause 3.44 - INTENDED USE
ISO 1 49 7 1 : 20 0 0 defi n e d the c o m po u n d term I NTENDED USE/I NTENDED PURPOSE because, at the
time t h at vers i o n was b e i n g d eve l o p e d , t h e re was no c o n s e n s u s o n w h i c h term to u se . T h e
E u ro p e a n M e d i c a l Device D i rective u s e s " i ntended p u r p os e , " whe reas t h e U n ited States
reg u l ati o n s use " i ntended u s e . " Both terms h ave esse n t i a l l y the same defin iti o n . After some
year of experi e n ce with applying ISO 1 49 7 1 , it has g e n e r a l l y b e e n accepted that t h e
c o m b i n e d term is u nwieldy a n d a c o n s e n s u s h a s e m e rged to u s e t h e s h o rter term " i ntended
use . " T h e second e d i t i o n of ISO 1 49 7 1 (in p r e p a rati o n ) is expected to use " i ntended use" as
t h e p referred term with " i ntended p u rpose" being a n " a d m itted term . " To avo i d being out of
ste p with t h e fut u re e d i t i o n of ISO 1 49 7 1 , t h i s sta n d a rd has a d o pted t h e s h o rter defi n ed term
I NTENDED USE. T h e d efi n it i o n itself is i d e ntical to t h at i n ISO 1 49 7 1 : 2 000 a n d to t h e d efi n it i o n
t h at is expected to b e i n t h e s e c o n d e d i t i o n of I S O 1 49 7 1 .
S u bclause 3.49 - MAINS PART
A d efi n it i o n of MAINS PART is n eeded to i d e ntify t h e p a rts to w h i c h c e rta i n req u i re m e nts a p p l y.

T h e d efi n it i o n g iven i n t h e fi rst a n d second editions of this sta n d a rd d e pe n d e d on a n o t h e r
defi n ed term, " c o n d u ctive con n ectio n . " D u ri n g t h e deve l o p ment of t h i s e d iti o n , a d ifficu lty with
t h e defi n it i o n of " co n d u ctive c o n n ecti o n " became a p p a r e nt and th e re q u i re m e nts were revi sed
so the d efi n e d term was n o l o n g e r n e e d e d . T h i s n e cessitated a new defi n it i o n of MAINS PART
foc u s s i n g o n the MEANS OF PROTECTION that s e p a rate the MAINS PART from ot h e r p a rts.
S u bclause 3 . 50 - MAINS PLUG
A d efi n it i o n of MAINS PLUG is n eeded to i d e ntify t h e p l u g to w h i c h ce rta i n req u i re m e nts a p p l y.

T h e words " ma i n s p l u g " wit h o u t a d efi n it i o n w o u l d a lso cover oth e r co n n ect o rs wit h i n
ME EQUIPMENT t h a t ca rry MAINS VOLTAGE.
S u bclause 3 . 56 - MAXI M U M MAI NS VOLTAGE
S eve ral req u i reme nts a n d tests of this sta n d a rd re l ate to the poss i b i l ity t h at an u n i ntended
voltage o r ig i n at i n g from a n exte r n a l s o u rce becomes co n n ected to t h e PATIENT o r to c e rta i n
pa rts o f t h e ME EQUI P M E NT. T h e act u a l m a g n it u d e o f s u c h a voltage is u n kn own b u t i t i s
assumed t o b e related t o t h e voltage o f t h e S U PPLY MAINS i n t h e location w h e re t h e
ME EQUIPMENT is u s e d . S e e also t h e rat i o n a l e fo r 8 . 5 . 3 .
I n t h e e a r l y stages o f p r e p a r i n g t h i s e d it i o n , a defi n ed term " re ference s u p p l y voltage" was

i ntrod uced to avo i d re p etit i o n of exte ns ive word i n g . D u ri n g t h e review of the N at i o n a l
'
C o m m ittees c o m m e nts o n a n e a r l y d raft, it b e c a m e a p parent t h at t h e re w a s s o m e co nfu s i o n
betwe e n t h e d efi n e d t e r m " refe r e n c e s u p p l y voltage" a n d t h e u n defi n ed term " refe r e n ce
voltage" w h i c h was used i n re lation to t h e re q u i re m e nts fo r d i e l ectric stre n gt h , CREEPAGE
DISTANCES and A I R CLEARANCES.
In order to c l a r ify t h e req u i re m e nts, the term " refe re n c e s u p p l y volta g e " h a s been rep laced by
MAXI M U M MAI NS VOLTAGE a n d " refe r e n ce voltage" has b e e n re p l aced by t h e d efi n e d terms
WORKING VOLTAGE a n d PEAK WORKING VOLTA G E .
S u bclause 3 . 57 - MAXI M U M PERMISSIBLE WORKING PRESS U RE
T h e MAXI M U M PERMISSI BLE WORKING PRESSURE is decided by a c o m petent p e rs o n , taki ng i nto

acco u nt the o r i g i n a l d e s i g n s pe c ificati o n , the m a n u facturer's rat i n g , the c u rrent c o n d i t i o n of
the vessel and the circu msta nces of use.
In some c o u ntries, t h e fi g u re c o u l d b e re d u ced fro m time to t i m e .

6060 1 - 1 © I EC : 20 0 5 - 433 -
S u bclause 3 . 58 - M EANS OF PROTECTION
One g u i d i n g p r i n c i p l e in t h e deve l o p m e nt of the t h i rd e d iti o n of t h is sta n d a rd was to m a ke it

less prescri ptive t h a n the second e d i t i o n , e s p e c i a l l y C la u ses 1 7 a n d 20 of the second e d it i o n .
T h e c o n c e pt o f MEANS OF PROTECTION was c o n c e ived a s a g e n e r i c o n e t h at c o u l d cover a
n u m b e r of th i n g s s u c h as PROTECTIVE EARTH CONNECTI ONS, BAS I C I NSULATION, SUPPLEME NTARY
I NSULATI O N , i m p e d a n ce s , etc; a n d that m i g ht a l so be expanded to i n c l u d e oth e r t h i n g s w h i c h
serve i n t h e same capa city b ut h ave n ot yet b e e n e nvisaged o r are not yet practi c a l . T h is
c o n c e pt, with t h e g e n e r a l req u i re m e nt fo r ME EQUI PMENT to h ave two MEANS OF PROTECTION,
fitted i n w e l l with t h e s i n g l e fa u lt p h i lo s o p h y, w h i c h all a g reed was to be reta i n e d i n t h e t h i rd
ed itio n . It e n a bles a c o n s i stent a p p roach to ca rry t h r o u g h a d e s i g n effort wit h o u t g etti n g
b o g g e d down i n t h e wordy p re s c r i ptive s u bc l a uses.
T h e con cept a lso fitted i n we l l w h e n it was d ecided to d iffe re ntiate p rotection of PAT I E NTS from
p rotect i o n of OPERATORS .
S o m e N at i o n a l C o m m ittee c o m m e nts d u ri n g t h e deve l o p m e nt of t h i s e d iti o n s u g g ested t h at

t h e c o n cept co u l d be exte nded to a p p l y to p rotect i o n a g a i n st HAZARDS ot h e r t h a n e l ectric
s h o ck. H oweve r it was d ecided t h at s u c h a c h a n g e wo u l d not be j u stified by t h e b e n efits.
S u bclause 3 . 59 - M EANS OF PATIENT PROTECTION
S e e the rati o n a l e fo r 8 . 5 . 1 .
S u bclause 3.60 - M EANS OF OPERATOR PROTECTIO N
S e e t h e rati o n a l e fo r 8 . 5 . 1 .
S u bclause 3.63 - M E DICAL ELE CTRICAL EQUIPMENT
T h e present defi n it i o n of ME EQUIPMENT exc l u d es m u lt i p l e c o n n ecti o n s to t h e same p a rt i c u l a r

S U PPLY MAI N S , b ut d oes not exc l u d e d i ffe rent co n n e ct o rs to d iffe rent p a rt i c u l a r S U PPLY MAI N S .
H oweve r , c o n nection to m o r e t h a n o n e of d iffe rent S U PPLY MAI NS a t t h e s a m e time s h o u l d be
avo i d e d . While it might be poss i b l e to design e q u i p m e nt with p rovi s i o n to be c o n n ected
s i m u lt a n e o u s l y to two d i ffe rent S U PPLY MAI NS in a n e l ect r i c a l l y safe m a n n e r , the p a rtic u l a r
HAZARDS that m i g ht a r ise h ave n ot b e e n i d e ntified i n t h i s sta n d a rd .
S u bclause 3.64 - M E DICAL ELE CTRICAL SYSTEM
It is c o m m o n p ractice for MANUFACTU RERS , RESPONSIBLE ORGAN I SATIONS and OPERATORS to

co n n ect ME EQUIPMENT and oth e r m e d i c a l or n o n - m e d i c a l e q u i p m e n t to M U LTIPLE SOCKET
OUTLETS . The i n c l u s i o n of s u c h a rr a n g e m e nts with i n the d efi n it i o n of ME SYSTEM bri ngs t h e m
with i n t h e scope of t h i s sta n d ard a n d th us a l l ows a p p r o p ri ate req u i reme nts t o be s p e c ified fo r
BAS I C SAFETY a n d ESSE NTIAL PE RFORMANCE .
To m i n i mize t h e i m p a i rment of t h e safety level of this sta n d a r d , t h e c o n n e ct i o n of a M ULTI PLE

SOCKET-OUTLET to t h e S UPPLY MAI NS is s u bj ect to ce rta i n co n d it i o n s . S u bc l a use 1 6 . 9 . 2 . 1
req u i res t h at M U LTIPLE SOCKET-OUTLETS are constructed to c o m p l y with t h e req u i re m e nts from
this sta n d a rd a p p l y i n g to ME E Q U I PMENT.
S u bclause 3.66 - MODEL OR TYPE REFERENCE
The MODEL OR TYPE REFERENCE is i ntended to esta b l i s h the relatio n s h i p of t h e ME EQUIPM ENT to
commercial and tec h n ical p u b l i cations, to ACCOMPANY I NG DOCUME NTS and betwee n s e p a r a b l e
pa rts of ME EQUIPMENT. It is a l s o i m p o rtant for i d e ntify i n g of ME EQUIPMENT o r ACCESSORIES i n
c a s e of a safety a l e rt o r oth e r re q u i red fi e l d acti o n .
6060 1 - 1 © I EC : 20 0 5 - 435 -
S u bclause 3.67 - MULTIPLE SOCKET-OUTLET
The defi n it i o n is de rived from I E C 60884- 1 .
I n t h e second e d it i o n of I EC 6060 1 - 1 - 1 [ 1 3 ] , there were defi n it i o n s fo r m u lt i p l e p o rt a b l e

soc ket- o ut l et a n d a ux i l i a ry m a i n s soc ket-outlet. I n t h i s e d it i o n , th ese d efi n it i o n s h ave b e e n
m e rg e d .
A s i n g le socket-o utlet fo r m i n g p a rt of a n e q u i p m e n t is a l s o consid ered a M U LTIPLE SOCKET

OUTLET.
M uLTI PLE SOCKET-OUTLETS are so metimes necessary a n d offer advantages a n d

d isadvanta g e s , w h i c h h ave to be i nvesti gated i n o rd e r to esta b l is h a b a l a n c e . M ULTI PLE
SOCKET-OUTLETS m i g ht b e necessary for t h e fo l l owi n g reaso n s :
- to m i n i mize t h e n u m b e r of POWER S U PPLY CORDS l y i n g on t h e floor;
- to a l low a l l t h e e q u i p me n t n ecessa ry fo r p ro p e r treatment o r d i a g n o s i s to be used d e s p ite
a n i n s uffi c i e nt n u m b e r of FIXED m a i n s socket- o ut l ets;
- to i m p rove m o b i l ity by h avi ng a l l e q u i p m e n t on o n e trolley;
- to red u ce pote ntial d iffe r e n ces wit h i n t h e protective e a rth w i r i n g to b e l ow th ose t h at occ u r
i n some FIXED i n st a l l ati o n s .
T h e u s e of M ULTI PLE SOCKET-OUTLETS s h o u l d b e avo i d e d as fa r as poss i b l e fo r t h e fo l l owi ng

rea s o n s :
c o m b i n e d EARTH LEAKAGE CURRENTS co u l d resu lt i n :
excess ive EARTH LEAKAGE CURRENT i n NORMAL CONDITION,
excess ive TOUCH CURRENT in t h e S I NGLE FAULT CONDI TION of the broken PROTECTIVE
EARTH CONDUCTOR of the M U LTIPLE SOCKET-OUTLET s u p p l y c a b l e ;
ava i l a b i l ity o f t h e S U PPLY MAI NS d e p e n d s o n t h e re l i a b i l ity o f a s i n g l e FIXED m a i n s soc ket
outlet;
a c o m p l ete interru pti o n of electrical s u p p l y is poss i b l e a n d might req u i re a l o n g set- u p time
to reactivate t h e c o m p lete ME SYSTEM;
o n ly o n e PROTECTIVE EARTH CONNECTION to t h e e l ectrical i n st a l l ati o n is prov i d e d ; t h i s is
less r e l i a b l e than w h e n each p a rt of t h e ME SYSTEM is d i rect l y e a rt h e d ;
- t h e p rotective e a rth res i sta nce is i n crea s e d .
T h e o pt i m u m s o l u t i o n i n c l u d e s i n sta l l i n g a n a d e q u ate n u m b e r of FIXED m a i n s socket-outlets

accord i n g to a p p ro p r i ate i n st a l l a t i o n ru l es.
S u bclause 3.68 - NETWORK/DATA COUPLING
The defi n it i o n of NETWORK/DATA COUPLING h a s been writt e n so as n ot to be restricted to a n y

p a rtic u l a r tec h n o logy, s u c h a s e lectro n i c transmission a l o n g wi res . T h e defi n it i o n a l lows fo r
w i r e l ess e lectro mag netic tra n s m i ss i o n , i nfra-re d , o pt i c a l , etc . , as we l l as a n y futu re
tec h n o logy.
S u bclause 3.73 - OPERATOR
T h e OPERATOR is defi n e d as t h e p e rs o n who h a n d l e s the e q u i p m ent, w h i c h co u l d be

ME EQUIPMENT or a n y ite m of e q u i p me n t in the co ntext of an ME SYSTE M . T h i s person c o u l d b e :
a h ealth c a r e p rofess i o n a l u s i n g t h e e q u i p m e nt with a PATI ENT,
e it h e r a PAT I E NT o r a layperson assisti n g a PAT I E NT i n a h o me-care e nv i ro n m e nt,
a person who is u s i n g the e q u i p m e n t to c o m p e n sate or a l l eviate the effects of d i sease,
i nj u ry or d i s a b i l ity, or
- t h e person t h at i n sta l l s , asse m b l e s , m a i n t a i n s o r repa i rs t h e e q u i p ment.
6060 1 - 1 © I EC : 20 0 5 - 437 -
P e o p l e w h o i n sta l l , ass e m b l e , m a i n t a i n o r re p a i r t h e e q u i p m ent are a l so refe rred to i n t h i s

sta n d a rd as S ERVICE P E RSONNEL.
Many re q u i re m e nts i n t h i s sta n d a rd are c o n structed so t h at S E RVICE PERSONNEL experience

t h e same RESI DUAL RISK as t h e p e rson w h o uses t h e e q u i p m ent for its I NTENDED U S E . H oweve r,
S ERVICE PERSONN E L , w h o are ofte n e n g i n e e rs or e n g i n e e r i n g tech n i c i a n s , are expected to
h ave c e rta i n c o m pete n c i e s and to take acco u nt of the tec h n ical descripti o n . Other OPERATORS
are expected to h ave d i ffe rent c o m pete n c i e s a n d to fo l l ow t h e i n struct i o n s fo r u s e . T h e refo re,
this sta n d a rd presu mes in cert a i n circu mstances t h at t h e safety of S ERVICE PERSONNEL
d e pe n d s p a rtly o n t h e i r knowledge and t ra i n i n g to take a p p r o p ri ate p reca uti o n s when g a i n i n g
access t o hazardous p a rts. T h e oth e r OPERATORS a r e p res u m e d t o b e c o m petent t o u se t h e
ME EQUIPMENT o r ME SYSTEM b u t a r e n ot necess a r i l y c o m petent to avo id RISKS that c a n arise
d u ri n g s e rvi c i n g .
S u bclause 3 . 7 5 - OXYGEN RICH ENVIRO N M E NT
At a 2 5 % oxyg e n c o n c e ntrati o n , t h e i n crease i n t h e b u r n i n g rate of a p a p e r stri p is o n ly

mode rate ( 3 0 %) ( pe r N F PA 99 [42]). I n N F PA 9 9 , 23 , 5 % is d efi ned to be oxyg e n - e n r i c h ed
atmosp h e re t h at req u i res p rotective m e a s u re s , but it a l l ows t h i s va l u e a lso fo r oxyg e n
c h a m b e rs at pressu res of m o r e t h a n 2 0 0 kPa. NASA a l l ows c o n c e ntrat i o n s of 2 5 , 9 % i n its
space sh uttles ( N F PA 53 [ 4 1 ] ) . U L 260 1 - 1 [44] uses 25 % as th res h o l d va l u e . A s a m p l e of
e p oxy ci rcu it b o a rd m ate r i a l b u rns i n c o m p l etely at 2 0 , 9 % and 2 5 , 9 % ( b u r n i n g l e ngth of 3 em
a n d 8 , 3 e m ) b ut c o m p l etely at 30 % accord i n g to R i m a n osky, E . M . et a l . , ASTM STP
1 267 [36].
When fi rst c o n s i d e r i n g t h e relati o n s h i p b etwe e n fl a m e rate a n d the a m o u nt of oxyg e n , it wo u l d

seem reas o n a b l e t h at t h e fl a m e rate w o u l d b e p r o p o rti o n a l to t h e tot a l l o c a l l y ava i l a b l e
a m o u nt o f oxyg e n , w h i c h is g iven by t h e p a rt i a l p ress u r e . H oweve r, e x p e r i e n c e sh ows t h at
t h i s is o n ly t r u e to a d e g re e . F i g u res C - 1 . 2 . 2( a ) a n d ( b ) i n N F PA 5 3 : 1 9 9 9 a n d F i g u re
A. 3 . 3 . 1 4 . 4 i n N F PA 9 9 : 2002 s h ow t h at fo r p a p e r stri ps t h e i n crease of fla m e rate with oxyg e n
c o n c e ntrat i o n at a set a b s o l ute p ress u re is stro n g e r t h a n t h e i n crease of fl a m e rate with
a b s o l ute p ress u re at a set c o n c e ntrati o n . F o r the b o r d e rl i n e " c o m p l ete c o m b u st i o n " to
" i n c o m p l ete c o m b usti o n " the oxyg e n c o n c e ntrat i o n seems to c o m e to the same n u m b e r ( 1 4 %)
at h i g h pressu res, i n d e pe n d e nt of the a b so l ute ( a n d p a rt i a l ) pres s u re . T h e refo re, to b e o n t h e
safe s i d e , two n u m b e rs are g ive n i n t h e defi n it i o n . T h e c o n ce ntration l i m it m a k e s s u re that fo r
s m a l l e r a m b i e n t p ress u res t h a n o n e atm o s p h e re t h e d a n g e r d o es n ot i n creas e . T h e p a rt i a l
p ress u r e l i m it m a kes s u re t h at fo r h i g h e r p ress u res ( e . g . i n oxyg e n c h a mbers) t h e s ituation is
safe.
S u bclause 3.77 - PATI ENT AUXILIARY C U RRENT
PATIENT AUXI LIARY CURRENT is a c u rrent t h at is n ecessa ry fo r:

- t h e ME EQUIPMENT to p e rfo rm its fu n ct i o n , e . g . e l ectrical i m p e d a nce imag i n g , m o n itoring of
res p i rati o n by i m p e d a n c e c h a n ges;
m o n it o r i n g t h e correct o peration of t h e ME EQUIPMENT, e.g. co ntact i m p e d a n ce of
e lectrodes with the PAT I E NT;
- t h e f u n ctio n i n g of t h e ME EQUIPMENT;
o r t h at is i n c i d e nt a l to t h e f u n cti o n i n g of t h e ME EQUI PMENT. An example is t h e b ias c u rrent of
a n a m p l ifi e r fo r p h y s i o l o g i ca l s i g n a ls .
PATI ENT AUXI LIARY CURRENT co u l d h ave a f u n ct i o n , b u t n ot a p h ys i o l o g i c a l fu n ctio n , o r i t co u l d

h ave n o f u n ct i o n .
6060 1 - 1 © I EC : 20 0 5 - 439 -
S u bclause 3.78 - PATI ENT CONNECTION
One of t h e HAZARDS assoc iated with t h e a p p l icat i o n of PAT I E NT CONNECTI ONS is t h e fact that
LEAKAGE CURRENT c a n flow t h r o u g h t h e PAT I E NT via t h e PAT I E NT CONNECTI ONS. P a rtic u l a r l i m its
are p l aced on t h e m a g n itude of these cu rrents, b oth in t h e NORMAL CONDITION a n d in va rious
fa u lt co n d it i o n s .
NOTE T h e c u rrent that flows through t h e PATIENT between various PAT I E N T CON N ECTI O N S is known as PAT I E N T
AUXI LIARY C U R R E N T . The LEAKAGE C U R RENT t h a t flows t h r o u g h the PATIENT t o e a rth is known as PAT I E N T L EAKAGE
CURRENT.
T h e d efi n it i o n of PAT I E NT CONNECTION is i n te n d e d to e n s u re t h e i d e ntificat i o n of each i n d iv i d u a l

p a rt of t h e APPLI ED PART betwe e n w h i c h cu rrent c o u l d flow as PATI ENT AUXI LIARY CURRENT, a n d
from w h i c h PAT I E NT LEAKAGE CURRENT co u l d flow i nto a n e a rthed PAT I E NT.
In some cases it w i l l be necessary to carry o ut PAT I E NT LEAKAGE CURRENT and PAT I E NT

AUXILIARY CURRENT m e a s u r e m e nts to dete r m i n e w h i c h p a rts of t h e APPLI E D PARTS are
i n d iv i d u a l PAT I E NT CONNECTI ONS.
PATIENT CONNECTIONS are not a lways access i b l e to touch. Any c o n d u ctive p a rts of t h e APPLI E D
PART t h at come i nto e l ectrical contact with t h e PATI E NT, o r w h i c h a re p reve nted from d o i n g so
o n ly by i n s u l at i o n or air g a ps t h at do n ot comply with t h e re l evant d ie l e ctric stren gth tests or
A I R CLEARANCE a n d CRE E PAGE DISTANCE req u i re m e nts s pe c ified in t h i s sta n d a r d , are PAT I E NT
CONNECTI ONS. S e e a lso t h e rati o n a l e fo r 3 . 8 .
Exa m p l e s i n c l u d e t h e fo l l owi n g .
A t a b l e t o p s u p porting a PAT I E NT is a n APPLI E D PART. S h e ets do n ot p rovi de a d e q u ate
i n s u l at i o n and the co n d u ct ive pa rts of the t a b l e top wo u l d t h e refo re be c l assifi e d as
PAT I E NT CONNECTI ONS.
T h e a d m i n istrat i o n set o r needle of a n i nfu s i o n contro l l e r is a n APPLI ED PART. C o n d u ctive
pa rts of the c o ntro l l e r s e p a rated from the ( potentia l l y c o n d u ct i n g ) f l u i d co l u m n by
i n adeq u ate i n s u l at i o n w o u l d be PAT I E NT CON NECTI ONS.
Where a n APPLI ED PART has a s u rface of i n s u l ati ng m ate r i a l , 8. 7 . 4 . 7 d ) sp ecifies t h at it is

tested using fo i l o r s a l i n e s o l uti o n . T h is is then c o n s i d e red as a PAT I E NT CONNECTION.
S u bclause 3.79 - PATIENT ENVIRO N M E NT
It is d iffi c u lt fo r t h i s sta n d a rd to defi n e d i m e n s i o n s fo r t h e vo l u me i n w h i c h d i a g n osis,

m o n it o r i n g o r treat m e nt occurs. T h e d i m e n s i o n s fo r t h e PAT I E NT E NVIRONMENT g ive n i n F i g u re
A. 9 h ave b e e n j u stified i n p ract i c e .
\
6060 1 - 1 © I EC : 20 0 5 - 441 -
/ / / / / / / / / /:/ / / / /< / / / / / / /
\
/
/
/
/
/
/
/
I
I
1 1 ,5 m
I
\
\
/ "
/ '
I 1 ,5 m \
I \
I I
\ I
\ I
' /
' /
-- -----------
IEC 2431105
NOTE The d i m e nsions i n the figure show m i n i m u m extent of the PATIENT ENVI RON M E N T i n a free s u rro u n d i n g .
F ig u re A.9 - Exam ple of PATIENT ENVIRO N M E NT
S u bclause 3 . 8 1 - PEAK WORKING VOLTAGE
T h i s d efi n it i o n was taken from I EC 60950-1 : 2 0 0 1 , s u bc l a use 1 . 2 . 9 . 7. U se of t h i s term a l o n g

with t h e defi n ed term WORKING VOLTAGE s h o u l d m a ke the I NS ULATION CO-ORDI NATION
req u i re m e nts i n corporated from I E C 60950-1 e a s i e r to u n d e rsta n d fo r t h o s e a l ready fa m i l i a r
with t h at sta n d a rd . S e e a lso t h e rati o n a l e fo r 3 . 5 6 .
S u bclause 3.99 - RE INFORCED INSULATION
T h e term " i n s u lation system" does n ot i m p l y that t h e i n s u lation has to be one h o m o g e n e o u s

p iece. It c o u l d c o m p rise seve ra l layers t h at c a n n ot b e tested s e p a rate l y as S UPPLEM ENTARY o r
BAS I C I NSULATI O N .
S u bclause 3 . 1 1 0 - S ECONDARY C I RCUIT
T h i s defi n it i o n is based o n t h e defi n it i o n of t h e same term i n I E C 60950-1 : 2 00 1 , su b c l a u s e

1 . 2 . 8 . 4 a n d i d e ntifies circu its t h at are s u bj ect to l ower tra n s i e n t overvoltages t h a n t h e MAINS
PART and t h e refo re h ave l ower va l u e s fo r d i e l ectric stre n gth test v o ltages a n d AIR CLEARANCE S .
S u bclause 3 . 1 1 2 - S EPARATION DEVICE
Asse m b l y of e q u i p m e nt i nto a n ME SYSTEM could i nvolve co n n e cti o n s t h at tran sfer power or

s i g n a ls. In both cases, t h e same s e p a rati o n req u i re m e nts are n e ed e d .
6060 1 - 1 © I EC : 20 0 5 - 443 -
S u bclause 3 . 1 1 5 - S I G NAL I NPUT/OUTPUT PART
If a S I GNAL I NPUT/OUTPUT PART carries e lectrical s i g n a ls , or if it carries n o n-e l ectrical s i g n als

b u t n evert h e less i ntrod uces a c o n d u ctive co n n ecti o n to t h e ot h e r e q u i p m e nt ( e . g . t h r o u g h an
optical f i b re cable with a m eta l s h e at h ) , a p p r o p ri ate s e p a rati o n from ot h e r circu its c a n b e
necessary to satisfy t h e re q u i re m e nts of t h i s sta n d a rd . Alte r n atively a S I GNAL I NPUT/OUTPUT
PART c o u l d h ave no c o n d u ct ive c o n n ect i o n s , i n w h i c h case it w i l l automat i c a l l y satisfy t h e
req u i re m e nts fo r e l ectrical BAS I C SAFETY.
S u bclause 3 . 1 20 - S UPPLY MAINS
An exte r n a l d . c. power s o u rce ( e . g . in an a m b u l a n c e ) is c o n s i d e red as a S U PPLY MAI N S .

M E EQUI PMENT s pec ified for co n n ecti o n t o s u c h a p o w e r s o u rce h as to satisfy a l l req u i re m e nts
fo r m a i n s p owered ME EQUI PMENT. I n t h e p ast, s o m e ME EQUI P M E NT spec ified for s u c h a power
sou rce has h a d a d i rect c o n n ect i o n between the E NCLOS URE and one side of the s u p p l y,
presu med to be at e a rth pote ntia l . I n t h e eve nt of i nterruption of t h e c o n n e ct i o n to t h i s side of
t h e s u p p l y, t h e E NCLOS URE of s u c h ME EQUIPMENT assumes t h e s u p p l y pote ntial a n d wo u l d
t h e refo re exceed t h e s p e c ified l i mit fo r TOUCH CURRENT. T h e fi rst a n d s e c o n d e d i t i o n s of t h i s
sta n d a rd were i ntended to exc l u d e s u c h a n a r ra n g e m e nt, but t h i s was not a lways u n d e rstood
by use rs of the sta n d a rd . T h i s rat i o n a l e has b e e n added to c l a rify the req u i re m e nt.
S u bclause 3 . 1 32 - TYPE B APPLIED PART
TYPE B APPLI E D PARTS p rovide t h e l owest d e g re e of PAT I E NT p rotect i o n of a l l t h e types of

APPLI ED PART and are n ot s u it a b l e fo r DI RECT CARDIAC APPLICAT I O N .
T h e PAT I E NT CONNE CTI O N ( S ) of a TYPE B APPLI E D PART co u l d b e :

PROTECTIVELY EARTHED;
co n n ected to e a rth b u t n ot PROTECTIVELY EARTHED; or
float i n g , but not i s o l ated from e a rth to t h e d eg re e that wo u l d b e req u i red fo r a TYPE BF
APPLI ED PART.
S u bclause 3 . 1 33 - TYPE BF APPLIED PART
TYPE BF APPLI E D PARTS p rovide a deg ree of PAT I E NT p rotect i o n h ig h e r t h a n p rovided by TYPE B
APPLI ED PARTS . T h i s is ach ieved by i s o l at i n g t h e PATIENT CONNECTIONS from e a rthed pa rts a n d
oth e r ACCESSI BLE PARTS of t h e ME EQUI PME NT, t h u s l i miting t h e m a g n it u d e of cu rrent t h at wo u l d
flow t h r o u g h t h e PAT I E NT i n t h e eve nt t h at a n u n i ntended voltage o r ig i n ati ng from a n exte r n a l
s o u rce is c o n n ected to t h e PATI E NT, a n d t h e r e b y a p p l ied betwee n t h e PAT I E NT CONNECTIONS
and earth. H oweve r , TYPE BF APPLI ED PARTS are n ot s u ita b l e fo r DI RECT CARDIAC APPLICATI O N .
S u bclause 3 . 1 34 - T Y P E CF A P P L I E D PART
TYPE CF APPLI ED PARTS p rovide t h e h i g h est deg ree of PAT I E NT p rotect i o n . T h i s is a c h i eved by
i n creased i s o l at i o n of t h e PAT I E NT CONNECTION from e a rthed p a rts a n d oth e r ACCESSI BLE PARTS
of t h e ME EQUI PME NT, fu rt h e r l i miting t h e m a g n it u d e of pos s i b l e c u rrent flow t h r o u g h t h e
PAT I E NT. TYPE CF APPLI E D PARTS are s u it a b l e fo r DI RECT CARDIAC APPLICATION i n sofa r a s
PAT I E NT LEAKAGE CURRENT is c o n c e r n e d , t h o u g h they c o u l d b e u n s u it a b l e i n oth e r respects,
such as ste r i l ity o r b i o c o m pati b i l ity.
6060 1 - 1 © I EC : 20 0 5 - 445 -
S u bclause 3 . 1 39 - WORKING VOLTAGE
T h i s defi n it i o n is taken from I EC 60950-1 : 2 0 0 1 , s u bc l a u s e 1 . 2 . 9 . 6 . Use of this term a l o n g with

the defi n ed term PEAK WORKING VOLTAGE s h o u l d make the I NS ULATION CO-ORDI NATION
req u i re m e nts i n corporated from I E C 60950-1 e a s i e r to u n d e rsta n d fo r t h o s e a l ready fa m i l i a r
with t h at sta n d a rd . S e e a lso t h e rati o n a l e fo r 3 . 5 6 .
S u bclause 4 . 1 -Co n d itions fo r appl ication to M E EQU I P M E NT o r M E SYSTE M S
T h e c o n d it i o n fo r a p p l icat i o n of RISK MANAGEMENT to ME EQUI P M E NT a n d M E SYSTEMS i n c l udes

reaso n a b l e fores e e a b l e misuse. T h e MANUFACTU RER i d e ntifies fores e e a b l e misuse as p a rt of
the RISK ANAYLSIS (see I S O 1 49 7 1 : 2 000, su b c l a u se 4 . 2 ) . T h is i d e ntificat i o n c o u l d i n c l u d e t h e
resu lts of a USAB I L I TY E N G I N E E RI NG PROCESS .
S u bclause 4.2 -RISK MANAG E M ENT PROCESS for M E EQU I P M E NT o r M E SYSTE M S
A c h a n g e i ntrod uced i n t h e th i rd e d iti o n of this sta n d a rd is that, i n sp ecify i n g m i n i m u m BASI C

SAFETY a n d ESSENTIAL PE RFORMANCE req u i re m e nts, p rovis i o n is made fo r assess i n g t h e
a d e q u acy of t h e d e s i g n PROCESS w h e re t h i s p rovides a n a p p ro p r i ate a ltern ative to t h e
a p p l icat i o n of l a b o rato ry test i n g w i t h sp ecific pass/fa i l crite r i a , ( e . g . i n assess i n g t h e safety o f
new tech n o lo g i e s ) . Ap p l i cation of th is p r i n c i p l e leads to t h e i ntrod u ct i o n of a ge n e r a l
req u i re m e nt to ca rry o ut a RISK MANAG E M E NT PROCESS as p a rt of demo nstrat i n g c o m p l ia n ce
with this sta n d ard.
T h e MANUFACTU RER is res p o n s i b l e for e n s u r i n g t h at t h e design a n d construction of t h e

ME EQUIPMENT r e n d e rs i t s u it a b l e fo r its I NTENDED PURPOSE a n d that any RISKS that are associated
with its use are acceptable when weighed against the benefits. I S O 1 49 7 1 s p e cifies a PROCEDURE
fo r the MANUFACTURER to i d e ntify HAZARDS associated with the ME EQUIPMENT or ME SYSTEM
and its ACCESSORIES, to esti mate and eva l u ate the RISKS associated with those HAZARDS , to
control those RISKS , and to m o n itor the effective n ess of t h at contr o l .
C o m p l i a n ce with t h e c l a u s es o f t h i s sta n d a rd t h at conta i n s s pe c ific, verifi a b l e re q u i rements is

presu med to re d u c e the associated RISK(s) to an acce pta b l e leve l .
T h e MANUFACTU RER o f M E SYSTEMS s h o u l d m a ke this dete r m i n a t i o n o n a system leve l . T h e

MANUFACTURER s h o u l d assess RISKS res u lt i n g f r o m t h e fact t h at i n d iv i d u a l system c o m p o n e nts
h ave b e e n i nteg rated i nto o n e syst e m . T h i s assessment s h o u l d i n c l u d e a l l aspects of t h e
i nfo rmat i o n exc h a n g e d between t h e system c o m p o n e nts. E v e n w h e n t h ese c o m p o n e nts are
n o n-ME E LECTRICAL c o m p o n e nts, t h e pote ntial RISK related to t h e integration of these
c o m p o n e nts i nto t h e M E SYSTEM n e e d to be considered. F u rt h e r re q u i reme nts fo r t h e
i ntegrat i o n of n o n -m e d i c a l e q u i p m e n t into a n ME SYSTEM are d escribed i n C la u se 1 6 . It g ives
the re q u i re m e nts fo r a n ME SYSTEM and how RISKS associated with n o n-ME EQUIPMENT are
a d d ressed.
It s h o u l d be n oted t h at c o m p l i a n ce with ISO 1 49 7 1 d o es not req u i r e t h at t h e MANUFACTURER

h ave a fo rmal q u a l ity syste m i n p l a c e .
T h i s RISK MANAGEMENT PROCESS resu lts i n a set of RECORDS a n d other docu ments: t h e R I S K
MANAG E M E NT F I L E . C o m p l i a n ce of t h e RISK MANAG EMENT PROCESS is c h ecked by i n s p e ct i o n o f
t h e RISK MANAG E M E NT F I L E .
I n a l l c a s e s , t h e MANUFACTURER is to be cons i d e red t h e expert o n t h e device b e i n g deve l o p e d

a n d o n t h e HAZARDS assoc iated with its u s e .
6060 1 - 1 © I EC : 20 0 5 - 447 -
Where c o m p l i a nce tests are by i n s p e ct i o n o r review of t h e RISK MANAG EMENT F I L E , o n ly t h e

rel evant p a rts of t h e RISK MANAG E M E NT F I LE need to be revi ewe d , e . g . MANUFACTURER'S
c a l c u l ati o n s o r test resu lts, o r t h e d etermination of RISK accepta b i l ity.
S o m e req u i re m e nts of t h i s sta n d a rd use the term u n acce pta b l e R I S K, oth e r req u i re m e nts u s e
t h e term HAZARDOUS S I TUATI O N . A l l u n accepta b l e RISKS res u lt f r o m a HAZARDOUS S I TUATI ON, n ot
a l l HAZARDOUS S I TUATIONS res u lt i n an u n acce pta b l e RISK.
In decid i n g which term to use i n a re q u i re m e nt t h e fo l l owi n g ru l e has b e e n u s e d .

U n acce pta b l e RISK is u s e d when t h e MANUFACTURER h a s to , o r is p e r m itte d to, m a ke a
j u d g me n t a b o ut t h e accepta b i l ity of t h e RISK. T h i s j u d g e m e nt needs to be s u p p o rted by a n
a p p r o p ri ate rat i o n a l e s u c h as exp e r i e n c e , h isto rical data, etc.
HAZARDOUS S I TUATION is u sed when the poss i b i l ity of HARM dete r m i n e s w h et h e r c e rta i n
req u i re m e nts a p p l y. I n th ese cases t h e o n l y dete r m i nation a MANUFACTURER has to m a ke i s
w h et h e r o r n ot a HAZARDOUS S I TUATI ON exists; this dete rm i n at i o n is made regard l ess of t h e
RISK res u lt i n g f r o m that HAZARDOUS S I TUATI O N .
T h e term HAZARD is used w h e n t h e HAZARD is n ot n e c e s s a r i l y e x p o s e d .
S u bclause 4.3 - ESSENTIAL P E RFORMANCE
The c o n c e pt of " safety" has b e e n broad e n ed from the BAS I C SAFETY c o n s i d e ratio ns i n the fi rst
a n d second editions of this sta n d a rd to i n c l u d e ESSE NTIAL PERFORMANCE matte rs, ( e . g . t h e
accu racy of p h ys i o l o g i c a l m o n it o r i n g e q u i p m e n t ) . A p p l i cati o n of t h i s p r i n c i p le leads to t h e
c h a n g e of t h e t i t l e f r o m " Safety of m e d i c a l e l ectrical e q u i p m ent, P a rt 1 : G e n e r a l req u i re m e nts
fo r safety" i n t h e second e d it i o n , to " M ed i c a l e l ectrical e q u i p m ent, P a rt 1 : G e n e r a l
req u i re m e nts fo r b a s i c safety a n d e s s e n t i a l p e rfo r m a n c e " .
F o r a n e x p l a nation of ESSE NTIAL PE RFORMANCE, see t h e rati o n a l e fo r 3 . 27.
S u bclause 4.4- EXPECTED S E RVICE LIFE
T h e EXPECTED S ERVICE LIFE n eeds to be dete rm i n e d by t h e MANUFACTURER, as p a rt of t h e RISK

MANAG E M E NT PROCESS, as a precondition fo r asses s i n g c o m p l i a n c e with m a n y re q u i re m e nts of
t h i s sta n d a rd , such as 4 . 5 , 4 . 7 , 7. 1 . 3 , 8 . 6 . 3 , 9 . 8 . 2 a n d 1 1 . 6 . 6 .
I n t h e ACCOMPANYI NG DOCUME NTS , t h e MANUFACTURER s h o u ld provide i nformati o n t o a l low t h e

RESPONSIBLE ORGANIZATI ON t o assess w h e n t h e ME EQUIPMENT is a p proac h i n g t h e e n d o f its
l ife. S u c h i nfo rmat i o n s h o u l d i n c l u d e t h e EXPECTED S E RVICE LIFE as dete r m i ned by t h e
MANUFACTURER ( e . g . i n t e r m s of ye a rs of service o r n u m b e r of u se s ) but c o u l d a l so i n c l u d e
tests to be p e rfo rmed a s p a rt o f p reve ntive m a i nt e n a nce, o r oth e r criteria t o a l l ow t h e
RESPONSIBLE ORGANIZATION t o m a ke a n a p p r o p riate d eterm i n at i o n . T h e n e e d fo r s u c h
i nfo rmat i o n a n d t h e a p p r o p ri ate way t o present i t s h o u l d be a d d ressed a s p a rt o f t h e RISK
S u bclause 4 . 5 - Eq u ivalent safety fo r M E EQU I P M E NT o r M E SYSTEMS
This su b c l a u s e a l lows altern ative means of a c h i evi ng e q u iva l e nt safety to be used. T h is is

i m p o rtant as it permits a MANUFACTURER to u s e i n n ovative s o l ut i o n s t h at m ig h t be safe r o r
h ave oth e r b e n efits, e . g . cost o r p e rfo r m a n c e .
D o c u m e ntat i o n i n t h e RISK MANAGE M E NT F I LE s h o u l d s h ow t h at t h e RESI DUAL RISK ach i eved

u s i n g t h e altern ative m e a n s is accepta b l e because it is e q u a l to or less t h a n the RESI DUAL RISK
ach i eved by applying t h e re q u i re m e nts of t h i s sta n d a r d .
6060 1 - 1 © I EC : 20 0 5 - 449 -
If t h e RESI DUAL RISK is g reater t h a n t h e RESI DUAL RISK ach i eved by a p p l y i n g t h e req u i re m e nts
of t h i s sta n d a rd , t h e ME EQUIPMENT or ME SYSTEM ca n n ot be reg a rded as c o m p l yi n g with t h i s
sta n d a r d , e v e n if t h e RESI DUAL RISK is fu l l y j u stified by other consid erat i o n s s u c h as t h e
c l i n i c a l b e n efit to t h e PAT I E NT.
S u bclause 4.6 - M E EQUIPMENT o r M E SYSTEM parts that con tact t h e PATIENT
A p a rt t h at u n i nt e nt i o n a l l y comes i nto contact with a n u n co n s c i o u s , a n aesthetized or

i n capa citated PAT I E NT c a n present t h e same RISKS as a n APPLI ED PART that necess a r i l y has to
contact t h e PAT I E NT. On t h e oth e r h a n d , a p a rt t h at an active PATI ENT c o u l d reach o u t a n d
t o u c h m i g ht present n o m o r e RISK to t h at PAT I E NT t h a n it p resents to a n OPERATOR.
The defi n it i o n of APPLI E D PART in the fi rst and second e d i t i o n s of t h i s sta n d a rd fa i l e d to

a d d ress t h i s p r o b l e m . The second a m e n d ment to the second e d iti o n exte nded the defi n it i o n to
i n c l u d e p a rts t h at can be b r o u g ht i nto co ntact with the PATI E NT, but the new d efi n it i o n
conti n u ed to c a u s e d iffi c u lt i e s .
S i n c e t h i s sta n d a rd now req u i res a RISK MANAG E M ENT PROCESS t o be fo l l owed, i t is a p p r o p riate
to use this PROCESS to esta b l is h w h eth e r such pa rts s h o u l d be s u bj e ct to the re q u i re m e nts for
APPLI ED PARTS o r n ot.
T h e exc l u s i o n of marking req u i reme nts refl ects t h e m aj o rity view of t h e Natio n a l C o m m ittees
t h at resp o n d ed to an e n q u i ry on t h e s u bj ect d u ri n g t h e deve l o p m e nt of this ed itio n . It would be
confu s i n g to OPERATORS if pa rts t h at are n ot intended to be APPLIED PARTS were ma rked l i ke
APPLI ED PARTS .
S u bclause 4.7 - S I NG L E FAULT CONDTION for ME EQU I P M E NT
T h e req u i re m e n t t h at ME EQUIPMENT is S I NG LE FAULT SAFE effectively p uts a l ower l i m it on t h e

p ro b a b i l ity of occu r re n ce of HARM f r o m a HAZARD. I f this p r o ba b i l ity is ach i eved t h e n t h e RISK
of t h e HAZARD is acce pta b l e . I n all cases where t h i s d i scuss i o n refers to t h e S EVERITY or
p ro b a b i l ity of a p a rticu l a r HAZARD, it is i ntended to refe r to t h e p ro b a b i l ity o r S EVERITY of t h e
HARM res u lt i n g fro m t h at HAZARD.
SI NGLE FAULT SAFE is a concept that flows fro m t h e s i n g l e fa u lt p h i l o s o p h y d escribed in

I EC/TR 60 5 1 3 [ 1 2] . S I NG LE FAULT SAFE is a characteristic of ME EQUIPMENT t h at assu res BAS I C
SAFETY d u ri n g its EXPECTED S ERVICE L I F E . F o r a h ig h S EVERITY HARM , a p p l icat i o n of a RISK
MANAG E M E NT PROCESS c a n c o n c l u d e that t h e s i n g l e fa u lt c o n c e pt d oes n ot a c h i eve a n
acce pta b l e RISK.
T h e p r o b a b i l ity of s i m u lt a n e o u s occu rre n c e of two s i n g l e fa u lts i s c o n s i d e red small e n o u g h to

be n e g l i g i b l e , p rovided t h at:
a ) a s i n g l e fa u lt causes o perat i o n of a p rotective d evice ( e . g . a fu s e , OVER-CU RRENT RELEAS E ,
safety catc h , etc . ) t h at p revents occurre n c e o f a HAZARD, o r
b ) a s i n g l e fa u lt i s d i scovered by a n u n m i staka b l e a n d clearly d i s c e rn i b l e s i g n a l t h at becomes
obvi o u s to t h e OPERATOR, or
c) a s i n g l e fa u lt is d i scovered a n d re medied by p e r i o d i c i n s pect i o n a n d m a i nt e n a n c e t h at is
p rescri bed i n t h e i n structions for u s e . T h e re is a fi n ite p ro b a b i l ity t h at a second fa u lt can
arise b efo re t h e n ext sched u l e d i n s pection a n d m a i nt e n a n c e cycle. As with case a ) a bove,
fo r the p r o b a b i l ity of this d o u b le fa u lt c o n d it i o n to be n e g l i g i b l e , the proba b i l ity of each fa u lt
has to be l ow. T h i s m e a n s t h at t h e freq u e ncy of i n s pect i o n a n d m a i nt e n a n c e h a s to be h i g h
c o m p a red t o t h e expected p ro b a b i l ity o f occurre n ce o f t h e fa u lt. T h e l o n g e r t h e t i m e t h at
o n e S I NGLE FAULT CON DITION re m a i n s present b efo re b e i n g detected a n d rectifi e d , t h e
6060 1 - 1 © I EC : 20 0 5 - 451 -
g re ater t h e p ro b a b i l ity t h at a second fa u lt w i l l a r i s e . T h e refo re, t h e MANUFACTURER m i g h t

need to e x p l i citly c o n s i d e r t h e d etect i o n t i m e i n re lation to t h e occu rre nce of a possi b l e
s e c o n d fa u lt as p a rt of RISK ANALY S I S .
N o n-exc l u s ive exa m p l e s of t h e categories a ) to c ) a r e :
REI NFORCED o r DOUBLE I NSULATI O N ;
CLASS I ME EQUI PMENT i n c a s e of a fa u lt i n BAS I C I NS U LATI O N ;
a b n o r m a l i n d icat i o n s of d i s p l ays, d efect i n a re d u n d a n t s u s p e n s i o n cord ca u s i n g exces sive
n o ise or fricti o n ;
deteriorat i o n o f a flex i b l e PROTECTIVE EARTH CONDUCTOR that is m oved i n NORMAL U S E .
S u bclause 4.9 - U se o f COMPONE NTS W I T H HIGH-INTEGRITY CHARACTERIS ITCS i n M E EQU I P M E NT
T h e first ste p to d eterm i n e a COMPONENT WITH H I G H-I NTEG RITY CHARACTERISTICS is to c o n d u ct a

RISK ANALYSIS to fi n d those c h a racte ristics t h at are req u i red to m a i nt a i n BAS I C SAFETY o r
ESSENTIAL PE RFORMA NCE . H avi ng d o n e t h i s , t h e a p p ro p ri ate c o m p o n e n t c a n b e s e l ected.
Refe r e n ce c a n b e made to I EC component sta n d a rds as p a rt of t h e dete r m i n at i o n of t h e
characteristics re q u i re d .
TYPE TESTS of COMPONE N TS WITH H I G H-I NTEG RITY CHARACTERISTICS are o n l y p a rt of t h e re q u i red
determ i n ati o n of s u ita b i l ity. S i nce a p a rt i c u l a r COMPONENT WITH HIGH-I NTEGRITY
CHARACTE RISTI CS has to fu nction as i ntended o r a HAZARD is l i kely to occur, a d d iti o n a l
c o n s i d e rati o n s i n c l u d e a s a p p r o p ri ate :
conti n u o u s s u rve i l l a n ce as p a rt of t h e m a n ufactu r i n g PROCESS a n d a l so after asse m b l y i nto
the end p rod u ct;
p a rtic u l a r c h a racte ristics of t h e device c o n c e r n e d ;
l ot test i n g ;
c a l i brat i o n ;
control of m a n ufact u r i n g defects;
m a i nt e n a n c e ;
EXPECTED S E RVICE L I F E of e q u i p ment;
use of re l evant c o m p o n e nt sta ndards;
fa i l u re mode c h a racte rist i cs;
e n vi r o n m e nt a l c o n d it i o n s ;
a n t i c i p ated m is u s e of e q u i p m ent;
i nteract i o n with other e q u i p ment.
S u bclause 4. 1 0 - Power s u pply
An alternating voltage is consid ered i n p ractice to be s i n u so i d a l if any i n stanta n e o u s va l u e of

t h e wavefo rm concerned d i ffers from t h e i n stanta n e o u s va l u e of t h e i d e a l wavefo rm at t h e
same m o ment by n o more t h a n ± 5 % of t h e p e a k v a l u e of t h e i d e a l wavefo rm.
A p o l yp h ase voltage system is c o n s id e red to b e symmetrical if n e ither t h e mag n it u d e of its

n e gative s e q u e n c e c o m p o n e nts n o r t h e m a g n it u d e of its zero s e q u e n c e c o m p o n e nts exceeds
2 % of the mag n it u d e of its pos itive s e q u e n c e c o m p o n e nts.
6060 1 - 1 © I EC : 20 0 5 - 453 -
A p o l y p h ase s u p pl y system is c o n s i dered to be sym m etrical if, w h e n s u p p l i e d from a

sym m etrical voltage syste m , t h e res ulti n g c u rrent system is sym m etri cal . T h at i s , t h e
m ag n it u d e o f n e i t h e r t h e n e gative s e q u e n c e cu rrent co m po n e nts n o r t h e zero s e q u e n c e
cu rrent c o m p o n e nts exceeds 5 % o f t h e m ag n itude o f t h e p ositive s e q u e n c e c u rrent
com p o n e nts.
Cla use 5 - G e n e ra l re q u i reme nts fo r test i n g M E EQU I P M E N T
I n ME EQUIPMENT t h e re c o u l d be m a n y p i eces o f i ns u l ati o n , co m po n e nts ( e l ectrical a n d

m e c h a n i c a l ) a n d constructi o n a l featu res i n w h i c h a fai l u re wo u l d n ot p r o d u c e a HAZARD t o
PAT I E NT, OPERATOR o r s u rro u n d i n gs , e v e n t h o u g h ca u s i n g a deteriorati o n i n o r a fa i l u re of
perfo r m a n c e of ME EQUIPMENT.
S u bclause 5 . 1 - TYPE TESTS
T h e RISK MANAG E M E NT PROCESS i d e ntifies t h e RISK CONTROL m e as u res t h at are n ecess a ry to

e n s u re t h at t h e ME EQUIPM ENT is safe.
U n l ess oth e rwi s e s pecifi ed in this sta n d a rd , tests s h o u l d n ot be repeated. T h i s a p p l i es

'
parti c u l arly to t h e d i e l ectric str e n gth tests , w h i c h are perfo r m e d o n l y at t h e MANUFACTU RER s
site or i n test l a borato ries.
In order to e n s u re that every i n d i v i d u a l l y produ ced ite m of ME EQUIPMENT confo r m s to this

sta n d a r d , t h e MANUFACTURER o r i nstal l e r s h o u l d ca rry out s u c h m e asu res d u r i n g m a n ufact u r e
o r i nsta l l at i o n ass e m b l y as to e n s u r e t h at each item satisfi es a l l req u i re m e nts ev e n if it is n ot
com p l etely tested i n di v i d u a l l y d u ri n g m a n ufact u r e or i nstal l ati o n .
S u c h m eas u res c o u l d take t h e form of:

a) p r o d u cti o n m ethods (to e n s u r e good m a n ufactu r i n g o utput a n d co nstant q u a l ity) where
s u c h q u a l ity w o u l d be r e l ated to safety;
b) p r o d u cti o n tests ( ro uti n e tests) p e rfo r m e d on ev e ry produced ite m ;
c ) p r o d u cti o n tests perfo r m e d o n a prod u ct i o n s a m pl e where resu lts w o u l d j u stify a s uffi c i e nt
confi d e n ce level .
P r o d u ct i o n tests n e e d n ot be i dentical with TYPE TESTS, b ut c a n be a d a pted to m a n ufact u ri n g

conditions a n d poss i b l y i nvoki n g l e s s R I S K f o r t h e q u a l ity o f t h e i ns u l ati o n o r oth e r
c h a racte risti cs i m portant for BAS I C SAFETY a n d ESSE NTIAL PERFORMANCE .
P r o d u ct i o n tests wo u l d , of course, be restricted to setti ngs ( possi b l y derived from TYPE TESTS )
t h at wo u l d provoke t h e worst case situati o n .
D e p e n d i n g u po n t h e n at u r e o f ME EQUIPM ENT, prod u cti o n m et h o ds o r tests co u l d concern

criti cal i ns u l at i o n of t h e MAINS PART, of t h e PAT I E NT CON NECTI ONS and t h e i ns u l ati o n o r the
se p a rati o n b etwe e n t h e s e p a rts .
S u g g ested test param eters c o u l d be LEAKAGE CURRENT a n d d i e l ectri c str e n gt h .
W h e n a p pl i c a bl e , t h e co nti n u ity o f p rotective e a rt h i n g c a n be a m aj o r test param ete r.

6060 1 - 1 © I EC : 20 0 5 - 455 -
S u bclause 5.2 - N u m ber of sam p les
The TYPE TEST s a m p l e o r s a m p l es n e e d to b e represe ntative of the u n its i nt e n d e d for t h e

RESPONSIBLE ORGANIZATION.
S u bc l a u se 5.7 - H u m id ity p reco n d i t i o n i n g t reatment
Accord i n g to I E C 60529, t h e E NCLOS URE of ME EQUI PMENT t h at is RATED I PX8 preve nts, u n de r
state d c o n d i t i o n s , t h e e ntry o f a n a m o u nt o f water w h e re i t s presence co u l d res u l t i n a
HAZARD.
T h e test c o n diti o n as wel l as t h e acce pta b l e a m o u nt and l ocati o n of water are to b e defi n e d i n
parti c u l a r sta n dards. I f n o i n g ress o f water i s tole rated ( s e a l e d E NCLOSURES) t h e a p pl i cati o n of
t h e h u m i dity p reco nditi o n i n g treat m e n t is i n a p pro p r i ate.
P a rts sens itive to h u m i dity, n o r m a l l y used in contro l l e d envi r o n m e nts and which do not
i nfl u e nce safety, n e e d not b e s u bj ected to t h i s test. Ex a m p l es are: h i g h - d e n s ity storage m e d i a
i n c o m p uter- based syste m s , d i s c a n d ta pe drives, etc.
To prevent c o n d e n s ati o n w h e n ME EQUIPM ENT i s pl aced in the h u m i dity c a b i n et, t h e

tem perature o f s u c h a c a b i n et s h o u l d be e q u a l to o r s l i ghtly l owe r t h a n t h e tem perature o f t h e
ME EQUIPMENT w h e n it is i ntrod u c e d . To av o i d t h e n e e d f o r a tem perat u re sta b i l izati o n system
for the air in the room o utsi d e the c a bi n et, the ca b i n et air t e m perature d u ri n g the treatm ent is
a d a pted to t h at of the outside air with i n the l i m its of the range of +20 oc to + 32 o c and t h e n
" sta b i lized" a t t h e i n itial v a l u e . Alth o u g h t h e effect of t h e c a bi n et t e m p e rat u r e o n t h e d e g ree of
a bs o rpti o n of h u m i d ity is reco g n ized, it is felt that t h e reprod u ci bi l ity of test res u lts is n ot
i m p a i r e d s u bsta nti a l l y a n d t h e cost-re d u ci n g effect is c o n s i d e ra bl e .
S u bclause 5.9 - Determ i n ation of APPL I E D PARTS a n d ACCESSIBLE PARTS
Exc e pt i n s pe c i a l cas e s , s u c h as PAT I E NT s u p po rts a n d wate rbeds , co ntact with ME EQUI PMENT
i s s u p p osed to b e m ade wit h :
o n e h a n d , s i m u l ated for LEAKAGE CURRENT m e a s u r e m e nts b y a m etal fo i l o f 1 0 em x 20 e m
( o r l ess i f t h e total ME EQUI PMENT i s s m a l l e r ) ;
o n e fi n g e r , stra i g ht o r b e nt i n a natural positi o n , s i m u l ated b y a test f i n g e r prov i d e d with a
sto p p l at e ;
a n edge o r s l it t h at c a n b e p u l l ed o utwa rds a l l owi n g s u bs e q u e n t e ntry o f a fi n g e r ,
s i m u l ated by a com bi n ati o n o f test h o o k a n d test fi n g e r .
S u bclause 5 . 9 . 2 . 1 - Test f i n g e r
An ACCESS COVER i s a p a rt o f t h e E NCLOS URE t h at can b e r e m o v e d i n o r d e r to a l l ow a ccess t o

parts o f el ectrical e q u i p m ent for p u r poses o f a dj ustm e nt, i ns pecti o n , r e p l a c e m e n t o r r e p a i r. I t
i s pres u m ed t h at parts t h at c a n b e rem oved wit h o ut t h e u s e of a TOOL a re i ntended to b e
r e p l a ced by a n y OPERATO R, n ot o n l y by S E RVICE PERSONNEL, e v e n if t h i s is n ot described i n t h e
i nstru cti o n s fo r u s e . O P E RATORS oth e r t h a n S ERVICE PERSONNEL m i g h t n ot be as well tra i n e d o r
ex p e r i e n c e d i n good s afety practices as S ERVICE PERSONNEL. T h e refo re , extra s afety
precaut i o n s a re needed to prevent accide ntal co ntact with hazardous voltages. T h at is why
parts such as l a m ps , fuses, and fuse h o l d e rs t h at c a n be re m ov e d wit h o ut t h e u s e of a TOOL
are to b e rem oved before determ i n i n g w h i c h parts i n s i d e the ACCESS COVER are to be
c o n s i d ered ACCESSI BLE PARTS .
6060 1 - 1 © I EC : 20 0 5 - 457 -
F u s e h o l ders w h e re t h e fusel i n k is h e l d i n a ca p that c a n be re m ov e d wit h o ut u s e of a TOOL are

a s pe c i a l c o n c e r n . I f t h e fuse l i n k does not come o ut when t h e cap i s re m ov e d , t h e OPERATOR
co u l d b e i n cl i n ed to try to r e m ove it by g r i p p i n g the end of the fus e l i n k with the fi ngers. T h e
OPERATOR c o u l d try to i n se rt a new fus e l i n k i nto t h e fuse h o l d e r wit h o ut fi rst i ns e rti n g it i n t h e
c a p . B o t h c a s e s c a n be considered reas o n a bly foreseea b l e m is us e . T h i s s h o u l d be t a k e n
i ntoco n s i de rati o n w i t h assess i n g what p a rts are access i bl e .
T h e reader is refe rred t o I E C 6 0 1 27-6 [7] f o r m o re i nfo r m at i o n o n fuse h o l d e rs .
Cla use 6 - Class ificat i o n o f M E EQUI P M E N T a n d M E SYSTE M S
M E EQUI PMENT c a n h a v e a m u l t i p l e cl assifi cati o n .
S u bclause 6 . 2 - P rotection aga i nst electric s h ock
T h e term " C l ass I l l e q u i p m e nt" is used i n some oth e r sta n d a rds to i d e ntify e q u i p m ent t h at i s
powered from a safety extra- l ow voltage ( S E LV) m a i ns s u p p l y syste m . T h e t e r m Cl ass I l l
e q u i p m e nt i s not fo r m a l l y u s e d i n this sta n d a rd . T h e BAS I C SAFETY of Cl ass I l l e q u i p m ent i s
criti c a l l y d e pe n d e nt o n t h e i nsta l l at i o n a n d o n oth e r C l ass I l l e q u i p m e n t co n n ected t h e ret o .
T h ese factors are outs i d e t h e c o n t r o l o f t h e OPERATOR a n d t h i s is c o n s i d ered to be
u n accepta b l e for ME EQUIPMENT. Additi o n a l l y , l i m itat i o n of voltage is n ot s uffi c i e nt to e n s u r e
safety o f t h e PAT I E NT. For t h e s e reas o n s , t h i s sta ndard d o es n ot reco g n ize Cl ass I l l
constructi o n .
S u bclause 6 . 3 - P rotection ag a i n s t h a rmfu l i n g ress of water o r part i c u l ate m atter
It s h o u l d be n oted that c o m p l i a n c e with the req u i re m e nts of t h i s sta ndard auto m atical l y a l l ows
MANUFACTURERS to rate ME EQUIPMENT as I P2X because t h e req u i re m e nts of I EC 60529 for
t h i s rati n g are the s a m e as the accessi b i l ity req u i re m e nts (see 5 . 9 ) .
S u bclause 6 . 6 - M od e of operation
CONTI NUOUS OPERATI ON and n o n-CONTI NUOUS OPERATION cover the range of o pe rati n g m odes
of vi rt u a l l y all e q u i pm ent. ME EQUI PMENT that r e m a i n s p l u g g e d i nto the S U PPLY MAI NS
conti n u o u s l y b ut is o p e rated i nterm itte ntly s h o u l d b e RATED for n o n-CONTI NUOUS OPERATI O N ,
have t h e a ppro pri ate i n d i cati o n o f o n/off ti m es i n t h e ACCOMPANYI NG DOCU ME NTS a n d m a rki n gs
on t h e ME EQUIPMENT (see 7 . 2 . 1 1 ) .
S u bclause 7 . 1 . 1 - U SABILITY of t h e i d e n t ificat i o n , m a r k i n g a n d docu m e n ts
For ME EQUI PMENT to be we l l d e s i g n e d , its m a rki n gs a n d ACCOMPANYI NG DOCU ME NTS s h o u l d b e

c l e a r , cons istent, a n d h e l p to red u ce p ote nti al use error. T h u s , m a rki ngs a n d ACCOMPANYI NG
DOCU MENTS s h o u l d u n de rgo the s a m e rigorous eva l u ati o n as ot h e r OPERATOR-ME EQUIPM ENT
i nterface e l e m e n ts .
S u bclause 7 . 1 . 2 - Leg i b i l ity o f m a r k i n g s
M a rki n gs o n ME EQUIPMENT are ex pected to b e CLEARLY L E G I B L E by a n OPERATOR o v e r t h e

range o f n o r m a l i l l u m i n ati o n levels where t h e ME E Q U I P M E N T i s ty p i c a l l y o pe rate d . T h e l ev e l s
used i n t h i s test a re d e r i v e d f r o m the fo l l owi n g reco m m e n ded i l l u m i nati o n l evels f o r use i n
i nterior l i g hti n g des i g n [5 1 ] :
6060 1 - 1 © I EC : 20 0 5 - 459 -
1 0 0 lx to 2 0 0 lx is reco m m e n d e d for worki n g s paces where v i s u a l tasks are p e rfo r m e d o n l y

occas i o n a l l y ;
5 0 0 lx to 1 000 lx i s reco m m e n d e d f o r v i s u a l tasks o f s m a l l s i z e o r read i n g m e d i u m - p e n c i l
h a n dwriti n g ;
1 0 0 0 lx to 2 0 0 0 lx i s reco m m e n d e d f o r v i s u a l tas ks o f l ow co ntrast o r very s m a l l s i z e : e . g .
rea d i n g h a n dwriti n g i n h a rd- p e n c i l o n poor- q u a l ity pa per.
I f m a rki n gs are n ot l e g i b l e to t h e OPERATOR u n der t h e ex p ected c o n diti o n s of u s e , t h e re wo u l d
be a n u n acce pta b l e RISK.
T h e M i n i m u m A n g l e of Resolution ( MAR) is a visual acu ity m ea s u re m e nt m ethod d ev e l o pe d

as a n i m prov e m ent o n t h e l o n g - u s e d S n e l l e n s c a l e . T h e v a l ues are ex press as a l o garithm of
t h e M i n i m u m A n g l e of Reso l uti o n . Log MAR c a n be c a l c u l ated from t h e S n e l l e n s c a l e , i . e .
l o g MAR = l o g ( 6/6) = 0 fo r n o r m a l vis i o n .
S u bclause 7 . 1 . 3 - D u ra b i l ity o f m a r k i n g s
T h e r u b b i n g test i s p e rfo r m e d w i t h disti l l ed wate r, m ethyl ated s pi rits a n d i s o p r o pyl a l co h o l .
Eth a n o l 9 6 % is defi n e d i n t h e E u ro p e a n P h a r m acopoeia a s a reagent i n t h e fo l l owi n g t e r m s :

C 2 H 6 0 ( MW46 . 0 7 ) .
I s o pro pyl a l c o h o l is d efi n e d i n t h e E u ro pe a n P h a r m acopoeia as a reagent i n t h e fol l owi n g

terms: C 3 H80 ( MW6 0 . 1 ) .
S u bclause 7 . 2 . 2 - Identification
T h i s s u b c l a u s e i s i nt e n d e d to a pp l y to a n y deta c h a b l e c o m p o n e n t w h e n m i s i d e ntificati o n
co u l d present a HAZARD. F o r ex a m p l e s , n o r m a l c o n s u m a bl es wo u l d p r o ba b l y n e e d to be
i d e ntifi e d , b u t a cos m et i c cov e r wo u l d n ot n e e d to be i d e ntifi e d .
Alt h o u g h a M O D E L OR TYPE REFERENCE u s u a l l y d e n otes a certa i n perform a n ce s pecifi cati o n , i t

m i ght n ot d e n ote t h e exact construct i o n , i n c l u d i n g t h e a p pl i e d c o m p o n e nts a n d m ate r i a l s . I f
t h i s is req u i re d , t h e MODEL OR TYPE REFERENCE can be s u p p l e m e nted b y a s e r i a l n u m ber. T h e
s e r i a l n u m be r c a n be u s e d for other p u r poses.
I n d i cati o n of a m a n ufact u ri n g s e ri es o n ly m i g ht n ot b e s uffi c i e nt if l ocal req u i re m e nts req u i re

i n d i v i d u a l i d e ntifi cat i o n .
I t is c h a racte ristic o f software t h at d iffe rent vers i o n s c a n r u n o n a P E M S . T h e i d e ntifi cati o n of

t h e softwa re wi l l oft e n be on t h e u s e r i nterface, alth o u g h this m i g ht n ot be poss i bl e e . g . w h e re
t h e software does n ot h ave a u s e r i nterface. I de ntifi cati o n of t h e s oftware c o u l d n e e d s pe c i a l
tools. For t h i s reaso n , t h e req u i re m ent p e r m its t h e i d e ntifi cat i o n to be o n l y avai l a b l e t o
des i g n ated p e o p l e .
S u bclause 7 . 2 . 3 - Con s u lt ACCOMPANYING DOCU M E NTS
It is not i nt e n d e d in ev e ry case w h e n t h e i nstru cti o n s for u s e conta i n warn i n g s , t h at t h e

ME EQUIPMENT b e m a rked with I EC 6 0 8 7 8 Safety 0 1 ( s e e T a b l e 0 . 2 , s afety s i g n 1 0) . T o o m a n y
wa r n i ngs a n d u n n ecess a ry wa rni n gs a r e c o u nte rpro d u ctive. O n l y w h e n t h e MANUFACTURER, a s
a RISK CONTROL m easure f o r a s pecific R I S K , d e c i d es to m a rk t h e ME EQUI PMENT to i nstruct t h e
OPERATOR to read t h e i nstru cti o n s for u s e , s h o u l d s afety s i g n I EC 60878 Safety 0 1 be u s e d .
6060 1 - 1 © I EC : 20 0 5 - 461 -
S u bclause 7 . 2 . 4 - ACCESSORI E S
RESPONSIBLE ORGANIZATI ONS a n d OPERATORS n e e d to be a bl e to i de ntify ACCESSORIES i n o rd e r

to k n ow w h i c h o n es can be used with out i m p a i ri n g BAS I C SAFETY o r ESSE NTIAL PERFORMANCE . A
MODEL OR TYPE REFERENCE a l o n e is n ot s uffi cient, because diffe rent MANUFACTURERS m i g ht u s e
t h e s a m e n u m ber. T h e n a m e m a rked o n t h e ACCESSORY co u l d be t h at of t h e ME EQUIPMENT
MANUFACTURER or a diffe rent n a m e .
S u bclause 7 .2 . 1 0 - APPLIED PARTS
Accord i n g to t h e second e d iti o n of t h i s sta n d a rd , the m a rki n g c o u l d be either on t h e APPLI E D

PART its e lf o r a dj a c e nt to t h e c o n n ecti o n poi nt. N e ith e r l ocati o n is s ati sfactory i n a l l cases.
Where a c o n d u ctor t h at i s n ot s e p a rated from PATI ENT CONNECTIONS ext e n ds up to the p o i nt

i ns i d e ME EQUIPM ENT w h e re a n i s o l at i o n barrier ex i sts , a TYPE BF or TYP E CF m a rki n g on t h e
APPLI ED PART its e lf c o u l d m i s l e a d t h e RESPONSIBLE ORGANIZATION o r t h e OPERATO R i nto
b e l i evi n g t h at i s o l at i o n i s b u i lt i nto the APPLI E D PART itself. If, o n the oth e r h a n d , t h e
cl assifi cati o n d e pe n ds o n t h e parti c u l a r APPLI ED PART i n u s e , a s i n g l e m a rki n g o n t h e
co n n e cti o n p o i n t wo u l d be i n accu rate a n d m u lti p l e m a rki n g wo u l d be confus i n g .
F o r DEFIBRI LLATION-PROOF APPLI ED PARTS , i f protect i o n a g a i nst t h e effect o f t h e d i s c h a rge o f a

card i a c defi b ri l l ator is partly i n t h e PAT I E NT c a b l e , a wa r n i n g to t h e OPERATOR is n ecessary
because t h e re are n o n-obvious HAZARDS if t h e wro n g c a b l e is u s e d . HAZARDS c a n i n c l u d e
decreas i n g t h e defi b ri l l at i o n e n ergy d e l ivered to t h e PAT I E NT, d a m ag e to t h e ME EQUI PMENT
with c o n s e q u ent l oss of ESSENTIAL PE RFORMANCE , o r e l ectric s h o c k to the OPERATOR o r oth e r
pers o n s .
S u bclause 7 . 2 . 1 2 - F u ses
Ex a m p l es of m a rki n g for fuses c o m plyi n g with I EC 6 0 1 27-1 a r e :

T 3 1 5L, 250V
T 3 1 5 m AL, 2 5 0 V
F 1 ,25H, 250V
F 1 , 25AH , 250V
T h e o pe rati n g s pe e d c a n be m a rked by t h e l ette r o r co l o u r codes in I E C 60 1 27- 1 , w h i c h are

as fo l l ows :
- very q u i c k acti n g : F F , or b l a c k
q u i c k acti n g : F , o r red
m edi u m ti m e l a g : M, o r yel l ow
- ti m e l a g : T, o r b l u e
l o n g ti m e l a g : T T , o r grey
6060 1 - 1 © I EC : 20 0 5 - 463 -
S u bclause 7 . 3 . 2 - H I G H VOLTAGE parts
H I G H VOLTAGE p a rts present a s i g nificant e l ectri c s h ock HAZARD to S ERVICE PERSONNEL a n d

oth e rs w h o co u l d b e req u i red t o work i ns i d e t h e ME EQUIPMENT w h i l e i t i s e n e rgized. Because
t h e p a rts are i ns i d e t h e E NCLOSURE , t h e RISK is perceived to be s u bstanti a l l y l ess t h a n that for
H I G H VOTAGE TERM I NAL DEVICES l ocated o n the o uts i d e of the M E EQUI P M E NT. T h e refo re, t h e
" d a n g e ro u s v o l t a g e " sym b o l ( I EC 604 1 7-5036) ( D B : 2002-1 0) is p e r m itted as a m a rki n g to a l e rt
S ERVICE PERSONNEL a n d oth e rs to t h e pote nti al pres e n c e of th ese d a n gerous voltages. T h e
MANUFACTURER i s perm itte d to u s e a safety s i g n 3 . T h e RISK MANAG E M E NT PROCESS co u l d
determ i n e t h at t h e s afety s i g n is t h e m ost a p pro p r i ate c h o ice if t h e perso n n el ex posed t o t h e
HAZARD have m i n i m a l trai n i n g o r m i g ht oth e rwi s e be u n aware t h at H I G H VOLTAGE is present.
S u bclause 7 . 3 . 4 - F uses, THERMAL CUT-OUTS a n d OVE R-CURRENT RELEAS ES
See the rati o n a l e fo r 7 . 2 . 1 2 .
S u bclause 7 . 8 - I nd icator l i g h ts a n d controls
For col o u rs of i n d i cator l i g h ts see also I E C 60073 [5].
S u bclause 7.9.1 - Ge n e ra l
I t i s i m porta nt t h a t ME EQUI PMENT o r a n ME SYSTEM is n ot u n i ntenti o n a l ly used i n a n a p pl i cati o n

for w h i c h i t i s n o t i nt e n d e d b y its MANUFACTURER.
S u bclause 7 . 9 . 2 . 1 - G eneral
RESPONSIBLE ORGANIZATI ONS and OPERATORS fre q u e ntly deal with many diffe rent types of
ME EQUI PMENT. Because of t h e co m pl ex i ty of m odern ME EQUI PM ENT, t h e i nstruct i o n s for use
are a n i m porta nt p a rt of t h e ME E Q U I PMENT. Some co m m o n a l ity in t h e structure for t h e
i nstr u cti o n s f o r u s e c o u l d h e l p OPERATORS to fi n d n e e d e d m aterial q u i c kl y a n d eas i l y .
H owever, b e c a u s e o f t h e divers ity o f ME EQUI P M E NT covered by t h i s sta n d a rd , n o o n e fo r m at
wi l l be e q u a l l y a pp l i c a b l e to a l l ME EQUIPM ENT. T h e refo re, t h e MANUFACTURER is e n c o u ra g e d ,
b u t not re q u i re d , to use t h e s e q u e n c e o f t o p i cs i n 7 . 9 . 2 . 2 to 7 . 9 . 2 . 1 6 as a n o u tl i n e w h e n
devel o p i n g t h e i nstr u cti o n s f o r u s e .
T h e p ro b l e m o f l a n g u ages used i n m a rki n gs a n d i n ACCOMPANY I NG DOCUME NTS ca n n ot be

solved by I EC . Even a re q u i re m ent that i d e ntificat i o n s and ACCOM PANYING DOCU ME NTS h ave to
be in the n at i o n a l l a n g u ages ca n n ot be u ph e l d worl d-wi d e .
S u bclause 7 . 9 . 2 . 2 - War n i ng and safety n otices
For CLASS I ME EQUI P M E NT, where o perat i o n fro m eith e r a S U PPLY MAINS or an I NTE RNAL
E LECTRICAL POWER SOURCE is s pecifi e d , t h e i nstructi o n s for use s h o u l d state t h at t h e I NTE RNAL
E LECTRICAL POWER SOURCE i s to be used if the i nteg rity of the PROTECTIVE EARTH CONDUCTOR or
the p rotective e a rth i n g system in the i n stal l at i o n i s in d o u bt.
S u bclause 7 . 9 . 2 . 6 - I nsta l l ation
T h e i nstr u cti o n s for use can conta i n a state m e nt s ay i n g t h at the MANUFACTURER, ass e m bl e r ,
i nsta l l e r o r i m porter c o n s i d e rs h i m s elf res po nsi b l e f o r t h e effect o n BAS I C SAFETY, rel i a bi l ity
a n d perfo r m a n c e of the M E EQUIPMENT o r ME SYSTEM o n l y if:
a p pro p r i ately tra i n e d perso n n e l ca rry o ut assem bly o p e rati o n s , exte n s i o n s , readj ustm e nts ,
m odificat i o n s or repai rs ;
6060 1 - 1 © I EC : 20 0 5 - 465 -
- t h e e l ectrical i nsta l l at i o n of t h e relevant room com p l i es with t h e a p pro p r i ate req u i re m e nts ;
and
- t h e ME EQUIPMENT or ME SYSTEM is used i n accord a n ce with t h e i nstr u cti o n s for u s e .
S u bclause 7 . 9 . 2 . 7 - I so l ation f r o m t h e S UPPLY MAI NS
A p l u g and socket prov i d e s u it a b l e means for i s o l ati o n from t h e S U PPLY MAINS to sati sfy
8 . 1 1 . 1 a ) , but they wo u l d n ot be s u it a b l e if they were n ot readily a ccessi b l e w h e n n e e d e d .
S u bclause 7 . 9 . 3 . 1 - G eneral
Accord i n g to t h e I NTENDED USE of ME EQUIPMENT, t h e MANUFACTURER s h o u l d s pecify t h e

perm i ss i bl e e n v i r o n m e ntal conditions f o r w h i c h a HAZARD i s n ot i n d u c e d . E nvi ro n m e ntal
con diti o n s such as t h e fol l owi n g are ex p ected to b e c o n s i d e re d :
- t h e effect of h u m i d ity;
- t h e effect of tem perat u r e ;
- t h e effect of atm o s p h e r i c press u re ;
- t h e effect of s h o c k a n d v i brati o n ;
- t h e effect of u ltra-v i o let radiati o n .
- t h e effect of t h e tem perat u re of t h e water for wate r cooled ME EQUIPMENT;
- t h e effect of p o l l u ti o n .
Acc u racy a n d preci s i o n are n o t poss i b l e to d efi n e i n t h i s sta n dard . T h e s e conce pts have t o b e
a d d ressed i n parti c u l a r sta n d a rd s .
T h e v a l u es l isted b e l ow w e r e used i n t h e s e c o n d editi o n o f I EC 6 0 60 1 - 1 to descr i b e t h e range

of envi ro n m e ntal c o n d i t i o n s over w h i c h ME EQUIPMENT was req u i re d to be s afe.
a) a n a m b i e n t tem perature r a n g e of + 1 0 oc to + 40 o c ;
b) a relative h u m i dity r a n g e o f 30 % to 75 % ;
c ) a n atm o s p h eric press u r e range o f 7 0 , 0 k P a t o 1 06 , 0 kPa;
d) a tem peratu re of t h e water at t h e i n let of water-co o l e d ME EQUIPM ENT n ot h i g h e r t h a n 2 5 o c .
T h ese e n v i r o n m e ntal con diti o n s w e r e based o n t h e c o n diti o n s i n b u i l di ngs wit h o ut a i r

conditi o n i n g i n c l i m ates where t h e a m b i e nt tem perat u re occas i o n a l ly re a c h es + 40 o c .
I n t h e s e c o n d editi o n o f I EC 606 0 1 - 1 , t h e ME EQUI PMENT h a d t o b e s afe w h e n o pe rated u n d e r

t h e a bove co nditi o n s b u t it o n l y n eeded t o b e f u l l y o pe r a b l e u n d e r c o n diti o n s s pecifi ed b y t h e
MANUFACTURER i n t h e ACCOMPANYI NG DOCUM E NTS .
T h i s e d iti o n s pecifies p a rti c u l a r envi ro n m e ntal conditions for s o m e re q u i re m e nts a n d tests .

Where t h i s is not t h e case, ME EQUIPM ENT has to re m a i n s afe a n d o pe rate co rrectly over t h e
range o f envi r o n m e ntal c o n diti o n s s pe cifi ed by t h e MANUFACTU RER i n t h e ACCOMPANYING
DOCUMENTS .
Atte nti o n is d rawn to t h e fact that t h e re was a l ways a p r o bl e m to a p ply a 40 oc e nvi ro n m e ntal
con diti o n to a ME EQUI PMENT in cases w h e re t h e APPLI ED PART n eeded to o pe rate at
tem peratu res c l o s e to t h e 4 1 o c l i m it.
T h e second editi o n of I E C 6060 1 - 1 s pecifi e d t h e fol l owi n g range of e nvi ro n m e ntal c o n ditions
for t r a n s po rt a n d sto rage of ME EQUIPM ENT u n l ess ot h e rwise s pecified by t h e MANUFACTURER:
6060 1 - 1 © I EC : 20 0 5 - 467 -
an a m b i e n t tem peratu re r a n g e of - 40 o c to + 70 o c ;
a relative h u m i dity range o f 1 0 % t o 1 00 % , i n c l u d i n g c o n d e n s ati o n ;
a n atm o s p h e r i c press u r e range o f 50 k P a t o 1 06 kPa.
Am e n d m e nt 2 to t h e s e c o n d e d iti o n repl aced t h e a bove l i st with a re q u i re m ent t h at t h e

MANUFACTURER state t h e p e r m i ss i b l e t r a n s po rt a n d storage c o n d i t i o n s . H owever, i n t h e
a bs e n c e of ot h e r i nform ati o n , t h e a bove l ist c a n s e rve as a u s efu l starti n g p o i nt i n determ i n i n g
t h e perm issi b l e l i m its.
I nfo r m ati o n o n e nvi ro n m e ntal p a r a m eters and a l i m ited n u m be r of t h e i r severities wit h i n the
range of c o n diti o n s m et by e l e ctrotech n i cal p r o d u cts when b e i n g t r a n s po rted, sto red, i nsta l l ed
a n d used c a n be fo u n d i n t h e I E C 6 0 7 2 1 s e ri es [ 1 8 ] .
For PERMANE NTLY I NSTALLED h i g h p ower ME EQUI PMENT, it m i g ht be n ecessary to control t h e

v o l t a g e d r o p i n t h e c usto m e r i nstal l ati o n to p r e v e n t i n put voltage g etti n g b e l ow t h e m i n i m u m
n o r m a l voltage d u e to l ocal c o n d iti o n s . Co ntrol can be d o n e by s pecify i n g t h e req u i red
a p pa r e nt i m p e d a n c e of t h e S U PPLY MAI NS .
S u bclause 7 . 9 . 3 . 4 - M a i n s isolation
S E RVICE PERSONNEL need to know how to i s o l ate the ME EQUI P M ENT from t h e S U PPLY MAI NS .
T h i s i s n ot always o bv i o u s , parti c u l arly if t h e r e i s a switch i n t h e MAINS PART t h at d o e s n ot
m eet t h e req u i re m e nts of 8 . 1 1 .
Cla use 8 - P rotect i o n a g a i n st e lectrical HAZARDS from M E EQUI PMENT
T h e fu n d a m e ntal pri n c i p l e f o r protect i o n agai nst el ectric s h o c k i s t h at t h e v o l t a g e o r cu rrent

betwe e n a n y access i b l e s u rface and a n y oth e r accessi b l e s u rface o r e a rt h i s low e n o u g h n ot
to pres e n t a HAZARD, i n a l l relevant ci rcu m sta nces i n cl u d i n g NORMAL CONDI TION a n d S I NGLE
FAULT CONDI TION.
R e q u i r e m e nts for ach i ev i n g p rotect i o n have b e e n form u l ated in v a r i o u s ways i n I EC b a s i c

safety sta ndards, i n prev i o u s editi o n s o f t h i s sta n da r d , a n d i n oth e r I EC p r o d u ct sta n dards.
In order for t h e fu n d a m e ntal pri n c i p l e to be s ati sfi e d :

a) parts t h at a r e " l ive" ( a s defi n e d i n t h e s e c o n d editi o n o f this sta n dard) o r " h aza rd o u s l ive"
(as d efi n e d in some oth e r sta n d a rd s , such as I E C 6 1 1 40 [23] a n d I EC 6 1 0 1 0- 1 [22]) h av e
to be i n access i b l e ( but see b e l ow regardi n g p r o bl e m s i n i d e ntify i n g w h a t i s " l iv e " ) a n d
b) ACCESSI BLE PARTS i n cl u d i n g APPLI ED PARTS have to be n ot " l ive" I " h azardous l i v e . "
NOTE The term " l ive" was defined i n the second e d ition o f this standard a s , "State o f a part which, when
con nection is made to that part, can cause a cu rrent exce eding the a l l owable L EA KA G E CURRENT (specified i n Sub
cla use 1 9 . 3) fo r the part concerned to flow from that part to earth o r from that part to a n ACC ESS I BLE PART of the
same EQU I P M ENT.
T h ese two req u i re m e nts are in pri nci p l e e q u i v a l e n t b u t s o m e sta n d a rds state b oth of t h e m .
T h ese req u i re m e nts i n t u r n i m p l y t h at:

c) ACCESSI BLE PARTS i n c l u d i n g APPLI ED PARTS have to b e s e parated from certa i n i nternal l i v e
parts : i n g e n e ral two s e p a rate MEANS OF PROTECTION a r e n ecess a ry, o n e to prov i d e
se parat i o n i n NORMAL CONDI TION a n d a s e c o n d to m a i ntai n BAS I C SAFETY i n S I NGLE FAULT
CONDI TION, a n d
6060 1 - 1 © I EC : 20 0 5 - 469 -
d) LEAKAGE CURRENTS ( a n d poss i b l y also voltages a n d e n e rg i es) have to be b e l ow acce pta b l e

l i m its.
M ost sta n d a rds i n c l u d e ex p l i cit req u i re m e nts cove r i n g each of th ese as pects of provi d i n g
protecti o n . F o r ex a m pl e t h e fi rst a n d s e c o n d editi o n s o f t h i s sta n d a rd dealt with a) i n C l a use
1 6 , with b) and d) in C l a u s e 1 9 a n d with c) in C l a u ses 1 7 , 1 8 a n d 20.
R e q u i re m ent a) h as ty p i c a l l y b e e n form u l ated as a r e q u i r e m ent for t h e prov 1 s 1 o n of

E NCLOS URES o r barri e rs to prevent contact with i nternal hazardous live parts . H oweve r it c a n
alte r n atively b e form u l ated i n terms o f the d eterm i n at i o n o f w h i c h p a rts are access i bl e .
Anyway t h e a d e q u acy o f E NCLOS URES o r barriers is dete r m i n e d b y u s e o f t h e r e l ev a nt test
fi n g e rs a n d probes.
A p pl i cati o n of t h e a bove a p proach to ME EQUI PMENT has presented some diffi c u lt i e s . T h e l i m its
for voltage a n d c u rrent d e p e n d on h ow, if at a l l , the p a rt(s) c o n c e r n e d can be c o n n ected to a
PAT I E NT, e . g . di rectly to t h e h e a rt, di rectly to oth e r parts of t h e body, o r i n di rectly v i a t h e
OPERATOR. T h i s h as l e d to diffi c u lties i n i d e ntifyi n g w h i c h parts are " l ive" p a rts.
The defi n i t i o n of " l ive" in t h e s e c o n d e d iti o n of this sta n d a rd refers to t h e a l l ow a b l e LEAKAGE

CURRENT. T h e d efi n i t i o n is t h e refo re diffi c u l t to a p pl y to i nternal parts for w h i c h no parti c u l a r
LEAKAGE CURRENT l i m its a r e s pe cifi e d .
Certa i n parts c o u l d be regarded as " l iv e " (wit h i n t h e defi n i t i o n of t h e s e c o n d e d iti o n o f t h i s

sta ndard) f o r s o m e p u r poses a n d a t t h e s a m e ti m e as n ot " l ive" f o r oth e r p u r poses. For
exa m pl e a n i nternal p a rt t h at c a n s o u rce a cu rrent of, say, 2 0 0 �-tA has to be s e p a rated from
all ACCESSI BLE PARTS, i n cl u d i n g PAT I E NT CONNE CTI ONS in NORMAL CONDITI O N .
T h e se parati o n from PATI ENT CONNECTI ONS o f TYPE CF APPLI E D PARTS has to re m a i n effective i n
S I NGLE FAULT CONDI TION, because a c u rrent o f 2 0 0 �-tA from these i s n ot p e r m issi b l e . T h e s a m e
part c a n h oweve r b e c o m e c o n n ected to oth e r ACCESSI BLE PARTS a n d PAT I E NT CONNECTIONS i n
S I NGLE FAULT CON DITI O N .
T h u s two MEANS OF PROTECTION ( DOUBLE I NS U LATION o r REI NFORCED I NSULATION ) wo u l d be

needed betwe e n such a part and t h e PAT I E NT CONNECTI ONS of TYPE CF APPLIED PARTS , but a
s i n g l e MEANS OF PROTECTION ( s u c h as BAS I C I NS U LATI ON a l o n e ) w o u l d be acce pt a b l e b etwe e n
s u c h a part a n d o t h e r ACCESSI BLE PART.
F u rt h e r m o re , re q u i re m e nts t h at s pecify the n e cessary s e parat i o n betwee n parts t h at a re

access i bl e a n d p a rts that are " l ive" do not easily take acco u n t of parts t h at are n ot " l ive" b u t
can b e c o m e " l iv e , " s u c h as t h e p a rts o f a fl oati n g circuit t h at b e co m e " l ive" w h e n a c o n n ecti o n
is m ade to a n oth e r part o f t h e s a m e c i rc u i t .
C o n s i d e r , f o r ex a m p l e , t h e si m pl e s i t u ati o n s h own i n F i g u re A. 1 0 .
M E EQUIPMENT Metal APPLIED PART

IEC 2432105
F ig u re A. 1 0 - F loat i n g c i rc u it
6060 1 - 1 © I EC : 20 0 5 - 471 -
T h e APPLI ED PART has a m etal E NCLOS URE t h at is not PROTECTIVELY EARTHED. If t h e re is a

d i rect c o n n ecti o n at p o i n t A, t h e n t h e oth e r e n d of t h e S ECONDA RY C I RCUIT is " l ive , " a n d even
t h e fi rst editi o n of t h i s sta ndard wo u l d have req u i red DOUBLE I NS U LATI ON o r REI NFORCED
I NS ULATION at p o i nt B .
I f , i nste a d , there i s a d i rect c o n n ecti o n a t p o i n t B , t h e fi rst e d iti o n wo u l d have req u i red o n l y

BAS I C INS ULATION a t p o i nt A; b ut this w a s d e a l t with i n t h e s e c o n d editi o n b y addi n g S u b c l a u s e
2 0 . 2 B-e, w h i c h req u i res DOUBLE I NS U LATI ON o r REI NFORCED I NS U LATION a t p o i nt A.
I f h oweve r there i s some i ns u l at i o n at both p o i nts A and B , then n o part of t h e S ECONDARY

C I RCUIT is " l ive" accord i n g to t h e d efi n i t i o n i n the s e c o n d e d iti o n , so t h e second editi o n of t h i s
sta ndard s pe cifies n o re q u i re m e nts f o r t h at i n s u l ati o n , w h i c h c a n t h e refo re be m i n i m a l . T h e
G e r m a n Nati o n a l C o m m ittee o f t h e I EC discovered t h i s p r o b l e m i n 1 99 3 , u nfo rt u n ately j ust too
l ate for it to be dealt with in the s e c o n d ( a n d fi n a l ) a m e n d m ent to t h e s e c o n d editi o n of t h i s
sta n d a r d . T h e a p proach a d o pted i n t h i s e d iti o n is i ntended to ove rco m e t h i s p r o bl e m .
T h e fo r m u lati o n p r o posed for t h e th i rd editi o n of t h i s sta n d a rd i s t o s pe cify :

1) h ow to determ i n e w h i c h parts are to be regarded as ACCESSI BLE PARTS ( by i n s p e cti o n a n d
w h e re necessary by t h e use o f a p pro p r i ate test probes a n d fi n ge rs ) ;
2) t h e p e r m issi b l e l i m its for v o ltage/c u rre nt/e n e rgy i n NORMAL CONDITION a n d rel evant S I NGLE
FAULT CON DITIONS ; these l i m its depend o n t h e poss i b l e circu m stances of c o n n ecti o n to a
PAT I E NT or to a n OPERATO R;
3) t h at NORMAL CONDI TION i n cl u des s h o rt circuit of a n y i ns u l ati o n , A I R CLEARANCE o r CRE E PAGE
DI STANCE o r i m p e d a n c e which does not com ply with s pecified req u i re m e nts for the
relevant WORKI NG VOLTAG E , and open c i r c u it of a n y e a rth c o n n ecti o n which does n ot
com ply with t h e req u i re m e nts for PROTECTIVE EARTH CONNECTI ONS; a n d
4) t h at S I NGLE FAULT CONDITIONS i n c l u d e s h o rt ci rcuit o f a n y i ns u l ati o n , A I R CLEARANCE o r
CREEPAGE DISTANCE w h i c h does com ply w i t h s pecifi ed req u i re m e nts f o r t h e rel evant
WORKING VOLTAGE, s h o rt circuit of any rel evant c o m p o n ent, a n d open ci rcuit of a n y e a rth
co n n ecti o n which does c o m ply with t h e req u i re m e nts for PROTECTIVE EARTH CONNECTI ONS.
T h i s a pproach avoids t h e n e e d to i n cl u d e ex p l i cit s e pa rate req u i re m e nts for p a rti c u l a r

protective m e a n s , a s s pecifi ed i n existi n g I EC sta n dards. Arg u a bl y it c o u l d avo i d ev e n a
g e n e ra l req u i re m ent for two MEANS OF PROTECTION, as presently s pecifi e d , but t h e worki n g
g ro u p c o n s i d ered t h at s u c h a r e q u i r e m e n t is des i r a b l e .
Where re q u i re m e nts from t h e s e c o n d e d iti o n t h at used t h e d efi n e d t e r m " l ive" h ave b e e n

reta i n ed , t h ey h ave b e e n re- p h rased s o as not t o use t h i s term .
G e n e r a l l y , protect i o n is o bta i n ed by a c o m b i n ati o n of:

l i m itat i o n of voltage o r e n e rgy, o r protective e a rt h i n g (see 8 . 4 a n d 8 . 6 ) ;
e n c l os i n g o r g u a r d i n g o f e n e rgized ci rcu its (see 5 . 9 ) ;
i ns u l at i o n o f a d e q u ate q u al ity a n d constructi o n ( s e e 8 . 5 ) .
T h e d i e l ectric stre n gth req u i re m e nts a r e i n cl u ded t o c h e c k t h e q u a l ity o f t h e i ns u l at i o n

m aterial u s e d a t diffe rent p l aces i n t h e ME E Q U I PM E NT.
6060 1 - 1 © I EC : 20 0 5 - 473 -
S u bclause 8 . 1 - F u ndam ental r u l e of p rotecti o n ag a i n st electric s h oc k
S u bclause 8 . 1 a)
I ns u l at i o n n ot co m plyi n g with 8 . 8 , s paci n g l ess t h a n s pecifi ed i n 8 . 9 , etc. are n ot MEANS OF

PROTECTION, b u t they c o u l d i nfl u e nce t h e v o ltages or LEAKAGE CURRENTS a p pe a ri n g o n
ACCESSI BLE PARTS i n c l u d i n g APPLI ED PARTS. M e as u re m e nts m i ght t h e refore n e e d to b e m ade
with such parts i ntact o r bypass e d , w h i c h ever i s t h e worse case.
As t h e re are i n g e n e ra l n o i nteg rity r e q u i r e m e nts for signal c o n n ecti o n s , i nterr u pt i o n of a

f u n cti o n a l e a rth c o n n ecti o n has to be c o n s i d e re d as a NORMAL CONDI T I O N .
S u bclause 8 . 1 b)
LEAKAGE CURRE NTS are n ot g e n e r a l l y m eas u re d i n t h e S I NGLE FAULT CONDI TION of b re a kdown of
BAS I C INS ULATION in CLASS I EQUIPMENT beca u s e e i t h e r t h e LEAKAGE CURRE NTS i n t h i s case flow
only d u ri n g t h e ti m e before a fuse o r OVER-CURRENT RELEASE o perates o r t h e use of an
isol ated p ower s u p p l y l i m its t h e LEAKAGE CURRE NTS to safe v a l u e s . Exc e pti o n a l l y , LEAKAGE
CURRE NTS are m ea s u red d u ri n g s h o rt ci rcuiti n g of BAS I C I NSULATION i n cases w h e re t h e re are
d o u bts c o n c e rn i n g the effectiv e n ess of PROTECTIVE EARTH CONNECTIONS i n s i d e t h e
ME EQUIPMENT (see 8 . 6 . 4 b ) ) .
I n certa i n i n stances t h e s h o rt-circuit c o n d i t i o n i s n ot n ecess a r i l y t h e wo rst c a s e . A s a n

exa m p l e , a n overvoltage devi c e , i nt e n d e d to prevent d a m a g e to i ns u l ati o n , c o u l d fa i l i n t h e
o pen-circuit c o n diti o n t h e r e by n o l o n ge r renderi n g i t s safety f u n cti o n . T h i s c o u l d l ead t o
d a m a g e d i n s u lati o n . I t i s reco g n i z e d that i n m ost c a s e s i n t h i s s u bc l a u s e , t h e o pen-ci rcuit
con diti o n i s s u p e rfl u o u s b u t for s e l ect co m po n e nts it was acknowledged that the o pen-circuit
con diti o n is a valid fai l u re mode. C o m p o n e nts of ME EQUIPMENT are also addressed in 4 . 8 .
With regard t o t h e pres e n ce o f t h e MAXI M U M MAINS VOLTAGE o n a n u n earthed ACCESSI BLE PART
i n cl u d i n g APPLI ED PARTS , see t h e rati o n a l es for 8 . 5 . 2 . 2 a n d 8 . 7 . 4 . 7 d ) .
I f ME EQUIPMENT were confi g u red as s h own i n F i g u re A. 1 1 , i n terru pt i o n o f t h e co n n ecti o n

wo u l d res u lt i n excess ive TOUCH CURRENT. T h i s situati o n is t h e refore o n e of the S I NGLE FAULT
CONDITIONS that s h o u l d be i nvest i g ated.
6060 1 - 1 © I EC : 20 0 5 - 475 -
M E EQUIPMENT
I I
First part Second part
s UPPLY
M A INS
II
SECONDARY
CIRCUIT
e.g. 1 2 V III
-Jc_
X
Broken
connection
IEC 2433105
F i g u re A. 1 1 - I n terru ption of a power-ca rry i n g cond uctor

between M E EQU I P M E NT parts in separate ENCLOSURES
S u bclause 8.3 - C lass ification of APPL I E D PARTS
S u bclause 8 . 3 a)
ME EQUI PMENT i nte n ded for DI RECT CARDIAC APPLICATION h av i n g o n e or m o r e TYPE CF APPLI ED
PARTS co u l d have o n e o r m o re additi o n a l TYPE B APPLI ED PARTS o r TYPE BF APPLI ED PARTS that
can be a pp l i e d s i m u l t a n e o u s l y (see a l s o 7 . 2 . 1 0 ) .
S i m i l arly ME EQUIPMENT co u l d have a m ixture o f TYPE B APPLI E D PARTS a n d TYPE B F APPLI ED

PARTS .
S u bclause 8 . 3 b)
M ost part i c u l a r sta n dards deve l o ped for ki nds of ME EQUIPMENT t h at have PAT I E NT e l ectrodes
req u i re the APPLI ED PARTS to be TYPE BF APPLI E D PARTS o r TYPE CF APPLI E D PARTS . For s i m i l a r
k i n ds o f ME EQUIPM ENT f o r w h i c h n o part i c u l a r sta n d ards are ava i l a b l e , it is better to i n c l u d e
s u c h a re q u i re m ent i n t h i s sta n dard t h a n t o a l l ow s u c h APPLI ED PARTS to be TYPE B APPLI E D
PARTS . T h e TYPE B APPLI ED PART classifi cati o n i s m a i n ly u s e d , i n pract i c e , f o r PAT I E NT
s u p po rti n g ME EQUIPMENT s u c h as X- ray t a b l e s , n ot for PAT I E NT e l e ctrodes.
S u bclause 8 . 3 d)
P a rts i d e ntifi ed accord i n g to 4.6 as n e e d i n g to be s u bj e ct to t h e re q u i re m e nts for APPLI ED

PARTS ( ex c e pt for m a rki n g ) wi l l typ i c a l l y contact PAT I E NTS l ess freq u e ntly t h a n APPLI ED PARTS,
so the b e n efits of el ectrical s e pa rati o n from eart h w o u l d be l es s . H oweve r i n s o m e cases t h e
RISK MANAG EMENT PROCESS co u l d i d e ntify a n e e d for s u c h p a rts to satisfy t h e req u i re m e nts for
TYPE BF APPLI E D PARTS o r TYPE CF APPLI ED PARTS . T h i s req u i re m e nt reflects the m aj o rity v i ew of
the Nati o n al C o m m ittees t h at res p o n d e d to an i n q u i ry o n t h i s s u bj ect d u r i n g the pre pa rati o n of
t h i s editi o n .
6060 1 - 1 © I EC : 20 0 5 - 477 -
S u bclause 8.4. 1 - PAT I E NT CONNECTIONS i nten d ed to del iver cu rrent
This sta n d a rd does n ot s pecify any l i m its for cu rre nts that are i ntended to produce a
p h ys i o l o gi cal effect i n t h e PATI E NT, b ut p a rti c u l a r sta n d ards c a n do s o . Any oth e r c u rre nts
fl owi n g between PAT I E NT CONNECTIONS are s u bj ect to the s pecifi e d l i m its for PAT I E NT AUXI LIARY
CURRENT.
S u bclause 8 . 4 . 2 - ACCESSIBLE PARTS i n c l u d i n g APPLIED PARTS
S u bclause 8 . 4 . 2 b)
It is pres u m ed t h at TOUCH CURRENT c a n reach t h e PAT I E NT by c h a n c e contact t h r o u g h various

paths, i n c l u d i n g a path v i a t h e OPERATO R. T h e l i m its for TOUCH CURRENT t h e refore a p ply to all
ACCESSI BLE PARTS exc e pt PAT I E NT CONNECTI ONS, w h i c h a re covered by 8 . 4 . 2 a ) , and parts t h at
satisfy t h e c o n d i t i o n s s pe cifi ed i n 8 . 4 . 2 c ) .
S u bclause 8 . 4 . 2 c)
T h e re is l ittl e or no j ustifi cati o n for t h e diffe r e n ce i n t h e s e co n d editi o n between t h e cases

w h e re there i s a cov e r t h at i s re m ov a b l e wit h o ut a TOOL and where t h e r e i s n o cover. The l i m it
v a l u es have b e e n h a r m o n ized with I E C 6 0 9 5 0- 1 : 2 0 0 1 b e c a u s e I nformati o n Tech n o l ogy ( I T)
e q u i p m e n t is c o m m o n l y used i n ME SYSTEMS, a n d t h e val ues i n I E C 6 0 9 5 0 - 1 are n ot m u ch
d iffe rent from those in t h e second editi o n of t h i s sta n d a r d . ( 6 0 V de i s t h e s a m e , and 42,4 V
p e a k is n ot m u ch diffe rent fro m 25 V r. m . s . ) .
Ess e n t i a l l y OPERATOR protect i o n i s now based o n I E C 6 0 9 5 0 - 1 a n d , t h e refo re, we n eed to

i n co r porate the protect i o n req u i re m e nts from t h at sta n d a rd . Previ o us l y I E C 606 0 1 - 1 d i d n ot
have a req u i re m e nt for p rotecti o n agai nst hazardous e n e rgy b u t t h e re is a defi nite RISK from
b u r n , fi re and flyi n g d e bris. This i s n ow a d d ressed u s i n g t h e req u i re m ent from
I EC 60950- 1 : 2 0 0 1 . The l i m it v a l u es h ave been esta b l i s h e d for many years in I E C 60950 a n d
its prede cess o r sta n d a rd s . T h e m axi m u m avai l a b l e e n e rgy i s a l l owed t o exceed 2 4 0 VA
d u r i n g t h e fi rst 6 0 s after co ntact with t h e ACCESSI BLE PART ( e . g . it takes ti m e for t h e c u rrent
l i m it circuit in a power s u p p l y to o pe rate and d u r i n g this ti m e the hazardous e n e rgy l ev e l can
be exceeded) .
S u bclause 8 . 4 . 2 d)
As wel l as parts that are determ i n ed to be ACCESSI BLE PARTS i n accord a n ce with 5 . 9 , e l ectrical
contact with i nte r n a l parts i s s u p p os e d to be made wit h :
a p e n c i l o r p e n , h e l d i n a h a n d , s i m u l ated by a g u i ded test pi n ;
a n ecklace o r s i m i l a r p e n dant, s i m u l ated b y a m etal rod s u s p e n ded over o p e n i n gs i n a t o p
cover;
a s crewdri v e r for adj ustm e nt of a p reset co ntrol by the OPERATOR, s i m u l ated by a n i ns e rted
m etal rod.
S u bclause 8 . 4 . 3 - ME EQU I P M E NT i nte n d ed to be co n n ected to a power sou rce by a p l u g
T h e 45 �-tC l i m it is t h e s a m e as t h at s pecifi e d i n I EC 60335- 1 , w h i c h i s b a s e d o n t h e l i m its i n

I EC 60479- 1 [ 1 1 ] . It is com para b l e (th o u g h n ot exactly e q u i v a l ent) to t h e 1 00 n F l i m i t s pecifi ed
in t h e second e d iti o n of this sta n da r d . With regard to BAS I C SAFETY t h e re i s n o reason to
s pecify a m o re stri n ge n t l i m it betwee n the l i n e a n d e a rth p i n s , as in the s e c o n d editi o n .
6060 1 - 1 © I EC : 20 0 5 - 479 -
S u bclause 8 . 4 . 4 - I n ternal capacitive c i rcu its
The l i m it has b e e n c h a n g e d from the 2 mJ s pecifi ed in the s e c o n d e d iti o n of t h i s sta n d a rd to

the s a m e v a l u e as s pecifi e d in the previ o u s s u bc l a u s e , beca u s e wh ateve r i s safe for an
OPERATOR, o r even a PAT I E NT, who t o u c h es the p i n s of a MAINS PLUG is a l s o safe for s o m e o n e
w h o o pe n s a n ACCESS COVER to g a i n access to t h e i ns i d e o f ME EQUI PMENT.
S u bclause 8 . 5 . 1 - M EANS OF PROTECTION
Two MEANS OF PROTECTION c a n be prov i d e d in several ways. The fol l owi n g are ex a m p l e s :
1 ) PATI ENT CONNECTI ONS a n d o t h e r ACCESSI BLE PARTS are se parated f r o m p a rts diffe rent from
eart h pote nti al by BAS I C I NSULATION o n l y , but PROTECTIVELY EARTHED and have such a low
i nternal i m p e d a n ce to e a rth that LEAKAGE CURRE NTS d o n ot exceed t h e a l l owa b l e val u es i n
NORMAL CONDITION a n d S I NGLE FAULT CONDI T I O N .
2) PATI ENT CONNECTI ONS a n d other ACCESSI BLE PARTS are se parated f r o m p a rts diffe rent f r o m
earth pote nti a l by BAS I C I NSULATION a n d a n i nte r m e d i ate PROTECTIVELY EARTHED m etal part,
which could b e a fully e n c l osi n g m etal scre e n .
3) PATI ENT CONNECTI ONS a n d other ACCESSI BLE PARTS a r e se parated from p a rts diffe rent from
eart h potenti al by DOUBLE o r REI NFORCED I NS ULATION.
4) I m p e d a n ces of co m po n e nts p revent t h e flow to PAT I E NT CONNECTIONS and ot h e r ACCESSI BLE
PARTS of LEAKAGE CURRE NTS and PAT I E NT AUXI LIARY CURRENTS exce e d i n g the a l l owa b l e
v a l u es .
A s u rvey o f i ns u l at i o n paths i s fo u n d i n A n n ex J .
P revi o u s editions o f t h i s sta n d a rd also recognized t h e poss i bi l ity o f a c h i evi n g se pa rati o n by

use of a PROTECTIVELY EARTHED i nterm e d i ate ci rc u it. H oweve r it i s in g e n e ra l n ot poss i b l e for
the w h o l e of a circuit to be co n n e cted with v e ry l ow i m p e d a n c e to the PROTECTIVE EARTH
TERM I NAL. Also, if o n e part of a circuit i s eart h e d , other p a rts of the circuit are t h e n d iffe rent
from earth potenti a l , s o have to b e furt h e r se parated from PATI ENT CONNECTIONS and oth e r
ACCESSI BLE PARTS .
Air c a n form p a rt or a l l of t h e BAS I C I NSULATION or S UPPLEM ENTARY I NSULATION.
In g e n e ral DOUBLE I NS ULATION i s prefe r a b l e to REI NFORCED I NS ULATIO N .
T h e fi rst e d iti o n o f t h i s sta n dard s pecifi e d n u m e rous p a i rs o f pa rts b etwe e n w h i c h s e p a rati o n

was req u i re d , b ut t h e l i st was i n c o m pl ete. It w a s ex p a n ded i n t h e s e c o n d editi o n b u t sti l l
re m a i n ed i n c o m p l ete, for ex a m pl e with regard t o t h e s i t u ati o n i l l u strated i n F i g u re A. 1 0 .
Discuss i o n i n t h e worki n g g r o u p at a n early sta ge of t h e d ev e l o p m e nt of t h i s editi o n

esta b l i s h e d t h a t test h o u ses act u a l l y h ave to i d e ntify t h e v a r i o u s circu its i ns i d e ME EQUIPM ENT
and the v a r i o u s p o i nts at w h i c h se parati o n c o u l d be n ee d e d . T h i s editi o n t h e refo re s pecifies
this PROC E DURE ex p l i citly.
T h e d i sti n cti o n betwe e n MEANS OF OPERATOR PROTECTION and M EANS O F PATI ENT PROTECTION
was i ntroduced in res p o n s e to concerns t h at t h e req u i re m e nts of prev i o u s e d iti o n s of this
sta ndard for i ns u l ati o n testi n g , CRE E PAGE DISTANCES a n d A I R CLEARANCES were too str i n gent.
6060 1 - 1 © I EC : 20 0 5 - 481 -
M a n y ME SYSTEMS i n corpo rate e q u i p m ent com plyi n g with I EC 6 09 5 0- 1 . Also m a n y ki n ds of

ME EQUIPMENT i n c o rporate p a rts, s u c h as power s u p p l i e s , that h ave b e e n p r i m arily desi g n e d
f o r use i n e q u i p m ent c o m plyi n g with I E C 6 0 9 5 0- 1 . T h i s l e d s o m e ex perts a n d Nati o n a l
C o m m ittees t o propose t h at t h e re q u i re m e nts o f t h i s sta n d a rd b e h a r m o nized with
I EC 6 0 9 5 0 - 1 as fa r as possi b l e .
H oweve r t h e test voltages a n d t h e m 1 n 1 m u m v a l u e s o f CREEPAGE DI STANCES a n d A I R

CLEARANCES s pe cifi ed i n I EC 60950- 1 a r e d e rived from I EC 60664-1 a n d are b a s e d o n
ass u m pt i o n s a bo ut possi b l e overvoltages i n m ai n s a n d oth e r ci rcuits, parti c u l a rly t h e
fre q u e ncy o f occu rre n ce o f vari o u s l ev e l s o f ov e rvoltage. Acco r d i n g to t h e u n dersta n d i n g of
t h e worki n g g ro u p ex perts w h o rev i s e d t h e corres p o n d i n g req u i re m e nts of t h i s sta n da r d ,
co m pl i a n c e w i t h t h e req u i re m e nts o f I EC 6 0664- 1 o r I EC 6 0 9 5 0- 1 l e aves a RISK t h at tra n s i e n t
i ns u l at i o n breakdown c o u l d occ u r with a fre q u e n cy u p to a bo ut o n c e p e r y e a r .
T h e pro b a b i l ity o f occurrence o f a n OPERATOR co m i n g i n contact with a relevant p a rt a n d with

earth at the m o m ent when brea kdown occ u rs i s l ow, so the RESI DUAL RISK is acce pta b l e fo r
ME EQUI PMENT, j ust as it is for I T e q u i p m ent. H owev e r t h e p r o b a b i l ity of occu rre n c e of a
PAT I E NT bei n g i n co ntact with a n APPLI ED PART a n d with earth is s i g n ificantly h i g h er. T h e
worki n g g ro u p t h e refo re d e c i d e d t h at a l a rger m a rgi n o f safety s h o u l d be a pp l i e d where
PAT I E NT safety i s c o n c e r n e d . H owev e r there was n o rel i a bl e basis for deci d i n g w h at additi o n a l
m a rgi n m i ght b e a p p l i ed to t h e v a l u es from I E C 60664- 1 , so t h e s a m e v a l ues t h at were
s pecifi ed in t h e s e c o n d editi o n of this sta n dard have been reta i n ed for MEANS OF PATI ENT
PROTECTION.
For MEANS OF OPERATOR PROTECTION t h i s reVIS I O n of t h e sta n d a rd a l l ows t h e MANUFACTU RER

three o pt i o n s (see F i g u re A. 1 2) . One o pti o n is to a pp l y t h e req u i re m e nts of I EC 60950-1 a n d
t o i d e ntify t h e a pp r o p r i ate i nsta l l ati o n cate g o ry a n d p o l l ut i o n degree. Alte r n atively, t h e
MANUFACTURER c a n a p ply t h e v a l ues i n t h e ta b l e s , w h i c h h av e b e e n derived from I EC 60950- 1
on t h e basis of reas o n a bl e ass u m pti o n s a bout t h e i nstal l at i o n c ategory a n d p o l l ut i o n degree.
T h e t h i rd o pti o n i s to treat t h e MEANS OF OPE RATOR PROTECTI O N as if it were a MEANS OF
PAT I E NT PROTECTION.
Y ca pacitors are used to reduce radio fre q u e n cy i nterfere n c e by provi d i n g a l ow i m p e d a n ce

path to earth for h i g h fre q u e n cy a . c. T h ey are a l s o used for bri d g i n g DOUBLE or REI NFORCED
I NS ULATION as p a rt of the i nterfe r e n c e s u p pres s i o n regi m e . T h e r e are fo u r typ e s : Y 1 , Y 2 , Y3
and Y 4 . Y1 ca pacitors a re desi g n e d fo r u s e with three p h ase m ai ns a n d have a WORKI NG
VOLTAGE of up to 500 V a . c. a n d a with sta n d voltage of 4 000 V a . c. Y2 ca pacitors are
des i g n e d for use with s i n g l e p h ase m ai ns a n d h ave a WORKI NG VOLTAGE u p to 300 V a . c . a n d
a withsta n d voltage o f 2 5 0 0 V a . c . Y3 ca pacitors a r e s i m i l a r to Y 2 ca p acitors b ut have a
WORKING VOLTAGE u p to 2 5 0 V a . c. Y4 ca p acito rs are desi g n ed for u s e with l ow voltage
m a i n s a n d h av e a WORKI NG VOLTAGE up to 1 5 0 V a . c. a n d a withsta n d voltage of 1 0 0 0 V a . c.
T h ese ca pacitors are s afety critical s i nce t h ey prov i d e a l ea ka g e path to earth or across a
barri e r . So t h ey m ust be certifi e d a n d m o n itored by a reco g n i s e d test h o use to I EC 6 0 3 84- 1 4 ,
w h i c h s e rves to control t h e i r m a n ufact u r e .
One Y1 capacitor c a n be used t o provide two MOOP's b u t only one MOPP ( PATI ENTS n e e d a h i g h e r
l ev e l o f protecti o n t h a n OPERATORS ) . A Y 2 ca pacitor c a n be u s e d t o prov i d e o n e MOOP o n l y .
6060 1 - 1 © I EC : 20 0 5 - 483 -
MANUFACTURER determines
which kind of part
the MOP will protect
Yes Is it an No
APPLIED
PART?
Is it a part that
is subject to the
Yes requirements for APPLIED PARTS No
as determined by RISK ASSESSMENT
according to 4.6?
Table 6 and Table 1 1 apply The INSULATION CO-ORDINATION

(same values as requirements of
I EC 60601 -1 : 1 988) I EC 60950-1 apply
MOP MEANS OF PROTECTION

MOPP MEANS OF PATIENT PROTECTION
MOOP MEANS OF OPERATOR PROTECTION
IEC 2434!V5
F ig u re A. 1 2 - I d entification of M EANS OF PAT I E NT PROTECTION

and M EANS OF OPERATOR PROTECTION
S u bclause 8 . 5 . 2 . 1 - F -TYPE APPL I E D PARTS
T h e esse nti a l feat u r e of a n F-TYPE APPLI ED PART i s its se parati o n from oth e r p a rts . T h i s
s u bc l a use s pecifies a n d q u a ntifies t h e n ecessary deg ree o f s e p a rati o n .
M u lti p l e fu n cti o n s c a n be considered a s m u lti p l e APPLI ED PARTS ( w h i c h have t o b e s e p a rated

from each other by o n e MEANS OF PATI ENT PROTECTI ON) or as o n e APPLI ED PART. T h i s is
decided by t h e MANUFACTURER after assessi n g t h e RISK that e a rt h i n g of o n e o r m o re of the
PAT I E NT CONNECTION(S) of one f u n ct i o n c o u l d res u lt in excessive LEAKAGE CURRENT t h ro u g h the
PAT I E NT CONNE CTI ON(s) of a n oth e r fu n cti o n , in t h e conditi o n in which a n u n i nt e n d e d voltage
o ri g i n ati n g from a n exte r n a l s o u rce b e c o m es c o n n ected to t h e PATI ENT.
T h e 500 V r. m . s . l i m it fo r protective devi ces was al ready s pecifi e d i n t h e fi rst editi o n of this
sta n d a r d . T h e o ri g i n a l rati o n a l e is n ot known, b ut t h i s voltage corres p o n d s to t h e h i g h est
RATED voltage s pecifi ed in 4 . 1 0.
S u bclause 8 . 5 . 2 . 2 - TYPE 8 APPL I E D PARTS
T h i s r e q u i r e m e n t a d d resses t h e poss i b i l ity t h at an u n i ntended voltage o ri g i n ati n g from a n

ext e r n a l s o u rce b e c o m es c o n n ected t o a p a rt o f t h e ME EQUIPM ENT. I n t h e a bs e n ce of
a p pro p r i ate se p a rati o n b etwe e n s u c h a part a n d PAT I E NT CONNECTI ONS , an excess ive PAT I E NT
LEAKAGE CURRENT co u l d res ult.
6060 1 - 1 © I EC : 20 0 5 - 485 -
Accord i n g to C l a u s e 1 7 c) of t h e s e c o n d editi o n of this sta n d a r d , this re q u i re m e n t a p p l i e d to

a l l APPLI ED PARTS , but i n m a n y cases it n o l o n g e r a p p l i e s :
For F-TYPE APPLI ED PARTS , t h e i s o l ati o n req u i red b y 8 . 5 . 2 . 1 a l s o covers t h i s s i t u ati o n ( but
TYPE BF APPLI ED PARTS req u i re an additi o n a l test, as ex p l a i n e d in the rati o n a l e to
8.7.4.7 d)).
T h e R I S K c a n not a r i s e if e i t h e r t h e ME EQUIPMENT part concerned o r t h e PAT I E NT
CONNECTIONS of a TYPE B APPLI ED PART are PROTECTIVELY EARTHED. ( F a i l u re of t h e
PROTECTIVE EARTH CONNECTION toget h e r with t h e a ppearance o f t h e u n i ntended voltage
wo u l d be a d o u b l e fa u l t c o n d iti o n . )
I f t h e ME EQUIPM ENT part c o n c e r n e d i s p h ys i c a l l y c o nti g u o u s with t h e APPLI ED PART (for
exa m pl e a d e ntal h a n d pi ece) the re q u i re m e nt does not a p p l y if the RISK of co ntact with a
s o u rce of voltage or LEAKAGE CURRENT a bove perm itted l i m its is acceptably l ow.
S u bclause 8.5.2.3 - PATIENT leads
T h e re are two sets of c i r c u m stances to g u a rd agai nst:

- fi rstly, for TYPE BF APPLI ED PARTS a n d TYPE CF APPLI ED PARTS, t h ere s h o u l d be no poss i b i l ity
of an acci d e ntal PATI E NT-to- earth c o n n ecti o n via any l e a d t h at can beco m e d eta c h e d from
t h e ME EQUIPM ENT; ev e n for a TYPE B APPLI E D PART a n u nwanted co n n ecti o n to e a rth can
have an a dv e rs e effect on t h e o p e rati o n of t h e ME EQUIPMENT;
secondly, for all ty pes of APPLI E D PART , t h e re s h o u l d be n o poss i b i l ity of c o n n ecti n g the
PAT I E NT acci d e nta l l y to parts of ME EQUI PMENT o r oth e r co n d u ctive parts in t h e vici n ity from
which a c u rrent in excess of t h e a l l owa b l e LEAKAGE CURRENT c o u l d flow.
An extr e m e case of t h e l atte r HAZARD wo u l d be a di rect c o n n ecti o n to t h e S U PPLY MAI NS,

res u lti n g from i nsert i o n of t h e c o n n ector i nto a m a i ns o ut l et or i nto t h e socket end of a
DETACHABLE POWER SUPPLY CORD. It is ess e ntial to prevent t h i s fro m occu rri n g .
With certa i n c o m b i n ati o n s o f PAT I E NT a n d MAINS CON NECTORS i t wi l l b e poss i b l e t o p l u g t h e

PAT I E NT con n ector acci d e nt a l l y i nto t h e m a i n s socket.
This possi b i l ity c a n n ot reas o n ably be r e m ov e d by d i m e n s i o n a l re q u i re m e nts as to d o s o wo u l d

m a ke s i n g l e- po l e c o n n ecto rs excess ively l a rge. S u c h a n i n ci d e nt i s ren dered s afe b y t h e
req u i re m e n t f o r t h e PAT I E NT c o n n ector to be protected b y i ns u l at i o n h av i n g a CRE E PAGE
DI STANCE of at l east 1 , 0 mm a n d a d i e l ectri c str e n gth of at l e ast 1 5 0 0 V. T h e l atte r o n its own
wo u l d n ot s uffi ce as 1 5 0 0 V protect i o n could easily be a c h i eved by th i n pl astic foi l t h at wo u l d
n o t sta n d u p to d a i l y wear o r t o bei n g p u s h e d , poss i bl y repeate d l y , i nto a m a i ns socket. For
t h i s reason also it c a n be seen t h at t h e i ns u l ati o n s h o u l d be durable and r i g i d .
T h e wordi n g o f t h i s req u i re m ent w a s m odifi ed fro m t h at i n t h e s e c o n d e d iti o n of t h i s sta n dard

to avo i d u s e of the p h rases " c o n d u ctive c o n n ecti o n " , which was e l i m i n ated as a defi n e d term .
T h i s c h a n g e was a di rect res u lt of N at i o n a l C o m m ittee c o m m e nts d u ri n g t h e pre pa rati o n of
t h i s editi o n .
Accord i n g t o t h e rati o n a l e i n t h e s e c o n d editi o n o f t h i s sta n d a r d , t h e test i n w h i c h t h e test

fi n g e r is a p p l i e d with a force of 1 0 N was i ntended "to c h e c k the stre ngth of the i ns u l ati n g
m ateri a l . " T h i s h as n ow b e e n s u ppl e m ented b y a n expli cit cross refe r e n ce t o 8 . 8 . 4 . 1 .
6060 1 - 1 © I EC : 20 0 5 - 487 -
I n respo n s e to a n e n q u i ry, o n e N at i o n a l C o m m ittee stated t h at t h i s test is " a m e c h a n i c a l test

of the protective cov e r over the pi n ; " s u g gesti n g that the t est was i ntended to apply
specifi ca l l y to one parti c u l a r ki n d of c o n n ector des i g n , i n w h i c h t h e contact i s s u rr o u n d e d by a
m ov a b l e s h e ath des i g n e d to a l low contact with t h e co rrect m ati n g c o n n ector but n ot with oth e r
parts .
D u r i n g t h e dev e l o p m e n t of t h i s editi o n of t h i s sta n d a rd , t h e q u esti o n arose whet h e r t h i s test

s h o u l d be restricted to s i n g l e- p o l e c o n n ectors, as in the s e co n d editi o n of t h i s sta n d a rd , o r
s h o u l d a pply t o m u lti - p o l e c o n n ecto rs a s we l l . S o m e m u lti - po l e c o n n ectors a r e o f s i m i l a r
s h a pe t o s i n gl e- p o l e co n n ectors a n d c o u l d s i m i l arly be i nserted i nto a MAINS CONNECTOR, s o
t h e s a m e consi derati o n s o f a d e q u acy o f i n s u l at i o n apply e q u a l l y . O n t h e oth e r h a n d , ty pical
k i n ds of m u lti - p o l e co n n ectors t h at are in c o m m o n u s e ca n n ot be i nserted i nto a MAINS
CONNECTOR, but w o u l d fai l t h i s test if they were s u bj ect to it, because t h e test fi n g e r c a n easily
t o u c h their co ntacts , even wit h o u t t h e a p pl i cati o n of a 1 0 N force.
A further e n q u i ry to t h e Nati o n a l C o m m ittees y i e l d e d a range of res ponses, with reas o n a bl e

c o n s e n s u s o n s o m e q u esti o n s b u t n o c o n s e n s u s as t o whether t h i s test s h o u l d a p p l y to a l l
co n n ectors o r s h o u l d be restricted to s i n g l e- p o l e c o n n ectors.
This test s h o u l d certa i n ly a p ply to a m u lti-pole c o n n ector t h at is of s u c h s h a pe and size that it

co u l d be i nserted i nto a m a i ns socket. In t h i s case, t h e RISK is the same as with a s i n g l e- p o l e
con n ecta r.
A n ot h e r reason for a pplyi n g this test to s o m e m u lti-pole co n n e ctors i s that t h e test with the
fl at pl ate does not exha ustively assess t h e poss i b i l ity of contact with c o n d u ctive parts in t h e
v i ci n ity from w h i c h a c u rrent i n excess o f t h e a l l owa b l e LEAKAGE CURRENT co u l d flow. A l m ost
any ki n d of co n n ector, if deta c h e d from the ME EQUI PMENT o r d r o p p e d , c o u l d poss i bly m a ke
contact with s o m eth i n g bes i des the i nt e n d e d m ati n g c o n n ector, but the RISK d e p e n ds o n t h e
s h a pe o f t h e c o n n ector a n d t h e ci rcu m stances. I n m ost cases t h e RISK i s l ow. For ex a m pl e a
ty pical " D " c o n n ector is l i kely to m a ke co ntact with a n earth e d o bj ect o n l y m o m e ntari l y ,
w h e reas a stra i g ht p i n co u l d m a ke co ntact for a pro l o n g e d peri od . H owev e r even pro l o n ged
contact with a m etal o bj ect c a n res u l t in a HAZARD only if it o c c u rs in c o m b i n at i o n with a f a u lt
or a b n o r m a l situati o n t h at a l l ows an excess ive cu rrent to fl ow t h ro u g h t h e PATI E NT. T h e RISK is
in all cases m u c h l ess than t h e RISK if t h e co n n e ctor c a n m a ke contact with a m a i ns socket.
The req u i re m e nts of t h i s sta n d a rd s h o u l d be fo r m u l ated in relati o n to the RISK. The sta n d a rd
s h o u l d m i n i m ise RISK to t h e PAT I E NT, w h i l e a l l owi n g MANUFACTU RERS a reas o n a b l e r a n g e of
c h o i c e of c o n n ectars.
"Any c o n n ector" s h o u l d be u n derstood to i n cl u d e m u lti p l e contact c o n n ectors, several

co n n ectors and c o n n ecto rs in series.
T h e d i m e n s i o n of 1 00 mm d i a m eter i s n ot in t h e l east i m porta nt and m e rely serves to i n d i cate

the s c a l e of the fl at s u rface. Any s h eet of co n d u ctive m at e r i a l l a rger t h a n t h i s wo u l d be
s u it a b l e .
S u bclause 8 . 5 . 3 - M AX I M U M MAINS VOLTAGE
Several req u i re m e n ts a n d tests of this sta ndard rel ate to t h e poss i b i l ity t h at an u n i nt e n d e d
v o l t a g e o r i g i n at i n g f r o m a n exte r n a l s o u rce beco m es c o n n ected to t h e PATIENT o r to certa i n
pa rts of t h e M E EQUIPMENT. T h e actu al m ag n itude of s u c h a voltage i s u n known; but accordi n g
t o t h e s e c o n d editi o n o f t h i s sta n d a rd it was ta k e n t o b e t h e h i g h est RATED MAINS VOLTAG E , o r
for polyphase e q u i pm ent t h e p h a s e t o n e utral s u pply volta g e . These v a l u es reflected a
reas o n a b l e worst-case ass u m pt i o n t h at t h e actual u n i ntended exte r n a l voltage is u n l i ke l y to
exceed t h e voltage of t h e S U PPLY MAI NS i n t h e l o cati o n w h e re t h e ME EQUI PMENT is u s e d , a n d
t h at ME EQUIPM ENT i s u n l i kely t o b e u s e d i n a l ocati o n w h e re t h e S U PPLY MAINS h a s a voltage
6060 1 - 1 © I EC : 20 0 5 - 489 -
h i g h e r t h a n its h i g h est RATED MAI NS VOLTAGE. F o r I NTERNALLY POWERED ME EQUIPM ENT t h e

v a l u e s pecifi ed was ( a n d r e m a i n s ) 2 5 0 V , because t h i s is t h e h i g h est c o m m o n l y e n c o u ntered
ph ase-to-ne utral voltage in l ocati o n s where ME EQUI PMENT i s u s e d .
I n early drafts o f t h i s e d iti o n , t h e co rres p o n d i n g wo rd i n g o n l y referred t o a . c . S U PPLY MAI N S .

T h i s m i stake w a s poi nted o ut d u ri n g t h e co m m ent period. D iscuss i o n o f t h i s co m m ent
confi r m e d t h at t h e req u i re m e nts s h o u l d n ot depend o n whether t h e S UPPLY MAINS i s a . c. o r
d . c . , but rev e a l e d a fu rth e r a n o m aly. If ME EQUIPMENT is specifi e d f o r c o n n ecti o n to a n extra
l ow voltage ( E LV) S U PPLY MAINS (for ex a m pl e 1 2 V in a n a m b u l a nce) but n ot to any h i g h e r
voltage S UPPLY MAI N S , t h e exte r n a l voltage ass u m ed f o r test p u r poses wo u l d b e o n l y t h e ELV.
Such ME EQUIPM ENT co u l d h oweve r be used in l ocati o n s w h e re a h i g h e r voltage S U PPLY MAI NS
i s a l s o i nsta l l e d . The wo rd i n g has t h e refore b e e n revised to r e m ov e t h i s a n o m aly.
I f ME EQUIPMENT h as a h i g h est RATED s u pply voltage l ess t h a n 1 00 V, it wi l l n ecessarily be

used in a s pe c i a l l ocati o n where t h at s u pply is ava i l a b l e , and we do n ot k n ow w h at oth e r
s u p pl i es c o u l d a l s o be present. T h e refore t h e exte r n a l voltage ass u m e d f o r relevant tests is
2 5 0 V , as for I NTE RNALLY POWE RED ME EQUIPM ENT.
H oweve r ME EQUIPM ENT havi n g a h i g h est RATED MAINS VOLTAGE of a ro u n d 1 1 5 V i s u n l i ke l y to

be used in l ocati o n s h av i n g h i g h e r voltage S U PPLY MAI NS , so the exte r n a l voltage ass u m ed for
relevant tests is e q u a l to the h i g h est RATED MAINS VOLTA G E , as in the s e c o n d editi o n of t h i s
sta n d a r d .
S u bclause 8 . 5 . 4 - WORKING VOLTAGE
T h e d i e l ectric stre n gth test voltages specifi ed i n T a b l e 6 are a ppropriate fo r i ns u l at i o n that is

n o r m a l l y s u bj ecte d to a c o nti n u o u s WORKI NG VOLTAGE a n d to tra n s i ent overvolta g e s .
T h e WORKI NG VOLTAGE f o r e a c h MEANS OF PROTECTION form i n g DOUBLE I NSULATION i s t h e

v o l t a g e t o w h i c h t h e DOUBLE I NS U LATION as a w h o l e i s s u bjected, beca u s e e i t h e r MEANS OF
PROTECTION c a n be s u bj e cted to t h i s voltage if t h e ot h e r MEANS O F PROTECTION fai l s .
F o r i ns u l at i o n betwe e n two i s o l ated parts o r between a n i s o l ated part a n d a n earthed part, t h e

WORKING VOLTAGE c o u l d i n s o m e cases b e e q u a l t o t h e arit h m eti c s u m o f t h e h i g h est voltages
betwe e n a n y two poi nts wit h i n both parts.
For DEFIBRI LLATION-PROOF APPLI ED PARTS , a test voltage d e d u c e d o n the basis of a WORKING
VOLTAGE equal to t h e defi b r i l l at i o n peak voltage wo u l d be far too h i g h for i ns u l ati o n t h at i n
NORMAL USE i s exposed o n l y occas i o n al l y t o voltage i m p u l s e s , n o r m a l l y s h o rter t h a n 1 0 s a n d
wit h o ut additi o n a l ov e rvoltage.
S u bclause 8 . 5 . 5 - D E F I B RI L LATION-PROOF APPL I E D PARTS
T h e s peci a l test descri bed in 8 . 5 . 5 is c o n s i dered to e n s u re s uffi c i e nt protect i o n agai nst

ex pos u re to d efi b r i l lati o n p u l s e s , n o s e p a rate d i e l ectric stre n gth test be i n g n eces s a ry .
S u bclause 8 . 5 . 5. 1 - Defi b r i l lation protecti o n
O n e o r t h e other o f t h e defi bri l l ati o n p a d d l es co u l d , b y v i rt u e of i t s cl i n i ca l a pp l i cati o n , b e

co n n ected to earth o r at l east referenced to e a rt h .
6060 1 - 1 © I EC : 20 0 5 - 491 -
When a d efi bri l l ator is used on t h e PATI E NT, a H I G H VOLTAGE c a n t h u s be i m pressed e i t h e r

betwe e n o n e part o f t h e ME EQUIPM ENT a n d a n other, o r between s u c h parts c o l l ectively a n d
earth. ACCESSI BLE PARTS s h o u l d be a d e q u ately i s o l ated f r o m PAT I E NT CONNECTIONS o r
protected i n s o m e oth e r w a y . T h e i ns u l at i o n o f t h e PAT I E NT CONNECTIONS ca n n ot be protected
by voltage l i m iti n g devices relyi n g o n e a rt h e d c o n n ecti o n s .
T h e DEFIBRI LLATI ON-PROOF APPLI ED PART m a rki n g i n d i c ates t h at a n APPLI E D PART c a n s afely
re m a i n attached to a PAT I E NT w h o is bei n g d efi bri l l ated wit h o ut any adverse effect o n
s u bs e q u e nt u s e o f t h e ME EQUIPMENT.
T h e tests e n s u r e :
a) t h a t a n y ACCESSI BLE PARTS o f ME EQUIPMENT, PAT I E NT c a b l e s , c a b l e c o n n ectors , etc. t h at
are n ot PROTECTIVELY EARTHED wi l l n ot d e l i v e r a h azardous l ev e l of ch arge or e n e rgy d u e to
fl ashover of defi bri l l ati o n voltage; a n d
b ) that t h e ME EQUIPM ENT wi l l conti n u e t o fu n cti o n ( at l e ast with regard t o BASI C SAFETY a n d
ESSENTIAL PE RFORMANCE) after ex pos u re to d efi bri l l at i o n volta g e .
T h e req u i re m e n t a n d t h e test PROCEDURE refe r to " a ny n e cess a ry ti m e" stated i n t h e

ACCOMPANYI NG DOCU ME NTS . T h e re i s n o re q u i re m ent f o r t h e ACCOMPANY I NG DOCUME NTS t o
i n c l u d e a state m e nt o f a recovery ti m e , but if t h e re is n o state m e nt t h e M E EQUIPMENT has t o
recover a n d d e l i v e r its BASI C SAFETY a n d ESSENTIAL PE RFORMANCE i m m ed i ately.
T h e tests a re c o n d u cted with t h e ME EQUIPMENT c o n n ected to t h e S UPPLY MAINS and i n

o p e rati o n accord i n g t o t h e i nstr u cti o n s for u s e because t h e tests d e a l n ot o n l y with t h e effect
of t h e defi bri l l at i o n e n e rgy on BAS I C SAFETY but also on t h e a b i l ity of t h e ME EQUIPMENT to
d e l i v e r its ESSE NTIAL PERFORMANCE after the stated recovery ti m e .
N ORMAL U S E i n cl u des t h e s i t u ati o n t h at a PAT I E NT i s defi bri l l ated w h i l e co n n ected to t h e

ME EQUIPMENT a n d , a t t h e s a m e ti m e , t h e OPERATOR o r a n oth e r pers o n i s i n co ntact with t h e
E NCLOS U R E . T h e poss i bi l ity o f t h i s occu rri n g a t t h e s a m e ti m e as t h e S I NGLE FAULT CONDI TION
of a defective PROTECTIVE EARTH CONNECTION i s v e ry u n l i kely and is t h e refo re d i s regarded.
H owev e r , i nterrupti o n of f u n cti o n a l earth co n n e cti o n s i s m o re pro b a bl e , and is t h e refore
req u i red for these tests .
T h e S EVERITY of e l e ctric s h ock t h at a pers o n receives w h e n to u c h i n g ACCESSI BLE PARTS d u r i n g

t h e discharge o f a d efi bri l l ator is l i m ited t o a val u e (corres p o n d i n g t o a c h a rg e o f 1 00 �-tC)
w h i c h c a n be felt and wh i c h c o u l d be u n p l easant, but w h i c h i s not d a n g e ro u s .
S I G NAL I NPUT/OUTPUT PARTS are i n c l u d e d , as s i g n a l l i n es to rem ote M E EQUIPMENT c o u l d

oth e rwise ca rry e n e rg i es t h at m i ght be hazard o u s .
T h e test circu its of F i g u re 9 a n d F i g u re 1 0 o f t h i s sta n dard a r e d es i g n e d to s i m pl ify t h e test by

i nteg rati n g t h e voltage a p pea ri n g across t h e test resistance ( R 1 ) .
T h e val u e o f t h e i n d u cta n c e L i n t h e test ci rcu its o f F i g u re 9 a n d F i g u re 1 0 i s c h o s e n to

prov i d e a s h o rter t h a n n o r m al rise ti m e in order to test a d e q u ately the i n co rporated p rotective
means.
Rationale for impulse test voltage
When a d efi bri l l at i o n voltage is a pp l i e d to t h e t h o rax of a PAT I E NT, v i a exte r n a l l y a p p l i e d

paddles ( o r defi bri l l at i o n e l ectrodes), t h e b o d y tiss u e o f t h e PATI ENT i n t h e v i c i n ity o f t h e
paddles a n d betwee n t h e paddles beco m es a v o l t a g e divi d i n g syste m .
6060 1 - 1 © I EC : 20 0 5 - 493 -
T h e voltage d istri buti o n c a n be g a u g e d r o u g h l y u s i n g th ree-d i m e n s i o n a l fi e l d t h e o ry but i s

m od ifi e d b y l o cal tiss u e c o n d u ctivity t h at is f a r fro m u n ifo r m .
I f t h e el ectro d e o f a n oth e r i t e m o f ME EQUIPMENT i s a p p l i e d to t h e PAT I E NT, r o u g h l y with i n t h e

com pass o f t h e defi bri l l ator paddles, t h e voltage t o w h i c h s u c h a n e l e ctrode is s u bj ecte d
d e p e n ds o n its positi o n but wi l l g e n e ra l l y be l ess t h a n t h e o n - l oad defi b r i l l ati o n voltage.
U nfort u n ately it is n ot possi b l e to say h ow m u ch l ess as t h e e l ectrode i n q u esti o n can be

placed a nywh e re in this area, i n c l u d i n g i m m e d i ately adj a ce n t to one of t h e defi bri l l ato r
paddles. I n t h e absence of a r e l ev a nt parti c u l a r sta n da r d , it is req u i red t h at s u c h an el ectrode
and t h e ME EQUIPM ENT to which it is c o n n ected i s able to withsta n d t h e fu l l d efi bri l l at i o n
v o l t a g e . T h i s i s t h e n o- l o a d v o l t a g e as o n e o f t h e d efi bri l l ator p a d d l es m i g h t n ot be m a ki n g
good contact with t h e PATIENT.
T h i s sta ndard t h e refore s pecifies 5 kV d . c. as t h e appropri ate test voltage in t h e a bs e n c e of a

relevant parti c u l a r sta n d a rd .
Applyi n g S u bc l a u s e 4 . 5 , a MANUFACTURER is a l l owed to u s e alte r n ate m e a n s to a d d ress a RISK

covered by t h i s sta n dard if t h e RESI DUAL RISK after a p plyi n g t h e alte r n ate m ea n s is equal o r
l ess t h a n t h e RESI DUAL RISK after a p plyi n g t h e req u i re m e nts o f t h i s sta n d a rd . I t is possi b l e fo r
a MANUFACTU RER to determ i n e t h at a l ower test voltage is a ppro priate d e pe n d i n g on t h e
I NTENDED USE o f t h e ME EQUIPMENT a n d t h e l ocati o n o f t h e APPLI E D PARTS o n t h e PAI ENT if it c a n
be d e m o nstrated t h at t h e test v o l t a g e s e l ected i s t h e m ax i m u m v o l t a g e t h at can a p p e a r o n t h e
APPLI ED PART w i t h 5 k V a p p l i e d to t h e c h est. S u c h parts c a n b e cl assifi e d a n d m a rked as a
DEFIBRI LLATION-PROOF APPLI ED PARTS .
S u bc l a u se 8 . 6 - P rotective earth i ng , f u n ct i o n a l eart h i ng a n d potential e q u a l ization of

ME EQUIPMENT
Ty pically, m etal ACCESSI BLE PARTS of CLASS I ME EQUIPMENT are PROTECTIVELY EARTHED.
H owev e r , t h ey c o u l d be s e pa rated by oth e r MEANS OF PROTECT I O N , in accord a n c e with 8 . 5 .
Also s o m e m etal ACCESSI BLE PARTS c o u l d be e a rt h e d i n c i d e nta l l y , n e i t h e r b y a PROTECTIVE
EARTH CONNECTION nor for fu n cti o n a l p u r poses . For exa m pl e , s u c h a part c o u l d be in co ntact
with a n ot h e r part that is PROTECTIVELY EARTHED but does n ot its e lf n e e d to be PROTECTIVELY
EARTHED.
S u bclause 8 . 6 . 1 - Ap p l i ca b i l ity of req u i rements
PROTECTIVE EARTH CONNECTIONS that are only relevant to t h e safety of OPERATORS are a l l owed
to com ply either with the req u i r e m e nts of t h i s sta n dard o r with those of I EC 60950- 1 , but the
l atte r alternative i s n ot a l l owed for PROTECTIVE EARTH CONNECTI ONS t h at are r e l ev a nt to t h e
safety o f both OPERATORS a n d PAT I E NTS .
S u bclause 8 . 6 . 2 - PROTECTIVE EARTH TERMI NAL
T h ese re q u i re m e nts a re i ntended to e n s u re a r e l i a b l e co n n ecti o n betwe e n the ME EQUIPM ENT

and t h e protective e a rth i n g syst e m of t h e e l ectri cal i nsta l l ati o n .
S u bclause 8 . 6 . 3 - P rotective earth i n g of m o v i n g parts
C o n n e ct i o n s to m ov i n g parts , whether m a d e by s l i d i n g contacts , by fl ex i bl e wi res o r by a n y

oth e r m ea n s , c o u l d be m o re suscepti b l e t h a n ordi n a ry FIXED co n n ecti o n s to d ete rio rati o n
d u r i n g t h e EXPECTED S E RVICE LIFE o f t h e ME EQUI PMENT. T h e refo re , t h ey are n ot accepta b l e a s
PROTECTIVE EARTH CONNECTIONS u n l ess th e i r re l i a b i l ity i s d e m o nstrated .
6060 1 - 1 © I EC : 20 0 5 - 495 -
S u bclause 8 . 6 . 4 a)
PROTECTIVE EARTH CONNECTIONS c a n o n l y perfo r m thei r protective fu n cti o n if they are a b l e to

ca rry t h e fa u l t c u rrent res ulti n g from a fai l u re i n BASI C I NS U LAT I O N .
S u c h a c u rrent i s ass u m e d to have s uffi c i e n t a m plitude to c a u s e o p e rati o n o f protectiv e

devices i n t h e el ectrical i nsta l l ati o n (fuses, ci rcu it-breakers, e a rt h l eakage circu it- brea kers
a n d t h e l i ke) i n a reas o n a bly s h o rt ti m e .
I t i s t h e refore n ecessary t o c h e c k both t h e i m peda n c e a n d t h e c u rrent-carry i n g c a p a b i l ity of

PROTECTIVE EARTH CONNECTI ONS.
T h e m i n i m u m ti m e req u i red for t h e test c u rrent is i ntended to rev e a l a n y ov e r h e ati n g of pa rts

of t h e co n n ecti o n d u e to t h i n wi r i n g or a bad contact. S u c h a "weak s pot" m i g ht not be
discovered by res i sta n c e m ea s u r e m e n t a l o n e .
PROTECTIVE EARTH CONNECTIONS c a n have z o n es o f h i g h e r i m p e d a n c e , for exa m pl e d u e to

ox i d ati o n of m ateri a l s . Use of a c u rrent s o u rce with an u n l i m ited voltage co u l d prevent
detect i o n of such z o n es because of thei r a b i l ity to fl ash t h r o u g h . The i m p e d a n ce is t h e refo re
dete r m i n e d fi rst, u s i n g a l i m ited voltage.
I f t h i s voltage is s uffi c i e nt to drive t h e s pecifi ed test cu rrent t h ro u g h t h e total i m peda n c e , t h e n

t h i s o n e test also s e rves to d e m o nstrate t h e cu rrent-carry i n g c a p a b i l ity o f t h e co n n ecti o n .
Otherwise a n additi o n a l test i s n eces s a ry, e i t h e r u s i n g a h i g h e r voltage o r b y assess i n g t h e
cross-secti o n a l area o f t h e co n n e cti o n b y i ns pecti o n .
S u bclause 8 . 6 . 4 b)
T h e fa u l t cu rrent co u l d be l i m ited to a r e l atively l ow v a l u e because of i n h e re nt i m pedance o r

t h e c h a racte ristic o f t h e power s o u rc e , f o r ex a m pl e w h e re t h e powe r syste m is n ot c o n n ecte d
to e a rth or c o n n ected to it v i a a h i g h i m p e d a n ce (see F i g u re A. 1 3) .
I n s u c h cases, t h e cross-secti o n of t h e PROTECTIVE EARTH CONNECTI ON can b e dete r m i n e d

pri m a r i l y b y m ec h a n ical cons i d e rati o n s .
6060 1 - 1 © I EC : 20 0 5 - 497 -
I
�-------- ��------c=c=c=�----��-- Short
circuit
LEAKAGE
CURRENT
IEC 2435105
Legend
ZPE I m pedance of PROTECTIVE EARTH C O N N ECTION i n o h m s (exce eding the l i m it specified in
8.6.4 a))
IF Max i m u m continuous prospective fa u lt c u rrent in a m peres in the PROTECTIVE EARTH
CON N ECT I O N caused by a single fa i l u re of the insulation to e a rth
MD Measuring device (see Figure 1 2)
NOTE The fig u re shows ME EQU I PM E NT having a m a i n ENCLOSURE and a remote part i n a separate ENCLOS U R E ,
as a n example o f a situation where t h e i m peda nce o f a PROTECT IVE EARTH CON N ECTION c o u l d exceed the
l i m it specified i n 8.6.4 a ) : however this situation could a l so exist i n ME EQU I PM E NT having a single
ENCLOS U R E .
F ig u re A. 1 3 - A l l owable protective earth i m ped a n ce wh ere t h e fau lt cu rrent is l i m ited
S u bclause 8 6 7 - POTE NTIAL EQUALIZATION CONDUCTOR

. .
M e d i c a l l y used rooms in m ost cou ntries have n o faci l i t i es for the use of detach a b l e POTENTIAL
EQUALIZATION CON DUCTORS . T h i s sta ndard t h e refo re does not re q u i re any m e a n s to be
prov i d e d for the co n n ecti o n of a POTENTIAL EQUALIZATION CON DUCTOR to the ME EQUIPMENT. If
h owev e r t h e ME EQUI P M E NT does have such m ea n s , for u s e in locati o n s w h e re POTENTIAL
EQUALIZATION CONDUCTORS are u s e d , the a ppro pri ate req u i re m e nts have to be s ati sfi e d .
S u bclause 8 . 6 . 9 - CLASS I I M E EQUIPMENT
This req u i r e m e n t a l l ows a CLASS 1 1 ME EQUIPM ENT to have a c o n n ect i o n to protective earth fo r
f u n cti o n a l reas o n s o n l y . G ree n/yel l ow is req u i red to av o i d c o nfu s i o n i n i nstal l ati o n . T h e
a l l owa n ce does n o t degrade t h e degree o f protect i o n a g a i nst e l e ctric s h ock.
S u bclause 8 . 7 . 2 - SINGLE FAULT CONDITIONS
S h o rt ci rcuiti n g of one p a rt of DOUBLE I NS U LATION wo u l d be l i ke l y to i n crease LEAKAGE CURRENT

by a factor of t h e order of 2 . I n s o m e cases the test c o u l d be diffi c u l t to ca rry o ut a n d , as the
a l l owable v a l ues fo r S I NGLE FAULT CONDI TION are five ti m es those for NO RMAL CONDITI O N , t h e
test wo u l d not prov i d e u s efu l i nformati o n .
S u bclause 8 . 7 . 3 - Al lowable values, Table 3 a n d Table 4
T h e v a l u e of e l ectri c c u rrent fl owi n g i n t h e h u m a n or a n i m al body t h at c a n c a u s e a certa i n

d e g ree o f sti m u l ati o n v a ri es from i n d i v i d u a l t o i n divi d u a l , accord i n g t o t h e way i n w h i c h t h e
co n n e cti o n t o t h e body i s m ade a n d accordi n g t o t h e fre q u e n cy o f t h e cu rre nt a pp l i e d a n d its
d u rati o n .
6060 1 - 1 © I EC : 20 0 5 - 4 99 -
C u rre nts of low fre q u e n cy fl owi n g di rectly i nto or t h r o u g h t h e h e a rt considerably i n crease t h e

d a n g e r o f ventr i c u l a r fi bri l l ati o n . F o r c u rre nts o f m e d i u m o r h i g h fre q u e n cy, t h e RISK o f e l ectric
shock is l ess o r n e g l i g i bl e , but t h e RISK of b u r n i n g re m a i n s .
T h e s e n s itivity o f t h e h u m a n o r a n i m al body t o e l ectric c u rrents, d e p e n d i n g u p o n t h e d e g ree

and n at u re of co ntact with t h e ME EQUI PMENT, l e ads to a system of class ifi cat i o n refl ecti n g the
d e g ree and q u a l ity of protect i o n prov i d e d by t h e APPLI ED PARTS ( c l assifi ed as TYPE B APPLI E D
PARTS , TYPE BF APPLI ED PARTS a n d TYPE CF APPLI E D PARTS ) . TYPE B APPLI ED PARTS a n d TYPE BF
APPLI ED PARTS are g e n e r a l l y s u itable fo r a p pl i cati o n s i nvolvi n g exte r n a l o r i nternal co ntact with
t h e PAT I E NT, excl u d i n g t h e h e a rt. TYPE CF APPLI ED PARTS are s u itable for DI RECT CARDIAC
APPLICATIONS with regard to LEAKAGE CURRENT.
I n c o nj u n cti o n with this cl assifi cati o n , t h e re q u i re m e nts for a l l ow a b l e LEAKAGE CURRENT h ave
been form u l ated. T h e a bs e n c e of s uffi c i e nt scie ntific d ata co n c e r n i n g t h e s e n s itiv ity of t h e
h u m a n h e a rt f o r c u rrents causi n g ventri c u l a r f i b r i l l ati o n sti l l prese nts a probl e m .
Nevert h e less, t h e p u b l i cati o n of t h e fi rst editi o n of t h i s sta n d a rd i n 1 977 prov i d e d e n g i n eers

with data e n a b l i n g t h e m to d e s i g n ME E Q U I PM E NT; a n d these re q u i re m e nts h ave proved ov e r
t h e years s i n c e t h e n to e n s u re a very l ow l ev e l o f RISK wit h o ut be i n g too o n e r o u s for
des i g n e rs .
T h e re q u i re m e nts for LEAKAGE CURRENT were form u l ated taki n g i nto accou nt:
- t h at t h e poss i bi l ity of v e ntri c u l a r fi bri l l at i o n is i nfl u e nced by facto rs other t h a n o n l y
e l ectrical p a r a m eters ;
- t h at t h e v a l u es for al lowa b l e LEAKAGE CU RRENTS i n S I NGLE FAULT CON DITI O N s h o u l d be as
h i g h as is considered safe, taki n g i nto acco u nt statistical c o n s i d e rati o n s , i n order not to
present d e s i g n e rs with u n n ecessary diffi culties; a n d
- t h at val u es fo r NORMAL CONDI TION are n ecess a ry to create a s afe c o n diti o n i n a l l situat i o n s
b y provi d i n g a s uffi c i e ntly h i g h s afety factor with respect to S I NGLE FAULT CONDI TIONS.
T h e m ea s u r e m e n t of LEAKAGE CURRE NTS has been descri bed in a way that e n a b l es t h e use of
si m pl e i nstru m e nts, avo i d i n g diffe rent i nte rpretat i o n s of a g i v e n case a n d i n di cati n g
poss i b i l ities for p e r i o d i c c h ecki n g b y t h e RESPONSI BLE ORGANIZAT I O N .
A l l owa b l e val ues o f LEAKAGE a n d PAT I E NT AUXI LIARY CURRE NTS fo r a . c . a n d d . c . c o m posite
wavefo rms with fre q u e n cies up to and i n cl u d i n g 1 kHz take acco u nt of t h e fo l l ow i n g
cons i d e rati o n s .
d) I n g e n e ral t h e R I S K of ventricu l a r fi bri l l at i o n o r p u m p fai l u re i n creases with t h e v a l u e o r

d u rati o n , u p to a few s e c o n d s , o f t h e c u rrent pass i n g t h r o u g h t h e h e a rt. S o m e a reas o f t h e
h e a rt are m o r e s e n sitive t h a n ot h e rs . T h at i s , a cu rrent t h at c a uses ve ntri c u l a r f i b ri l l at i o n
w h e n a p p l i e d to o n e part o f t h e h e a rt co u l d have n o effect w h e n a p p l i e d to a n ot h e r part of
t h e h e a rt.
e) The RISK is h i g h est and a p prox i m ately e q u a l for fre q u e n ci es i n the 1 0 Hz to 2 0 0 Hz r a n g e .

I t is l ower, b y a factor o f nearly 5 , a t d . c . a n d b y a pprox i m ately 1 , 5 at 1 kHz. B eyo n d 1 k H z ,
t h e RISK decre ases rapi d l y [45] . T h e val u es i n T a b l e 3 a n d T a b l e 4 a p ply to c u rre nts
m e as u red with t h e m e as u ri n g device s h own i n F i g u re 1 2 a ) , w h i c h a u to m at i c a l l y a l l ows for
the reduced s e n s itivity at h i g h e r fre q u e n c i es . SUPPLY MAI NS freq u e n c i es of 50 Hz a n d
60 Hz a re i n t h e r a n g e of h i g h est RISK.
f) Alt h o u g h as a g e n e ra l rule re q u i re m e nts in a g e n e ra l sta n d ard are l ess restrictive t h a n the

req u i r e m e nts in parti c u l a r sta n dards, some of t h e a l l ow a b l e v a l ues i n T a b l e 3 and T a b l e 4
have been s et at s u c h a v a l u e t h at:
6060 1 - 1 © I EC : 20 0 5 - 501 -
- t h e m ajority of ME EQUIPMENT ty pes c a n c o m ply, a n d

- they c a n be a p p l i e d t o m ost ME EQUI PMENT types ( ex isti n g o r future) fo r w h i c h n o
parti c u l a r sta n d a rds exist.
EARTH LEAKAGE CURRENT
T h e EARTH LEAKAGE CURRENT fl owi n g t h r o u g h t h e PROTECTIVE EARTH CONDUCTO R is n ot a

HAZARD per s e . T h e PATIENT a n d OPERATOR are protected by s pecify i n g a ppro priately l ow
v a l u es for PAT I E NT LEAKAGE CURRENT a n d TOUCH CURRENT i n NORMAL CONDI TION a n d i n r e l ev a nt
S I NGLE FAULT CONDITIONS i n c l u d i n g i nterr u pti o n of t h e PROTECTIVE EARTH CONDUCTOR.
H owev e r , a n excessive EARTH LEAKAGE CURRENT could pose a poss i bl e problem for t h e
'
i nsta l l ati o n s e a rth i n g system a n d a n y ci rcuit brea kers o pe r ated b y cu rrent i m ba l a n c e
detectors .
S e e a l s o I EC 60 364-7-7 1 0 [ 1 0 ] .
TOUCH CURRENT
T h e l i m its are based on t h e fo l l owi n g c o n s i d e rati o n s .
g) T h e TOUCH CURRENT o f ME EQUIPMENT is s u bj ect to t h e s a m e v a l ues regardl ess o f t h e

type(s) o f APPLI ED PARTS , if any, because e v e n M E EQUIPMENT t h a t d o e s n ot itself h a v e a
TYPE CF APPLI E D PART c o u l d be used i n s i t u ati o n s w h e re i ntracard i a c PROCEDURES are
perfo r m e d .
h ) Alt h o u g h TOUCH CURRENT flows f r o m parts oth e r t h a n PATI E N T CONNECTI ONS, it c a n reach
t h e PAT I E NT by c h a nce contact t h r o u g h v a r i o u s pat h s , i n c l u d i n g a path via the OPERATO R.
2
i ) T h e cu rrent dens ity c reated at t h e h e a rt by c u rrent enteri n g t h e c h est is 50 �-tA/m m per
a m pere [46] . The c u rrent d e nsity at t h e h e a rt for 500 �-tA ( m axi m u m a l l owa b l e v a l u e i n
2
S I NGLE FAULT CONDI TION ) enteri n g t h e c h est i s 0 , 025 �-tA/m m , wel l below t h e l evel of
concern.
j ) T h e probabil ity o f t h e TOUCH CURRENT fl owi n g t h r o u g h t h e h e a rt a n d causi n g ve ntri c u l a r

fi bri l l ati o n o r p u m p fa i l u re .
ToucH CURRENT co u l d c o n ceivably reach a n i ntracard i a c s i t e if carel ess PROCEDURES are

used in h a n d l i n g i ntracard i a c c o n d u ctors o r fl u i d fi l l ed cath eters . Such devices s h o u l d
a l ways be h a n d l e d with g re at care a n d always with d ry r u b b e r g l oves. T h e fol l owi n g RISK
ANALYSIS is based o n pess i m i st i c ass u m pt i o n s a b o ut t h e d e g r e e of care exe rcised.
T h e probabil ity of a di rect contact betwee n a n i ntracard i a c d e v i ce and a n ME EQUIPM ENT

E NCLOS URE i s c o n s i dered to be v e ry l ow, p e r h a ps 1 in 1 00 m ed i c a l proce d u re s . T h e
probabil ity o f a n i n d i rect contact v i a t h e m ed i c a l staff i s considered to be s o m ewh at h i g h er,
say 1 in 1 0 m ed i c a l procedures. T h e m axi m u m a l l ow a b l e LEAKAGE CURRENT in NORMAL
CONDI TION is 1 00 �-tA, w h i c h itself has a probabil ity of i n d u ci n g v e ntri c u l a r fi bri l l at i o n of
0 , 0 5 . I f the probabil ity of i n di rect contact i s 0 , 1 t h e n the overall probabil ity i s 0 , 00 5 .
Alt h o u g h t h i s probabil ity wo u l d a p p e a r u n desi rably h i g h , it s h o u l d be reca l l e d t h at with
correct h a n d l i n g of the i ntracard i a c device t h i s proba b i l ity can be reduced to that for
m ec h a n i cal sti m u l at i o n a l o n e , 0 , 0 0 1 .
T h e probabil ity of t h e TOUCH CURRENT n s 1 n g to t h e m ax i m u m a l l owable l evel of 500 �-tA

( S I NGLE FAULT CONDI TION ) is c o n s i d e re d to be 0 , 1 i n de part m e nts with poor m a i nt e n a nce
PROCE DURE S . T h e probabil ity of t h i s cu rrent c a us i n g ventri c u l a r fi bri l l at i o n is taken as 1 .
6060 1 - 1 © I EC : 20 0 5 - 503 -
T h e probabil ity of acci d e ntal co ntact di rectly with t h e e n c l o s u r e i s , as above, considered as

0 , 0 1 , giv i n g an ove r a l l probabil ity of 0 , 00 1 , e q u a l to t h e m ec h a n i ca l sti m u l ati o n a l o n e
probabil ity.
The probabil ity of TOUCH CURRENT at the m axi m u m a l l owa b l e l ev e l of 500 �-tA ( S I NGLE FAULT
CONDI TION) be i n g c o n d u cted to an i ntracard i a c dev i c e via t h e m ed i c a l staff is 0 , 0 1 ( 0 , 1 for
the S I NGLE FAULT CONDI TION, 0 , 1 for accide ntal c o ntact) . S i n c e the probabil ity of t h i s c u rrent
caus i n g v e ntri c u l a r fi bri l l at i o n i s 1 , t h e overa l l probabil ity i s also 0 , 0 1 . Aga i n this probabil ity
is h i g h ; h owev e r it can be bro u g ht down to the m ec h a n ical sti m u l ati o n a l o n e probabil ity of
0 , 0 0 1 by a d e q u ate m ed i c a l proce d u res.
k) T h e probabil ity of t h e TOUCH CURRENT be i n g percept i b l e to t h e PAT I E NT.
T h e probabil ity of 500 �-tA bei n g percepti b l e is 0 , 0 1 for men a n d 0 , 0 1 4 for wo m e n when
u s i n g grip el ectrodes with i ntact s k i n [45] [48]. There i s a h i g h e r percepti b i l ity for c u rrent
pass i n g t h r o u g h m u cous m e m branes o r skin p u n ctu res [4 8 ] . S i n ce distri buti o n is n o r m a l ,
t h e r e wi l l be a probabil ity t h at s o m e PAT I E NTS wi l l perceive very s m a l l c u rrents. O n e pers o n
i s reported to h a v e s e n s e d 4 �-t A pass i n g t h r o u g h a m u cous m e m brane [48].
PA TIENT LEAKA GE CURRENT
T h e a l l owable v a l u e of PAT I E NT LEAKAGE CURRENT for ME EQUI P M E NT with TYPE CF APPLI E D

PARTS i n NORMAL CONDI TION is 1 0 �-tA, w h i c h has a proba b i l ity o f 0 , 002 f o r caus i n g ventr i c u l a r
fi bri l l at i o n o r p u m p fa i l u re w h e n a p pl i e d t h r o u g h s m a l l a r e a s to a n i ntraca r d i a c site.
Even with zero cu rrent, it h as been o bserved t h at m ec h a n ical i rritati o n c a n p r o d u ce

ventri c u l a r f i b ri l l at i o n [ 5 0 ] . A l i m it of 1 0 �-tA is rea d i l y a c h i evabl e a n d does not s i g n ifica ntly
i n crease the RISK of ventr i c u l a r fi bri l l ati o n d u ri n g i ntracard i a c procedures.
T h e 50 �-tA m axi m u m a l l owed in S I NGLE FAULT CONDI TION for ME EQUI PMENT with TYPE CF
APPLI ED PARTS is based o n a value of cu rrent t h at has been fo u n d , u n de r cl i n i cal c o n diti o n s , to
have a v e ry l ow probabil ity of caus i n g v e ntri c u l a r fi b ri l l at i o n o r i nterfe rence with t h e p u m p i n g
act i o n o f t h e h e a rt.
F o r catheters 1 , 2 5 mm - 2 mm d i a m eter l i ke l y to co ntact t h e myocardi u m , t h e probabil ity of

50 �-tA c a us i n g v e ntri c u l a r fi bri l l at i o n i s near 0 , 0 1 (see F i g u re A. 1 4 and its expl a n ati o n ) . S m a l l
2 2
cross-sect i o n a r e a ( 0 , 22 m m a n d 0 , 93 m m ) cath eters u s e d i n a n g i o g raphy h av e h i g h e r
probabi l ities o f ca u s i n g v e ntri c u l a r fi bri l l at i o n o r pu m p fai l u re i f placed d i rectly o n se nsitive
areas of t h e h e a rt.
T h e ov e r a l l probabil ity of ventr i c u l a r fibri l l ati o n be i n g caused by PAT I E NT LEAKAGE CURRENT i n

S I NGLE FAULT CONDITION i s 0 , 0 0 1 ( 0 , 1 for proba b i l ity of S I NGLE FAULT CONDITI O N , 0 , 0 1
probabil ity o f 50 �-tA causi n g v e ntri c u l a r f i b ri l l at i o n ) e q u a l t o t h e probabil ity for m e c h a n i c a l
sti m u l at i o n a l o n e .
T h e 50 �-tA cu rrent a l l owed i n S I NGLE FAULT CONDITION i s n ot l i ke l y t o result i n a c u rrent dens ity
s uffi ci e nt to sti m u l ate n e u ro m u s c u l a r tissues n o r , if d . c . , c a u s e n ecros i s .
For ME EQUIPM ENT with TYPE B APPLI E D PARTS a n d TYPE BF APPLI E D PARTS w h e re t h e m axi m u m
a l l owa b l e PAT I E NT LEAKAGE CURRENT u n d e r S I NGLE FAULT CONDITION i s 5 0 0 �-tA, t h e s a m e
rati o n a l e a p pl i es a s t h at f o r TOUCH CURRENT s i n c e t h i s cu rrent wi l l n ot f l ow di rectly t o t h e
h e a rt.
6060 1 - 1 © I EC : 20 0 5 - 505 -
As t h e ex i ste nce of an e a rth co n n ecti o n to a PAT I E NT is a NORMAL CONDI TION, n ot o n l y PAT I E NT

AUXILIARY CURRENT but a l s o PAT I E NT LEAKAGE CURRENT can fl ow for a prol o n g e d peri o d . A v e ry
l ow val u e of di rect cu rrent is t h e refore n ecess a ry to avoid tiss u e n ecros i s , regardl ess of t h e
cl assificat i o n o f t h e APPLI ED PART.
T h e a p pearance of MAINS VOLTAGE, from a l ow-i m pe d a n c e s o u rc e , on the PAT I E NT

CONNECTIONS of a n F-TYPE APPLI ED PART wo u l d have to be c a u s e d by a d o u b l e fai l u re of
protective m e a n s in oth e r ME EQUIPMENT, s i m u l t a n e o u s l y c o n n ected to t h e PAT I E NT a n d
com ply i n g with t h i s sta n dard o r a n oth e r I E C sta n d a rd , o r b y a s i n g l e fa i l u re o f protective
m e a n s in e q u i p m e n t n ot com plyi n g with a sta n d a r d . As s u c h t h i s con diti o n i s extre m e l y
u n l i ke l y i n good m e d i c a l p ract i c e .
H oweve r t h e a p pearance o f a l esser voltage, o r o f a LEAKAGE CURRENT fro m a s o u rce h av i n g

a n open-circuit voltage o f t h e order o f MAINS VOLTA G E , is poss i b l e .
S i n c e t h e m a i n s afety feature o f ME EQUIPM ENT with a n F-TYPE APPLIED PART i s t h at t h e PAT I E NT

is not e a rthed by t h e c o n n ecti o n to t h e ME EQUIPMENT, t h e e l ectrical se parat i o n of an F-TYPE
APPLI ED PART from earth is to h ave a m i n i m u m q u a l ity. T h i s is ass u re d by t h e re q u i re m ent that,
eve n if a h y poth eti cal voltage of s u pply freq u e ncy a n d equal to the h i g h est s u pply voltage to
earth present in the l ocati o n w h e re the ME EQUIPMENT is used wo u l d appear o n the PAT I E NT
CONNECTI ONS, t h e l i m i t for t h e PAT I E NT LEAKAGE CURRENT w o u l d n ot be exc e e d e d .
For TYPE CF APPLI ED PARTS , t h e PAT I E NT LEAKAGE CURRENT wi l l b e l i m ited to 50 �-t A , n o worse
than t h e prev i o us l y d i s c u ss e d S I NGLE FAULT CONDI TION.
For TYPE BF APPLI ED PARTS t h e m axi m u m PAT I E NT LEAKAGE CURRENT u n d e r th ese c o n diti o n s is
5 mA. Even t h i s val u e e nteri n g t h e c h est wo u l d produce only a c u rrent d e n sity at t h e h e a rt of
2
0,25 �-tA/m m T h i s c u rrent wo u l d be very percepti b l e to t h e PATI E NT, h oweve r t h e probabil ity
of its occu rre n ce i s v e ry l ow. The RISK of h a rmful phys i ol og i cal effects is s m a l l a n d t h e
MAXI M U M M A I N S VOLTAGE used f o r t h i s test re prese nts a worst c a s e , m o re s e v e r e t h a n is l i ke l y
to arise i n practice.
To tal PA TIENT LEAKAGE CURRENT
T h e val u es of PAT I E NT LEAKAGE CURRENT i n t h i s sta n d ard are for a s i n g l e f u n ct i o n of a TYPE B

APPLI ED PART or TYPE BF APPLI E D PART or a s i n g l e PAT I E NT CONN ECTI ON of a TYPE CF APPLI ED
PART. With m u lti p l e f u n cti o n s o r m u lti p l e APPLI ED PARTS t h e total PAT I E NT LEAKAGE CURRENT
co u l d be m u c h h i g h er. T h i s total PAT I E NT LEAKAGE CURRENT is t h e v ecto r sum of t h e i n di v i d u a l
PAT I E NT LEAKAGE CURRE NTS . T h e refo re, it i s n e cessary to s pe c ify l i m its f o r total PATI ENT
LEAKAGE CURRENT. These req u i re m e nts are derived from I E C 6 06 0 1 -2-49 : 2 0 0 1 [ 1 6] .
T h i s sta ndard d o e s n ot f i x t h e n u m be r o f APPLI ED PARTS con n ected to a s i n g l e PATI E NT. I t h as

been esti m ated that t h e n u m be r of APPLI ED PARTS co n n ected to a s i n g l e PAT I E NT ranges from
one to fiv e .
To tal PA TIENT LEAKAGE CURRENT for TYPE C F APPLIED PARTS
For TYPE CF APPLI ED PARTS t h e PAT I E NT LEAKAGE CURRENT for t h e NORMAL CONDITION is 1 0 �-tA.
T h e fol l owi n g is to be c o n s i d e re d for m u lti p l e PAT I E NT f u n cti o n s :
I) T h e c u rrent e nteri n g t h e h e a rt is d istri buted ove r a l l o f t h e PATI ENT CONNECTIONS a n d is n ot

a p p l i e d to t h e s a m e s m a l l se nsitive area of t h e cardiac tis s u e .
6060 1 - 1 © I EC : 20 0 5 - 507 -
m ) T h e n u m be r of PAT I E NT CONNECTIONS co n n e cted d i rectly to cardiac tiss u e is n ot l i ke l y to

exceed t h r e e . Accord i n gly, t h e LEAKAGE CURRENT enteri n g a s i n g l e s m a l l area of t h e h e a rt
is l ess t h a n 50 �-tA a n d is i n t h e vi c i n ity of 1 5 �-tA to 20 �-tA for an a l g e braic s u m m at i o n of
t h e cu rre nts . T h e c u rrent wo u l d be l ess for a v ecto r s u m m ati o n . T h e probabil ity of
ventri c u l a r fi bri l l ati o n , accord i n g to t h e rati o n a l e for PAT I E NT LEAKAGE CURRENT, is i n t h e
r a n g e o f 0 , 0 0 3 even if a l l t h e PAT I E NT CONNECTIONS a r e very c l o s e together. T h i s i s n ot
m u c h diffe rent fro m t h e proba b i l ity of 0 , 002 t h at is accepted for a s i n g l e APPLI ED PART
co n n e cted di rectly to t h e h e a rt.
n ) The LEAKAGE CURRENT from APPLI ED PARTS o n the s u rface of the body fl ows in a d istri buted
m a n n e r t h r o u g h t h e body. Accord i n g to the rati o n a l e for PATI ENT LEAKAGE CURRENT, 5 mA
2
enteri n g t h e ch est produ ces a c u rrent de nsity at t h e h e a rt of 0 , 025 �-tA/m m
T h e refo re, 50 �-tA for NORMAL CONDI TION for total PAT I E NT LEAKAG E CURRENT is c o n s i d ered
accepta b l e .
For S I NGLE FAULT CON DITION t h e LEAKAGE CURRENT f o r TYPE CF EQUIPM ENT h a s been i n creased
to 0 , 1 mA. The rati o n a l e for PAT I E NT LEAKAGE CURRENT gives a p r o b a b i l ity of 0 , 07 of ve ntri c u l a r
fi bri l l ati o n f o r cu rrent di rectly enteri n g t h e h e a rt. T h e probabil ity o f a S I NGLE FAULT CONDI TION
was given as 0, 1 . This was over a decade ago. Because of i m provem ents i n desi g n , m ore rel i a b l e
co m po n e nts, better m ateri a l s , a n d t h e u s e o f RISK MANAG E M E NT i n accord a n c e with I SO 1 4 9 7 1
a n d t h e co nseq u e nt u s e o f associ ated tools, s u c h as HAZARD based RISK ANALYSI S , t h e
probabil ity o f a S I NGLE FAULT CONDI TION s h o u l d be m u c h l es s . I t i s n ow f e l t to be i n t h e v i ci n ity
of at l east 0 , 0 2 . T h e probabil ity of ventr i c u l a r f i b ri l l at i o n is 0 , 07 x 0 , 02 , or 0 , 00 1 4 , cl ose to that
accepted fo r a s i n gl e TYPE CF APPLI ED PART.
To tal PA TIENT LEAKAGE CURRENT for TYPE BF APPLIED PARTS
T h e total PAT I E NT LEAKAGE CURRENT h as been i n creased to 5 0 0 �-tA for NORMAL CONDI TION a n d
to 1 0 0 0 �-tA f o r S I NGLE FAULT CONDI TION. A s expl a i n e d i n c) a bove, t h e c u rrent d e n s ity at t h e
h e a rt f o r c u rrent o f 5 0 0 0 �-tA is q u ite s m a l l . T h e re s h o u l d be n o c o n c e r n f o r e i t h e r t h e NORMAL
CONDI TION o r the S I NGLE FAULT CONDI TION.
To tal PA TIENT LEAKAGE CURRENT caused b y a n external voltage o n the PA TIENT CONNECTION
For TYPE CF APPLI ED PARTS, t h e l i m it h as been i n creased to 1 0 0 �-tA. T h e rati o n a l e for PAT I E NT
LEAKAGE CURRENT states t h at t h e probabil ity of fai l u re of protective earth i n g of CLASS 1
ME EQUIPMENT is 0 , 1 a n d t h at t h e probabil ity of a fa u l t i n o n e MOP is less t h a n 0 , 1 . T h i s was a
decade a g o . As expl a i n ed e a r l i e r , th ese pro b a bi l it i es s h o u l d be m u c h l ower today a n d are
c o n s i d ered to be no worse than 0 , 0 2 . The probabil ity of MAI N S VOLTAGE appea r i n g o n t h e
PAT I E NT is 0 , 02 x 0 , 02 , o r 0 , 0004. T h i s i s b e l ow t h e probabil ity o f 0 , 0 0 1 accepted i n t h e
s e c o n d editi o n o f I EC 6060 1 - 1 .
PA TIENT AUXILIARY CURRENT
T h e a l l owa b l e v a l ues for PAT I E NT AUXI LIARY CURRENT are based on s i m i l a r c o n s i d e rati o n s to
those for PATI ENT LEAKAGE CURRENT. T h ey a p ply regardless of w h et h e r t h e PAT I E NT AUXI LIARY
CURRENT is n ecess a ry for t h e f u n cti o n i n g of t h e ME EQUIPMENT ( e . g . i m p e d a n ce
p l ethys m o g ra p h s ) or i n ci dental to its fu n cti o n i n g . Lowe r v a l ues are g i v e n for d . c . to prevent
tiss u e n ecrosis with l o n g-term a p p l i cati o n .
6060 1 - 1 © I EC : 20 0 5 - 509 -
99,99
99,9
99,8
Starmer 60 Hz 0 = 1 ,25 m m
Watson 5 0 H z 0 = 2,0 m m
99
98
95
/
90 ./
80
70 fi'
60 ./-
/..
/
'#. 50
§'
:.0
y
/
"'
v
..Q ·
e ·
[J_
•
10
5 • v
v
/
/
1'
0,5 1/
0,2
0,1 �
0,05
0,01
0 50 1 00
68
I. �31"
1" Standard deviation IEC 2436105
NOTE Refer to original papers by Sta rmer [53] and Watson [54] for i nterpretation of data .
F i g u re A. 1 4 - P robabi l ity of ve ntric u l a r fi b r i l lation
Explanation o f Figure A . 1 4
Art i c l es by Sta r m e r [53] a n d Watso n [ 54] prov i d e data on ve ntri c u l a r f i b r i l l ati o n caused by
50 Hz a n d 6 0 Hz c u rrents a p p l i e d di rectly to t h e h e a rts of h u m a n po p u l at i o n s with cardi a c
d i s e a s e . F i b r i l l at i o n probabil ity was o bta i n e d as a f u n ct i o n o f th e e l ectrode d i a m eter a n d t h e
m ag n itude o f t h e cu rrent. For el ectrodes o f 1 , 2 5 m m a n d 2 m m d i a m eter a n d c u rrents u p t o
0 , 3 mA, t h e d i str i b ut i o n a p pears n o r m a l . Acco rd i n g l y , it h as been extrapolated to e n c o m pass
the v a l u es c o m m o n ly used in assessi n g PAT I E NT RISK (va l u es noted o n F i g u re A. 1 4) . From t h i s
extrapo l ati o n , it i s s e e n t h at:
6060 1 - 1 © I EC : 20 0 5 - 51 1 -
a n y val u e of cu rrent, h owev e r s m a l l , h as s o m e probabil ity of caus i n g ventricu l a r

fi bri l l ati o n , a n d
t h e c o m m o n l y u s e d v a l ues h av e l ow probabil ities, ra n g i n g f r o m a p p rox i m ately 0 , 002 t o
0, 0 1 .
S i n c e ventr i c u l a r fi bri l l at i o n is governed by m a ny factors ( PATI ENT c o n diti o n , probabil ity of

cu rrent e nteri n g a m o re sens itive area of t h e myocard i u m , p r o b a b i l ity of fi bri l l at i o n as a
f u n ct i o n of c u rrent o r cu rrent d e n s ity, physi o l ogy, e l ectri c fi e l d , etc. ) , it is reas o n a b l e to u s e
statisti cs i n d eterm i n i n g t h e possi b i l ity o f RISK f o r t h e m u lti p l e c o n d it i o n s .
Heating effect o f LEAKAGE CURRENTS
A cu rrent of 1 0 mA wi l l produce n o s e nsati o n of h e at i n g with a typical PAT I E NT CONNECTI O N

2
with a co ntact a r e a o f t h e o r d e r o f 1 cm , but a cu rrent a few ti m es h i g h e r t h a n t h i s wo u l d
produce a b u r n . T h e R I S K o f a b u r n d e p e n ds o n t h e m ag n itude o f t h e cu rrent b u t n ot o n its
fre q u e n cy, s o the cu rrent has to be m e as u red with a n o n-fre q u e n cy-we i g hted device, s u c h as
a device s i m i l a r to that s h own in F i g u re 1 2 a) but wit h o ut C1 a n d R1 .
S u bclause 8 . 7 . 4 . 2 - M eas u ri n g s u pply ci rcu its
For co rrect res u lts of LEAKAGE CURRENT m eas u re m e nts, it i s essential to have a co m m o n
refe rence poi nt with i n t h e m e as u r i n g ci rcuit. T h e poi nt also has to be el ectrically refe renced to
a l l pa rts of t h e ci rcuit. Also t h e m eas u re d LEAKAGE CURRENT c o u l d be diffe rent accordi n g to t h e
parti c u l a r s u pply confi g u rati o n . For ex a m pl e , if M E EQUIPMENT t h at i s s pecifi e d for co n n ecti o n
to a s u pply h avi n g o n e s i d e a t earth pote ntial is c o n n ected i n stead to a s u pply havi n g two
sym m etrical phases ( s u c h as a 2 3 0 V s u pply i n t h e U SA) t h e m e a s u red LEAKAGE CURRENT wi l l
b e m u ch l ower t h a n t h e worst case. If t h e i nsta l l e d S U PPLY MAINS o f t h e room where t h e
m e as u re m e nts a re m a d e does n ot re present t h e worst cas e , a s pecific s u pply ci rcuit h as t o be
esta b l i s h e d . T h i s can be d o n e by u s i n g an i s o l ati n g transfo r m e r with the a p propriate poi nt i n
t h e S ECONDARY C I RCUIT co n n ected t o t h e refere n ce poi nt. Acc u rate a n d repro d u c i b l e resu lts
w h e n m a ki n g LEAKAGE CURRENT m e a s u re m e nts can a l s o be o bt a i n e d without an i s o l ati n g
transform er. H oweve r t h i s wo u l d d e p e n d o n t h e q u a l ity o f t h e S U PPLY MAINS used for t h e
m ea s u re m e nts. F acto rs t h at n eed to be c o n s i dered wo u l d i n c l u de transi ents, i nterfere nce
s i g n a l s a n d voltage d iffe rences betwe e n n e utral and earth in t h e m eas u ri n g ci rcuit.
The e a rth sym bols in the figu res represent this co m m o n refe rence poi nt, which i s n ot
co n n e cted to t h e protective e a rth of t h e S U PPLY MAI NS . S u c h a s e pa rate refe rence poi nt c a n
prov i d e additi o n a l p rotect i o n for t h e person carry i n g out t h e m eas u r e m e nts .
A vari a bl e-voltage transfo r m e r is necessary to prov i d e 1 1 0 % of t h e RATE D s u pply voltage to

t h e ME EQUIPM ENT. Alt h o u g h it wo u l d be poss i bl e to test with t h e MAINS VOLTAGE n o r m a l l y
present i n t h e test r o o m a n d to m u ltiply t h e m easured LEAKAGE CURRENT v a l ues b y t h e
a p propriate factor, t h i s wo u l d n ot always produce t h e s a m e res u l t as testi n g with 1 1 0 % o f t h e
RATED s u pply voltage, parti c u l a rly w i t h ME EQUIPM ENT t h a t i n c l u des a switc hed-m ode power
s u pply.
T h e switches S 1 o r S 1 + S 2 o r S 1 + S 2 + S 3 in Figure F . 1 to F i g u re F.4 ( i ncl usive) c a n be

o m itted a n d t h e i nterrupti o n s of t h e r e l ev a nt l eads c a n be o bta i n e d by other m ea n s .
I nste ad o f t h e s i n g l e o r polyph ase i s o l ati n g tra nsfo r m e rs w i t h adj usta b l e o u t p u t volta g e ( s ) , a s

s h own i n F i g u re F . 1 to F i g u re F . 5 ( i n c l u s i v e ) , a c o m b i n at i o n o f a n i s o l at i n g tra nsfo r m e r with
set o utput voltage a n d a n a uto-transfo r m e r with a dj usta b l e o utput voltage can be u s e d .
6060 1 - 1 © I EC : 20 0 5 - 513 -
S u bclause 8 . 7 . 4 . 3 - Con nection to t h e m eas u ri n g s u pply c i rc u it
Alt h o u g h it is not u n l i ke l y t h at ME EQUI PMENT is used w h i l e pl aced on or i n a n e a rt h e d m etal

e n v i r o n m ent, such a pos iti o n wo u l d be rat h e r d iffi c u l t to descri b e in a way that test res u lts
wo u l d beco m e repro d u c i b l e . The advice in the n ote in 8. 7 . 4 . 3 d) 1 ) i s t h e refore to be
c o n s i d ered as a conve nti o n .
T h e fact t h at PAT I E NT c a bl es c a n have a s i g n i fi c a nt capacita n c e t o earth i s u s u a l l y i m portant

and of c o n s i d e r a b l e i nf l u e n c e on test resu lts . A pos iti o n provi d i n g re prod u c i b l e res u lts is
t h e refore prescri bed.
T h e i s o l at i o n tra nsfo r m e r in t h e m e as u ri n g s u pply circuit provides additi o n a l protect i o n for t h e

pers o n m a k i n g t h e m eas u r e m e nts a n d i n c reases t h e accu racy o f t h e LEAKAGE CURRENT
m eas u re m e nts . H owev e r , it is n ot absol utely n ecessary to u s e an i s o l ati n g tra nsfo r m e r wh e n
m a k i n g LEAKAGE CURRENT m eas u re m e nts. I n s o m e cases, s u c h a s h i g h i n put powe r M E
EQUIPMENT a n d ME SYSTEMS , u s e o f a n i n s o l at i n g transfo r m e r i s n ot feas i b l e . W h e n m a k i n g
LEAKAGE CUURENT m eas u re m ent wit h o u t a n i s o l ati n g tra nsform er, t h e MANUFACTURER n e eds t o
cons i d e r t h e fo l l owi n g :
is it poss i b l e t o extrapol ate t h e LEAKAGE CURRE NTS a t 1 1 0 % o f t h e RATED s u pply voltage;
- t h e i nf l u e n c e of cu rre nts t h at are driven by voltage d iffe r e n ces betwe e n t h e protective
earth a n d the m a i n s s u pply n e utral of ME EQUIPMENT o r for ME SYSTEMS with m u lti p l e
PROTECTIVE EARTH CONNECTI ONS.
M e as u ri n g wit h o u t a n i s o l ati o n tra nsfo r m e r c a n produce LEAKAGE CURRENT read i n gs that are
g re ater than the LEAKAGE CURRENT m eas u r e m e nt with a n i s o l ati n g tra nsfo r m e r.
S u bclause 8 . 7 . 4 . 5 - M eas u re m e n t of EARTH LEAKAGE CURRENT
The m eas u r i n g device re prese nts a m e as u r i n g m et h o d th at takes i nto acco u nt the

phys i o l o g i ca l effect of a cu rrent t h r o u g h t h e h u m a n body, i n cl u d i n g t h e h e a rt, as we l l as t h e
poss i bi l ity o f a l ow i m pe d a n c e contact betwe e n a PAT I E NT CONNECTION a n d t h e PAT I E NT.
Alt h o u g h I E C 60990 [20] s pecifies some m e as u r i n g devi ces for g e n e ra l u s e , none of th ese
wo u l d be a p propriate for m e as u r i n g PAT I E NT LEAKAGE CURRENT. As the m e a s u r i n g device of the
s e c o n d editi o n is bei n g reta i n ed for that p u r pose, it is m ost conve n i e n t to u s e the s a m e device
for all LEAKAGE CURRENT m e a s u r e m e nts, apart from t h e m ea s u r e m ent of cu rre nts o r cu rrent
co m po n e nts with fre q u e n ci es exce e d i n g 1 kHz in relat i o n to the 1 0 rnA l i m i t specifi ed i n
8.7. 3 d).
S u bclause 8 . 7 . 4 . 6 - M eas u re m e n t o f the TOUCH CURRENT
Where m etal foil is to be a p p l i e d to an ENCLOSURE m a d e of i ns u l ati n g m ateri a l , i nt i m ate

contact can be a c h i ev e d by pressi n g t h e fo i l a g a i n st the i n s u l ati n g m aterial with a pres s u r e of
a p prox i m ately 5 kPa ( 0 , 5 N/cm \
S u bclause 8 . 7 . 4 . 7 - M eas u re m e n t of PATI ENT LEAKAGE C U RRENT
S u bclause 8 . 7 . 4 . 7 b)
This test co nfi rms t h at the s e p a rati o n betwe e n the PAT I E NT CONNECTIONS and oth e r parts is
a d e q u ate to l i m i t t h e PAT I E NT LEAKAGE CURRENT to t h e a l l owed val u e w h e n a n exte r n a l voltage
i s present.
I f t h e APPLI ED PART c a n be disco n n ecte d from t h e ME E Q U I P M E NT, it i s poss i b l e t h at the

contacts of its c o n n ecto r could touch a n e a rt h e d o bj ect, but t h at s i t u ati o n is covered by
th etests of 8 . 5 . 2 . 3 , not by 8 . 7 . 4 . 7 b ) , which appl i es to the ME EQUIPM ENT and the APPLI E D PART
toget h e r .
T h e 20 em x 1 0 e m m etal foi l represe nts t h e size o f a h u m a n h a n d . F o r s o m e ME E Q U I PMENT,

t h e area of co ntact is g reater then t h e size of t h e h a n d . In this case, t h e size of t h e foi l c a n be
i n creased.
6060 1 - 1 © I EC : 20 0 5 - 515 -
S u bclause 8 . 7 . 4 . 7 c)
S o m e of t h e tests s pecifi ed i n t h e s e c o n d e d iti o n of this sta n d a rd r e l ated to t h e poss i b l e

pres e n c e o f MAINS VOLTAGE o n a S I G NAL I NPUT PART o r a S I G NAL OUTPUT PART ( a s d efi n e d i n
t h at e d iti o n , n o w covered b y t h e co m bi n ed t e r m S I GNAL I NPUT/OUTPUT PART) . T h e re were
v a r i o u s exc l u s i o n s , but if n o n e of the excl u s i o n s a p p l i e d this c o n diti o n was regarded as a
S I NGLE FAULT CON DITI O N . T h e ass u m pt i o n m ade i n t h i s t h i rd e d iti o n is t h at, if t h e
ACCOMPANYI NG DOCU MENTS p l a c e n o restri cti o n s o n w h at o t h e r e q u i p m e nt i s a l l owed to b e
co n n e cted to t h e S I GNAL I NPUT/OUTPUT PART, t h e prese n c e o f t h e MAXI M U M MAINS VOLTAGE
s h o u l d be regarded as a NORMAL CONDITI O N .
I nste ad o f a n i s o l at i n g transfo r m e r T2 w i t h a n adj usta b l e o u t p u t v o lt a g e , a com bi n ati o n o f a n

isol ati n g tra nsfo r m e r w i t h a s e t o u t p u t v o l t a g e a n d a n a uto-tra nsfo r m e r w i t h a n adj usta b l e
output voltage c a n be u s e d .
S u bclause 8 . 7 . 4 . 7 d)
T h e test with a n exte r n a l voltage a p p l i e d to u n eart h e d m etal ACCESSI BLE PARTS reflects t h e
req u i re m ent i n 8 . 5 . 2 . 2 f o r i s o l ati o n betwe e n s u c h parts a n d u n e a rt h e d PAT I E NT CONNECTIONS
of TYPE B APPLI E D PARTS .
For TYPE BF APPLI ED PARTS this test a p pl i es as wel l as t h e test of 8 . 7 . 4 . 7 b) , ev e n t h o u g h both

test the i s o l ati o n between the PAT I E NT CONNECTIONS and other parts, because the PAT I E NT
LEAKAGE CURRENT m i ght not be t h e s a m e i n th ese two s i t u ati o n s a n d d i ffe rent l i m it v a l ues
a p pl y .
I nste ad o f a n i s o l at i n g tra nsfo r m e r T 2 w i t h a n adj usta b l e o u t p u t v o lt a g e , a com bi n ati o n o f a n

isol ati n g tra nsfo r m e r w i t h a s e t o u t p u t v o l t a g e a n d a n a uto-tra nsfo r m e r w i t h a n adj usta b l e
output voltage c a n be u s e d .
C a r e s h o u l d be t a k e n t h at t h e capacitance o f t h e m eas u r i n g d e v i ce a n d i t s c o n n ecti n g l e ads

to e a rth and to the body of the ME EQUIPMENT i s kept as l ow as possi b l e .
A s expl a i n e d i n t h e rati o n a l e to 8 . 7 . 3 , t h e pres e n c e o f t h e MAXI M U M M A I N S VOLTAGE o n a

PAT I E NT represe nts a worst case, t h i s is m o r e s evere t h a n is l i ke l y to arise i n pract i c e , a n d t h e
a l l owa b l e PAT I E NT LEAKAGE CURRENT f o r a TYPE BF APPLI ED PART i n t h i s s i t u ati o n i s 5 mA. I t was
poi nted out that the a pp l i cati o n of MAINS VOLTAGE to an u n eart h e d ACCESSI BLE PART c o u l d
t h e refore cause a PAT I E NT LEAKAGE CURRENT of u p to 5 m A to fl ow f r o m t h e PAT I E NT
CONNECTIONS of a TYPE BF APPLI ED PART; w h e reas i n t h e s a m e sit u ati o n a TYPE B APPLI E D PART
(wh i c h i n g e n e ral offers a l owe r l evel of s afety) was a l l owed o n l y 5 0 0 �-tA. I n order to resolve
this a n o m al y , t h e test of 8 . 7 . 4 . 7 d), with 1 1 0 % of the MAXI M U M MAINS VOLTAGE o n u n eart h e d
ACCESSI BLE PARTS , also a p pl i es t o TYPE BF APPLI E D PARTS, a n d i n t h i s con diti o n t h e a l l owable
PAT I E NT LEAKAGE CURRENT is t h e g e n e ra l 5 0 0 �-tA val u e for S I NGLE FAULT CONDI TION.
T h e re is n o n e e d to perfo rm t h e test of 8 . 7 . 4 . 7 d) o n TYPE CF APPLI E D PARTS because for these

t h e same a l l owa b l e val u e of 5 0 �-tA wo u l d a p ply as in t h e test of 8 . 7 . 4 . 7 b ) .
6060 1 - 1 © I EC : 20 0 5 - 517 -
S u bclause 8 . 7 . 4 . 7 h)
T h e req u i re m e nt re prese nts a c o m pro m i s e betwee n re q u 1 r1 n g exte nsive testi n g , which with
m ost ME EQUIPMENT wo u l d yield n o u s eful i nfo r m ati o n , and havi n g n o s pecific re q u i re m ent to
a d d ress t h i s RISK.
M ost TYPE B APPLI E D PARTS are e a rt h e d , s o t h e m ea s u r e m ent accord i n g to 8 . 7 . 4 . 7 g) ( a l l

PAT I E NT CON NECTI ONS o f a s i n g l e fu n ct i o n c o n n ected di rectly together) wi l l g i v e t h e s a m e
res u l t a s t h e m ea s u r e m e n t accordi n g t o 8 . 7 . 4 . 7 h ) ( a l l PAT I E NT CONNECTIONS o f a l l APPLI ED
PARTS of t h e same type co n n ected togeth er) . I f t h i s is with i n t h e PAT I E NT LEAKAGE CURRENT
l i m it it wi l l certa i n l y be with i n the total PAT I E NT LEAKAGE CURRENT l i m it. H oweve r it is possi b l e
to have TYPE B APPLI ED PARTS t h at are n ot d i rectly e a rt h e d , a n d i n t h at c a s e t h e m easured
v a l u es c a n be d iffe rent.
S u bclause 8 . 7 . 4 . 9 - ME EQU I P M E NT with m u lt i p le PATI ENT CONNECTIONS
This req u i re m ent was i ntroduced in t h e s e c o n d a m e n d m ent to t h e second editi o n of t h i s

sta n d a r d . It a d d resses a RISK t h at c a n a r i s e , fo r ex a m pl e , with e q u i p m e nt f o r m e as u r i n g
phys i o l o gi cal s i g n als where a n a m pl ifi e r drives o n e e l ectrode to red u ce co m m o n - m o d e
i nterfe r e n c e . I f o n e o f t h e s e n s i n g e l ectro des i s d i s co n n ected from t h e PAT I E NT a n d pi cks u p a
l a rge voltage at m a i ns fre q u e n cy, t h e a m pl ifi e r c o u l d drive a l a rge c u rrent i nto t h e PAT I E NT i n a
v a i n atte m pt to cancel t h e i nterfe r e n c e .
T h e req u i re m e nt re prese nts a c o m pro m i s e betwee n re q u 1 r1 n g exte nsive testi n g , w h i c h with

m ost ME EQUIPMENT wo u l d y i e l d n o u s eful i nfo r m ati o n , a n d havi n g n o s pecific re q u i re m ent to
a d d ress this RISK.
S u bs e q u e ntly I EC 6060 1 -2-4 9 : 2 0 0 1 [ 1 6] i ntrodu ced a c o m pre h e n s i v e s et of tests, to be

perfo r m e d o n a l l e q u i p m e n t with i n t h e scope of that sta n da r d . T h e s e i n c l u d e m ea s u r e m e n t of
w h at i s termed " PART LEAKAGE CURRENT" in t h at sta n d a rd : t h i s i s t h e c u rrent fl owi n g betwe e n
t h e PAT I E NT CONNECTIONS o f o n e fu n ct i o n a n d t h e PAT I E NT CONNECTIONS o f oth e r f u n cti o n ( s ) ,
w h i c h i s covered i n t h i s editi o n o f t h e g e n e ra l sta n dard b y t h e revised defi n i t i o n o f PATI E NT
AUXILIARY CURRENT.
C o n s i d e rati o n was given to i n co rporati n g these tests in this g e n e ral sta n d a rd , but it was
decided t h at s u c h specific testi n g s h o u l d be l eft to parti c u l a r stan dards. The s c e n a rios to
which they r e l ate, s u c h as h av i n g t h e PAT I E NT CONNECTIONS of one fu n ct i o n in u s e a n d
co n n e cted t o t h e PAT I E NT w h i l e t h e PAT I E NT CONNECTIONS o f a n ot h e r fu n ct i o n a re not i n u s e
a n d c o u l d m a ke co ntact w i t h e a rth o r oth e r o bj ects, are l i ke l y to a ri s e w i t h m u ltifu n cti o n
PAT I E NT m o nitori n g e q u i p m ent but u n l i ke l y with m ost oth e r ki nds of ME EQUI PMENT.
F i g u re A. 1 5 , based o n F i g u re KK. 1 0 1 of I EC 6060 1 -2-4 9 : 2 0 0 1 [ 1 6] , s h ows an ex a m pl e of

m e as u ri n g the PAT I E NT LEAKAGE CURRENT from one fu n ct i o n of a TYPE BF APPLI E D PART wh i l e
t h e PAT I E NT CONNECTI ONS o f a n oth e r fu n cti o n o f t h e s a m e APPLI ED PART a n d o f two TYPE CF
APPLI ED PARTS are e i t h e r floati n g or earth e d .
S u bclause 8 . 8 . 1 - Ge n e ra l
C a r e s h o u l d be t a k e n t h at t h e voltage a p p l i e d t o a REIN FORCED I NS ULATION d o e s n o t

ove rstress e i t h e r o f t h e MEANS OF PROTECTION i n t h e ME EQUIPME NT. I f t h e re a r e m u lti p l e paths
betwe e n the s a m e poi nts , th ese m i ght n e e d to be tested s e p a rate l y . T h ere co u l d , for ex a m pl e ,
b e o n e path fro m t h e MAINS PART t o a PAT I E NT CONNECTI O N t h at h a s BAS I C I NS U LATI ON p l u s a
PROTECTIVE EARTH CONNECTION p l u s PATI ENT CONNECTIONS i s o l ati o n as req u i red by 8 . 5 . 2 . 1 , a n d
a para l l e l path havi n g REI NFORCED I NS U LAT I O N . M E EQUIPMENT parts m i g h t n e e d t o be
disco n n ecte d to a l l ow the REI NFORCED I NSULATION to be teste d wit h o ut ove rstress i n g t h e
sepa rate i ns u l at i o n of t h e M A I N S PART o r t h e PAT I E NT CONNECTIONS .
6060 1 - 1 © I EC : 20 0 5 - 519 -
T h i s co u l d be avoided, for ex a m pl e i n t h e case of a tra nsfo rm e r, by t h e u s e of a voltage

divi d e r with a tappi n g poi nt c o n n ected to t h e core o r some oth e r s u itable con n ecti n g poi nt to
e n s u re t h e correct voltage d i v i s i o n over t h e act u a l i ns u l ati o n s , o r by t h e use of two test
transform ers, co rrectly p h a s e d .
Q)
l
I
TYPE CF
APPLIED PART
0
I
I
TYPE CF
APPLIED PART
I
0
Function 1
TYPE BF
0
APPLIED PART
Function 2
P1
1 --------------�
�---------.�() P•--
IEC 2437105
For legends, see Table 5.

Key
All measure m e nts are made with S14 closed and again with S14 o pe n .
F i g u re A. 1 5 - Exam p i e of a m eas u r i n g c i rc u it for t h e PATIENT LEAKAG E CURRENT from a
PAT I E NT CONNECTION to earth for ME EQU I P M E NT with m u lt i p le PATIENT CONNECTIONS
S u bclause 8 . 8 . 2 - D istance t h ro u g h solid i n s u lation o r use of t h i n s h eet m aterial
The second e d iti o n of this sta n d ard placed n o restri ct i o n s on t h e t h i ckness of s o l i d i n s u lati o n ,
except a s s pecifi e d i n 57 . 9 . 4 e) fo r transfo r m e rs a n d for t h e n e e d for a l l i n s u lati o n covered by
C l a use 20 to be t h i c k e n o u g h to pass t h e d i e l ectri c stre n gth test. A very t h i n fi l m of i ns u l ati n g
m aterial m i g ht pass t h at test but m i ght n ot prov i d e r e l i a b l e i ns u l at i o n d u ri n g t h e EXPECTED
S ERVICE LIFE of all producti o n ite m s .
S o m e Nati o n a l C o m m ittee c o m m e nts d u r i n g t h e d ev e l o p m e nt o f t h i s editi o n proposed

i ntrod u c i n g r e l ev a nt req u i re m e nts derived from I EC 60950- 1 to add ress this o m iss i o n . B oth
WG 14 (Testi n g ) and WG 1 6 ( E l e ctrical h azards) reco m m e n d e d accept i n g th ese propos a l s .
6060 1 - 1 © I EC : 20 0 5 - 521 -
T h ese req u i re m e nts have been i n c l u d e d i n I E C 6 0 9 5 0 - 1 for m a ny years with out ca u s i n g

probl e m s . T h ey s h o u l d n ot b e o n erous i n practice f o r ME EQUIPMENT, a n d i n de e d m ost
ME EQUIPMENT des i g n ed accord i n g to the prev i o u s editi o n s of t h i s sta n d a rd wo u l d h ave
satisfi e d th e m .
T h e re q u i re m e nts that have been i ntro d u c e d a re i nt e n d e d t o b e t e c h n i c a l l y e q u i v a l e n t t o those

of I E C 60950- 1 , but t h e edito r i a l structure h as b e e n c h a n g e d for c l a rity, as fo l l ows .
I EC 6 0 9 5 0 - 1 s pecifies a g e n e ra l re q u i re m ent fo r distance t h r o u g h i ns u l ati o n , with a n
exce pti o n for voltages u p t o 7 1 V. T h i s h a s been c h a n g e d t o state ex p l i citly t h at t h e
req u i re m e n t a p p l i e s above 7 1 V .
I EC 6 0 9 5 0 - 1 s pecifies a n exce pti o n from t h e req u i re m ent for distance t h r o u g h i n s u l at i o n
w h e re t h e r e q u i r e m e nts for t h i n s h eet m aterial a p pl y , as set o u t i n another s u bc l a u s e , b u t
t h at s u bc l a use does n ot refer ex p l i citly to t h e 7 1 V l i m it. T h i s has been m ade explicit by
stat i n g t h e re q u i re m e nts for t h i n s h eet m at e r i a l as an alternative to t h e t h i ckness
req u i re m ent, u n d e r the s a m e i ntro d u ctory word i n g .
I EC 60950- 1 s pecifies t h at " I n s u l at i o n i n t h i n s h eet m ate rials i s perm itted . . prov i d e d t h at"
certai n c o n diti o n s are s ati sfi e d . T h i s has been c h a n g e d to a n ex p l i cit req u i re m e nt that
i ns u l at i o n i n thin s h eet m ateri a l s n e e d s to satisfy these c o n d i t i o n s .
I EC 60950- 1 req u i res t h at i ns u l ati o n i n t h i n s h e et m aterials " is used with i n t h e e q u i pm ent
E NCLOS URE " . H oweve r t h e E NCLOS URE as defi n e d in this sta n dard i n cl udes all outer
s u rfaces , i n cl u d i n g t h e s u rfaces of cables, APPLI ED PARTS , etc. T h e re q u i re m ent h as
t h e refore been r e p h ra s e d .
E lsewh e re i n t h i s sta n d a rd t h e terms SUPPLEMENTARY I NSULATION a n d REI N FORCED I NS U LATION

have m ostly been replaced by refe ren ces to M EANS OF PROTECTION, but they have been
reta i n ed h e re beca u s e , as in I EC 60950- 1 , t h e req u i re m e nts c o n ce rn i n g distance t h r o u g h
i ns u l at i o n a n d t h e u s e o f t h i n s h e et m ateri a l a pply to SUPPLEME NTARY INS ULATION a n d t o
REI NFORCED I NS U LAT I O N , but n ot to BAS I C I NS U LATI ON. T h u s t h e s e req u i re m e nts do not apply
w h e re BAS I C I NSULATI O N , as one MEANS OF PROTECTION, i s used i n c o nj u n ct i o n with a
PROTECTIVE EARTH CONNECTION as t h e ot h e r MEANS OF PROTECTION. W h e re DOUBLE I NS U LATI ON
i s used, t h ese req u i re m e nts a pply to wh i c h ever co nstituent part t h e reof i s regarded as the
S UPPLEM ENTARY I NSULATI O N .
S u bclause 8 . 8 . 3 - D i e l ectric stre ngth
C o m p o n e nts des i g n e d to l i m it t h e voltage m i g ht n eed to be removed in order to a l low t h e full

test voltage to be a p p l i e d to t h e i ns u l ati o n be i n g tested .
T h e p u r pose o f t h i s test is to c h e c k a l l s o l i d i n s u lati o n u n de r t h e wo rst-case c o n d i ti o n after

havi n g a c h i ev e d o pe rati n g tem perat u re . F o r h e ati n g e l e m e nts, the wo rst case is a c h i eved with
h e aters r e m a i n i n g e n e rgized d u ri n g m ea s u r e m e nt.
T h e test voltages s pecifi ed are a p propriate for solid i ns u l at i o n only. Spaci n gs ( CRE E PAGE
DI STANCES and CLEARANCES ) are eva l u ated by 8 . 9 . I E C 6 0664- 1 g ives deta i l s of e l ectrical test
m et h o ds for clea rances usi n g i m pu l s e voltage d i e l ectric stre ngth tests. These tests c a n be
used u n d e r t h e I E C 60950-1 route for MOOPs , but are not s pecified for MOPPs. I E C 60664- 1
states t h at t h e 2U + 1 000 V type of d i e l ectri c strength test " i s n ot r e l ev a nt for t h e testi n g of
clearances".
Since t h e d i e l ectric strength test is applied i m m e d i ately after t h e h u m i dity preco n diti o n i n g
treat m e nt, with t h e ME EQUIPMENT sti l l i n t h e h u m i dity cabi n et, a d e q u ate precauti o n s for t h e
protect i o n o f l a bo ratory perso n n e l c o u l d b e n ecess a ry.
6060 1 - 1 © I EC : 20 0 5 - 523 -
I n T a b l e 6 , t h e v a l ues for OPERATOR protecti o n are taken from I E C 6 0 9 5 0 - 1 a n d t h e v a l ues for

PAT I E NT protect i o n are taken from the s e c o n d editi o n of I EC 6 0 6 0 1 - 1 . I n constructi n g t h e
t a b l e , th ree pri n c i p l es were e m pl oy e d :
MOPP are a lways a t a h i g h e r val u e t h a n MOOP.
M a i ns circu its are effected by tra n s i e nt overvoltages as detai l e d in Table 1 0 . I n
S ECONDARY C I RCUITS , t h e tra n s i e nt overvoltage l ev e l i s a t l e ast o n e l ev e l l ess t h a n t h e
m a i ns ci rcuits.
The val u e of test voltage i s p r i m arily dete rm i n ed by t h e tra n s i ent voltage o n t h e S U PPLY
MAINS w h i c h is u s u a l l y o rders of m ag n itude l a rger t h a n the WORKI NG VOLTA G E .
I n order to a l i g n w i t h t h e seco n d e d iti o n o f I EC 6060 1 - 1 f o r t h e c o m m o n WORKING VOLTAGE of

220 V r . m . s to 240 V r. m . s . t h e test voltage of 4 0 0 0 V r. m . s . was reta i n ed even t h o u g h this
value i s m o re t h at twi ce t h e test voltage fo r o n e MOPP. H owev e r , each i n d i v i d u a l MOPP has to
m eet t h e 1 5 0 0 V r. m . s . m i n i m u m req u i re m ent.
S u bclause 8 . 8 . 3 a)
T h e test voltage c a n be prov i d e d by a transform er, by a d . c . power s o u rce or by u s i n g t h e

transform er(s) o f t h e ME EQUIPMENT. I n t h e l ast c a s e , to prev ent ov e r h e ati n g , t h e test voltage
can have a fre q u e ncy that is h i g h e r than t h e RATED freq u e n cy of the ME EQUI PMENT.
The PROCEDURE and d u rati o n of the test for WORKI NG VOLTAGE e q u a l to o r h i g h e r than 1 0 0 0 V
a. c. or 1 5 0 0 V d . c. or peak v a l ues c a n be s pecifi ed further by parti c u l a r sta n d ards.
S u bclause 8 . 8 . 4. 1 - M echan ical strength and res istance to h eat
Tests concern i n g flam m a bi l ity of m ate rials wi l l be fo u n d i n I EC 60695- 1 1 - 1 0 .
S u bclause 8 . 9 - C RE EPAG E DISTANCES a n d AIR CL EARANCES
For ME EQUI PMENT i ntended to be s u ppl i e d from the S U PPLY MAI NS , A I R CLEARANCE a n d
d i e l ectric stre ngth req u i re m e nts a r e bas e d o n t h e ex pected overvoltage transie nts t h at co u l d
enter t h e e q u i p m e nt from t h e S U PPLY MAI N S . Accord i n g to I EC 60664- 1 , t h e m ag n itude of
these tra n s i e nts is dete r m i n e d by t h e n o r m a l s u pply voltage a n d t h e s u pply arra n g e m e nts.
T h ese transie nts are categorized accordi n g to I EC 60664- 1 i nto fo u r g ro u ps c a l l e d
overvoltage cate gories I to I V ( a l s o k n own as i nsta l l ati o n cate g o r i es I to I V) . E lsewh e re i n t h i s
sta n dard overvoltage cate g o ry I I i s ass u m e d .
T h e desi g n o f s o l i d i ns u l at i o n a n d A I R CLEARANCES s h o u l d be co-ordi n ated i n s u c h a way t h at,

if a n i n c i d e nt overvoltage tra n s i e n t exceeds t h e l i m its of overvoltage cate g o ry I I , t h e s o l i d
i ns u l at i o n can withsta n d a h i g h e r voltage t h a n t h e A I R CLEARANCE S .
T h e v a l u e s i n T a b l e 1 3 t o T a b l e 1 5 co rres p o n d to t h o s e o f I EC 6 0 9 5 0 - 1 f o r overvoltage
category I I for MAINS PARTS and overvoltage categ o ry I for S ECONDARY CI RCUITS . If
ME EQUIPMENT i s i nte n d e d to be used in locati o n s w h e re the S U PPLY MAINS i s in overvoltage
category I l l o r IV, th ese v a l u es wi l l be i n a d e q u ate.
A S ECONDARY C I RCUIT de rived fro m a S U PPLY MAI NS wi l l n o r m a l l y be overvoltage cate g o ry I if

the S U PPLY MAINS i s overvoltage cate gory I I ; the m axi m u m tra n s i e nts fo r v a r i o u s S U PPLY MAINS
v o ltages in ov e rvoltage category I are s h own in the col u m n h ea d i ngs of Table 1 3 .
For i n s u l at i o n between t h e E NCLOS URE a n d t h e PAT I E NT CONNECTION of an F-TYPE APPLI ED PART

speci a l r u l es a p pl y :
6060 1 - 1 © I EC : 20 0 5 - 525 -
1) I n t h e case of an F-TYPE APPLI ED PART conta i n i n g no voltage diffe r e n c e , t h e i ns u l at i o n

betwe e n t h e PAT I E NT CONNECTIONS a n d t h e E NCLOS URE w i l l o n l y be stressed to t h e MAINS
VOLTAGE in the case of a fa u lt in other e q u i pm ent co n n ected to the PAT I E NT.
T h i s c o n diti o n rarely o c c u rs ; furt h e r m ore t h i s i n s u l ati o n i s n ot n o r m a l l y s u bj ect to the

tra n s i e n t overvoltages fo u n d in t h e MAINS PART. In v i ew of t h e above, t h e i ns u l ati o n
n ecess a ry between t h e APPLI ED PART a n d t h e E NCLOS URE for t h e case q u oted, n e e d o n l y
sati sfy t h e re q u i re m e nts f o r BAS I C I NS U LAT I O N .
2) I n t h e case o f a n F-TYPE APPLI E D PART contai n i n g parts w i t h v o l t a g e diffe rence, t h e

co n n ecti o n o f a PAT I E NT CONNECTION to e a rth v i a a n eart h e d PAT I E NT ( NORMAL CONDI TION)
co u l d s u bj e ct t h e i ns u l at i o n between oth e r parts and t h e E NCLOSURE to t h e whole of the
voltage with i n t h e APPLI E D PART.
S i n c e t h i s voltage a p p e a rs i n NORMAL CONDI T I O N , even t h o u g h i nfre q u e ntly, the r e l ev a nt

i ns u l at i o n s h o u l d satisfy t h e re q u i re m e nts for DOUBLE I NS ULATI O N or REI NFORCED
I NS ULATI O N . I n v i ew of the l ow probabil ity of this cond iti o n occu rri n g , t h e CREEPAGE
DI STANCES and AIR CLEARANCES given in Table 1 1 are c o n s i d e r e d a d e q u at e .
3) T h e v a l u e to be a p p l i e d i s t h e h i g h est o f t h e val ues fo u n d accord i n g to I t e m s 1 ) a n d 2)

above.
In t h e a bs e n ce of a t h e o reti cal backgro u n d to refer t o , it was decided t h at t h e v a l ues above

1 0 0 0 V would be d rawn from Table 7 of I EC 6 1 0 1 0- 1 : 2 0 0 1 [22] for CREEPAGE DISTANCES u s i n g
t h e c o l u m n f o r m aterial g ro u p l l l a- b , pol l ut i o n degree 3 , w h i c h correlates with t h e existi n g
v a l u es i n t h e s e c o n d editi o n o f I E C 6060 1 - 1 o r is s l i ghtly m o re o n e r o u s . For A I R CLEARANCES,
t h e val ues have been esti m ated based on t h e r e l ati o ns h i p between creepage and clearance
for v a l ues below 1 000 V r. m . s . from T a b l e 1 2 . T h es e derived v a l ues are s h own in T a b l e A. 1 .
T a b l e 1 6 of t h e s e c o n d editi o n of I E C 6060 1 - 1 was s pl it i nto two tables i n t h i s sta n dard

(Tables 9 and 1 0) . To align it with t a b l es derived from oth e r sta n d a rds such as I EC 60950- 1 ,
t h e factor betwe e n t h e a . c. voltages a n d t h e d . c. voltages was c h a n g e d fro m 1 , 2 to a bo u t 1 , 4 .
T h i s r e l ax ati o n was accepted a s it i s a c o m m o n a p proach i n oth e r sta n d a rds a n d it preve nts
havi n g d iffe rent CRE E PAGE DI STANCES o r A I R CLEARANCES i n c i r c u its w h e re t h e re is a d . c .
voltage rectifi ed from a n a . c . voltage.
Table A. 1 - Va l u es of AIR C L E ARANCE a n d CRE EPAG E DISTANCE derived from Table 7 of

I EC 6 1 0 1 0-1 :2001 and Table 1 2
S pacing provi d i n g
o n e MEANS O F PATI E N T PROTECTION S pacing provi d i n g
WORKING WO R K I N G two M E A N S O F PAT I E N T PROTECTION
VOLTAGE VOLTAGE
V d.c. V r. m . s C R EEPAGE C R EEPAGE
u p to and u p to and AIR CLEARA N C E DISTAN C E A I R CLEARA N C E DISTAN C E
including including mm mm mm mm
1 500 1 250 1 1 ,5 20 23,0 40

1 920 1 600 1 4,5 25 29,0 50
2 400 2 000 1 8,5 32 37,0 64
3 000 2 500 23,0 40 46,0 80
3 840 3 200 29,0 50 58,0 1 00
4 800 4 000 36,0 63 72,0 1 26
6 000 5 000 46,0 80 92,0 1 60
7 560 6 300 57,0 1 00 1 1 4,0 200
9 600 8 000 71 ,5 1 25 1 43,0 250

1 2 000 1 0 000 91 ,5 1 60 1 83,0 320
6060 1 - 1 © I EC : 20 0 5 - 527 -
T a b l e A . 2 conta i n s CRE E PAGE DI STANCES for WORKING VOLTAGE above 1 0 0 0 V derived from
I EC 60664- 1 , Table 4.
S u bclause 8 . 9 . 1 - Va l u es
When u s i n g t h e v a l ues of CRE E PAGE DISTANCE a n d A I R CLEARANCE , it s h o u l d be n oted t h at

peak, d . c . a n d r. m . s . v a l u es a re a l l u s e d . It is i m portant to read th e t a b l es ca refu l l y .
T h e t a b l es fo r MOOPs u s e val ues from I E C 6 0 9 5 0 - 1 repres e nti n g t h e fol l owi n g bas i c p r i n c i p l e s ,

taken f r o m I EC 60664- 1 :
" T h e basis for t h e dete r m i n ati o n of a CREEPAGE DISTANCE is t h e l o n g-te rm r. m . s . v a l u e of
t h e voltage existi n g across it. "
" C LEARANCES s h a l l be d i m e ns i o n e d to withsta n d t h e re q u i re d i m p u l s e withsta n d volta g e " .
I m pu l s e withsta n d voltage is t h e " h i g h est peak v a l u e o f with st a n d voltage . . . . "
H owev e r , t h e tables for MOPPs are taken from t h e second editi o n of I E C 6060 1 - 1 , where both
creepages a n d c l e a ra n ces were related to r. m . s . or d . c. voltages.
Table A.2 - C REEPAGE DI STANCES to avo id fai l u re due to trac k i n g from I E C 60664-1
Spacing for o n e MEANS O F O P ERATO R PROTECTION
Pol l u ti o n
degree 1 P o l l u ti o n degree 2 P o l l u ti o n degree 3
WO R K I N G VOLTAGE
Material g ro u p Material g ro u p Material g ro u p
v
r. m . s or d . c . I , I I , l i la, l l l b I II lila or l l l b I II lila or l l l b
1 250 6,3 9,0 1 2 ,5 1 6,0 1 8,0 20,0

1 600 8,0 1 1 ,0 1 6,0 20,0 22,0 25,0
2 000 1 0,0 1 4,0 20,0 25,0 28,0 32,0
2 500 1 2 ,5 1 8,0 25,0 32,0 36,0 40,0
Use the
3 200 AIR C LEARA N C E 1 6,0 22,0 32,0 40,0 45,0 50,0
from the
4 000 appropriate 20,0 28,0 40,0 50,0 56,0 63,0
table
5 000 25,0 36,0 50,0 63,0 71 ,0 80,0
6 300 32,0 45,0 63,0 80,0 90,0 1 00,0
8 000 40,0 56,0 80,0 1 00,0 1 1 0,0 1 25,0
10 000 50,0 71 ,0 1 00,0 1 25,0 1 40,0 1 60,0
S u bclause 8 . 9 . 1 . 6 - I nterpolation
I nterpolati o n for CREEPAG E DISTANCES but n ot for AIR CLEARANCES i s a l l owe d , except where the
WORKING VOLTAGE i s a bove 2 kV r. m . s . o r 2 , 8 kV d . c . T h i s a p proach is g e n e r a l l y c o n s i stent
with I E C 60950- 1 and I E C 6 1 0 1 0- 1 [22] .
S u bclause 8 . 9 . 1 . 1 5 - C RE E PAG E DISTANCES a n d AIR C L E ARANCES for D E F I B RI L LATION -PROOF

A P P L I E D PARTS
From I EC 60664- 1 , T a b l e 2, a distance of 4 m m is a d e q u ate for p u lses of 5 kV h av i n g a s h o rt

d u rati o n of l ess t h a n 1 0 m s , s u c h voltages arisi n g typ i c a l l y from t h e u s e of a defi bri l l ator.
6060 1 - 1 © I EC : 20 0 5 - 529 -
S u bclause 8 . 9 . 2 - Appl icat ion
S u bclause 8.9.2 a)
D e pe n d i n g o n t h e I NTENDED USE of t h e ME EQUIPMENT, o pe rati o n of t h e fuse o r OVER-CURRENT

RELEASE can be a HAZARD. The o pe n i n g of a branch ci rcuit breaker i s n ot accept a b l e .
S u bc l a use 8 . 9 . 2 a) i s b a s e d o n t h e fact t h at t h e re i s a n over- c u rr e nt device i n t h e i n put o f t h e
ME EQUIPMENT befo re t h e part o f t h e c i r c u i t w h e re t h i s s u bc l a u s e is a p p l i e d . B efore t h i s ov e r
cu rrent devi c e , t h e spaci n gs n e e d to com ply with t h e bas i c requ i re m e n t for pa rts of o p posite
p o l a rity wit h i n t h e MAINS PART.
S u bclause 8 . 9 . 3 - S paces f i l led by i n s u lat i n g co m po u n d
CREEPAGE DISTANCES a r e m easured t h r o u g h t h e j o i n t betwe e n two pa rts o f a n i ns u l at i o n

barri e r , except f o r ce m e nted j o i nts, i . e . th ose i n wh i c h :
either t h e two parts form i n g t h e j o i nt a r e b o n d e d by h e at s ea l i n g o r oth e r s i m i l a r m e a n s at
t h e pl ace w h e re t h i s is of i m port a n c e ;
o r t h e j o i n t is c o m p l etely f i l l e d w i t h a d h esive at t h e n ecessa ry p l a c e s a n d t h e a d h esive
b o n ds to t h e s u rfaces of t h e i ns u l ati n g barri e r so that h u m i di ty c a n not be s u c ked i nto the
j o i nt.
I n t h e s e c o n d editi o n of this sta n d a r d , the c a pti o n s to F i g u res 43 to 4 5 refe rred to

" u n c e m e nted j o i nts . " I t e m 7 of the l eg e n ds to these fi g u res refe rred to 5 7 . 9 . 4 f), s e c o n d das h ,
"for a descripti o n o f c e m e nted j o i nts" but d i d n o t s pecify a n y test m eth ods oth e r t h a n
i ns pecti o n . D u r i n g t h e pre pa rati o n o f t h i s editi o n , it w a s proposed to i ntroduce relevant
req u i re m e nts derived from I EC 60950- 1 to address t h e related s u bj ect of potti n g .
T h e req u i re m e nts that h ave b e e n i ntrodu ced a r e closely based o n t h ose o f I E C 6 0 9 5 0 - 1 a n d

cover potti n g , e n c a ps u l ati o n , c e m e nted j o i nts , etc. T h e editori a l str u ct u r e has been s o m ewhat
revised from t h at of I EC 60950- 1 for c l a rity. T h e s e re q u i re m e nts h av e been i n c l u d e d i n 8 . 9
rat h e r t h a n 8 . 8 because t h ey s pecify ci rcu m stances that a l l ow exe m pt i o n from t h e
req u i re m e nts f o r CRE E PAGE DISTANCES a n d A I R CLEARANCES , rat h e r t h a n additi o n a l
req u i re m e nts a p plyi n g to s o l i d i ns u l ati o n .
S u bclause 8 . 9 . 4 - M eas u re m e n t of CREEPAG E DISTANCES A N D AI R CLEARANCES
N a rrow g a ps , r u n n i n g in the directi o n of a poss i bl e creepage path a n d b e i n g s o m e tenths of

1 m m wide o n l y , s h o u l d be avoi d e d as fa r as poss i bl e , for d i rt a n d m oisture c a n deposit t h e r e .
S u bc lauses 8. 1 0. 1 - F ix i n g o f co m po n e n ts
I n m a ny cases it wi l l be o bv i o u s t h at c o m po n e n ts a n d wi ri n g are a d e q u ately secured ( e . g .

s m a l l c o m p o n e nts s o l dered t o a pri nted circuit board) wit h o ut t h e n eed f o r s pecific j ustifi cati o n
i n t h e RISK MANAGEMENT F I L E ; b u t if a n y r e l evant i nfo r m ati o n i s i n c l u d e d i n t h e R I S K
MANAG E M E NT F I L E , it s h o u l d be t a k e n i nto acco u nt i n asses s i n g c o m p l i a n c e w i t h these
req u i re m e nts .
S u bclause 8 . 1 0. 2 - F i x i n g of w i r i n g
I t is g e n e r a l l y accepted t h at wi ri n g c o n n ecti o n s a r e s u bj ect to t h e S I NGLE FAULT CONDI TION.

T h at is those h av i n g o n l y one means of bei n g secured t h at wo u l d prevent a l oosen ed/broken
wi re from c reati n g a HAZARD, such as r e m ov i n g a PROTECTIVE EARTH CONNECTION o r bridgi n g a
MEANS OF PROTECTION, are c o n s i dered n ot i n c o m p l i a n c e .
Ex a m pl es o f co n n ecti o n t h at co u l d c o m ply w i t h S I NGLE FAULT CONDITION are:

double cri m pi n g of both t h e wire and t h e wi re i ns u l at i o n ;
m ec h a n i cal s e c u rity o f t h e wi re a n d s o l deri n g ;
6060 1 - 1 © I EC : 20 0 5 - 531 -
m ec h a n i cal secu rity of t h e wi re a n d wi re m ov e m ent restrai nts s u c h as t i e wraps , wire

cl a m ps , b u n d l i n g straps , etc. ;
stra i n rel i ef m e c h a n i s m s a n d m ec h a n i cal secu rity.
S u bclause 8 . 1 0.4 - Cord -co n nected HAND-HELD parts and co rd -co n n ected foot-ope rated
control devices
HAND- H E LD switc h es a n d footswitches are i n practice exposed to severe c o n d iti o n s . T h i s

req u i re m ent e n s u res t h at even i n t h e wo rst cas e , w h e re t h e E NCLOSURE o f s u c h a switch i s
co m pl etely broke n , o n l y pa rts a t voltages wit h i n t h e l i m its s pecifi e d i n 8 . 4 . 2 c) , w h i c h are safe
to to u c h , can beco m e ex pos e d .
S u bclause 8 . 1 0. 5 - Mechan ical p rotection o f w i r i n g
T h e re i s n o re q u i re m e nt f o r s pecific j u stificat i o n to be g i v e n i n t h e RISK MANAGE M E NT F I L E , b u t

if a n y r e l evant i nfo r m at i o n is i n c l u ded i n t h e RISK MANAG E M E NT F I LE it s h o u l d be ta k e n i nto
acco u nt in assess i n g c o m pl i a n ce with th ese re q u i re m e nts .
S u bclause 8 . 1 0. 7 - I ns u lation of i nternal w i r i n g
C o n d u ctors c a n be routed i n s e pa rated j a c keted cords o f a d e q u ate rati n g . W h e re c o n d u ctors

of diffe rent circuit cate g o r i es h ave to be r u n t h r o u g h co m m o n cords, wi ri n g c h a n n el s , c o n d u its
o r c o n n ecti n g devices, a d e q u ate s e p a rati o n is realized by s uffi ci ent rati n g of the c o n d u ctor
i ns u l at i o n and by arra n g i n g for s uffi c i e nt AIR CLEARANCES and CREEPAGE DI STANCES, c o m plyi n g
with t h e re q u i re m e nts o f 8 . 9 , betwe e n c o n d u ctive pa rts i n c o n n ecti n g devices.
S u bclause 8 . 1 1 . 1 - Isolation from t h e S UPPLY MAI NS
S u bclause 8 . 1 1 . 1 a)
S ki l l e d pers o n s , s u c h as S ERVICE PERSONNEL, who n e e d to g a i n access to i ntern a l , poss i bly

hazardous, ME EQUIPMENT parts, n e e d a m ea n s by which t h e M E EQUI P M E NT can be i s o l ated
from t h e S U PPLY MAI N S .
A m ai ns i s o l ati n g switc h , w h e r e provi d e d , co u l d a l s o serve as a f u n cti o n a l off switch for

routi n e use o r for d i s a bl i n g hazardous output in a n e m e r g e n cy . H oweve r it does not
n ecess a r i l y s e rv e th ese p u r poses, nor does this sta n dard specify any g e n e ral re q u i re m ent for
a n e m e rg e n cy off switch.
S u bclause 8 . 1 1 . 1 c)
In t h e s e c o n d editi o n of this sta n da r d , t h e req u i re m e n t for m 1 n 1 m u m contact s paci n g of

switc hes u s e d to prov i d e i s o l ati o n from t h e S UPPLY MAI NS was s pecifi ed i n I EC P u bl i cati o n
328. I E C 6 1 0 5 8 - 1 s u perseded I E C 328 i n 1 99 0 . T h e fi rst editi o n o f I E C 6 1 0 5 8 - 1 req u i red
3 mm co ntact s paci n g for f u l l disco n n ecti o n from t h e S U PPLY MAI N S . N o m e nti o n of overvoltage
category was m a d e . The t h i rd e d iti o n of I E C 6 1 0 5 8 - 1 i ntroduced the c o n c e pt of overvoltage
category accordi n g to I EC 60664- 1 . For a 2 3 0 V S U PPLY MAI NS in overvoltage cate gory I I ,
T a b l e 2 2 of I EC 6 1 0 5 8 - 1 a l l ows a m i n i m u m co ntact s pac i n g of 1 , 5 m m . W h i l e t h e
req u i re m e nts i n t h i s sta n dard g e n e r a l l y relate to overvoltage category I I ( s e e 8 . 9 . 1 . 1 1 ) , it was
t h o u ght p r u d e nt to stay with the 3 m m req u i re m ent associated with a 230 V S UPPLY MAI NS I N
overvoltage cate g o ry I l l for a l l switches i nt e n d e d t o prov i d e isolation from the S U PPLY MAI N S .
Not o n l y is t h i s c o n s i stent with t h e req u i re m ent o f t h e s e c o n d e d i t i o n o f I EC 6060 1 - 1 but it i s
also h a rm o n i o us with t h e re q u i re m e nts o f I EC 60065 and I EC 60950- 1 , which both require a
m i n i m u m contact separation of 3 m m for switches i ntended to provide isolati on from the S U PPLY
MAI NS .
6060 1 - 1 © I EC : 20 0 5 - 5 33 -
S u bclause 8 . 1 1 . 1 h )
S u c h a protective d e v i c e w h et h e r o r not it c a u s e d t h e o p e rati o n o f a n over-current protect i o n

device b u i l t i nto t h e ME EQUI PMENT, wo u l d be l i kely a l s o to c a u s e a f u s e o r c i r c u i t breaker i n
t h e i nstal l at i o n to o pe rate, t h u s rem ovi n g t h e s u pply o f powe r to o t h e r ME EQUIPMENT, possi bly
i n cl u d i n g l ife-s u p po rt ME EQUIPMENT. Such a device m i ght also c a u s e u n d e s i r a b l e t h e r m a l
effects i n s i d e t h e ME EQUI PMENT a n d m i g ht a n yway n ot be a re l i a b l e m et h o d o f protecti n g
agai nst t h e relevant HAZA RDS .
S u bclause 8 . 1 1 . 1 i)
P a rts t h at c a n not be disco n n ected from t h e s u pply m i ght i n cl u de , for ex a m pl e , a ci rcuit for
room l i g hti n g o r a circuit for rem ote c o ntrol of t h e m a i ns switch. Such pa rts co u l d bec o m e
access i bl e w h e n a cover i s o p e n e d , f o r ex a m pl e fo r t h e pu rpose o f m a i nt e n a n c e .
A s pati a l l y s e p a rated a r r a n g e m ent i s o n e w h e re parts t h at n e e d to be access i b l e for s e rvi c i n g

a r e l ocated s u c h t h at t h e S E RVICE PERSONNEL a r e u n l i kely t o c o m e i n contact with parts
e n e rgized at v o ltages exceedi n g th ose s pecifi ed i n t h i s sta n dard w h i l e perfo r m i n g t h e req u i red
service. In t h i s case, a wa r n i n g is d e e m e d to prov i d e a d e q u ate safety for t h e S ERVICE
PERSONNEL.
S u bclause 8 . 1 1 . 2 - M ULTIPLE SOCKET-OUTLETS
T h i s re q u i re m ent redu ces t h e probabil ity t h at other e q u i p m e n t is c o n n ected that m i ght l e a d to

excess ive LEAKAGE CURRENT.
S u bclause 8 . 1 1 . 3 . 4 - APPLIANCE COUPLERS
A POWER S UPPLY CORD co n n e cted to a MAINS CONNECTOR is s u bj e ct to s i m i l a r stresses to a

n o n-DETACHABLE POWER S UPPLY CORD. If it is not a d e q u ately protected from excess ive
be n d i n g , a HAZARD co u l d res ult.
S u bclause 8 . 1 1 . 3 . 5 - Cord anch orage
I f a power cord were n ot a d e q u ately p rotected a g a i nst strai n a n d a bras i o n , there wo u l d be a

h i g h probabil ity of d a m age to i ns u l ati o n prov i d i n g MEANS OF PROTECTION a n d , with CLASS I
ME EQUI PMENT, a h i g h probabil ity of breakage or d i s c o n n ecti o n of t h e PROTECTIVE EARTH
CONDUCTO R .
S u bclause 8 . 1 1 . 3 . 6 - Cord guards
If a power cord were n ot adeq u ately protected agai nst exces s i v e b e n d i n g , t h e re wo u l d be a

h i g h probabil ity of brea kage of powe r-carryi n g co n d u ctors, giv i n g a RISK of fi re, a n d with
CLASS I ME E Q U I PMENT, a h i g h proba b i l ity of breakage of t h e PROTECTIVE EARTH CONDUCTOR.
T h e be n d i n g test described i s i d entical to that s pecifi ed in 3 . 2 9 of I E C 60950- 1 : 2 00 1 . The

second editi o n of I EC 6060 1 - 1 i n cl u ded t h e wordi n g " G u a rds which fa i l t h e a bove d i m e ns i o n a l
test s h a l l h ave to pass t h e test descri bed i n I E C 60335- 1 , Am e n d m e n t 6 . 1 9 8 8 , s u bc l a use
25 . 1 0." T h i s alte r n ative has b e e n reta i n e d , but t h e refe rence is now to a l ater editi o n of
I EC 60335- 1 . Also t h e req u i re m e n t to perform o n e test i n a l l cases, and then to perform t h e
oth e r test if t h e ME EQUIPM ENT fa i l s t h e fi rst test, has been c h a n g e d to a l l ow either test to be
perfo r m e d fi rst , beca u s e t h i s m a kes n o d iffe rence to whether t h e ME EQUIPMENT co m pl i e s .
6060 1 - 1 © I EC : 20 0 5 - 535 -
S u bclause 8 . 1 1 . 4 . 1 - General req u i re m e nts fo r MAINS TERM I NAL DEVICES
M a i ns term i n als s h o u l d e ns u re co n n ecti o n s of s uffi c i e ntly l ow res ista n c e to av o i d ov e r h e ati n g

a n d s h o u l d m i n i m i s e t h e R I S K o f d i s c o n n ecti o n . R e l i a b l e c o n n ecti o n c a n be m a d e b y m ea n s of
sc rews , n uts , s o l d eri n g , c l a m p i n g , cri m pi n g of c o n d u ctors or e q u a l ly effective m et h o d s .
U s e o f term i n a l s o f co m po n e nts oth e r t h a n term i n al bl ocks as te r m i n a l s i ntended for exte r n a l

c o n d u ctors is a l l owed i n s pe c i a l c a s e s w h e re t h e term i n a l arra n g e m ent i s a d e q u ate
( access i bl e a n d clearly m a rked) a n d com ply i n g with t h i s sta n d a r d . T h e wi ri n g term i n a l s of
certa i n ty pes of com pon e n ts are oft e n rated for fi e l d wi r i n g p u rposes. T h e s e i n c l u d e fuse
h o l ders, EMC filters, ci rcuit breakers, co ntactors, wi ri n g stri ps , m otor controll e rs and phase
detectors . Each of these can be one of t h e fi rst c o n n ected co m po n e nts t h e r e by putti n g them
in a good pos iti o n to accept t h e fi rst wi ri n g c o n n ecti o n s .
S u bclause 8 . 1 1 .4.2 - Arra n g e m e n t o f MAINS TERMI NAL DEVICES
S u bclause 8 . 1 1 .4.2 a)
O n e natu ral l y expects to see all the te r m i n a l s fo r c o n n ecti o n of exte r n a l cords o r POWER
S U PPLY CORDS grou ped together. T h e poss i b i l ity of a n i n c o rrect c o n n ect i o n can i n crease if t h e
term i n a l s are n ot g ro u pe d toget h e r .
S u bclause 8 . 1 1 . 4 . 4 - C o n nections t o m a i n s term i n a l s
T h e term " s p e c i a l pre pa rati o n o f t h e c o n d u ctor" covers s o l d e ri n g o f t h e stra n ds , u s e o f c o r d

l u g s , atta c h m e n t o f eyel ets, etc. , b y S ERVICE P E RSONNEL ( i . e . i n t h e fi e l d ) , but n ot t h e
res h a p i n g o f t h e co n d u ctor before i t s i ntrod u cti o n i nto t h e term i n al o r t h e twi sti n g of a
stra n d e d c o n d u ctor to cons o l i d ate t h e e n d . W h e n preparati o n of t h e c o n d u ctor is perfo r m e d
b y t h e MANUFACTURER a n d t h e fl ex i bl e cord i s prov i d e d as t h e o n ly accepta b l e replace m ent
pa rt, such part i s c o n s i d e re d to co m pl y with t h i s re q u i re m e nt.
S u bclause 8 . 1 1 . 5 - Mains fuses and OVER-CURRENT RELEAS ES
P rovi s i o n of fuses o r OVER-CURRENT RELEASES in M E EQUIPMENT redu ces the RISK that a f a u lt i n
t h e ME EQUIPM ENT wi l l cause a protective device i n t h e i nstal l ati o n t o o p e rate, t h u s rem ovi n g
t h e s u pply o f power t o ot h e r M E EQUIPMENT, pos s i bly i n cl u d i n g l ife-s u pport ME EQUI PMENT.
I t is o bvi o u s t h at fus i n g in a PROTECTIVE EARTH CONNECTION wo u l d be i n a ppropri ate .
F u s i n g of t h e n e utral c o n d u ctor of PERMANE NTLY I NSTALLED ME EQUI P M E NT wo u l d serve n o

pu rpose a n d , with 3-phase e q u i pm ent, m i ght l e a d t o ove rstressi n g o f i ns u lati o n i n t h e event
t h at such a fuse were to o pe rate w h i l e t h e l i n e co n n ecti o n s re m ai n ed i ntact. H owever an
OVER-CURRENT RELEASE t h at i nterr u pts a l l poles, i n c l u d i n g the n e utral , s i m u l t a n e o u s l y is
accepta b l e .
T h e exe m pt i o n f o r t h e c a s e w h e re DOUBLE I NS ULATION o r REI NFORCED I NS ULATION is present

betwe e n all parts of o ppos ite p o l a rity with i n the MAINS PART was s u p po rted by t h e N ati o n a l
'
C o m m ittees responses t o a n i n q u i ry d u ri n g t h e preparat i o n o f t h i s editi o n . I t co u l d apply
w h e re provisi o n of a fuse o r OVER-CURRENT RELEASE wo u l d be i n co n ve n i e nt, for ex a m pl e in a
s m a l l pl u g-i n powe r s u pply.
6060 1 - 1 © I EC : 20 0 5 - 537 -
Cla use 9 - P rotection ag ai nst M ECHANICAL HAZARDS of ME EQU I P M E NT a n d ME SYSTEMS

R e q u i r e m e nts in C l a use 9 descri be HAZARDS of a m ec h a n ical n at u r e caused by ME EQUI PMENT
( HARM caused by m ovi n g parts, by rough s u rfaces , by s h a rp e d g es and corners, by i n st a b i l ity,
by ex p e l l e d parts, by vi brati o n and n oi s e and by brea kdown of PAT I E NT s u pports a n d of
s u s p e n s i o n m ea n s for ME EQUIPMENT parts ) . R e q u i re m e nts descr i b i n g HAZARDS caused by
d a m a g e or d ete riorati o n of ME EQUIPM ENT ( m ec h a n i cal stre ngth) h av e been coll ected i nto
1 5.3.
M E EQUI PMENT c a n beco m e u nsafe because o f parts d a m ag e d o r d ete riorated b y m ec h a n ical

stresses s u c h as b l ows , press u re s , s h ocks, vi brati o n , by i n g ress of solid parti c l e s , d ust, fl u i d s
a n d m oisture a n d a g g ressive g a s e s , b y t h e r m a l a n d dyn a m i c stresses, b y co rros i o n , by
l o os e n i n g of faste n i n gs of a m ov i n g part or a s u s p e n d e d m as s , a n d by radiati o n .
Effects o f m e c h a n i ca l ove rl o a d s , m ateri a l fa i l u re o r we a r c a n be a v o i d e d by :

m e a n s that i nterr u pt or r e n d e r n o n - h azardous t h e ope rati o n or t h e e n e rgy s u pply (for
exa m pl e , fuses, press u re-rel i ef valves) as s o o n as ov e rl oa d i n g occurs; or
m e a n s t h at g u ard a g a i nst o r catch flyi n g o r fa l l i n g parts ( c a u s e d by m aterial fai l u re s , wear
o r overload) t h at co u l d constitute a HAZARD.
Protecti o n agai nst brea kdown of PAT I E NT s u pports and s us p e n s i o n s c a n be prov i d e d by

red u n d a n cy o r t h e provi s i o n of safety catc h e s .
M E EQUI PMENT pa rts t h at are i ntended to be h e l d i n t h e h a n d o r posi t i o n e d o n a bed n e e d t o

be s uffi c i e ntly r o b u s t to withsta n d a fal l . T h ey c a n be s u bj ect to v i brati o n a n d s h ocks, n ot o n l y
w h e n tra ns ported but also w h e n used i n v e h i c l es .
S u bclause 9 . 2 - HAZARDS associated w i t h m ovi ng parts
O PERATORS , PAT I E NTS a n d oth e r people n e e d to be protected from MECHANICAL HAZARDS . T h i s

can be a c h i ev e d i n a n u m be r o f ways, for ex a m pl e :
b y provi d i n g s uffi ci e nt d i sta nce between people a n d HAZARDS ;
by restri cti n g access to a reas t h at pres e n t HAZARDS;
by provi d i n g a barri e r , whet h e r m ec h a n i ca l o r n o n - m ech a n i cal , between people a n d
HAZARDS ;
by reduci n g t h e RISK ass ociated with HAZARDS ;
by e n s u r i n g a d e q u ate OPERATOR control over t h e m ov e m e nts c a u s i n g a HAZARD; o r
b y provi d i n g back- u p syste m s so t h at a n acceptable RESI DUAL RISK is a c h i eved w h e n t h e
i n itial co ntrol system fai l s .
W h e n refe rence i s m a d e , i n t h i s s u bc l a u s e , t o t h e R I S K t o pers o n s , rat h e r t h a n t o t h e PAT I E NT

or OPERATO R , it s h o u l d be n ote d , t h at t h e re c a n be oth e r p e o p l e , i n additi o n to t h e PAT I E NT o r
OPERATOR i n t h e v i c i n ity o f ME EQUI PMENT. D e p e n d i n g u p o n t h e M E EQUIPMENT, visitors, fa m i ly
m e m bers and oth e r n o n - q u a l ifi ed pers o n n el c o u l d be in t h e v i ci n i ty.
6060 1 - 1 © I EC : 20 0 5 - 539 -
R e q u i r e m e nts concern i n g m ov i n g parts h a v e b e e n based o n t h o s e i n oth e r sta n d a rds applyi n g

t o n o n - m e di cal e q u i p m e nt a n d m a c h i n e ry, but h ave been m odified to t a ke acco u nt o f t h e
necess ity for ME EQUIPMENT to be i n contact w i t h o r very close to t h e PATI E NT.
D u e to the divers ity of situati o n s , it is n ot poss i b l e in t h i s sta n d a rd to d i ctate w h e re t h e

wa r n i ngs to a d d ress RESI DUAL R I S K s h o u l d be p l a c e d . D e p e n d i n g o n t h e a ppl i cati o n , a n d t h e
l ev e l o f RESI DUAL R I S K , it c o u l d be i m porta nt to p l a c e a wa rni n g o n t h e product. I t m i g ht,
h owev er, be acce pta b l e to place t h e wa r n i n g only in t h e ACCOMPA NYI NG DOCUME NTS .
S u bclause 9 . 2 . 2 . 4 - G UARDS and p rotective meas u res
The degree of protect i o n req u i red for E NCLOS URES o r G UARDS protecti n g m ovi n g parts d e pe n ds
u p o n t h e g e n eral des i g n a n d I NTENDED USE of t h e ME E Q U I PM ENT. F acto rs to be taken i nto
cons i d e rati o n in j u dgi n g the accept a b i l ity of exposed m ov i n g parts i n c l u d e the d e g ree of
expos u re , t h e s h a pe of t h e m ov i n g parts, t h e probabil ity of occu rre n c e of acci d e ntal co ntact,
the s pe e d of m ov e m e nt a n d the probabil ity of occurrence t h at fi n gers, a r m s o r c l ot h i n g wi l l be
d rawn i nto m ov i n g pa rts (fo r exa m pl e w h e re gears m e s h , w h e re belts travel o n to a p u l l ey or
w h e re m ovi n g parts close in a pi n c h i n g o r s h eari n g acti o n ) .
T h ese factors c a n b e c o n s i d ered with respect t o both NORMAL U S E a n d t h e setti n g o f a n y

adj ustm e nts , o r t h e replace m ent o f a n y ACCESSORY o r atta c h m ent, possi bly i n c l u d i n g t h e
i nsta l l ati o n , because G UARDS c a n b e prov i ded a t i nsta l l at i o n a n d m i g h t n ot b e part o f a s i n g l e
i t e m o f STATIONARY e q u i p m ent.
Features of G UARDS that can be c o n s i dered i n c l u d e :

removable with t h e u s e o f TOOLS o n l y ;
removable f o r s e rvi c i n g a n d repl a c e m e nt;
stre n gth a n d r i g i dity;
com pl ete n es s ;
creati o n o f addit i o n a l HAZARDS s u c h as p i n c h poi nts , a n d t h e n ecessity for additi o n a l
h a n d l i n g because o f t h e i n c reased n e e d f o r s e rvi ci n g s u c h as f o r cl e a n i n g .
Protective m eas u res a d d ressed b y t h i s c l a use a r e a l s o i ntended t o i n c l u d e col l i s i o n detect i o n

syst e m s , s u c h as those e m pl oyi n g l i ght barri e rs .
Protective m e a s u res c a n be used i n l i e u o f co nti n u o u s activat i o n type contro l . T h e protective

m e a s u res n e e d to prov i d e fee d back contro l .
S u bclause 9 . 2 . 2 . 5 - Cont i n u o u s activation
M oti o n control syst e m s with the OPERATOR in t h e fe ed back l o o p need to e m ploy co nti n u o u s
activ ati o n ( e . g . m o m e ntary contact, dead- m a n switc h ) . S u c h facto rs as speed of m ot i o n a n d
v i s i b l e f e e d b a c k to t h e OPERATOR a l s o n e e d t o be a d e q u ate.
In some circu m sta n c e s , OPERATOR trai n i n g and oth e r q u a l ifi cati o n s are n e cess a ry in order to
have adeq u ate OPERATOR contro l . I n s u c h cas e s , it c o u l d be d e s i r a b l e to uti l ize " l ock out
controls" t h at req u i re i nt e nti o n a l acti o n to a l l ow m ov e m e nt. Exa m pl es of s u c h controls i n cl u d e :
a key switch w i t h a n " e n a bl e " fu n cti o n ;
a fi n g e r print switch with a n " e n a b l e " f u n cti o n ;
a passwo rd card.
6060 1 - 1 © I EC : 20 0 5 - 54 1 -
I n ot h e r ci rcu m stances, accide ntal control c a n be a c o n c e r n . I n t h i s cas e , controls c o u l d

e m ploy s u c h constructi o n tech n i q u es a s :
control w i t h a n " e n a bl e " f u n cti o n , before a n y m ot i o n s are poss i bl e ;
controls with recessed act u ators ; t h i s co u l d prevent m ov e m ent i f a h a n d o r l e g h i ts
act u ator u n i nte nti o n a l l y .
I f t h e OPERATO R c o u l d h ave access to hazardous m ov i n g parts, controls c o u l d be d e s i g n e d

w h i c h w o u l d prevent access t o t h e TRAPP I NG Z O N E b y l ocati o n of t h e OPERATOR controls. A n
exa m pl e i s a control system t h at n eeds two - h a n d activat i o n .
For OPERATOR control syste m s wit h o ut conti n u o u s activat i o n , th ere c a n be a n accepta b l e

m iti gati o n o f RISKS , h owever it i s necessary to eva l u ate t h e system t o t h e oth e r o pt i o n s i n
9.2.2. 1 .
T h i s c l a u s e deals with el ectro n i c m ot i o n control syste m s . F o r m a n u al l y driven m ot i o n systems

see oth e r o pti o n s in 9 . 2 . 2 . 1 .
S u bclause 9 . 2 . 2 . 6 - S peed of m oveme nt(s)
For s o m e m ed i c a l e q u i pm ent t h e re wi l l be u n avo i d a b l e HAZARDS due to m ov i n g parts.
S u bclause 9 . 2 . 3 - Other HAZARDS associated with m o v i n g parts
S u bc l a use 9 . 2 . 2 . 1 deals with HAZARDS caused by TRAPPING ZONE S . M ov e m ent c o u l d result i n

oth e r HAZARDS , s u c h a s i m pact, p u n ct u re , etc.
S u bclause 9 . 2 . 4 - E m ergency sto p p i n g devices
E m e rg e n cy sto ppi n g devices are des i g n e d to prevent acci d e nt a l d a m age by prev e nti n g or
sto ppi n g m ov e m e nts of ME EQUIPMENT parts. T h e r e c o u l d be m o re t h a n one e m e rg e n cy
sto ppi n g device o n ME E Q U I PMENT. ME EQUIPM ENT can also i n cl u d e e m e rg e n cy off devices t h at
are i nte n d e d to disco n n e ct a l l power to t h e i nstal l ati o n . E m ergency off devices are not s u bj ect
to t h e req u i re m e nts of t h i s s u bc l a u s e u n l ess t h ey are also i nt e n d e d to prov i d e t h e e m e rg e n cy
sto ppi n g fu n cti o n . E m e rg e n cy sto ppi n g devices c o u l d be o n l y o n e part of t h e e m e rg e n cy
switc h i n g f u n cti o n .
S u bclause 9 . 2 . 5 - Release of PATI ENT
T h i s re q u i re m ent takes a cco u nt of t h e poss i b l e effect of a power i nterr u pt i o n ca u s i n g

u nwanted m ov e m e nts , a n d t h e l i ke l y n e e d i n t h at situati o n , f o r t h e removal o f com press i o n
forces o r t h e rem oval o f PAT I E NTS from a hazardous positi o n .
S u bclause 9 . 3 - HAZARD assoc iated with s u rfaces, corn ers a n d edges
T h e RISK associ ated with a s h a r p edge d e p e n ds u p o n t h e positi o n of t h e s h a r p edge a n d t h e

a p pl i cati o n o f t h e ME EQUI PMENT. F o r t h i s reaso n , c o m p l i a n c e w i t h t h i s s u bc l a use i s c h ecked
by i ns pe cti o n . I n cases of d o u bt, the test for s h a r p edges descri bed in UL 1 439 [43], c a n be
used as g u i da n c e .
T h i s s u bc l a u s e a p pl i es for s u rfaces access i b l e d u ri n g NORMAL U S E . C a re s h o u l d be g i v e n to

protecti n g S ERVICE PERSONNEL, or other i nternal syste m s w h e re d a m age c o u l d result i n a n
u n accepta b l e RISK ( e . g . fl u i d syste m s ) .
6060 1 - 1 © I EC : 20 0 5 - 5 43 -
S u bclause 9 . 4 - I nsta b i l ity HAZARDS
I n NORMAL USE, m a n y ty pes of ME EQUIPMENT are exposed to a v a r i ety of c o n d it i o n s d u r i n g

trans port ( m ov e m e nt from room t o r o o m d u r i n g NORMAL U S E ) . W h i l e t h e req u i re m e nts o f t h i s
sta ndard atte m pt t o represent those t h at m i ght be e n c o u ntered, t h e R I S K MANAG E M E NT
PROCESS s h o u l d eval u ate t h e c o n d iti o n s u n de r w h i c h t h e ME E Q U I P MENT is i nt e n d e d to be used
and how th ose c o n diti o n s m i ght i m pact BAS I C SAFETY o r ESSENTIAL PE RFORMANCE .
Where fai l u re to r e m a i n sta b l e d u r i n g t h e perfo r m a n c e of these tests c o u l d cause HARM to t h e

OPERATOR, PAT I E NT a n d oth e r p e r s o n s ( e . g . f r o m crus h i n g o r fa l l i n g) ; o r res u l t i n t h e ME
EQUIPMENT fa i l i n g to m eet t h e a p p l i c a b l e BAS I C SAFETY req u i re m e n ts of t h i s sta n dard (such as:
expos i n g h azardous voltages, red u c i n g CRE E PAGE DISTANCES o r A I R CLEARANCES o r creati n g
breaches i n fi re p ro of E NCLOS URES w h i c h a re not c l e a r l y o bv i ous) o r caus i n g a l oss of
ESSENTIAL PE RFORMANCE , i nsta b i l ity s h o u l d be c o n s i dered to res u lt i n an u n accepta b l e RISK.
S u bclause 9 . 4 . 2 - I n sta b i l ity - over ba l a n ce
As an a i d to u n d e rsta n d i n g , T a b l e A. 3 a n d F i g u re A. 1 6 i l l ustrate t h e l o g i c be h i n d t h e sta b i l ity

test re q u i re m e nts.
Table A.3 - I n sta b i l ity test co n d it i o n s
Test p l a n e a n g l e
Transport war n i n g 1 oo plane 5° p l a n e
Transport warning not provided Must pass in all positions Not applicable (represented by 1 0'
test)
Transport warning provided Must pass in transport position M ust pass in all positions except
(only) Must pass in all positions transport
except tra nsport
0 0
Any NORMAL USE mode Transport only mode

(including transport) Pass 1 0•
Pass 1 o·, or warn and pass 5• IEC 2438105
F ig u re A. 1 6 - I n stab i l ity test co n d i t i o n s

6060 1 - 1 © I EC : 20 0 5 - 545 -
S u bclause 9 . 4 . 2 . 4 - Castors a n d w h eels
C o m pl i a nce with this s u bc l a u s e is re q u i re d n ot only to avo i d o bv i o u s u n acce pta b l e RISK but

also to e n s u re t h e s u bsta nti a l l y o p e rative m ov e m ent as a n E S S E NTIAL PE RFORMANCE . F o r
ME E Q U I P M E N T to be c o n s i d e re d M O B I L E , it m ust be a b l e to be m ov e d f r o m r o o m to ro o m .
S u bclause 9 . 5 - Expel led parts HAZARD
Ex p e l l e d parts are ME EQUI PMENT parts or fra g m e nts of ME EQUI P M ENT parts , s u c h as parts of a
d a m aged vacu u m display, a m ec h a n i ca l s p ri n g , a gas pres s u r e cyl i n d e r , a rotati n g flyw h e e l o r
a n ex p l o d e d l ith i u m battery that c o u l d be ex p e l l e d b y c o l l i s i o n , ex pans i o n etc.
The d e g ree of protecti o n agai nst " ex pe l l e d parts" d e p e n ds u p o n the probabil ity of occu rre n c e
o f HARM a n d t h e S EVERITY o f HARM . P rotective m e as u res c a n i n c l u de a n E NCLOSURE, barri er, o r
e l ectro n i c m e a n s ( e . g . red u n da n t m e a n s to prevent l it h i u m battery c h a rgi n g cu rre nt) .
Excessive n oi s e c a n c a u s e fati g u e , i nterfe r e n c e with s p e e c h a n d acousti c s i g n a l s , o r even

damage to heari n g . L i m its to prevent h e a ri n g d a m age a re descri b e d in I SO sta n d a rd s .
I n m ed i c a l l y used roo m s , m u ch l ower l i m its are needed f o r t h e comfo rt o f PAT I E NTS a n d
m ed i c a l pers o n n e l . T h e act u a l effect o f ME EQUIPMENT n oi s e i s stron gly i nfl u e n c e d b y t h e
acousti cal prope rties of t h e ro o m , t h e i ns u l at i o n between r o o m s a n d i nteracti o n of
ME EQUIPMENT parts.
Excessive vi brati o n wi l l cause disco mfort to the PAT I E NT, OPERATO R, and oth e r pers o n s .
Prol o n ged ex pos u re c a n c a u s e vas c u l a r , n e u ro l o g i cal , o r osteo-arti c u l a r d i s o rders. Excess ive
vi brati o n c a n a l s o cause damage to ME EQUIPMENT o r a s h ift i n cal i brati o n .
M ost ME EQUIPMENT covered b y t h i s sta n dard exposes t h e PATI ENT a n d OPERATOR o r oth e r
pers o n s to n e g l i g i b l e l ev e l s o f n oi s e a n d v i brati o n . T h e RISK MANAG E M E NT PROCESS s h o u l d b e
a b l e to clea rly i d e ntify those cases w h e re m ea s u r e m e nts are re q u i re d .
S u bclause 9 . 6 . 2 - Aco ustic energy
T h ese val u es are based o n t h e pote nti a l for l o n g term h e a ri n g i m pa i r m ent. T h e val u e u s u a l l y
used f o r reg u l atory p u rposes worl dwi d e i s c u rrently 9 0 d BA with a n offs et o f 5 d B A . H oweve r
t h e l atest research i n di cates a v a l u e o f 85 dBA f o r 8 h over a 24 h period w i t h a n offset of
3 d BA w h e n t h e ti m e d o u bles or h alves [34].
Alt h o u g h t h e criteri a for j u d g i n g whether a noise i s considered i m pact noise is i ntenti o n a l ly not
provi d e d , j u dg e m ent s h o u l d be used referri n g to t h e situati o n . Ex a m pl es of i m pact n o i s e
i n cl u d e : t h e g r a d i e n t n o i s e o f M R I e q u i pm ent, a n d l it h otri psy i m p u l s e s .
S u bclause 9 . 6 . 3 - H a n d -tra n s m itted v i b ration
T h re s h o l d v a l ues for v i brati o n are m u ch l ess clear than those for acousti c e n e rgy ( n o i s e ) . T h e
v a l u e used h e re is fro m t h e Directive of the European Parliament and of the Council o n the
minimum health and safety requirem ents regarding the exposure of workers to the risks
arising from physical agents (vibration) ( s ixteenth i n di v i d u a l D i r e ctive wit h i n t h e m e a n i n g of
Arti c l e 1 6( 1 ) of D i rective 89/39 1 /E E C ) . It co rres p o n ds to a bo u t a 1 0 % i n c i d e n c e of bl a n c h i n g
( i n di cative o f n e u rological dam age) after 8 years o f reg u l a r expos u re accord i n g t o I SO 5349- 1 .
It is m o re d iffi c u l t to esta b l i s h l i m i t v a l u e s for w h o l e body vi brati o n . T h e refo re t h i s sta n dard
6060 1 - 1 © I EC : 20 0 5 - 547 -
does n ot s pecify s u c h l i m its. T h e e n d poi nts s u c h as back pai n a n d oth e r a dverse h ealth
effects are not eas i l y q u a ntifi a b l e , and so n o a g re e d- u po n ex pos u re sta n d a rds h av e been
deve l o pe d . R e l ev a nt i nfo r m ati o n of t h i s s u bj e ct c a n be fo u n d i n sta n d a rds such as
I SO 5805 [2 8 ] , a n d I SO 8 0 4 1 [29] .
When a pers o n is exposed to various l evels of acce l e rati o n over a 24 h period, a l l owa b l e
c u m u l ative ex posu re c a n be dete r m i n e d as fol l ows. C o n s i d e r fi rst T a b l e A . 4 o f a l l owa b l e t i m e
o f ex pos u re over a 2 4 h period for e a c h l ev e l o f accele rati o n .
Table A.4 - Al lowable t i m e expos u re for l evel of acce leration
Allowable t i m e of expo s u re
over a 24 h period Acceleration
2
h m/s
1 7,07
2 5,00
3 4,08
4 3,54
5 3,16
6 2 ,89
7 2,67
8 2 ,50
9 2 ,36
12 2 ,04
16 1 , 77
24 1 ,44
S o m e ex a m pl es of a l l ow a b l e c u m u l ative expos u r e are prov i d e d bel ow.

2
I f a pers o n were exposed to a 5 m/s acce l e rat i o n for 1 h (wh i c h re prese nts 1 /2 d a i l y
2
a l l owa b l e ex pos u re ti m e f o r t h i s accele rati o n ) , fol l owed b y a n ex pos u re to a 1 , 44 m /s
accele rati o n for 1 2 h (wh i c h re prese nts 1 /2 d a i l y a l l owable ex pos u re ti m e for t h i s
accele rati o n ) , this w o u l d be a n accepta b l e c u m u l ative ex pos u re over a 24 h p e r i o d .
2
I f a p e r s o n w e r e exposed to a 4 , 08 m/s acce l e rati o n for 1 h (which re prese nts 1 /3 t h e
2
a l l owable d a i l y ex pos u re ti m e f o r t h i s accele rati o n ) , fo l l owed by ex pos u re to a 2 , 36 m/s
accele rati o n for 3 h (which re prese nts 1 /3 a l l owa b l e d a i l y expos u re ti m e for this accele rati o n ) ,
2
fol l owed b y expos u r e t o a 1 , 44 m/s accele rati o n for 8 h (which r e prese nts 1 /3 a l l owa b l e d a i l y
ex pos u re ti m e f o r t h i s accele rati o n ) , t h i s wo u l d be a n accepta b l e c u m u l ative ex pos u re ove r a
24 h period.
2
I f a person were exposed to a 5 m/s acce l e rati o n for 1 h (wh i c h re prese nts 1 /2 t h e a l l owa b l e
2
d a i l y ex pos u re ti m e f o r this accele rati o n ) , fo l l owed b y ex pos u re to a 4 , 08 m/s acce l e rati o n for
1 h (wh i c h re prese nts 1 /3 a l l ow a b l e d a i l y ex pos u re ti m e for t h i s accele rati o n ) , fol l owed by
2
ex pos u re to a 2 , 04 m/s acce l e rati o n for 2 h (wh i c h re prese nts 1 /6 a l l owa b l e d a i l y ex posure
ti m e for this accele rati o n ) , t h i s wo u l d be a n accepta b l e c u m u l ative ex pos u re over a 24 h
period.
6060 1 - 1 © I EC : 20 0 5 - 549 -
To s u m m arize, for each acce l e rati o n d eterm i n e t h e fract i o n a l val u e of a l l owable d a i l y

ex pos u re b y div i d i n g t h e act u a l ex posu re ti m e f o r a g i v e n accel e rati o n b y t h e a l l ow a b l e d a i l y
ex pos u re t i m e f o r t h a t accele rati o n . T h e s u m o f t h e fracti o n a l v a l ues f o r each accel e rati o n i s
not to be g reater t h a n 1 .
S u bclause 9 . 7 - P ress u re vessels and parts s u bj ect to p n e u m atic a n d h yd ra u l ic

press u re
T h e req u i re m e nts of t h i s s u bc l a u s e do not re present t h e m ost stri n gent c o m bi n at i o n of

nati o n a l r e g u l at i o n s or sta n d a rds.
In some co u ntries such reg u l at i o n s o r sta n d a rds a pply.
Type of syste m s considered i n c l u d e p n e u m at i c pressure syste m s , hydra u l i c press u re

syst e m s , ste a m pressure syste m s a n d co m bi n at i o n s t h e re of. T h e s e syste m s m i ght or m i g h t
not i n c l u d e pressure vessels.
HAZARDS
a) M ec h a n i cal r u pt u re or breakage ( HARM: l acerati o n s , pu n ct u r e wo u n ds)

T h e re q u i re m e nts from C l a u s e 4 5 of t h e second editi o n d e a l i n g with t h i s HAZARD, h ave
been m oved to this s u bc l a u s e , and re m a i n u n c h a n g e d .
R e q u i r e m e nts h a v e been c l a rifi e d to i n d i cate t h at a l l parts h ave a MAXI MUM PERMISSI BLE
WORKING PRESSURE not less t h a n the press u re in NORMAL CONDI TI O N o r S I NGLE FAULT
CONDI TION. I n pri n c i pa l t h e re s h o u l d be a s u it a b l e s afety factor betwe e n the MAXI M U M
PERMISSI BLE WORKI NG PRESSURE a n d t h e b u rsti n g press u r e , w h e re t h e bu rsti n g press u re i s
t h e pres s u re at w h i c h a part s uffers from p e r m a n ent ( pl astic) defo r m ati o n o r l eakage.
I n d ustry sta n d a rds for p ress u re parts vary, but s u it a b l e s afety factors are 3 x , 4 x , a n d
s o m eti m es 5 x ( I SO , AS M E , SAE ) . As a s u itable safety factor c a n vary, d e p e n d i n g o n
factors ass o c i ated with t h e e n d-use a p p l i cati o n a n d R I S K , it w a s considered i n a ppropriate
to s p ecify a m i n i m u m s afety factor i n t h e defi n it i o n of MAXI M U M PERMISSI BLE WORKI NG
PRESS URE , but i n stead l eave this to the decla rati o n of the MANUFACTURER of s u c h part. I t is
ass u m ed t h at MAXI M U M PERMISSI BLE WORKING PRESSURE d e c l a rati o n s wi l l be based on
reco g n ized i nternati o n a l o r n at i o n a l sta n d a rds, and t h e refore below bu rsti n g press u res at
l east in l i n e with t h e m u lti p l i cati o n factor s h own in F i g u re 3 2 , ( 3 x , de rated after 1 MPa to
as low as 1 , 3 x after 3 0 M P a ) .
F o r pres s u r e vessels exceedi n g both a n e n e rgy l i m it ( press u r e x v o l u m e) a n d a m axi m u m
press u r e l i m it, t h e req u i re m ent i s t o c o n d u ct a hyd rostatic ov erpressure test bas e d o n t h e
MAXI M U M PERMISSI BLE WORKING PRESSURE decl a rati o n a n d t h e m u ltipl i cati o n factor s h own i n
F i g u re 3 2 , ( 3 x , derated after 1 M Pa t o a s l ow a s 1 , 3 x after 3 0 M P a ) .
b) M ec h a n i cal l oss o f s u p p o rt ( HARM: crus h , p u ncture wo u n ds)

R e q u i r e m e nts h ave been c l a rifi ed to specify t h at c o m p o n e nts in a pres s u r e syste m , s u c h
as th ose i n a hydra u l i c l i ft system w h o s e i nteg rity i s r e l i e d o n to red u ce t h e R I S K from l oss
of s u pport n eed to com ply with the NORMAL CONDI TION TENS I LE SAFETY FACTORS s pecifi ed i n
9 . 8 . T h e TENS I LE SAFETY FACTOR i s ty p i c a l l y 4 x for parts n ot i m pa i re d by wear, a n d 8 x for
pa rts i m pa i red by we a r ( C ase B). T h u s parts s u bj e ct to press u re whose fa i l u re c o u l d res u lt
i n m ec h a n i ca l r u pt u r e a n d l oss i n s u pport n e e d to have a MAXI MUM PERMISSI BLE WORKI NG
PRESS URE based on t h e h i g h e r of t h e S I NGLE FAULT CONDITION press u re a n d t h e
'
MANUFACTURER s decl a rati o n f o r each system com p o n e nt as s pecifi ed i n 9 . 7 , o r t h e NORMAL
CONDI TION pressure a n d the TENSILE SAFETY FACTOR as s pe cifi e d in 9 . 8 .
6060 1 - 1 © I EC : 20 0 5 - 551 -
c) Leakage of tox i c gas or l i q u i d ( HARM: c h e m ical or b i o l ogical c e l l d a m age)
T h e req u i re m e nts from C l a u s e 45 of t h e second editi o n deal i n g with t h i s HAZARD h av e been

m ov e d to t h i s clause, and re m a i n u n ch a n g e d .
R e q u i r e m e nts h a v e been c l a rifi ed to i n d i cate t h a t a l l press u re system c o m po n e nts n e e d t o

h a v e a MAXI M U M PERMISSI BLE WORKING PRESSURE based o n t h e S I NGLE FAULT CON DITION
'
press u r e and t h e MANUFACTURER s decl arat i o n for each syste m co m po n e nt.
d) Leakage of fl a m m a b l e gas o r l i q u i d ( HARM: fi re c a us i n g b u rns o r property d a m age)
T h e re q u i re m e nts from C l a u s e 4 5 of t h e second editi o n d e a l i n g with t h i s HAZARD, h ave

been m oved to this c l a u s e , and r e m a i n u n c h a n g e d .
R e q u i r e m e nts h a v e been c l a rifi ed to i n d i cate t h a t a l l press u re system c o m po n e nts n e e d t o

h a v e a MAXI M U M PERMISSI BLE WORKING PRESSURE based o n t h e S I NGLE FAULT CON DITION
press u r e and MANUFACTU RER ' s d e c l a rati o n each syste m co m po n ent.
S u bclause 9 . 7 . 5 - P ress u re vessels
I t i s ass u m ed t h at a h y d ra u l i c test i s n ot n ecess a ry if t h e press u r e is l ess t h a n o r equal to

50 kPa o r t h e product of t h e press u re and vo l u m e i s l ess t h a n o r equal to 2 0 0 k P a · I .
T h e s afety factors i m pl i ed by F i g u re 32 are h i g h e r t h a n t h o s e g e n erally a p pl i e d i n testi n g

press u r e vessels. H owever, w h e reas hydra u l i c testi n g i s n o r m a l l y u s e d t o ve rify t h at a
press u r e vessel is free from producti o n fa u lts o r serious dete r i o rati o n , t h e adeq uacy of t h e
des i g n bei n g dete r m i n e d i n oth e r ways , t h e pres e n t hydra u l i c t est i s i nt e n d e d to ve rify t h e
a d e q u acy o f a d e s i g n w h e re t h i s c a n not be esta b l i s h e d i n oth e r ways .
T h e d e l eti o n of n at i o n a l referen ces i n t h e a m e n d e d text avo i ds s u bordi n ati n g t h e

req u i re m e nts o f t h e sta n dard to those o f l ocal r e g u l at i o n s . T h e M E EQUIPM ENT wi l l s o m eti m es
have to s ati sfy bot h , or t h e m o re d e m a n d i n g , ass u m i n g that t h e r e are no l ocal reg u l at i o n s t h at
confl i ct with t h i s sta n d a r d .
A hydra u l i c test is s pecifi ed even for p n e u m at i c v esse l s , as t h i s is safer f o r t h e teste r. I n

ach i evi n g t h e test press u re with a gas, t h e gas wi l l com press , res u l ti n g i n m o re sto red e n e rgy
in the test vessel t h a n wo u l d a hydra u l i c test m et h o d . B oth m eth ods res u l t in the s a m e test
press u r e , w h i c h is t h e o bj ective of the test.
S u bclause 9.8 - HAZARDS assoc iated with s u p port syste m s
T h e t e r m " s u p po rt" i s t a k e n to i n cl u d e " s uspensi o n " a n d l oads can i n c l u d e PAT I E NTS ,

OPERATORS a n d oth e r m asses.
S u pport syste m s c a n broadly be cate g o rized as fo l l ows .

- A s us p e n s i o n system is o n e t h at conta i ns fl ex i n g or r i g i d e l e m e nts t h at are des i g n e d to
s u s p e n d m asses, i n cl u d i n g PAT I E NTS a n d OPERATORS d u r i n g NORMAL U S E .
F l ex i n g e l e m e nts i n c l u d e r o p e s , c a b l e s , c h a i n s , belts, b a n d s a n d s pr i n g s . Additi o n a l l y a
jack screw n ut is c o n s i dered i m pa i red by we a r to t h e exte nt n e e d i n g a h i g h e r TENS I LE
SAFETY FACTOR.
- An actu ati n g syste m is o n e t h at contai ns e l e m e nts s u c h as e l e ctric, p n e u m atic or hydra u l i c
act u ators , m otors, g e a r boxes, s h afts, beari n g s , p u l l eys , s h e aves, b a n d wheels a n d
g u i des.
6060 1 - 1 © I EC : 20 0 5 - 553 -
A s u pport structure is g e n e r a l l y a r i g i d device t h at c a n be static or m ovi n g a n d w h i c h

s u p po rts ME EQUIPM ENT, exte r n a l l oads a n d , where n ecess ary, PAT I E NTS a n d OPERATORS .
TENSILE SAFETY FACTORS are a p pl i e d to prov i d e a m a r g i n of s afety to t h e d e s i g n after a l l

reas o n a b l e a l l owa n ces for o p e rati n g c o n diti o n s , m aterial a n d m a n ufactu r i n g v a r i a b l es , etc . ,
have been m a d e .
I n determ i n i n g whether c a s e A o r B is to be used from T a b l e 2 1 , certai nty o f m aterial stre n gth

i s req u i red i n order to a pply case A val u es . Add iti o n a l l y t h e re n e eds to be confi de n c e in the
dete r m i n at i o n of TOTAL LOAD in order to apply case A v a l ues. TOTAL LOAD i s co nstituted from
" stat i c force" and " dy n a m i c force" co m po n e nts. T h e static force is n o r m a l l y clear. But the
dyn a m i c force/l o adi n g i s s o m eti m es u n certa i n . When t h e dy n a m i c fo rces are k n own as we l l as
static forces, the TENS I LE SAFETY FACTOR i s d ete r m i n e d with case A. W h e n the dy n a m i c fo rces
are n ot c l e a r , a n d the stat i c forces are k n ow n , t h e TENS I LE SAFETY FACTOR is dete r m i n e d with
case B.
Ext e r n a l forces fo r PAT I E NT s u pports c a n i n c l u d e th ose g e n e rated by a p pl i cati o n of C P R , etc.
E l o n gati o n at break of 5 % i s based o n h i stori cal ex peri e n ce with m eta l l i c m at e r i a l s , i n

parti c u l a r steel a n d cast i ro n . M ateri a l s with e l o n g ati o n a t break l ess t h a n 5 % are c o n s i d ered
britt l e and thei r fa i l u re is l i kely catastro p h i c , and t h e refore a h i g h e r s afety factor i s c o n s i d ered
a p propriate.
For n o n - m etal l i c m at e r i a l s :
- W h e r e n o oth e r ex p e r i e n c e exists , a n d w h e re fai l u re m o d e i s l i ke l y catastro p h i c , t h i s
e l o n gati o n factor is c o n s i d e r e d appropri ate , a n d t h e refo re a h i g h e r TENS I LE SAFETY FACTOR
is c o n s i d ered a p propriate.
- Where ex peri e n ce and testi n g s h ow oth e rwi s e , an e l o n gati o n at break of l ess than 5 %
can be a p p ropriate before a h i g h e r TENS I LE SAFETY FACTOR i s j ustifi e d .
For exa m pl e , PAT I E NT t a b l es of X-ray/CT/M R syst e m s a r e oft e n d e s i g n e d with pl ast i c m ateri a l s

l a m i n ated o r rei nforced b y carbon fi bres/cl oths o r gl ass fi bres/c l ot h s , s i nce th ese PAT I E NT
tables m ust be o pti m is e d for l ow absorpt i o n of X-ray radi ati o n ( a l u m i n i u m e q u ival e n c e ) , M R
com pati b i l ity ( l ow proto n s i g n a l ) , a s well a s structural sta bi l ity. Alt h o u g h these p l astic
m aterials rei nfo rced by carbon fi bres/cl oths c a n have e l o n gati o n at break of l ess than 5 % ,
m a n y years k n owl e d g e , acq u i re d ex pert i s e , a n d post-m a rket s u rv e i l l a n ce c a n prov i d e
s uffi ci e nt evi d e n ce t h at s u itable structural sta b i l ity o f PAT I E NT t a b l e s i s a c h i eved b y a pplyi n g a
TENS I LE SAFETY FACTOR from T a b l e 2 1 , S i t u ati o n 1 ( rath e r t h a n S i t u at i o n 2 ) .
At e n d o f l ife o r p e r i o d i c m ai nt e n a n c e cyc l e , ME EQUIPMENT n e eds to m a i nt a i n structural

i ntegrity. L i n e 1 of Table 21 i s n o r m a l l y a ppro pri ate for end of l i fe o r the end of t h e p e r i o d i c
m a i nt e n a n c e cyc l e s i nce w e a r is n o l o n g e r c o n s i d e r e d .
S us p e n s i o n a n d a ct u ati n g syst e m s have T E N S I L E SAFETY FACTORS t h at a re n ecessarily h i g h t o

red u ce t h e effects o f dete riorati o n t h r o u g h we a r a n d fati g u e .
P a rti c u l a r atte nti o n s h o u l d b e g i v e n t o t h e fix i n g o f structu res t o fl o o rs , ce i l i n gs , etc. t h at are

s u bj ect to vari a b l e TENS I LE SAFETY FACTORS .
A h i d d e n defect is o n e t h at is n ot rev e a l e d d u ri n g m a n ufact u r e , s e rv i c e or n o r m a l operati o n of

t h e ME EQUI PMENT but that c o u l d cause fa i l u re of a part t h at c o u l d result in a HAZA RD.
Ex a m pl es are h i g h i nternal stresses in h e at-treated parts s u c h as s pr i n g s , broken stra n ds of
wi re i ns i d e c a b l es and po ros ity i ns i d e cast i n gs .
6060 1 - 1 © I EC : 20 0 5 - 555 -
F i g u re A. 1 7 conta i n s an ex a m p l e of determ i n i n g t h e a ppro priate TENSILE SAFETY FACTOR u s i n g

T a b l e 2 1 . F i g u re A. 1 8 conta i n s a n ex a m pl e o f determ i n i n g d e s i g n a n d test l oads. T h ese
exa m ples a re n ot i ntended to cover a l l poss i b l e cases. F o r a part i c u l a r d es i g n , th ese TENS I LE
SAFETY FACTORS a n d d e s i g n/test l oads c a n vary accordi n g to t h e m ateri a l s u s e d , t h e i r we a r
c h a racte ristics, l o adi n g c o n diti o n s , etc.
T h i s s u bc l a u s e focuses o n safety factors as the s u g gested approach to have c o nfi d e n c e t h at

t h e e q u i p m ent w i l l m a i nta i n structural i nteg rity d u ri n g its EXPECTED S E RV I CE L I F E . I n s o m e
cases t h e s pecifi ed safety factors a r e m o re t h a n n e e d e d , a n d i n s o m e cases eve n l a rger
factors could be c o n s i dered appropri ate . T h e c o m p l i a n c e criteria c a n be satisfi ed by RISK
MANAG E M E NT rat h e r than by t h e use of t h e safety factor route. F o r new m aterials o r fo r
stru ctu res with s o p h i sti cated m o nitori n g of stress es, t h e s afety factors m i g ht n ot be
n ecess a ry.
I f it i s deemed t h at t h e fa i l u re mode of t h e part does n ot result i n a n u n accepta b l e RISK, the

TENS I LE SAFETY FACTORS s pecifi ed i n T a b l e 2 1 do n ot a p pl y . For exa m pl e , for propri etary
co m po n e nts s u c h as beari n gs it is accepta b l e to rely o n t h e c o m p o n ent MANUFACTURER ' s d ata
for l o a d a n d l ife ex pecta n cy wit h o u t applyi n g a TENSILE SAFETY FACTO R .
S u bclause 9 . 8 . 3 - Strength o f PATI ENT o r OPERATOR s u pport o r s u spension syste m s
T h i s s u bc l a u s e d e a l s w i t h forces a p pl i e d o n s u pport o r s u s p e n s i o n pa rts o f ME EQUIPM ENT,

i ntended to s u pport o r s us p e n d the m ass of a h u m a n body o r p a rt of the m ass of a h u m a n
body, a n d t o ACCESSORI ES used o n s u c h s u p p o rt o r s us p e n s i o n parts. F o r a d u lt PAT I E NTS o r
OPERATORS t h e 1 35 k g m ass represent t h e 9 9 perce nti l e o f t h e popu l ati o n . F o r s pecifi c
p o p u l at i o n s , h i g h e r m ass or l owe r m ass c a n be used ( e . g . h eavy person o r paediatric
a p p l i cati o n ) .
M ECHANICAL PROTECTIVE DEVICE

Pulley wheel shaft. elongation > 5 % © (e. g. safety catch)
SF = 2.5 (case 1 A) or SF = 2.5 (case ?A) or
SF = 4 (case 1 B) SF = 4 (case ?B)
@
Casting not impaired by wear. elongation <5 %
Cable with MECHANICAL No MECHANICAL PROTECTIVE DEVICE
®
ll
PROTECTIVE DEVICE (item C) SF = 4 (case 2A) or
SF = 2.5 (case 5A) or A SF = 6 (case 2B)
SF = 4 (case 58)
Movement
PATIENT su pport
Fixing. elongation >5 %

SF = 2.5 (case 1 A) or
SF = 4 (case 1 B) ®
Jack screw nut. no MECHANICAL PROTECTIVE DEVICE

SF = 5 (case 3A) or
SF = 8 (case 3B) IEC 2439105
F ig u re A. 1 7 - Exam p l e of d eterm i n i ng TENSILE SAFETY F ACTOR u s i n g Table 2 1

6060 1 - 1 © I EC : 20 0 5 - 557 -
- Structure
im----- Support part (bolt) not im paired by wear, no

MECHANICAL PROTECTIVE DEVICE
TOTAL LOAD = W1 + W2
SF = 2,5 (case 1A), design/test load = 2,5 x (W1 + W2); or
SF = 4 (case 1 8), design/test load = 4 (W1 + W2)
1------ Support part (cable) impaired by wear, no

MECHANICAL PROTECTIVE DEVICE
TOTAL LOAD = 0,5 X W1
SF = 5 (case 3A), design/test load = 5 x 0,5 x W1 or
ll
SF = 8 (case 38), design/test load = 8 x 0,5 x W1
Movement
IEC 2440105
NOTE ToTAL LOAD is shown based on only static forces to obtain actual total loads, dynamic
forces also need to be included.
F ig u re A. 1 8 - E xa m p l e of d eterm i n i ng d e s i g n a n d test loads
S u bclause 9 . 8 . 3 . 2 - Static forces d u e to load i n g from persons
F i g u re A 1 9 conta i n s a n ex a m pl e of h u m a n body m ass distribution for PAT I E NT s u p po rt

s u rfaces .
Dimensions in m i l l i metres
1 80 500 1 80 550 450
20 20
I 3,7 %
I�
(\ I 1 1 ,1 %
II 7,4 %
I
I
7,4 % 40,7 %
II
�
I 7,4 %
18
1 1 ,1 %
I 3,7 %
1 900
IEC 2441105
F ig u re A. 1 9 - Exam p l e of h u m a n body m ass d istribution

6060 1 - 1 © I EC : 20 0 5 - 559 -
T h e distr i b ut i o n m ass of a body d i a g ra m is an average d istri buti o n based on anth ropo m etrical
data. Due to t h e vari ety of p o p u l ati o n o r s pecific cate gories of age, it can v a ry. F o r s e d e ntary
people n ot havi n g a physical activity t h e m ass of t h e u pper part of t h e body c a n repres e nt a
m o re i m portant percentage.
T h e v a r i ety of ME EQUIPMENT does n ot a l l ow m o re prec1 s 1 o n to be given in t h i s g e n e ral

sta n d a r d . I t i s up to t h e pa rti c u l a r sta n dard to d efi n e m o re adeq u ately t h e d i stri buti o n area o r
t h e worst-case positi o n , rat h e r t h a n dyn a m i c tests .
A foot rest is tested for twi ce its n o r m a l l o a d , rat h e r t h a n a l o a d based o n a TENSILE SAFETY
'
FACTOR v a l u e from T a b l e 2 1 , as it is i ntended to s u p po rt a PATI E NT s wei g ht for o n l y a s h o rt
d u rati o n of ti m e .
T h e test with a m ass o f 80 k g p l a ced 60 m m from t h e outer e d g e is i nt e n d e d t o s i m u l ate t h e

centre o f g ravity o f a PAT I E NT sitti n g o r l e a n i n g o n t h e edge o f a s u pport s u rface.
S u bclause 9 . 8 . 3 . 3 - Dynam ic forces d u e to load i n g from persons
A g e n e ra l dyn a m i c test is defi n e d w h i c h represe nts c o m m o n situat i o n s represe nted by a

pers o n s i tti n g down or sta n d i n g u p.
T h e req u i re m ent of t h i s s u bc l a u s e is i ntended to apply to t h e c h a i rs for dental s u rg i c a l

proced u re s , X- ray tables, a n d m a ny oth e r s i m i l a r types o f ME EQUIPMENT. T h e ME EQUIPMENT
s h o u l d be i n a l l o p e rati n g m odes a n d positi o n s where dyn a m i c l o ads from PAT I E NTS can be
reas o n ably expected. F o r exa m pl e , w h e n a PAT I E NT t a b l e is positi o n e d i n an area of a CAT o r
m a g n et stru ctu re, t h e dy n a m i c test i s not a pp l i c a b l e as t h e d y n a m i c l o adi n g caused b y a
PAT I E NT is n e g l i g i bl e .
M E EQUI PMENT s h o u l d be des i g n e d t o b e a r a repeati n g force, b y c o n s i deri n g a ppro priate

TENS I LE SAFETY FACTORS and t h e resu lts of fati g u e c a l c u l at i o n s . T E NS I LE SAFETY FACTORS exist
to s h ow t h e re l i a b i l ity of t h e e q u i p m e nt wit h o ut real test i n g .
T h e bottom porti o n o f t h e h u m a n body test m ass a p pa ratus s h own i n F i g u re 33 i s foa m , a n d

s h o u l d s i m u l ate co ntact b y t h e relevant PAT I E NT part.
S u bclause 9 . 8 . 4 - Systems with M ECHANICAL PROTECTIVE DEVICES
T h e i ntent of a MECHANICAL PROTECTIVE DEVICE i s to act to prev e nt HARM in t h e event of the

fai l u re of t h e pri m a ry s u pport means t h at i s s u bj ect to wear. T h e fai l u re of t h e pri m a ry s u pport
m e a n s s u bj ect to we a r is c o n s i dered a S I NGLE FAULT CONDI TION if it has a TENSILE SAFETY
FACTOR i n acco r d a n ce with T a b l e 2 1 , rows 5 a n d 6 . To protect a g a i nst HARM i n t h i s S I NGLE
FAULT CONDI TION, t h e MECHANICAL PROTECTIVE DEVICE acts as a backup, and n e eds to have t h e
TENS I LE SAFETY FACTOR i n di cated i n T a b l e 2 1 , Row 7 . I t i s c o n s i d e red good e n g i n e e ri n g
practice to construct a MECHANICAL PROTECTIVE DEVICE from n o n - britt l e m ateri a l s , a n d
t h e refore R o w 7 does n o t i n cl u d e a n e l o n gati o n col u m n .
T o test a MECHANICAL PROTECTIVE DEVI CE, t h e pri m a ry s u pport m e a ns s u bj ect t o we a r n e e ds to

be defe ated . For ex a m p l e if the pri m a ry s u pport system i s a cabl e , the c a b l e wo u l d be cut.
6060 1 - 1 © I EC : 20 0 5 - 56 1 -
Cla use 1 0 - P rotect i o n a g a i n st u nwanted a n d excess ive rad iat i o n HAZARDS
R a d i ati o n from ME EQUIPMENT can occur i n a l l fo rms k n own in phys i cs . BASIC SAFETY
req u i re m e nts are concerned with u nwanted radiati o n . P rotective m ea s u res are n ecess a ry for
ME EQUIPMENT and for the e n v i ro n m e n t and m et h o ds for determ i n i n g l ev e l s of radi ati o n n eed
to be sta n dardized.
T h i s c l a use i s i nt e n d e d to deal with stray radiati o n ( s u c h as scattered radiati o n from

rad i ol og i c a l e q u i pm e nt) and i n c i dental radi ati o n ( s u c h as X-ray e m itted by C RT s ) . A
req u i r e m e n t for u n i nt e n d e d or excessive o utput of radi ati o n that ME EQUI PMENT is i nt e n d e d to
d e l i v e r to t h e PAT I E NT is covered i n 1 2 . 4 . 5 .
F o r i o n izi n g radiati o n I E C re q u i re m e nts g e n e r a l l y com ply with t h e I nternati o n a l C o m m i ssi o n

for R a d i at i o n Protecti o n ( I C R P ) R e co m m e n d at i o n s . T h e i r pu rpose is t o prov i d e data that are
i m m e d i ately usable by des i g n e r and RESPONSI BLE ORGANIZATION.
Their eval u ati o n i s poss i bl e only by a d e q u ate study of operati n g m et h o ds and d u rati o n of
o p e rati o n of ME EQUIPM ENT a n d positi o n i n g of OPERATOR a n d assista nts , because a pp l i cati o n
o f worst c a s e c o n diti o n s w o u l d give r i s e to s i t u ati o n s t h at m i ght h a m per proper d i a g nosis o r
treat m e nt.
R e c e nt I C R P p u b l i cati o n s a l s o i nstruct t h e OPERATOR i n m et h o ds for t h e restri cti o n of

i ntenti o n a l i rrad i ati o n .
S u bclause 1 0. 1 . 1 - M E EQUIPMENT n ot i ntended t o p rod uce d iag nostic or th erapeutic

X- rad iation
S p u r i o u s X- rad i ati o n from com p o n e nts such as Video D i s p l ay U n its (VDU) is a pote nti a l
s o u rce o f c o n c e r n f o r ME EQUIPMENT, m a n y o f w h i c h conta i n V D U s . An n ex H of
I EC 60950- 1 : 2 0 0 1 conta i n s a wel l -acce pted PROCE DURE for m e as u ri n g s u c h s p u r i o u s
e m i s s i o n s f o r i nfo r m at i o n te c h n o l ogy e q u i pm ent. T h e l i m its i n t h at a n n ex a r e based o n I C R P
60 [ 3 9 ] . T h e req u i re m e nts fro m An n ex H o f I EC 6 0 9 5 0- 1 : 20 0 1 were i n co rporated i nto t h e body
of t h i s sta n da rd because t h i s was t h e o n l y n o r m ative refere nce that re q u i red t h e u s e of I E C
60950- 1 .
Oth e r n o r m ative refe r e n ces to I E C 60950-1 are alte r n ative m e a n s of a d d ressi n g items s u c h
as CRE E PAGE DISTANCE a n d A I R CLEARANCE . A u s e r o f t h i s sta n d a r d d o e s n ot h a v e to refe rence
60950- 1 u n l ess t h ey wi s h to use t h e i ns u l at i o n coord i n ati o n m et h o d s conta i n in t h at
d o c u m ent.
S u bclause 1 0. 4 - Lasers and light em itt i n g d iodes ( L E Os)
A dated refe rence to I E C 60825- 1 was used because at the ti m e of p u b l i cati o n of t h i s

sta ndard I E C/TC 7 6 was i n t h e e a rly sta ges o f deve l o p i n g a t h i rd editi o n o f I E C 6 0 8 2 5 - 1 a n d
was consi d e ri n g r e m ovi n g t h e re q u i re m e nts for L E Os f r o m I EC 6 0 825- 1 .
S u bclause 1 1 . 1 - Exces s ive tem pe ratu res i n M E EQU I P M E NT
T e m perature l i m its are req u i red to prevent HAZARDS for a l m ost a l l types of ME EQUIPM ENT with
the pu rpose of preve nti n g rapid agei n g of i ns u l at i o n a n d disco mfo rt w h e re ME EQUIPMENT is
touched o r m a n i p u l ated, o r i nj u ri es where PAT I E NTS co u l d co ntact ME EQUI PMENT parts .
M E EQUI PMENT parts m i g ht be i n s e rted i nto body caviti es, u s u a l l y t e m porarily but s o m eti m es
perm a n e ntly.
For PAT I E NT co ntact, s pe c i a l t e m perature l i m its have b e e n s et.

6060 1 - 1 © I EC : 20 0 5 - 563 -
S u bclause 1 1 . 1 . 1 - M ax i m u m tem perat u re d u ri n g NORMAL USE
T a b l e 22 add resses l i m its for pa rts t h at co u l d affect co m pl i a n c e of t h e ME EQUIPMENT with this

sta ndard in g e n e ral ( e . g . e l ectri cal BAS I C SAFETY ) .
It is n ot i nt e n d e d t h at t h e ME EQUI PMENT pa rts be tested i n every poss i bl e confi g u rati o n of

NORMAL USE as l o n g as t h e MANUFACTU RER c a n determ i n e t h e worst-case c o n d iti o n s . T h e
"wo rst case" wi l l a l m ost a l ways i n c l u d e t h e h i g h est a l l owabl e a m bi e nt tem perature a n d
o p e rati o n o f t h e ME EQUI PMENT a t t h e m ax i m u m DUTY CYCLE , b u t oth e r s pe cific as pects o f t h e
confi g u rati o n o f t h e ME EQUIPMENT ( s u c h as atta c h m ent o f ACCESSORIES ) s h o u l d be dete r m i n e d
b y t h e MANUFACTURER based o n a t h o r o u g h u n d e rsta n d i n g o f t h e M E EQUIPMENT ' s des i g n .
S u bclause 1 1 . 1 . 2 - Tem perat u re of APPLIED PARTS
T a b l e 23 a n d T a b l e 24 add resses HAZARDS that c o u l d arise from h u m a n contact with h i g h e r

tem peratu res . H u m a n contact t e m peratu res were bas e d o n c l i n i ca l ex perti s e , c l i n i cal
l iteratu r e [52] and ex pe r i m e ntati o n . In a d d iti o n , t h e v a l u es agree with th ose of t h e E u ro p e a n
N o r m E N 563 [ 3 8 ] .
Alt h o u g h t h e m axi m u m s u rface tem perature f o r a n APPLI E D PART w a s raised from 4 1 o c to

43 o c in response to t h e c l i n i cal i n put m e nti o n e d a bov e , i n put fro m some c l i n i c i a n s poi nted
o u t that i nfa nts as well as s o m e other (th e r m a l ly) h i g h risk g ro u ps co u l d be m o re pro n e to
HARM from h eated s u rfaces at 43 o c .
I de a l ly, pa rti c u l a r sta n d a rds for ME EQUIPM ENT used fo r these PAT I E NT g ro u ps wo u l d have
req u i re m e nts for (where necessary) l owe r conta ct tem perat u r e s . In o rd e r to add ress those
cases w h e re such parti c u l a r sta n d a rds do not ex i st, t h e worki n g group felt t h at n otificati o n of
t h e RESPONSIBLE ORGANIZATION w h e n tem peratu res exceed t h e s ec o n d editi o n l i m it of 41 o c
was a d e q u ate. H owev er, t h e new 43 o c l i m it is to be c o n s i d e red a n a bs o l ute m axi m u m .
When m ea s u r i n g APPLI ED PART tem peratures, t h e m ethod used s h o u l d s i m u l ate t h e wo rst-case

confi g u rati o n when possi b l e u s i n g real o r s i m u l ated h u m a n ski n . Dete r m i nati o n of the wo rst
case confi g u rati o n s h o u l d c o n s i d e r as pects s u c h as t h e l i ke l y body tem perature a n d whether
o r n ot t h e part of t h e body o r APPLI ED PART itself is covered (such as with a bl a n ket) .
S i m u l ated h u m a n ski n for these pu rposes co u l d i n c l u d e m aterials s u c h as s i l i co n r u b be r .
S u bclause 1 1 . 1 . 2 . 2 - APPLIED PARTS n o t i nte n d ed t o s u pply h eat t o a PATI ENT
T a b l e A. 5 i s prov i d e d as g u i d a n c e for ME EQUIPMENT t h at creates low tem peratu res (cools) for
t h e rape utic pu rposes o r as part of its o p e rat i o n . N o r m ative r e q u i re m e nts h ave n ot been
i n cl u d e d in t h i s sta n d a rd beca use s u c h ME EQUI P M E NT i s u n com m o n .
6060 1 - 1 © I EC : 20 0 5 - 565 -
Table A . 5 - G u id a n ce on s u rface tem pe ratu res for ME E QU I P M E NT that creates low

tem peratu res (coo ls) fo r t h e rapeutic p u rposes or as part of its o peration
M i n i m u m Tem perature a
'C
M E E Q U I P M E N T and its parts Al u m i n i u m Steel
External s u rface of t< 1 s -20 -20

ME EQU I P M ENT and its
parts that are l i kely to 1 s � t < 10 s -10 -15
b e touched for a time
"l" b
1 0 s � t < 60 s -2 -7
• The a l lowable m i n i m um tem perature l i m it va l ues for exte rnal surfaces that are l i kely to be
touched by the PATIENT, OPERATOR and other persons are based o n freezing threshold
va l ues of a finger touching different materials (frostbite thresho ld) .
b The proba b i l ity of occurrence of contact a n d the d u rati o n of contact should be dete r m i ned
and documented i n the RISK MANAG E M EN T F I L E .
S u bclause 1 1 . 1 . 3 - M eas u re m ents
T h e proper u s e of therm ocou ples is recognized i n other sta n dards as a v a l i d test tec h n i q u e .
T h e t e m perature l i m its a r e l owered t o com pensate for e rrors t h at c o u l d occ u r i n t h e
constructi o n a n d pl aci n g o f t h e t h e r m o c o u p l e .
S u bclause 1 1 . 2 - F i re p reve ntion
Wit h i n m ost e n v i ro n m e nts where ME EQUIPM ENT i s u s e d , other s o u rces of "fuel" for c o m busti o n
are typi c a l l y far m o re s i g n ifi cant t h a n t h at prov i ded b y t h e ME EQUI PMENT itself. T h e
req u i re m e nts a d d ress i n g fire i n t h i s sta n d a rd focus o n prev e n ti n g t h e ME EQUI PMENT from
be i n g the s o u rce of com busti o n . For this reas o n , th ese req u i re m e nts focus on ME EQUIPMENT
t h at conta i n s or is used i n t h e pres e n c e of OXYGEN RICH E NVIRONMENTS . T h ese re q u i re m e nts
atte m pt to e n s u re t h at a n y potenti a l s o u rce of i g n i t i o n re m ai ns i s o l ated from t h e OXYGEN RICH
E NV I RONME NTS u n de r NORMAL USE and S I NGLE FAULT CONDI TIONS.
Where ME EQUIPMENT i s n ot used in such e n v i ro n m e nts, ass u r i n g t h at t h e l i m its for o pe rati n g

tem peratu res a n d req u i re m e nts f o r overl o a d protecti o n a re m et s h o u l d be c o n s i dered
a d e q u at e .
For ME EQUIPM ENT that c o u l d prov i d e a s i g n ificant s o u rce o f fuel ( i n c o m parison to t h e n o r m a l

o p e rati n g e n v i ro n m e nts ) additi o n a l req u i re m e nts s h o u l d b e prov i d e d b y parti c u l a r sta ndards.
Where n o parti c u l a r sta n dard exists , such iss u es s h o u l d be specifi c a l l y a d d ressed in a p plyi n g
t h e RISK MANAG E M E NT PROCESS as req u i re d i n 4 . 2 .
S u bclause 1 1 . 2 . 1 -St rength and rig id ity req u i red t o p revent f i re i n M E E QU I P M E NT.
At l east a l l el ectrical parts t h at co u l d res u lt in a HAZARD, with t h e except i o n of POWER SUPPLY

CORDS a n d oth e r n ecess a ry i nterco n n ecti n g cords, s h o u l d be e n c l os e d i n m ate r i a l that wi l l n ot
s u p po rt c o m b u sti o n .
T h i s does n o t precl u d e t h e u s e o f a n o uter cov e r o f oth e r m at e r i a l cove r i n g a n i n n e r cover

com ply i n g with the a bove reco m m e n dati o n .
F o r g u i d a nce o n assess i n g fi re HAZARDS , s e e I EC 60695- 1 - 1 [ 1 7] .

6060 1 - 1 © I EC : 20 0 5 - 567 -
S u bclause 1 1 . 2 . 2 - M E EQU I P M E NT a n d ME SYSTEMS used i n conj u n ction with OXYG E N RICH

E NVI RO N M E NTS
Wh i l e n ot a fl a m m a b l e m ixtu re , the pres e n c e of an OXYGEN RICH ENVIRONMENT i n c reases t h e

fl a m m a b i l ity of m a ny s u bsta n c e s . R e p o rts of fi res i n OXY G E N R I C H E NV I RONM ENTS i n
ME EQUIPMENT are u n us u a l . H owever, w h e n s u c h fi res do occ u r i n t h e hos pital e n v i r o n m ent
they c a n have tragic conse q u e n ce s .
M E EQUI PMENT i nte n d e d to operate i n c o nj u n cti o n w i t h a n OXYGEN R I C H E NV I RONMENT s h o u l d be

des i g n e d to m i n i m ize t h e probabil ity o r occ u rr e n ce of i g n it i o n of fl a m m able m at e r i a l s .
W h e r e a p propriate, pa rti c u l a r sta n d a rds s h o u l d specify t h e correspo n d i n g req u i re m e nts.
S u bclause 1 1 . 2 . 2 . 1 a)
Cotton is regarded to be the m aterial with the l owest i g n it i o n t e m p e rature and e n e rgy i n
com pari s o n with e l ectro n i c circu its a n d i t i s ass u m ed that i t c a n b e fo u n d i n t h e i nte r i o r of a
device as dust.
T h e m ax i m u m s u rface tem perat u re l i m it i s bas e d o n t h e m 1 n 1 m u m h otpl ate i g n it i o n

tem perature f o r fi re retardant cotton i n 1 0 0 % oxyg e n t h at i s g i v e n i n N F PA 5 3 [4 1 ] as 3 1 0 ° C .
T h e ass u m pt i o n was t h e refore m ade t h at 3 0 0 o c was a n accepta b l e tem perature l i m it i n
ME EQUIPMENT with OXYGEN RICH E NV I RONME NTS .
T h e worst case c o n diti o n s descri bed i n t h e text m a ke it poss i b l e to prov i d e s i m pl e n u m bers as

l i m itati o n s .
T h e v a l u es f o r s pa rki n g a r e t a k e n f r o m Ko h l , H . -J . et a/. , ASTM S T P 1 3 95 [37].
T h i s s u bc l a use a l l ows t h e use of e l ectro n i c ci rcu its in OXYGEN RICH E NVIRONMENTs only w h e n
t h e i r power s u pply is l i m ited. T h e res i stive l i m itati o n o f t h e power i n put i s n ecess a ry f o r t h e
S I NGLE FAULT CONDI TION o f a n o pe n s o l d e r j o i nt that m i ght s park. T h e s a m e reas o n a pp l i es t o
t h e l i m itati o n o f e n ergy i n capacita n ces a n d i n d u cta nces. I n m ost c a s e s t h e l i m itati o n i n item
4) to 3 0 0 o c i s m o re restrictive than these. For m ost s m a l l c o m p o n e nts l i ke deco u p l i n g
capacitors , o r w h e re t h e fai l u re o f a com p o n e nt causes t h e m ax i m u m possi b l e power t o be
d rawn from the s o u rc e , it i s n ecess a ry to l i m it the powe r to a b o ut 1 W. The PROCE DURE to fi n d
t h e n ecess a ry v a l u e t o l i m it t h e powe r so that t h e 3 0 0 o c l i m it is n ot exceeded c a n b e as
fol l ows :
l o o k for t h e s m al l est c o m po n e nt that c a n m atch to t h e power s o u rce i n a S I NGLE FAULT
CONDI TION;
- esti m ate its thermal resista nce;
- c a l c u l ate t h e power l i m itati o n = 2 0 0 o c I thermal resista n c e .
S u bclause 1 1 . 2 . 2 . 1 b ) 2 )
T h i s ite m a d d resses t h e c o n diti o n o f a n u n d etected oxyg e n l e a k . I n accord a n c e w i t h t h e

defi n it i o n of S I NG LE FAULT SAF E , s u c h a l e a k ( because it i s u n detected ) i s c o n s i dered a NORMAL
CONDI TION (see 4 . 7 ) . S i m i l arly, o n l y the fai l u re of the v e nti l ati o n , w h i c h i s u n detected , n e eds to
'
be considered a NORMAL CON DITION. W h e re a venti l at i o n syste m s desi g n m a kes it u n l i ke l y t h at
it wi l l be co m pl etely b l o c ked i n NORMAL USE, s u c h b l o c kages s h o u l d not be c o n s i d e r e d . T h e
o n l y way to fi n d t h e m ax i m u m l e a k rate t h at n eeds to be c o n s i d e re d i s to fi n d t h e m i n i m u m
l e a k rate t h at c a n safely b e detected by t h e RESPONSIBLE ORGANIZATI O N .
6060 1 - 1 © I EC : 20 0 5 - 569 -
S u bclause 1 1 . 2 . 2 . 1 b) 3)
T h e c a u s e of t h e HAZARDOUS S I TUATION i s : a l e a k occ u rs a n d is n ot detected ; s o m e ti m e l ater

a n el ectrical fai l u re occ u rs t h at sta rts a n i g n i ti o n . The ti m e i nterval tc for ch ecki n g the s e a l s
can be c a l c u l ated as fol l ows :
- esti m ate t h e probabil ity per ti m e Pe of an e l ectrical fai l u re t h at exceeds t h e v a l ues g i v e n i n
1 1 .2.2. 1 a);
- esti m ate t h e probabil ity per ti m e o f t h e oxyg e n l e a k Po ;
- determ i n e t h e accepted probabil ity of d a n gerous fa i l u res per ti m e r ;
- c a l c u l ate: tc = r I ( 0 , 5 x Pe x Po ) .
S u bclause 1 1 . 2 . 2 . 2 - External exhaust outlets for OXYGE N RICH E NVIRO N M E NT
S e r i o u s oxy g e n fi res h ave been reported w h e re t h e i g n i t i o n s o u rc e h as been a fau lty el ectrical

co n n e ctor close to a n oxy g e n o ut l et.
S u bclause 1 1 .3 - Constructional req u i rement for fire ENCLOSURES of ME EQUIPMENT
The requirements for fire ENCLOSURES from I EC 6 1 0 1 0- 1 [22] have been i ncluded pri m arily as an
alternate to the tests related to S I NGLE FAULT CONDITIONS (associated with com bustion and its
conseque nces l isted i n Clause 1 3). By requiring fl a m e resistance for the ENCLOSURE and m aterials
contai ned withi n it, the probabil ity of occurrence of fire escapi ng such ENCLOSURES is considered
m i nimal. Where the fire ENCLOSURE constitutes only a part of the ME EQUIPMENT, careful a n alysis
s h o u l d be perfo r m e d to ass u re t h at a reliable ba rri e r to t h e propagati o n of fi re ex i sts.
S u bclause 1 1 . 4 - ME EQU I P M E NT a n d M E SYSTEMS i n ten ded fo r u s e with flam mable

a n aesthetics
Wh i l e t h e use of fl a m m a b l e a n aesth eti cs is u n c o m m o n , it was determ i n ed d u r i n g t h e writi n g of

t h i s editi o n t h at s o m e MANUFACTU RERS m i ght sti l l want to rate t h e i r ME EQUIPM ENT as
CATEGORY AP o r CATEGORY APG . I n order to m a ke t h i s e d iti o n m o re u s a b l e ( by r e m ov i n g t h e
r a r e l y used s e cti o n o n t h i s t o p i c) wh i l e m a i nta i n i n g t h e avai l a b i l ity o f t h e CATEGORY AP a n d
'
CATEGORY A P G RATI NGS, t h e m aterial has been m oved to a n a n n ex a n d o n l y t h i s c l a use s brief
refe rence to it r e m a i n s i n t h e body of t h e sta n d a rd .
T h e fi n a l determ i n ati o n o f whether ME EQUIPM ENT s h o u l d be RATED CATEGORY AP o r CATEGORY

APG s h o u l d be dete rm i n ed by t h e MANUFACTURER based on t h e I NTENDED USE. R e q u i r e m e nts
related to CATEGORY AP a n d CATEGORY APG are fo u n d i n A n n ex G (see also t h e rati o n a l e fo r
A n n ex G).
S u bclause 1 1 . 5 - M E EQU I P M E NT a n d M E SYSTEMS i n ten ded fo r u s e w i t h flam mable agents
W h i l e it was n ecess a ry to address cases w h e re ME EQUIPMENT is used with fl a m m a b l e age nts

( s u c h as s o m e d i s i nfectants) or i n areas w h e re t h ey a re co m m o n l y used a n d w h e re t h e
MANUFACTURER o f t h e ME EQUIPMENT h as g i v e n n o s pe c i a l h a n d l i n g i nstruct i o n s o r preca uti o n s ,
t h e vari ety o f s u c h a g e nts, t h e i r vol atil ity as we l l as m a n y oth e r dete r m i n a nt factors precl u des
givi n g s pecifi c i nstru cti o n s . The o n l y reaso n a b l e sol uti o n in s u c h cases i s to ass u r e t h at t h e
MANUFACTURER ev a l u ates a n d add resses t h e ass o c i ated R I S K .
A m ixture o f t h e v a p o u r o f a fl a m m a b l e d i s i nfect i o n o r c l e a n i n g a g e nt w i t h a i r c a n be treated

as a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR s u bj e ct to n ati o n a l o r l ocal reg u l at i o n s .
6060 1 - 1 © I EC : 20 0 5 - 571 -
S u bclause 1 1 . 6 . 2 - Overflow in ME EQU I P M E NT
T h e pu rpose of this test is to assess n ot o n l y w h et h e r t h e l i q u i d a ct u a l l y wets a n y pa rts i n a

way t h at w o u l d adversely affect a MEANS OF PROTECTION or result i n a HAZA RD; but a l s o
w h et h e r a s i m i l a r a m o u nt o f l i q u i d t h at c o u l d ov e rfl ow o n a n o t h e r o ccasi o n a n d r e a c h t h e
s a m e pa rts o f t h e ME EQUIPMENT, but poss i bly n ot l a n d i n exactly t h e s a m e w a y , c o u l d
advers e l y affect a MEANS OF PROTECTION o r res u l t i n a HAZARD. T h e res u lts o f the test s h o u l d
b e eva l u ated t o assure they realistically represent co nditi o n s t h at wi l l be ex peri e n ced w h e n
t h e ME EQUIPM ENT i s u s e d .
S u bclause 1 1 . 6 . 3 - S p i l lage o n M E EQU I P M E NT a n d M E SYSTEMS
I n a d d iti o n to ME EQUIPMENT that req u i res the u s e of fl u i ds , m a n y types are exposed to fl u i d

s p i l l s a s part o f t h e i r REASONABLY FORES E EABLE M I S US E S . I n s u ch cases ( as we l l a s for
ME EQUIPMENT req u i ri n g fl u i ds ) the a m o u nt a n d l ocat i o n w h e re s p i l l s can occur vary g reatly.
O n l y a proper ev a l u ati o n of t h e ME EQUIPM ENT bei n g tested c a n determ i n e a n a ppro pri ate
a p pl i cati o n of t h e re q u i re m e nt. D o i n g s u c h an ev a l u ati o n is t h e respo n s i b i l ity of t h e
MANUFACTURER a n d t h e resu lts a r e t o be prov i d e d to th ose perfor m i n g t h e test (ty p i c a l l y i n t h e
RISK MANAGE M E NT F I L E ) . T h i s re q u i re m e nt w o u l d be a n a ppropriate area f o r eval u at i o n by
writers of pa rti c u l a r sta n dards.
Ex a m i n ati o n of t h e NORMAL USE of ME EQUI PMENT s h o u l d prov i d e a n a d e q u ate esti m ate of the
a m o u nt of fl u i d t h at i s l i kely to be s p i l l e d o n it.
S p i l l age for e q u i p m e n t that does n ot req u i re t h e use of fl u i ds i s c o n s i dered to be a S I NGLE

FAULT CONDI TION.
S u bclause 1 1 . 6 . 4 - Leakage
leakage i s c o n s i dered to be a S I NGLE FAULT CONDITION.
S u bclause 1 1 . 6 . 5 - lng ress of water and part i c u l ate m atter i n to M E EQU I PM E NT and
M E SYSTEMS
Alt h o u g h it i s u n l i ke l y t h at ME EQUIPM ENT wo u l d be RATED for protect i o n agai nst parti c u l ate
m atter, I E C 60529 does a d d ress the poss i bi l ity a n d it s h o u l d b e c o n s i d ered a val i d o pti o n .
T h e pres e n ce o f a n y wate r o r parti c u l ate m atte r i ns i d e t h e E NCLOS URE afte r test i n g i n
accord a n c e with its I E C 60529 cl ass ifi cati o n i s regarded a s a NORMAL CONDI T I O N . T h e
req u i re m ent i s t h e refore t o assess t h e poss i b i l ity o f a HAZARDOUS S I TUATION d u e t o s u c h
i n g ress i n c o m b i n at i o n with a poss i bl e S I NGLE FAULT CONDI TION ( s u c h a s a n i nterrupted
PROTECTIVE EARTH CONNECTI O N ) .
S u bclause 1 1 . 6 . 8 - Com pati b i l ity with s u bstan ces u s e d with t h e M E EQU I PM E NT
M E EQUI PMENT, ACCESSORIES a n d parts t h e reof s h o u l d be desi g n ed to be used s afely with t h e

s u bstan ces with w h i c h t h e y a r e i ntended t o co m e i nto co ntact i n NORMAL U S E .
W h e r e a p propriate, pa rti c u l a r sta n d a rds s h o u l d specify t h e correspo n d i n g req u i re m e nts.
S u bclause 1 1 . 8 - * I n terru ption of t h e power s u pply I S UPPLY M AINS to M E EQUIPMENT
I nterr u pti o n of t h e powe r s u pply c o u l d res u l t in a HAZARD d u e to l oss of f u n cti o n a l ity. T h i s

HAZARD i s dealt w i t h i n 7 . 9 . 2 . 4 . R esto rati o n o f t h e powe r s o u rce c a n a l s o res u l t i n HAZARDOUS
S ITUATI ONS . Ex a m ples co u l d i n c l u d e u n i nt e n d e d activat i o n of m ov i n g parts or res u m pt i o n of
d a n gerous outputs . T h e s e pote nti a l l y HAZARDOUS S I TUATION a n d t h e d u rati o n of t h e power
i nterr u pt i o n t h at c o u l d result in the HAZARDS n eed to be c o n s i dered as part of the RISK
6060 1 - 1 © I EC : 20 0 5 - 573 -
I EC 6 1 000-4- 1 1 [2 1 ] d efi nes g e n e ral a n d repro d u c i b l e c o n d it i o n s fo r t h e operati o n of e l ectrical

and e l ectro n i c e q u i p m e nt if they u n dergo voltage d i ps , s h o rt i nterr u pt i o n s and voltage
variati o n s . T h e voltage l ev e l and d u rati o n of s h o rt i nterrupti o n s a re d efi n e d in T a b l es 2 1 0 and
2 1 1 of I EC 6060 1 - 1 -2 : 2 0 0 1 . I E C 6 06 0 1 - 1 -2 treats these s h o rt i nterr u pti o n s as a NORMAL
CONDI TION.
For ME EQUIPMENT in w h i c h t h e s afety of t h e PAT I E NT d e p e n ds o n t h e conti n u ity of t h e powe r ,

parti c u l a r sta n d a rds s h o u l d i n cl u d e req u i re m e nts regard i n g power fa i l u re a l a r m s o r oth e r
preca uti o n s .
Cla use 1 2 - A c c u racy of co ntro l s and i nst ruments and p rotect i o n a g a i n st

h azard o u s o utp uts
I EC 606 0 1 - 1 is the g u i d e l i n e for all parti c u l a r sta n d a rds a n d , t h e refo re, conta i n s o m e
req u i re m e nts o f a m o re g e n e ra l c h a racter i n order t o s e rve t h i s p u rpos e . F o r t h i s reas o n , it i s
n ecess a ry t o h a v e s o m e g e n e ra l l y form u l ated req u i re m e nts i n C l a us e 1 2 .
Sta n d a rdizati o n bodies, i n cl u d i n g t h ose o utsi d e I E C , have a d o pted t h e system of t h i s I EC

p u b l i cati o n i n order to h ave a s i n gl e u n iform system of sta n dards. I n s u c h cases it is m ost
i m porta nt to give a g u i d e l i n e in t h i s c l a u s e .
T h i s c l a use i ntrodu ces t h e c o n c e pt o f USAB I L I TY . T h e t e r m w a s c h o s e n o v e r t h e c o m m o n ly

used terms of " user e rror" or " h u m a n error" because n ot a l l e rrors are t h e res u l t of ove rsi g ht
or c a r e l essn ess on t h e part of t h e OPERATO R of t h e ME EQUI P M ENT. A l l too fre q u e ntly, u s e
errors are t h e di rect result o f poor h u m a n i nterface d e s i g n that s e d uces t h e OPERATO R i nto a n
i n correct decisi o n . U s e e rrors c a u s e d b y i n a d e q u ate USAB I L I TY h a v e bec o m e a n i n creas i n g
cause for concern . T h e USAB I L I TY ENGI NEERING PROCESS descri bed i n I EC 6060 1 - 1 -6 i s
i ntended t o achi eve reas o n a b l e USAB I L I TY , w h i c h i n t u r n is i nt e n d e d t o m i n i m ise u s e e rrors a n d
t o m i n i m i s e u s e associated RISKS .
S u bc l a u se 1 2.4. 1 - I ntentional exceed i n g o f safety l i m its
I f the control range of M E EQUIPMENT i s s u c h that the d e l ivered o utput in a part of the range
c o n s i d erably differs fro m t h e o utput t h at i s regarded as n o n - h az a r d o u s , means s h o u l d be
prov i d e d t h at prevent such a s etti n g o r t h at i n d i cate to t h e OPERATOR (for exa m pl e by m ea n s
o f a n a pparent additi o n a l res i sta n ce w h e n t h e co ntrol is s et o r t h e bypassi n g o f a n i nterlock)
t h at t h e s e l ected sett i n g is i n excess of a s afety l i m it.
Where a p propriate, pa rti c u l a r sta n d a rds s h o u l d s pecify safe output levels.
S u bclause 1 2.4.3 - Accidental selection of excess ive o u t p u t val ues
Protecti o n fo r t h e accide ntal s e l ecti o n of excessive o utput v a l ues can be o bta i n e d by

a p propriate steps to m i n i m ise the poss i bi l ity to accidentally s e l e ct excess ive output, e . g . by
i nterl ocks in o rd e r to a c h i eve d e l i be rate a cti o n o r by s e p a rated o utput term i n a l s . I n
cons i d e r i n g t h e m e as u res for protecti o n , t h e sta n dard o n h u m a n factors co u l d b e take n i nto
accou nt.
Cla use 1 3 - HAZA RDO US SITUATIONS and fa u lt c o n d itions
M E EQUI PMENT o r its pa rts co u l d res u l t i n HAZARDS d u e to a b n o r m a l ope rati o n o r fa u lt

con diti o n s , w h i c h , t h e refo re, n e eds to be i nvesti gate d . Wh i l e t h i s c l a u s e i d e ntifies s pecific
fa u lt c o n d iti o n s , 4.7 req u i res that t h e RISK ANALYS I S be used to i d e ntify ot h e r fai l u res w h i c h
s h o u l d be i nv esti gated.
6060 1 - 1 © I EC : 20 0 5 - 575 -
S u bclause 1 3. 1 . 1 - Gen eral
W h i l e sepa rati o n req u i re m e nts ( CREEPAGE DISTANCES a n d AIR CLEARNACES) a n d i n s u l at i o n

req u i re m e nts are deta i l ed i n C l a u s e 8 , th ese req u i re m e nts s h o u l d n ot be vi ewed as a pplyi n g
o n l y t o RISKS ass o c i ated with el ectrical HAZARDS . I n a d d i t i o n t o t h e pote nti al for el ectri c
cu rrents to cause fibri l l at i o n ( d u e to e l ectric s h ock), these c u rrents c a n a l s o be t h e root c a u s e
o f i nj u ries not di rectly r e l ated to e l e ctric s h ock.
Ex a m pl es of these oth e r HAZARDS ( r e l ated to i n a d e q u ate o r fa u l ty i ns u l at i o n o r s h o rt ci rcu its

across physical spac i n g used as i ns u l ati o n ) c o u l d i n cl u d e s p a rks t h at c o u l d beco m e a s o u rce
of i g n i t i o n of fl a m m a b l e m aterials (as discussed in Clause 1 1 ) o r fu n cti o n a l fa i l u res t h at co u l d
cause a l oss o f ESE NTIAL PE RFORMANCE . I n these cas e s , c o m pl i a nce with t h e i n s u l ati o n
req u i r e m e nts o f C l a u s e 8 s h o u l d always be c o n s i dered evi d e n c e t h at RISKS a ri s i n g from t h e
fai l u re o f i ns u l at i o n o r spaci n g h ave been adeq u ately a d d ressed w h e n eva l u ati n g t h e s afety of
ME EQUI PMENT.
F i n a l ly , it s h o u l d be n oted t h at the re q u i re m e nts for CREEPAGE DI S TANCES and AIR CLEARNACES

are not i nt e n d e d to be re q u i re d at the circuit board l ev e l w h e re th e re i s no s i g n ifi cant RISK t h at
spaci n gs w i l l be c o m pro m ised ( s h o rted) by conta m i n ates (from NORMAL USE or t h e
m a n ufact u r i n g PROCESS) s u c h as fl u i ds o r parti c u l ate m atte r ( s e e a l s o I E C 6 0 5 2 9 ) . I n m ost
a p pl i cati o n s , spaci n g between (fo r exa m ple) circuit board traces a n d c o m po n ent l eads are n ot
c o n s i d ered l i kely to fa i l . I n cases w h e re t h e re is d o u bt as to w h et h e r spaci n g co u l d fai l
(wh eret h e CRE E PAGE DISTANCE a n d A I R CLEARNACE req u i r e m e nts o f 8 . 9 are n ot m et ) , t h e
'
MANUFACTURER s RISK ANALYSIS s h o u l d eva l u ate t h e l i ke l i h ood o f s h o rt i n g across s u c h g a ps ,
but o n l y w h e re s u c h s h o rt-ci rcuiti n g c o u l d di rectly res u l t i n u n accepta b l e RI RKS . W h e re
s h o rti n g across spaci n g or i ns u l at i o n fa i l u res are clearly not l i kely to res u l t i n u n acce pta b l e
RISKS , s u c h a n alysis s h o u l d not be req u i re d .
S u bclause 1 3. 1 . 2 - E m i s s i o n s , d eformation o f E NCLOSURE or exceed i n g m axi m u m

tem perat u re
T h e d e l ivery of u n i nt e n d e d h azardous q u a ntiti es of e n e rgy or s u bsta nces to a PAT I E NT o r i nto
the n atural e nv i r o n m e nt co u l d be addressed by parti c u l a r sta n d a rd s .
H a z a r d o u s q u a ntities o f p o i s o n o u s o r i g n i t a b l e gas d e p e n d o n t h e t y p e o f gas, c o n c e ntrati o n ,

place o f e m i s s i o n etc .
SI NGLE FAULT CONDITIONS t h at m i g h t res u lt i n a s m a l l fi re, but w h ere t h e fi re wo u l d re m a i n

conta i n ed wit h i n a fi re E NCLOS U R E , a r e a cc e ptable because t h e contai n m ent w i l l l i m i t t h e
effects to t h e area i ns i d e o f t h e fi re E NCLOS URE.
At a power dissi pati o n of l ess t h a n 1 5 W i n t h e absence of a n i n c reased oxy g e n c o n c e ntrat i o n

(see 1 1 . 2 . 2 ) , n o fi re HAZARD ex i sts. W h e re ci rcu its c o u l d dissi pate 1 5 W o r g re ater, it s h o u l d
b e d e m o nstrated t h at co m po n e nts with i n s u c h circu its wi l l n ot cause f i r e , m olte n m etal , etc. to
propagate in s u c h a way as to res u l t in a HAZARD ( by setti n g the s u rr o u n d i ngs on fi re for
exa m pl e ) . H owev e r , as in I E C 6 1 0 1 0- 1 [22] , it is c o n s i dered that w h e n s u c h co m po n e n ts are
e n c l os e d in a fi re E NCLOSURE as defi n e d in 1 1 . 3 , a d e q u ate protect i o n from such propagat i o n is
provi d e d .
I t i s f e l t t h at l i m iti n g t h e m axi m u m t e m p e ratu res for APPLI ED PARTS to t h e NORMAL CONDITION

v a l u es is appropri ate because exce e d i n g them is known to res u l t in HARM and t h e PAT I E NT is
fre q u e ntly u n a b l e to pull away.
6060 1 - 1 © I EC : 20 0 5 - 577 -
S u bc l a u se 1 3. 2 . 9 - I n te r r u ption and s h o rt c i rc u i t i n g of motor capacitors
T h e effect of f u n cti o n i n g ce ntrifu g a l switch e s c a n be ta k e n i nto accou nt. A l ocked rotor

con diti o n is specifi ed beca u s e s o m e capacitor m otors m i ght o r m i ght n ot start, ca u s i n g
v a r i a b l e resu lts . Ca pacitor voltage is c h ecked t o ass u r e t h at its d i e l ectri c wi l l n ot be stress e d
caus i n g t h e accu m u l at i o n o f h a z a r d o u s gases i n c l u d i n g hydrog e n .
Wh i l e t h e s h o rt circuit o r o p e n circuit of t h e ca pacito r i s a S I NGLE FAULT CONDI TION a n d l oc ki n g

o f t h e rotor is a l s o a S I NGLE FAULT CONDI TION (see 1 3 . 2 . 8) t h i s i s regarded as a n i nsta n c e of
t h e situati o n refe rred to i n 4 . 7 , where o n e S I NGLE FAULT CONDI TION c a n res u l t u n avoida bly i n
a n ot h e r S I NGLE FAULT CONDI TION a n d t h e two fa i l u res are co n s i dered a s o n e S I NGLE FAULT
CONDI TION.
S u bclause 1 3. 2 . 1 0 - Ad d it i o n a l test criteria fo r motor ope rated M E EQUIPMENT a n d Table

26, last l i n e
T e m perature l i m its o f m otor wi n d i n gs i n ME EQUIPMENT a r e dete r m i n ed after t h e fi rst h o u r a s

a n a rith m et i c av erage because ex p e r i e n c e o f test h o uses has s h own t h at ME EQUIPM ENT for
n o n-CONTI NUOUS OPERATION reaches v a r i a b l e v a l ues that c o u l d t e m porarily d iffer from t h e
m ax i m u m v a l u e s . T h e refo re, l ower t e m perature l i m its are re q u i re d . T h e v a l ues i n T a b l e 26 are
based o n t h e req u i re m e nts of I E C 60950- 1 : 2 0 0 1 .
S u bclause 1 3. 2. 1 3. 1 - G eneral overload test co nd itions
T h e b a l l pres s u re test i s n ot i ntended to repres e nt t h e exact c o n d it i o n s expe r i e nced in use.

T h e test i s perfo r m e d at e l evated te m peratu res to test t h e rob ustn ess ( a d e q u ate safety factor)
of the m e c h a n ical properties of the i ns u l ati o n . The pri nci p l e i s n ot u n l i ke d i e l ectri c withsta n d
test i n g w h i c h s u bj e cts i ns u l at i o n to v o ltages far i n excess o f t h o s e s e e n i n u s e .
S u bclause 1 3. 2 . 1 3. 4 - M E EQUIPMENT RAT E D for n o n -CONTINUOUS OPERATION
Where ME EQUIPM ENT o r parts t h e reof are RATED for n o n-CONTI NUOUS OPERATI ON but controls
a l l ow OPERATORS to l eave it in o p e rati o n ( s h o u l d a m ed i c a l o r other e m e rg e n cy occ u r ) , the
CONTI NUOUS OPERATI ON of the ME EQUIPMENT is c o n s i dered reas o n a b l y fores e e a b l e m i s u s e .
Where s afety is d e p e n d e n t o n switc h i n g t h e ME EQUI PMENT o r parts t h e reof off after a
prescri bed period, ste ps s h o u l d be take n to ass u re t h at i ntenti o n al acti o n is not req u i re d to d o
SO.
Cla use 1 4 - P ROGRA M MABLE ELECTRICAL M E DICAL SYSTEMS ( PEMS)
C o m pute rs are i n creas i n g l y used in ME EQUIPM ENT, often in s afety-critical roles. T h e use of
com puti n g tech n o l o gi es i n creases the l evel of c o m p l ex ity in ME EQUIPM ENT. T h i s co m pl exity
m ea n s t h at syste m at i c fai l u res c a n escape t h e practical l i m its of testi n g . Accordi n gly, t h i s
c l a u s e g o e s beyo n d t ra d iti o n a l test a n d m easu r e m e nt o f the fi n i s h e d ME E Q U I P M E N T a n d
i n cl u des req u i re m e nts for t h e PROCESSES b y w h i c h it i s dev e l o pe d . Testi n g o f t h e fi n i s h e d
product is n ot, b y its elf, a d e q u ate to a d d ress t h e s afety o f PROGRAMMABLE M E EQUIPMENT.
For these reaso n s , t h i s clause req u i res t h at a PROCESS with s p e cifi c e l e m e nts be esta b l i s h e d
a n d fo l l owe d . T h e i nte nti o n i s to esta b l i s h t h e s e s pecifi c PROCESS e l e m e nts, l eavi n g t h e u s e r
o f this c l a use to d eterm i n e i n det a i l how to acco m pl i s h t h e m . T h i s i s s i m i l a r to t h e a p proach
take n in t h e I SO 9000 series. Because users of this c l a u s e a r e ex pected to be q u a l ified to
perform the i d e ntifi ed activities, d eta i l h as been kept to a m i n i m u m .
6060 1 - 1 © I EC : 20 0 5 - 579 -
Wh i l e ite rati o n of s o m e e l e m e n ts of t h e PROCESS is ex pecte d , n o s pecifi c req u i re m e nts to do

so h ave been i n cl u d e d . T h ese req u i r e m e nts were o m itted because t h e n eed to repe at
PROCESSES or porti o n s of t h e m is u n i q u e to each parti c u l a r dev i c e . I n additi o n , t h e n e e d for
s u c h iterat i o n wi l l arise from the m o re deta i l ed u n de rsta n d i n g t h at e m erges d u r i n g the desi g n
PROCESS.
Because u s e rs of this sta n dard are re q u i re d to esta bl i s h , m a i ntai n and a p ply a RISK
MANAG E M E NT PROCESS as part of co m pl i a n c e , t h i s c l a u s e est a b l i s hes those c h a racte ristics
u n i q u e to progra m m a b l e syst e m s that s h o u l d be c o n s i d ered as p a rt of t h at PROCESS.
T h e effecti v e a p pl i cati o n of Clause 14 w i l l req u i re , s u bj ect to t h e task i n h a n d , com pete n c e in

t h e fol l owi n g :
a p pl i cati o n o f t h e s pe cific ME EQUIPM ENT with e m p h as i s o n s afety c o n s i de rati o n s ;
ME E Q U I P M E N T dev e l o p m e n t PROCESS;
m et h o ds by w h i c h s afety is ass u re d ;
- tech n i q ues of RISK ANALYSIS a n d RISK CONTROL.
R e q u i r e m e nts h av e b e e n m i n i m ized to th ose t h at are essential to ass u ri n g BAS I C SAFETY a n d

ESSENTIAL PERFORMANCE . T h i s has been d o n e i n recogn iti o n of t h e extensive a n d g rowi n g
l iteratu r e i n t h e f i e l ds o f software ass u ra n c e a n d RISK ASSESSMENT tech n i q u e s as we l l as t h e
rapid ev o l ut i o n o f this d i s ci pl i n e .
S u bclause 1 4. 1 - General
T h i s sta n d a rd re q u i res t h e appl i cati o n of a RISK MANAGE M ENT P ROCESS in accord a n c e with
I SO 1 4 9 7 1 . This is parti c u l a rly relevant to PEMS , because of the d iffi c u l ty of s h owi n g the
correctness of s oftware o r c o m p l ex h a rdwa re. T h e refore t h e d esi g n of a PEMS h as to be
perfo r m e d wit h i n a RISK MANAG E M E NT PROCESS, in which RISK CONTROL m eas u res are r e l ated
to the RISKS bei n g control l e d . If the appl i cati o n of I SO 1 497 1 s h ows t h at a PESS has the
pote ntial to contri bute to a HAZARDOUS S I TUATI O N , and n o n-software RISK CONTROL m eas u res
ext e r n a l to t h e PESS have not reduced t h e RISK to a n acce pta b l e l evel , C l a u s e 14 adds extra
RISK MANAG E M E NT a n d l ife-cycle PROCESSES for the PEMS.
C o m p l i a n c e VERI F I CATI O N req u i res t h e MANUFACTU RER ' s i nt e r n a l assess m ent to cover not o n l y
t h e re q u i re m e nts o f t h i s c l a u s e b u t a l s o t h o s e o f I SO 1 4 9 7 1 .
C o m pl i a nce with t h e req u i re m e nts of C l a u s e 1 4 is j u dged by exam 1 n 1 n g t h e d o c u m e ntat i o n

produced b y t h e PROCESSES req u i red i n t h e v a r i o u s s u bc l a u se s . C l a use 1 4 s h o u l d be a p pl i e d
a s a w h o l e a n d n ot s e l ectively. A l l o f t h i s docu m e ntati o n is req u i red t o b e i n t h e RISK
MANAG E M E NT FILE .
T h e c o n c e pt of assess m e nt has been i ntrod u ced i n t h e c o m p l i a nce stat e m ent to a l l ow for

m et h o ds oth e r t h a n i ns pecti o n where n ecess a ry, s u c h as a u dit. T h u s , a l th o u g h there i s n o
g e n e ra l re q u i re m ent for t h e MANUFACTU RER t o o p e rate a q u al ity m a n a g e m e n t system i n
accord a n c e with I SO 1 34 8 5 [30], certa i n featu res o f s u c h a s ystem are n ecess a ry. O n e
feat u re that is c o m m o n l y regarded a s ess e nti a l for a q u a l ity m a n a g e m e nt system t o be
effective i s a PROCESS of a u d i t and review perfo r m e d wit h i n the o r g a n isati o n to confirm t h at it
is act u a l l y fol l owi n g its own PROCEDURES ; t h i s i s separate from a n y exte r n a l asses s m e n t t h at
co u l d be perfo r m e d to d e m o nstrate co m pl i a n c e with sta n d a rds or regul atory re q u i re m e nts .
T h i s sta n d a rd , t h e refo re, req u i res t h at t h e MANUFACTURER not o n l y d o c u m e n t certa i n as pects
of the des i g n PROCESS but a l s o ca rry out an assess m e nt to co nfi rm that the re q u i re m e nts of
t h i s c l a u s e have been fol l owe d .
6060 1 - 1 © I EC : 20 0 5 - 581 -
S u bclause 1 4. 2 - Docu mentation
The ex pected way by which c o m p l i a n ce with PROCESS req u i re m e nts c a n be dete r m i n ed i s by

ass u r i n g t h at t h e doc u m e ntat i o n req u i red for each PROCESS ste p has been g e n e rated. W h i l e
m ost of t h e re q u i re m e nts o f I SO 1 49 7 1 a r e c r u c i a l c o m po n e nts of a n a d e q u ate software l ife
cyc l e , C l a u s e 1 4 conta i ns m a n y additi o n a l PROCESS steps not req u i red by t h at sta n da r d .
T h e refo re, t h e doc u m e ntati o n that these additi o n a l PROCESS ste ps ( i n C l a use 1 4 ) req u i re i s
n ecess a ry fo r a certifi cat i o n b o d y to determ i n e t h at t h e PROCESS ste ps h a v e been perfo r m e d .
B e c a u s e C l a u s e 1 4 a d d resses t h o s e RISKS ass ociated with P E M S , t h i s d o c u m e ntati o n is
req u i red to be i n c l u d e d in t h e RISK MANAG EMENT F I L E .
S i n c e c o m p l i a nce with C l a u s e 1 4 is dete r m i n e d b y i ns pecti o n a n d assess m e nt to a s s u r e t h at

t h e req u i red doc u m e ntati o n has been g e n e rated, t h e q u a l ity a n d a c c u ra cy of these d o c u m e nts
is i m po rta nt. Because d e m o n strati o n of t h e s afety of a PEMS d e pe n ds on docu m e ntati o n , a n
effective system i s needed t o e n s u re t h e i nteg rity o f t h e d o c u m e ntati o n a n d , i f d iffe rent
vers i o n s of a d o c u m ent exist, to i d e ntify the a ppl i ca b i l ity of each vers i o n . T h e refore it is
req u i red t h at t h e d o c u m e nts be g e n e rated , revised and m a i ntai n ed u n der a fo r m a l d o c u m ent
control syst e m . MANUFACTURERS s h o u l d ass u r e t h at this d o c u m e ntati o n is clear and
com prehe nsive to ass i st in t h e assess m e nt PROCES S .
S u bclause 1 4. 3 - RISK MANAG E M ENT plan
I SO 1 497 1 req u i res t h at a RISK MANAGE M ENT pl a n be prepared and m a i nta i n e d i n t h e RISK
MANAG E M E NT FILE .
I n additi o n to e l e m e n ts of t h e RISK MANAG E M E NT p l a n req u i red by I S O 1 4 9 7 1 , a PEMS

VAL I DATION plan i s re q u i re d beca u s e v a l i d ati o n i s seen as a n e cessary activity w h e n
deve l o p i n g a P E M S .
S u bclause 1 4. 4 - P E M S DEVELOPMENT L I F E -CYCLE
A docu m ented l ife-cyc l e h e l ps e n s u re t h at safety i s s u es are c o n s i dered t h ro u g h o ut a

product's deve l o p m ent. T h i s is i m porta nt for a l l products a n d it is vital for P E M S . Safety c a n n ot
be added to a PEMS after it has been dev e l o pe d . Two reas o n s for t h i s are as fo l l ows .
a) T h e act u a l PROCESSES used i n t h e devel o pm e nt of a PEMS, a n d t h e q u a l ity a n d r i g o u r of

those PROCES S E S , a re d e c i d e d as a res u l t of RISK ASSESSMENT. If it is discovered l ater o n
t h at i n a ppropriate PROCESSES were used o r t h at i n a d eq u ate q u a l ity a n d r i g o u r were
a p pl i e d , t h e n the devel o p m ent wi l l have to be re peated with c o rrect PROCES S E S .
b) C h a nges m ade at a l ate s t a g e i n t h e P E M S DEVELOPMENT L I FE-CYCLE a re l i kely to b e

ex pensive ( both i n ti m e a n d m o n e y ) . T h i s i s pa rti c u l a rly t r u e if a syste m req u i re m e n t i s
i n correct o r m i s s i n g . Syste m arch itect u re c a n a l s o be v u l n e r a b l e to l ate c h a n ges. Ofte n ,
t h e arch itect u re i s part o f the safety cas e . Late c h a nges c a n re q u i re s i g n ificant rework i n
order t o m a i ntai n t h e i ntegrity of a n arch itectu ral s o l uti o n .
Framework
A l ife-cycle for t h e d ev e l o p m e n t of a prod u ct prov i des a fram ework that a l l ows t h e n ecessary
safety a ctivities to take place i n a t i m ely a n d syste m at i c m a n n e r . It s h o u l d n ot i m pose
u n n ecess a ry restri cti o n s and it s h o u l d e n s u r e that a l l t h e req u i re d s afety activ ities take p l a c e .
T h e l ife-cycle n e eds to be d e c i d e d e a rl y . D iffe rent l ife-cycle m od e l s are accepta b l e .
C l a use H . 2 ex p l a i n s PEMS DEVELOPMENT LIFE-CYCLES i n m o re deta i l . I EC 6 2 3 0 4 [ 2 6 ] descri bes
t h e PROCESSES to be i n c l u d e d in t h e s oftware dev e l o p m e n t l ife-cycle for t h e devel o p m ent of
safe m ed i c a l device softwa re.
6060 1 - 1 © I EC : 20 0 5 - 583 -
Milestones and activities
T h e req u i re m e n t fo r m i l esto n es , a n d activities with i n p uts a n d outputs for e a c h , e n s u res that

due c o n s i d e rati o n i s g i v e n t o :
- t h e a ctiviti e s ,
- w h at n e eds to be d o n e before t h e activity c a n start, a n d
- w h at t h e activity n e e ds to prov i d e ,
so t h at VERI F I CATI O N o f t h e res u lts c a n be perfo r m e d .
T h e s e q u e n c e o f activities i n t h e l ife-cycle i s req u i red to be defi n e d i n t e r m s o f m i l esto nes

because t h i s offers t h e greatest fl ex i bi l ity to t h e MANUFACTURER. N o req u i re m e n t i s m a d e
conce r n i n g t h e n u m be r o r nature o f t h e m i l esto n e s , n o r is t h e re a n y i m p l i cati o n t h at a l l proj ect
activities h ave to pass t h r o u g h t h e m i l esto n es si m u lt a n e o usly. T h i s sta n d a rd has not used t h e
term " ph ases" alth o u g h t h i s term w a s used i n I EC 6060 1 - 1 -4 [ 1 4] . T h e term has been avoi d e d
because it i s d iffi c u l t to ex press c o n c u rr e n cy a n d ove r l a p i n a p h ase m o d e l .
I n a g o o d l ife-cycl e :
- t h e n eces s a ry activities a re defi n e d i n advance of thei r perfo r m a nce;
- t h e PROCESSES used i n dev e l o p m e n t activities c o u l d be s pecified as a n outc o m e of RISK
MANAG E MENT;
- t h e s e q u e n c e of activities is defi n e d so as to e n s u re t h at n ecessary i n p uts to a n activity
are ava i l a b l e befo re t h e activ ity starts;
criteri a are defi n e d for deci d i n g w h eth e r t h e activity h as been satisfactorily co m pl eted; a n d
accou nta b i l ity i s faci l itated.
Activities are d efi n e d in terms of i n puts and o utputs because it i s si m pl e to m easure whet h e r
t h o s e i n p uts a n d outputs exist. T h e MANUFACTURER i s res p o n s i b l e f o r d e ci d i n g h ow t h e
m i l esto nes are a c h i eved a n d h ow t h e req u i red doc u m e ntati o n i s p r o d u c e d .
I n order to d eterm i n e whether each activity h as been s atisfacto rily com pleted, it is req u i red
t h at t h e criteri a for VERI F I CATION of each activ ity be defi n e d . VERIFICATION exa m i n es w h et h e r
t h e i n puts h ave b e e n tra nsfo r m e d i nto t h e o utputs com pletely, co rrectly a n d accord i n g to t h e
req u i red PROCESS . N o req u i re m ent is m a d e c o n cern i n g t h e ty pe o r extent o f VERI F I CATI O N ,
except fo r VERI F I CATI ON of RISK CONTROL m e as u res a n d ESSENTIAL PE RFORMANCE (see 1 4 . 1 0) .
S u bclause 1 4. 5 - P roblem reso l u tion
Where a p propriate, a d o c u m ented system for pro b l e m reso l ut i o n is req u i red by t h i s sta n d a rd .
P r o bl e m s can arise:
- with t h e product;
- wit h i n a PROCESS;
betwe e n PROCES S E S .
Ex a m pl es o f pro b l e m s a r e :
i n co n s istent req u i re m e nts;

a m bi g u o u s req u i re m e nts;
m i ssi n g s pecifi cati o n s ;
c a d i n g e rrors;
i n co rrect o p e rati o n of the PEMS.
6060 1 - 1 © I EC : 20 0 5 - 585 -
A syst e m for pro b l e m reso l ut i o n is n e e d e d to e n s u re that w h e n a problem arises, its i m pact o n

HAZARDS a n d t h e i r cons e q u e nt RISK i s m a n a g e d . A d h o c m ethods for res o lv i n g pro b l e m s can
u n de rm i n e t h e ben efits o btai n e d by u s i n g a system atic l ife-cy c l e approach. An appropriate
place to d o c u m e n t the system for probl e m reso l ut i o n i s as part of the PEMS DEVELOPMENT LIFE
CYCLE.
S u bclause 1 4. 6 . 1 - I d e n t ification of known a n d fo reseeable HAZARDS
PEMS have extra i n itiati n g causes for HAZARDS .
S u bclause 1 4. 6 . 2 - RISK CONTROL
As t h e choice of t h e PROCEDURES and tools used by a MANUFACTURER for t h e deve l o pm e nt of a

PEMS wi l l be i nfl u e n ced by m a ny factors , t h i s s u bc l a u s e req u i res t h at o n e of t h e facto rs for t h e
c h o i c e is t h e RISK reducti o n req u i red f o r t h e RISK CONTROL m ea s u r e . A RISK CONTRO L m ea s u r e
t h at i s developed usi n g PROCEDURES a n d t o o l s t h at are k n own to be good i s m o re l i kely to
ca rry out its i ntended fu n cti o n s than one deve l o ped u s i n g PROCEDURES a n d tools t h at are of
u n k n own q u a l ity.
S u bclause 1 4. 7 - Req u i re m e n t s pecificat ion
RISK CONTROL m e as u res are used to control t h e RISK of i de ntifi e d HAZARDS . T h e re q u i re m e nts
for these m eas u res are d o c u m e nted i n req u i re m e n t s pecifi cati o n s . T h e req u i re m ent s h o u l d
both specify w h at t h e m ea s u r e does a n d h o w we l l it does i t . I SO 1 4 9 7 1 does n ot d e m a n d a
req u i re m e nts s pecificati o n .
Verifiable requirem ents
R e q u i r e m e nts s h o u l d be verifi a b l e . T h i s a pp l i es to both t h e f u n cti o n of t h e RISK CONTROL

m eas u re a n d how l i ke l y it is to perform co rrectly. Q u a ntitative V E R I F I CATI ON of fai l u re rates i s ,
g e n e ra l ly, i m practical fo r softwa re. VERI F I CATI ON o f a q u a l itative a p proach wo u l d be by
ve rifyi n g t h at t h e appropriate PROCESSES were u s e d .
Identifiable safety requirements
T h e req u i re m ent to d i sti n g u i s h t h e RISK CONTROL m e a s u res a n d ESSENTIAL PE RFORMANCE is

needed to e n s u re t h at they are i m pl e m e nted and to e n s u re that if t h e re is a n e e d to c h a n g e
t h e ESSE NTIAL PE RFORMANCE o r a RISK CONTROL m eas u re , t h e i m pact o f t h e c h a n g e o n t h e
RESI DUAL RISK c a n be ass essed.
De com position
Ex a m pl es of a PEMS structure are s h own i n A n n ex H . Req u i re m e nts to i m pl e m ent t h e RISK

CONTROL m eas u res s h o u l d be s pecifi e d for t h e PEMS and for a ny PESS that i m pl e m e nts o r
pa rti a l l y i m pl e m e nts o n e o r m o re RISK CONTROL m eas u re . T h i s c a n be i n a s i n g l e docu m e nt o r
i n s e v e r a l d o c u m e nts .
S u bclause 1 4. 8 - Arch itect u re
An architect u re s pecifi cati o n is n ot req u i red by I S O 1 4 9 7 1 . It is a n additi o n a l re q u i re m ent for

PEMS beca u s e :
oft e n t h e arch itect u re c h o s e n wi l l be part o f a RISK CONTROL m e a s u r e . R I S K CONTROL
m e as u res n e e d to be ex pl i cit for com p l ex syst e m s s u c h as a P E M S ;
arch itect u re s pecificati o n s are r e c o g n i z e d as a n e cess a ry part o f a good s oftware
devel o p m ent PROCESS s u c h as i s re q u i re d for a PEMS.
6060 1 - 1 © I EC : 20 0 5 - 587 -
T h e re is a l i st of arch itect u re features for i n c l u s i o n i n t h e s pecifi cati o n where a p propriate. T h i s

l ist has been s e l ected because i n part i c u l a r c i rc u m stances o n e o r m o re o f t h e featu res c o u l d
be used t o co ntrol t h e RISK o f a HAZARD. F o r ex a m pl e , t h e u s e o f a COMPONENT W I T H HIGH
I NTEGRITY CHARACTE RISTICS wi l l effectively rem ove a n y RISK t h at wo u l d res u lt from t h e fai l u re
of t h at c o m p o n e nt.
S u bclause 1 4. 8 e)
P a rtiti o n i n g of f u n ct i o n a l ity c a n be u sefu l w h e n t h e re is a s i g n i f i c a nt n eed for rigorous safety

v a l i d at i o n of PEMS.
T h e software (fi rmware and appl i cati o n l ayers) i s disti n ctly divi d e d i nto critical , n o n-criti cal
and s u perviso ry secti o n s . Partiti o n i n g is used so t h at t h e i nstructi o n s a n d data of t h e criti cal ,
n o n-criti cal a n d s u p e rv i s o ry s e cti o n s do n ot i nterfere with e ach oth e r a n d t h at there i s
separati o n o f duties a m o n g t h e s e ct i o n s o f t h e softwa re. I f t h e r e i s n o separati o n o f duties
a m o n g t h e s e ct i o n s of t h e softwa re, all s oftwa re s h o u l d be defi n e d as criti c a l , to m a ke s u re
t h at t h e a n alysis has taken i nto c o n s i d e rati o n t h e c riti cal s e ct i o n of t h e s oftwa re.
R e q u i r e m e nts for s e p a rati n g critical code from n o n -criti cal code i n c l u d e RISK ASSESSMENT of
t h e e ntire syst e m , RISK CONTROL strat e g i es e m ployed, a n alysis of physical reso u rces a n d a n
a n alysis o f l o g i c a l pro perties ( e . g . , control a n d d ata c o u p l i n g ) . I n g e n e r a l , partiti o n i n g s h o u l d
separate a n d i s o l ate t h e safety- related fu n cti o n a l ity f r o m t h e n o n-s afety- r e l ated fu n cti o n a l ity
i n t h e des i g n a n d i m pl e m e ntati o n . T h i s PROCESS can m i n i m iz e , o r at l e ast reduce, t h e
VERI F I CATI ON n ecess a ry to ass u re t h at d ata s h a red b y o r pass e d t o t h e criti cal secti o n does
not affect the s pecifi ed operati o n of t h e s afety critical code.
P a rtiti o n i n g i n c l u des t h e fo l l owi n g steps :
a) i d e ntifi cati o n of criti ca l , n o n-criti c a l a n d s u perviso ry s e cti o n s . T h e m ea n s of i d e ntifi cati o n

d e p e n ds u po n t h e m o d u l a rity o f t h e c o d e , t h e progra m m i n g l a n g u a g e , t h e c o d e d e s i g n a n d
oth e r s pecificat i o n attri butes;
b) descri pti o n of the i nterfaces between t h e critical and n o n-criti c a l s e cti o n s :

1 ) i d e ntifi cati o n o f d ata o r vari a bl es g l obal to t h e critical a n d n o n-criti cal secti o n s ,
m o d u l e s , etc . , i d e ntifi ed i n ste p a ) ;
2) i d e ntifi cati o n o f a n y param ete rs t h a t are passed between critical a n d n o n-criti cal
secti o n s , m od u l es , etc. , i d e ntifi ed in step a);
3) descri pt i o n of t h e fl ow of t h e d ata, v a r i a bles o r param eters i d e ntifi ed in steps b) 1 ) a n d
b) 2);
4) descri pt i o n o f t h e m e c h a n i s m w h i c h is u s e d t o prevent d ata corr u pti o n , ove rwriti n g o r
oth e r e rrors o f t h e a bove i d e ntifi ed data , v a r i a bl es o r p a r a m eters w h i c h w o u l d affect
safety criti cal perform a n c e ;
c) v a l i d at i o n o f t h e i nteg rity o f t h e partiti o n . T h i s c a n be acco m p l i s h e d b y fu n cti o n a l testi n g

a n d stress testi n g tec h n i q u e s .
S u bclause 1 4. 8 g ) to n)
T h e re i s a l i st of items to be taken i nto consi derati o n in t h e arch itecture s pecifi cati o n . This l i st
has been s e l ected because each of these ite m s co u l d i nfl u e n c e t h e c h o i c e of architect u r e .
S u bclause 1 4. 9 - Des i g n and i m pleme ntation
T h e tec h n ical s o l ut i o n s chosen n e e d to be defi n e d . I t i s ofte n a p pro pri ate to decom pose a
PEMS i nto s u bsyste m s . F i g u re H . 1 s h ows ex a m ples of PEMS/ PESS str u ctu res with d iffe rent
a m o u nts of decom positi o n . Reasons for d e co m pos i n g a PEMS c o u l d i n cl u d e t h e fol l owi n g .
6060 1 - 1 © I EC : 20 0 5 - 589 -
Keeping the complexity of subsystems manageable
T h e l ess c o m p l ex t h e system t h e eas i e r it is to u n de rsta n d a n d c o n s e q u ently easi e r to desi g n

a n d t h e n m a i ntai n . T h e res u lti n g des i g n is m o re l i ke l y to be correct a n d e a s i e r to test. C o d i n g
sta n d a rds s h o u l d specify l i m its f o r co m pl ex ity.
Architecture
T h e system arch itect u re co u l d m a ke it l og i c a l to separate syste m s e . g . if diverse syste m s are

n e e d e d they s h o u l d be i m pl e m e nted as d i sti n ct s u bsyst e m s .
Mo dularity
M o d u l a rity c a n fac i l itate t h e prov i s i o n of d iffe rent system o pti o n s , reuse of a n existi n g prov e n
s u bsystem a n d t h e exte n s i o n o f system f u n cti o n a l ity.
Physical components
A s e n s i b l e d i v i s i o n of phys i c a l s u bsyste m s wi l l h e l p t h e d i a g n os i s a n d repa i r of h a rdwa re

fa u lts .
Different technologies
Often diffe rent e n g i n ee rs w i l l i m p l e m ent t h e h a rdwa re a n d t h e s oftware des i g n . I n t h i s case

s pecifyi n g each as a s e p a rate s u bsyst e m wi l l e n a b l e each to be i m pl e m e nted i n d e pe n d ently.
T h e overall system wi l l only fu n ct i o n co rrectly if each of its constituent s u bsyste m s has been
a d e q u ately s pecifi e d . T h i s l e ads to t h e req u i re m e n t for a design s pecifi cati o n for each
s u bsyste m . A design s p e cificati o n for a s u bsyst e m wo u l d typi c a l l y i n c l u d e a d eta i l e d i nterface
s pecifi cati o n , a n d co u l d i n c l u d e i m pl e m e ntati o n d eta i l s , e . g . a l g o r i th m s .
E a c h s u bsystem s h o u l d b e tested t o s h ow that t h e d e s i g n specificati o n h a s b e e n correctly

i m pl e m ented. T h i s l eads to the req u i re m ent for a test specifi cati o n for each s u bsyste m .
T h e des i g n a n d test s pecificat i o n s c a n b e docu m e nted i n w h atever fo r m i s pract i c a b l e , e . g .

they c a n b e separate docu m e nts o r they c a n b e c o m b i n e d i n a l a rger d o c u m ent. T h e d e s i g n
s pe cifi cati o n a n d t h e test s pecificat i o n f o r e a c h s u bsyste m s h o u l d be i d e ntifi a b l e .
Ex a m pl es o f t h e e l e m e nts o f the des i g n e n v i r o n m e n t a r e g i v e n i n H . 4 a ) . S u c h e l e m e nts wi l l

h a v e a n i nfl u e n c e o n t h e q u a l ity a n d co rrectn ess of t h e d es i g n . S o m e e l e m e nts wi l l h a v e b e e n
i d e ntified as t h e s u itably val i d ated t o o l s a n d PROCEDURES (see 1 4 . 6 . 2 ) . T h e desc ri ptive data
regard i n g the des i g n e n v i r o n m e n t fac i l itates VERI F I CATION t h at t h e s u itably v a l i d ated tools a n d
PROCEDURES h ave been u s e d .
S u bclause 1 4. 1 0 - VERIF ICATION
I SO 1 4 9 7 1 req u i res VERI F I CATI ON of RISK CONTROL m ea s u res. There are a d d iti o n a l
req u i re m e nts f o r P E M S . T h e s e a r e t h at:
- t h e ESSENTIAL PERFORMANCE is verifi e d ; a n d
- there is a VERI F I CATI ON pl a n .
ESSENTIAL PE RFORMANCE i s s i g n ificant for PEMS because t h e PEMS uses a PESS t o control its
f u n cti o n s . EssENTIAL PERFORMANCE wi l l oft e n d e p e n d on the PEMS fu n ct i o n s be i n g carried out
correctly.
6060 1 - 1 © I EC : 20 0 5 - 591 -
A VERI F I CATI ON pl a n l eaves it u p to t h e MANUFACTURER how to a c h i eve t h e req u i re m e nts of t h i s

c l a u s e . T h i s is a better a n d m o re flex i bl e a p p r o a c h t h a n s pecifyi n g how to ve rify a P E M S i n t h i s
c l a u s e . T h e MANUFACTU RER i s res pons i bl e f o r pl a n n i n g t h e VERI F I CATION S O t h at it i s
a d e q u ately t h o r o u g h a n d t h e n to i m pl e m ent t h e pl a n .
T h e req u i re m e n t l ists activities t h at affect t h e t h o ro u g h n ess o f t h e VERI F I CATI ON a n d w h i c h

n e e d to be p l a n n ed .
S u bclause 1 4. 1 1 - PEMS VALI DATIO N
T h e fi n a l p h a s e o f a n y P E M S DEVELOPMENT L I F E -CYCLE m odel i s P E M S VAL I DATION. PEMS

VAL I DATION is i ntended to assure t h at t h e r i g ht product i s b u i lt. Va l i d at i o n i s i m porta nt for PEMS
because u n ex pe cted i nte racti o n s betwe e n f u n ct i o n s m i ght occ u r t h at c a n only be discovered
by v a l i dat i o n .
P E M S VAL I DATION c a n i n c l u d e tests f o r a h i g h v o l u m e o f data, h e avy l oads o r stresses, h u m a n

facto rs , secu rity, perform a n c e , confi g u rati o n c o m pati b i l ity, fault testi n g , doc u m e ntati o n a n d
safety.
I n d e p e n d e nce is n eeded to avo i d co nfl i cts of i nte rest a n d because the ass u m pt i o n s of t h e
des i g n e r s h o u l d not i nfl u e n c e o r l i m it t h e exte nt o f t h e PEMS VALI DATION. Exam ples o f level of
i ndependence i nclude:
separate pers o n ;
separate m a n a g e m ent;
separate organ izati o n .
S u bclause 1 4. 1 2 - M od i fication
Ty pical l y t h e des i g n of a PEMS i s n ot c o m p l etely n ew but i s partly o r ev e n l a rgely d e rived from

e a r l i e r des i g n ( s ) . Neverth e l es s , it m i g ht be poss i bl e to treat t h e d e s i g n as if it were co m pl etely
new and to est a b l i s h t h e RISK MANAG E M E NT report and d e m o n strate c o m p l i a n c e with the
req u i r e m e n ts of t h i s sta n dard wit h o ut refe r e n ce to prev i o u s d o c u m e n tati o n . I f h oweve r t h e
RISK MANAG E M E NT report d o e s n e e d to i n cl u d e s o m e i nfo rm at i o n from t h e docu m e ntati o n o f t h e
prev i o u s des i g n ( s ) , it i s t h e n n e cessary to co nfi rm t h at a l l s u ch i nfo r m at i o n re m ai ns val i d
des pite t h e c h a n ges i ntroduced i n t h e n e w des i g n .
S u bclause 1 4. 1 3 - Con nection of a PEMS b y NETWORK/DATA COUPLING t o other eq u i pm ent
Many h ospitals are o p e rati n g ME EQUIPMENT in a n etworked e n v i r o n m ent today. O r i g i n a l l y ,

t h e s e n etwo rks were i nstal l e d to o pti m ize b u s i n ess e co n o m i c a n d tec h n i cal a re a . F o r t h i s , a
fast e l e ctro n i c data i nterc h a n g e is re q u i re d . Today, these n etwo rks are used for m ed i c a l
a p pl i cati o n s wit h i n t h e h o s pita l , betwe e n h ospitals, a n d f r o m h o m e .
I n iti a l l y , t h e u s e was o n l y t h e exc h a n g e o f l a boratory d ata. N o w t h e re a r e l a rge a m o u nts of

data transpo rted over t h e n etwo rks, s u c h as m ed i c a l i m a g e dat a . T h e re are furt h e r r e q u ests
from t h e user to get " real ti m e " s o l utions ( e . g . control of o p e rati o n robots v i a n etwork).
Additi o n a l g u i da n c e o n NETWORK/DATA COUPLI NG i s fo u n d in A n n ex H.

S u bc l a u se 1 5. 1 - Arra n g ements of contro l s and i n d icators of M E EQUIPMENT
Co ntro l s , i nstr u m e nts, i n d i cati n g l a m ps , etc. t h at are ass ociated with a s pecifi c f u n ct i o n of the
ME EQUIPMENT s h o u l d be grou ped toget h e r .
6060 1 - 1 © I EC : 20 0 5 - 593 -
S u bclause 1 5. 2 - S e rviceabi l ity
The exc h a n g e of s u c h pa rts i s ex pected to be easy to perfo r m , prefera bly wit h o u t s pe c i a l

TOOLS . I n additi o n , t h e d i s ass e m bly o f t h e w o r n out part o r o f t h e part ex c h a n ged preventively
and t h e asse m bl y of the s p a re one s h o u l d n ot c reate a HAZARD. To e n s u re t h i s , the
i nstru cti o n s for perfo r m i n g such activities h ave to be e asy to u n d e rsta n d and to fo l l ow, wit h o ut
i ntrod u c i n g a n y RISK of m ix - u p .
S u bclause 1 5. 3 . 2 - P u s h test
ENCLOS URES n eed to have a d e q u ate rigi dity if they are to m a i ntai n a level of protect i o n from
i nternal l ive parts. T h i s req u i re m ent is h a r m o n ized with t h e force test of I EC 60950- 1 . T h e
force i s d e p e n d e n t o n t h e person h a n d l i n g t h e ME EQUIPM ENT, n ot t h e we i g ht o f t h e
ME EQUI PMENT. I n m ost c a s e s , t h e a pp l i cati o n o f a force o f 2 5 0 N i s c o n s i dered reas o n ably
fores e e a b l e . H owev e r t h e re c a n be cases w h e re a RISK ASSESSMENT fi nds t h at t h e 4 5 N force
2
a p p l i e d ove r a n area of 625 m m , as re q u i re d by the s e c o n d e d iti o n of this sta n d a rd , wo u l d
conti n u e t o be a n accept a b l e VERI F I CATI ON m ethod for determ i n i n g a n accepta b l e l ev e l o f RISK.
For ex a m pl e , u ltraso u n d tra n s d u ce rs a n d s i m i l a r s m a l l HAND-HELD APPLI E D PARTS , w h i c h
b a l a n ce t h e n e e ds o f robustness with oth e r n eeds r e l ati n g to effi cacy a n d
biocom pati b i l ity, h av e establ i s h e d track RECORDS o f safety a n d effectiv e n ess over m a ny years,
and t h e refore could conti n u e to u s e t h e older VERI FICATION test.
I nternal com pon e n ts are not s u bj ected to the force test of I E C 60950- 1 beca u s e t h e i r
rob ustn ess is verified p e r t h e tests o f 1 5 . 3 . 4 a n d 1 5 . 3 . 5 .
S u bclause 1 5. 3 . 3 - I m pact test

'
An E NCLOS URE s resistance to i m pact is req u i red to prevent u n acce pta b l e RISK d u r i n g
reas o n ably fores e e a b l e m is us e . T h e e n e rgy o f t h e test i m pact a p prox i m ates ME EQUIPMENT
be i n g accidentally struck by a n o bj e ct i n t h e h a n d of a pass e r-by or by a broomsti ck or m o p
h a n d l e d u ri n g c l e a n i n g o f t h e fl o o r . T h e test e q u i pm ent h a s b e e n s i m pl ifi e d a n d h a r m o nized
with oth e r sta n d a rds conta i n i n g E NCLOS URE i m pact req u i re m e nts , i n cl u d i n g I EC 60950- 1 .
Where a MANUFACTURER feels t h e req u i re m e nts of t h i s s u bc l a u s e are not n ecess a ry to

m iti gate an u n accept a b l e RISK, j ustifi cati o n is d o c u m ented i n t h e RISK MANAG EMENT F I LE per
4 . 5 , a l o n g with a n i d e ntifi cati o n of alte r n ate req u i re m e nts m et. F o r exa m pl e , FIXED
ME EQUIPMENT c a n h ave o n e side of t h e E NCLOS URE protected by t h e fl o o r , wall o r cei l i n g . T h e
MANUFACTURER d o c u m e nts t h e eval u at i o n o f t h e probabil ity t h at t h e ME EQUIPMENT co u l d b e
m ov e d o r i nstal l e d i n c o rrectly . T h e MANUFACTURER a l s o eva l u ates a n d i d e ntifi e s , t h r o u g h t h e
R I S K MANAG E M E NT PROCESS, what res i sta n c e t o i m pact t h e protected s i d e o f t h e E NCLOS URE
n e eds to h ave to e n s u r e no u n acce pta b l e RISKS are g e n e rated by fa i l u re to com ply with the
o ri g i n al req u i re m e nts of this s u bc l a u s e .
S u bclause 1 5. 3 . 4 - D r o p test
T h e tests for HAND- H E LD ME EQUIPM ENT o r its pa rts t h at a re h a n d h e l d are d iffe rent from t h e
test f o r PORTABLE a n d MOBILE M E EQUIPM ENT because o f t h e d iffe re n ce i n practical a p p l i cati o n .
3
A d ro p s u rface o f wood o f dens ity > 6 0 0 kg/m a l l ows s e l ecti o n o f m ost co m m o n h a rdwoods.
O a k, beech, b i r c h , ash and maple are accepta b l e . T h e s e vari eti es have s i m i l a r h a rd n ess
3
wh i l e h a rdwoods of d e n s ity < 600 kg/m ( e . g . m a h o g a n y , el m , sweet g u m , c h e rry) a n d
softwoods h ave g reatly decreased h a r d n ess i n c o m paris o n .
6060 1 - 1 © I EC : 20 0 5 - 595 -
S u bclause 1 5. 3 . 4 . 2 - PORTAB LE ME EQUIPMENT
This test re prese nts NORMAL USE, as ex pl a i n e d in t h e rati o n a l e for 1 5 . 3 . 5 . This test is n ot
i ntended to represent reas o n a bl y fores e e a b l e m i s u s e . T h e r e is n ot c u rrently a test that
d i rectly a d d resses free fa l l type reas o n a bl y forese e a b l e m i s u s e , h owev e r it i s felt t h e ball
i m pact test in 1 5 . 3 . 3 represe nts fores e e a b l e m i s u s e , al beit i n di rectly. As stated in 4 . 2 , if the
RISK MANAG E M E NT PROCESS c o n cl u des that a m o re severe test i s a ppropriate, t h i s s h o u l d be
done.
S u bclause 1 5. 3 . 5 - Ro u g h hand l i ng test
Co ntrary to what is oft e n ass u m ed , ME EQUI P M E NT can be used i n a h osti l e envi ro n m e nt. I n
case of e m e rg e n cy, M E EQUIPMENT i s carried o r w h e e l e d o n troll eys ove r doorsteps a n d i nto
e l evators and s u bj ected to bu m ps and v i brati o n . Such c o n d i t i o n s can in fact typify NORMAL USE
for s o m e ME EQUI PMENT. E n c o u nte r i n g o bstacles is c o n s i d e r e d c o m m o n pl ace and q u ite
reas o n ably fores e e a b l e m is us e . N ot a l l o bstacles are clearly m a rked a n d the OPERATOR
can not a l ways stop the M E EQUIPMENT in ti m e after havi n g beco m e aware of the o bstacl e
T h e test req u i re m e n ts of 1 5 . 3 . 5 are m eant to j u dge resistance to r o u g h h a n d l i n g , a n d n ot

sta b i l ity. Sta b i l ity test req u i re m e n ts for MOBILE ME EQUIPMENT are i n 9 . 4 .
T h e m e a n i n g o f " i n its n o r m a l di recti o n o f trav e l " i s t h e d i recti o n ( s ) t h e ME EQUIPMENT i s l i ke l y

to travel at t h e m ax i m u m n o r m a l s pe e d . F o r m ost cases , t h i s w o u l d be t h e forward d i recti o n .
S o m e ME EQUIPMENT, s u c h a s a bed, i s l i ke l y t o travel i n a forward o r backward d i recti o n , at
n o r m a l s pe e d , a n d t h e refore each test s h o u l d be c o n s i dered for e ach di recti o n .
S u bclause 1 5. 3 . 6 - M o u ld stress rel ief test
M a n y therm ofo rm i n g PROCESSES c a n l eave res i d u a l stresses i n pl asti cs. Because p o l y m e r

c h a i n s are h e l d toget h e r b y weak v a n der W a a l s b o n d s , these resi d u a l stresses c a n res u l t i n
viscous fl ow ( d efo r m at i o n ) . E l evated t e m perature res u lts i n weake n i n g of v a n d e r Waals
b o n ds and a n i n crease in t h e rate of viscous flow. T h e r m opl astics with l ow m elti n g
tem peratu res , s u c h as polyethyl e n e a n d polypropyl e n e , are m o r e s uscepti b l e to stress rel i ef
defo r m at i o n t h a n poly m e rs with h i g h e r m elti n g tem peratures, s u c h as polyc a r b o n ate a n d
polyeth e ra m i d e .
C o m p l i a n c e s h o u l d be ve rifi ed b y a n alysis o f t h e polym e r p r o pe rties, w h e n possi b l e . T h i s

VERI F I CATI ON s h o u l d c o n sist o f a d o c u m ented c o m parison o f t h e m ax i m u m tem perature t h e
'
poly m e r wi l l be ex pos e d to i n NORMAL USE a n d t h e p o l y m e r m a n ufactu rer s reco m m e n d e d
tem perature use r a n g e .
S u bclause 1 5. 3 . 7 - E n v i ron m e n tal i nf l u e n ces
a) ME EQUI PMENT i s often used o r sto red in envi ro n m e ntal c o n d it i o n s t h at are with i n t h e
I NTENDED USE as declared b y t h e MANUFACTE R. I n s u c h cases n o HAZARD is expecte d .
H oweve r t h e e nv i r o n m e ntal c o n d it i o n s c o u l d differ from t h o s e declared a n d sti l l t h e
ME EQUIPMENT i s expected to re m a i n s afe. To e ns u re t h i s , t h e RESPONSIBLE ORGANISATION
has to perform t h e p e r i o d i c i ns pecti o n and m a i nt e n a n ce prescri bed by the MANUFACTURER.
T h ese activities are expected to prevent any d ete rio rati o n of the s afety l evel and also
detect s i g n s of co m m e n ci n g of a ny such dete riorati o n . To e n s u re this, t h e i n structi o n s for
preventive m ai nt e n a n ce have to be easy to u n d e rsta n d and to fo l l ow, wit h o u t i ntro d u c i n g
a n y RISK f o r m i x- u ps o r f o r overl o o ki n g o f s afety-r e l ev a nt sym pto m s .
6060 1 - 1 © I EC : 20 0 5 - 597 -
b) T h e exc h a n g e of s u c h parts is expected to be e asy to perfo r m , preferably wit h o ut s pe c i a l

TOOLS . I n addit i o n , t h e disass e m bly o f t h e w o r n o u t part o r o f t h e part exc h a n g e d
preventively a n d t h e ass e m bl y o f t h e s p a re o n e s h o u l d not c reate a HAZARD. To e n s u re
t h i s , t h e i nstru cti o n s for perfo r m i n g s u c h activities have to be easy to u n d e rsta n d a n d to
fol l ow, wit h o ut i ntroduci n g a n y RISK of m ix - u p .
S u bclause 1 5.4.3 - Batteries
If a HAZARDOUS S I TUATION m i g h t dev e l o p as a result of ex h a u st i o n of t h e battery, m e a n s

s h o u l d be prov i d e d to forewarn o f t h i s conditi o n .
Where a p propriate, pa rti c u l a r sta n d a rds s h o u l d specify t h e correspo n d i n g req u i re m e nt.
S u bclause 1 5.4.4 - I n d icators
It is i m porta nt for an OPERATOR a n d S ERVICE PERSONNEL to be a b l e to d eterm i n e the f u n ct i o n a l

status o f ME EQUIPM ENT. I n NORMAL USE, t h e OPERATOR n eeds to be a b l e to d isti n g u i s h
betwe e n ME EQUIPMENT i n sta n d - by a n d ME EQUI PMENT i n a f u l l y f u n cti o n a l state. S o m e
ME EQUI PMENT h as a n exte n d e d warm - u p peri o d . Oth e r ME EQUI P M ENT h a s sta n d by o r battery
chargi n g m odes.
I t can be h azardous for ME EQUIPMENT to be l eft u n atte n ded in t h e wro n g state. S E RVICE
PERSONNEL n e e d to be able to determ i n e w h e n ME EQUIPMENT is e n e rgized to av o i d HAZARDS .
S u bclause 1 5. 4 . 7 . 3 - E n try of l i q u ids
T h e fo r m e r I PX8 rati n g req u i re m e n t for foot switches a m o u nts to n o m o re than " g re ater
protect i o n than I PX7 . " By m a ki n g this req u i re m ent I PX6 m i n i m u m , t h e req u i re m e nt sets a
defi n e d l ev e l of protect i o n w h i l e a l l owi n g h i g h e r l ev e l s where appropriate.
For e q u i pm ent used o n t h e fl oor in areas w h e re l i q u ids a re u s u a l l y n ot fo u n d , t h e I PX1

req u i re m ent is i n c l u ded beca u s e it is c o n s i dered extre m e l y l i kely t h at some wetti n g wi l l occur.
S u bclause 1 5. 5 - M AINS S UPPLY TRANSFORMERS of M E EQUIPMENT a n d t ra n sfo rmers

prov i d i n g separation i n accordance with 8 . 5
T h e additi o n o f " a n d transform e rs prov i d i n g s e p a rati o n i n acco r d a n c e with 8 . 5" t o t h e o ri g i n a l

title t h at o n l y i d e ntifi e d " M a i n s transfo r m e rs " i s i ntenti o n a l . T h e tests for tra nsfo r m e rs s h o u l d
b e uti l ized a n y ti m e t h at t h e tra nsfo r m e r i s used t o esta b l i s h s e pa rati o n betwe e n OPERATORS,
PAT I E NTS , etc. and a HAZARD.
Rev i s i o n s to 1 5 . 5 d o n ot c h a n g e s i g n ificantly c u rrent m et h o ds ( i n c l u d i n g t h ose of t h e s e c o n d

editi o n o f t h i s sta ndard) o f testi n g . T h e m et h o ds a n d req u i re m e nts w e r e s i m pl ifi e d a n d n ow
i n cl u d e a l l diffe rent types of protectors l i ke : PTCs, feedback control ( switch m ode power
s u p p l i e s ) , pri m a ry o r s e c o n d a ry over- c u rrent devi ces, etc. T h o s e transfo r m e rs that have not
been tested in acco r d a n ce with the 5X fre q u e n cy a n d 5X voltage tests of 1 5 . 5 . 2 to esta b l i s h
t h e a d e q u acy o f i n s u l ati o n betwe e n t h e t u r n s o f a wi n d i n g t h a t are s h o rted a t t h e term i n a l s
( rath e r t h a n ext e r n a l to t h e transform er) to ass u re t h at fai l u re o f t h at i ns u l at i o n wi l l n ot cause
m ax i m u m a l l owa b l e tem peratu res to be ex ceeded.
Because of t h e diffi cu lties t h at wo u l d be e n c o u ntered w h e n tryi n g to test tra nsfo r m e rs t h at are

RATED for high fre q u e n ci es (such as th ose used in switch m ode powe r s u p pl i es ) , t h e 2X
fre q u e ncy a n d voltage tests are s pecifi ed in t h o s e cases as wel l . T h e s e c o n d editi o n o n l y
a p p l i e d t h i s test w h e r e t h e voltage ex ceeded 5 0 0 V.
6060 1 - 1 © I EC : 20 0 5 - 5 99 -
S u bclause 1 5. 5. 1 . 1 - T ra n sfo rm ers
O utput wi n d i ngs are req u i red to be "tested in t u r n " because u n d e r ov e r l o a d con diti o n s , testi n g
a l l wi n d i n gs si m u lt a n e o u s l y c a n c a u s e over t e m p e ratu re dev i c e s to o pe rate w h i c h wo u l d n ot
o p e rate if o n l y o n e wi n d i n g was bei n g ov erloaded. A s i n g l e output wi n d i n g bei n g ove rloaded
is act u a l l y q u ite l i kely. T h e refore t h i s c o m b i n at i o n of c o n diti o n s i s c o n s i dered t h e l i kely worst
case s c e n a r i o .
T h e i ntent o f t h e req u i re m ent is to test u n de r t h e wo rst-case c o n diti o n ( n early always with

either a full load o r no-l oad) . Such a wo rst case c a n be dete rm i n ed t h r o u g h eval u at i o n of the
tra nsfo r m e r d e s i g n o r by perform i n g a few s pot tests. G e n e r a l l y , t esti n g all poss i b l e c o n d i t i o n s
to determ i n e worst c a s e i s u n n ecess a ry.
T h e l i m its of T a b l e 3 1 are a p p l i e d at a 2 5 o c a m b i e nt beca u s e of t h e i m practi cal ity of

perfo r m i n g the ov e r l o a d a n d s h o rt tests i ns i d e of a t h e r m a l c h a m ber.
S u bclause 1 5. 5. 2 - D i e lectric stre n g t h
I t i s n ecessary to r a i s e t h e fre q u e ncy o f t h e test v o l t a g e i n pro po rti o n to t h e v o l t a g e to prevent

satu rati o n of t h e m ag n et i c core and c o n s e q u ent v e ry h i g h c u rrent.
T h e e l ectri cal i n s u lati o n between t h e p r i m a ry wi n d i n g and oth e r wi n d i n g s , screens and the

core of a MAINS S UPPLY TRANSFORMER is pres u m ed to h av e been i nvestigated by t h e d i e l ectric
stre n gth tests perfo r m e d o n the ass e m bl e d ME EQUI PMENT as d escri bed in 8 . 8 . 3 . The d i e l ectric
stre n gth tests of 8 . 8 . 3 n e e d not be re peated.
S u bclause 1 5. 5. 3 - Construction of transfor m e rs u sed to p rovide sepa ration as req u i red

by 8 . 5
T h e req u i re m e nts s pecifi ed i n I E C 6 1 5 5 8- 1 , S u bc l a use 5 . 1 2 a r e g e n e r a l l y s i m i l a r to t h o s e i n

t h e s e c o n d editi o n o f t h i s sta n dard but tra nsfo r m e rs com plyi n g w i t h t h e m a r e l i kely t o be m o re
readily avai l a b l e .
Additi o n a l l y , A n n ex U o f I E C 6 0 9 5 0- 1 : 2 0 0 1 i n c l u des re q u i re m e nts r e l ati n g t o t h e u s e o f tri p l e

i ns u l ated wi n d i n g wi re i n tra nsfo r m e rs i nste ad of a s e p a rate l ayer of i ns u l ati o n betwe e n
wi n d i ngs (as wo u l d be traditi o n a l l y be prov i d e d b y b o b b i n s fo r ex a m p l e ) . T ra nsform e rs w h i c h
use t h i s m et h o d o f s e pa rati o n betwe e n wi n d i ngs a n d w h i c h c o m pl y with a l l ot h e r req u i re m e nts
of t h i s sta n dard s h o u l d g e n e r a l l y be c o n s i dered to prov i d e an a d e q u ate l ev e l of BAS I C SAFETY.
Cla use 1 6 - M E SYSTEMS
I n creas i n g l y , ME EQUIPM ENT is bei n g c o m b i n e d with oth e r pieces of e q u i pm ent t h at m i g ht n ot

have o ri g i n a l l y b e e n i ntended for m ed i c a l a p pl i cati o n to create systems w h e re o n e or m o re of
t h e e l e m e n ts of t h e syste m co m e i nto contact with t h e PATI ENT. C l a u s e 1 6 prov i d es
req u i re m e nts to e n s u r e t h e s afety of t h e PAT I E NT w h o c o u l d c o m e i nto co ntact with
ME SYSTEMS.
C l a use 16 o n ME SYSTEMS is i nt e n d e d to be used by MANUFACTURERS of c o m bi n ati o n s of

e l ectrical e q u i p m e nt t h at i n c l u d e one o r m o re ite m s of ME EQUI P M ENT. T h e e q u i p m ent c a n be
separate items or can be in a s i n g l e E NCLOS URE o r a co m bi n ati o n of th ese cases .
C l a use 1 6 is a l s o i ntended to be u s e d by pers o n n el from i nstituti o n s for m ed i c a l practice w h o

ass e m b l e o r a d a pt ME SYSTEMS, as they c a n bec o m e t h e MANUFACTU RER b y t h at acti o n . I n t h i s
cas e , e n g i n eeri n g ex pertise i n t h e a p pl i cati o n o f t h e e l ectri cal e q u i pm e n t des i g n sta n d a rds is
req u i red to e n s u re t h at t h e ME SYSTEM c o m p l i es with a l l req u i re m e nts of C l a u s e 1 6 .
6060 1 - 1 © I EC : 20 0 5 - 601 -
M o re a n d m o r e , s u c h ME SYSTEMS c o m prise e q u i pm ent o r i g i n a l ly m a n ufactured fo r use i n

d iffe rent s pecific a pp l i cati o n f i e l d s , n ot n ecess a r i l y m ed i c a l , t h at are c o n n ected with each
oth e r in a di rect o r i n di rect way. M E EQUIPM ENT c o m plyi n g with t h i s sta n dard c a n be c o n n ected
with oth e r , n o n-ME EQUIPMENT. The l atte r e q u i pm ent m i g ht f u l l y m eet the req u i r e m e nts in t h e
safety sta n d a rds a pp l i c a b l e i n t h e i r s pecific a p p l i cati o n fi e l d . H owev e r , t h ey do n ot a l ways
com ply with the s afety req u i re m e nts for ME EQUI PMENT a n d , t h e reby, i nf l u e n c e the s afety of
t h e w h o l e ME SYSTEM. It is for t h i s reason that t h e MANUFACTURER is re q u i red to apply RISK
MANAG E M E NT to t h e w h o l e ME SYSTEM. One exa m p l e of a n additi o n a l HAZARD is t h e i g n iti o n of
fi re w h e n an ME SYSTEM contai n i n g n o n-ME EQUIPMENT is used i n an OXYGEN RICH
E NVIRONMENT, possi bly a cci d e ntally.
T h e el ectrical e q u i pm ent c a n be s i t u ated e i t h e r in a m ed i c a l l y used room t h at is i ntended fo r

d i a g n os i s , treat m e n t or m o n i to r i n g of PAT I E NTS , or i n a n o n - m e d i c a l l y used room w h e re n o
m ed i c a l practi ce is perfo r m e d . With i n a m ed i c a l l y used roo m , e l ectrical e q u i p m e n t m i ght b e
p l a c e d i n s i d e o r outs i d e a v o l u m e t h a t is d efi n e d as PAT I E NT ENVI RONMENT.
T h e re are two s i t u at i o n s poss i bl e in m edi cal pract i c e .

a) W h e r e C l a u s e 1 6 d o e s n ot a p p l y
S i m u lta n e o u s l y o pe rated ME EQUIPM ENT, i . e . diffe rent ME EQUI P M ENT co n n ected at t h e s a m e

ti m e t o a PAT I E NT b u t n o t c o n n ected t o e a c h oth e r . S u c h ME EQUIPM ENT c a n i nfl u e nce each
oth e r . For ex a m pl e , h i g h-fr e q u e n cy s u rg i c a l e q u i p m e n t in t h e o pe rati n g th eatre can
i nfl u e nce PAT I E NT m o n itori n g .
NOTE Assistance can be ava ilable from the instructions for use for each M E EQU I P M E N T .
b) Where Clause 16 appl i es
M E SYSTEMS, consisti n g of ME EQUIPM ENT a n d poss i bl y a l s o n o n-ME EQUIPMENT,

i nterco n n ected p e r m a n ently o r tem porari l y for a certa i n pu rpose such as d i a g nosis o r
treat m e nt o f a PATI E NT. Exa m pl e s : ME SYSTEMS f o r d i a g n ostic X-ray ex a m i nati o n ,
e n doscopes with v i d e o ca m e ra , PAT I E NT m o n i to r i n g , ultras o u n d e q u i p m e n t with a pers o n a l
com pute r , c o m puted t o m o g ra p hy o r m ag n etic res o n a nce i m ag i n g .
T h e v a r i o u s parts o f s u c h a n ME SYSTEM co u l d be s it u ated with i n t h e PAT I E NT E NV I RONMENT

o r o utsi d e it but sti l l with i n a m ed i c a l l y used ro o m , o r pa rts of t h e ME SYSTEM co u l d be
l ocated in a n o n - m e d i c a l l y used room conta i n i n g , for exa m pl e , el ectrical power d istr i b ut i o n
o r d ata process i n g e q u i p m ent.
S u bclause 1 6. 1 - General req u i rem ents fo r t h e M E SYSTEMS
The basic re q u i re m ent for t h e s afety of ME SYSTEMS i s t h at, after i nsta l l ati o n o r s u bs e q u e nt
m odifi cati o n , an ME SYSTEM does not res u l t i n a n u n acce pta bl e RISK. C o m pl i a n c e with t h e
req u i re m e nts i m posed o n ME SYSTEMS i n t h i s sta n dard wi l l i m pl y t h at t h e RESI DUAL RISK i s
pres u m ed to be accepta b l e , u n less t h e re is OBJECTIVE EVI DENCE to t h e co ntrary.
The MANUFACTURER of ME SYSTEMS t h at c a n be reconfi g u re d by t h e OPERATOR o r the

RESPONSIBLE ORGANIZATION c o u l d be c h a l l e n g e d to prov i d e i nform ati o n o n all possi b l e
com bi n ati o n s o f t h e e q u i pm ent, w h i c h c o u l d represent a n u n reas o n a b l e b u r de n . R I S K
MANAG E M E NT m et h o ds prov i d e a v e ry a d e q u ate m ea n s o f determ i n i n g w h i c h c o m b i n at i o n of
items constitutes t h e l a rgest RISKS , a n d w h i c h m eas u res n eed to be taken to prov i d e for t h e
a d e q u ate l evel o f safety. U lt i m ately, co m pl i a n c e test i n g c a n be d o n e after ass e m bl y of t h e
com pl ete ME SYSTEM.
6060 1 - 1 © I EC : 20 0 5 - 603 -
Appropriate d o c u m e ntati o n c o n c e rn i n g t h e sta n d a rds c o m pl i a n ce c a n be a d e c l a rati o n of

conform ity by t h e MANUFACTU RER or a certifi cate from a test h o u s e .
M E SYSTEMS, b y t h e i r n atu re, can be fre q u e ntly m odifi e d ; C l a u s e 1 6 d o e s n ot a p p l y t o t h e

m o d ificati o n o f i n di v i d u a l i t e m s i n a n ME SYSTEM
S u bclause 1 6. 2 - ACCO M PANYI NG DOCU M E NTS of an M E SYSTEM
The d o c u m e nts that acco m pany an ME SYSTEM i nt e n d e d for DI RECT CARDIAC APPLICATION
s h o u l d provi d e d ata on s u c h items as:
use of ru bber g l oves;
use of sto p-cocks m ade of i n s u l ati n g m ateri a l ;
m i n i m u m d i stan ces betwee n PAT I E NT a n d e q u i pm ent bei n g p a rt o f t h e ME SYSTEM ( PATI ENT
E NV I RONMENT) ;
i nstr u cti o n s a b o ut h ow to use t h e ME EQUIPM ENT i n t h e typical m edi cal a pp l i cati o n , for
exa m pl e , u s e of a catheter.
For s afety reaso n s , parti c u l a r attenti o n s h o u l d be paid to t h e d i ffe rent l evels of RISK wh e n ,
with i n t h e PAT I E NT E NVI RON M E NT, e l ectrodes o r oth e r body s e n s o rs a re used o n t h e PATI E NT,
exte r n a l l y a n d i nt e r n a l l y , i n c l u d i n g di rect c o n n ecti o n s to the h e a rt .
P ossi b l e c o n n ecti o n s t o t h e h e a rt o f a PAT I E NT s h o u l d be kept iso l ated from t h e e q u i pm ent.
T h e warn i n g not to place M ULTI PLE SOCKET-OUTLETS o n t h e floor is to prevent t h e i n g ress of

l i q u i ds and to prevent m ec h a n ical d a m a g e .
F u rt h e r m o re , m e a s u res s h o u l d be take n to e ns u re t h at, w h e n asse m bl i n g o r m odifyi n g a n

ME SYSTEM i n co rpo rati n g M ULTI PLE SOCKET-OUTLETS , t h e s e a r e m o u nted i n s u c h a way as t o
prevent i n g ress o f l i q u i ds a n d to av o i d m ec h a n i cal d a m a g e d u ri n g NORMAL USE a n d
trans po rtati o n .
R e l ev a nt safety sta n dards for n o n- M E EQUIPMENT c o u l d s pecify o r req u i re d i s c l o s u re of

perm i s s i b l e e nvi ro n m e ntal c o n d iti o n s . Accord i n gly, t h e e nvi ro n m e ntal c o n d it i o n s perm itted for
v a r i o u s items in a n ME SYSTEM can be diffe rent. The p e r m i ss i bl e envi ro n m e ntal c o n d it i o n s for
the ME SYSTEM i s to be s pecifi e d so that no HAZARD wi l l arise w h e n o p e rati n g it with i n these
s pecifi ed l i m its .
S u bclause 1 6. 3 - Power s u pply
T h i s r e q u i r e m e n t i s to e n s u re t h e safety accordi n g to I EC 6060 1 - 1 at t h e ME SYSTEM l eve l .
BASI C SAFETY after ass e m bly i s m a i nt a i n e d , for ex a m pl e , by o n e o r m o r e of t h e fo l l owi n g

m ea s u re s :
m e a s u res t h at are b u i lt-i n with i n t h e ME E Q U I PM E NT, f o r ex a m pl e , s e p a rati o n o f relevant
ci rcu its;
S E PARATION DEVICES prov i d e d as ACCESSORI ES to the ME EQUI P M ENT (see 1 6 . 5) ;
S E PARATION DEVICES prov i d e d a s ACCESSORIES t o t h e ME SYSTE M ;
separati n g tra nsform er;
additi o n a l PROTECTIVE EARTH CONDUCTORS .
N o n- M E EQUI PMENT c a n prov i d e t h e s pecifi e d power s u pply for ME EQUIPMENT i n accord a n c e

with 5 . 5 f ) , 7 . 9 . 2 . 1 4 a n d 8 . 2 . 1 .
6060 1 - 1 © I EC : 20 0 5 - 6 05 -
S u bclause 1 6. 5 - S E PARATI ON DEVICES
The BAS I C SAFETY of s o m e ME EQUIPMENT d e p e n ds o n t h e prec o n diti o n that any S I GNAL

I N PUT/OUTPUT PARTS a re con n ected o n l y to e q u i pm ent t h at i s s pecifi ed for this pu rpose,
oth e rwise LEAKAGE CURRE NTS co u l d be i n creased by u nwanted cu rre nts fl owi n g through s i g n a l
cables.
HAZARDOUS S I TUATI ONS could occ u r if t h e S I GNAL I NPUT/OUTPUT PART of ME EQUIPM ENT is
co n n e cted to e q u i pm ent o utsi d e t h e m ed i c a l l y used roo m , possi bly in another b u i l d i n g and
t h e refore c o n n ected to a n other m a i n s s u pply branch c i rc u i t .
A S E PARATION DEVICE p reve nts a HAZARD t o t h e PAT I E NT o r OPERATOR. Add iti o n a l l y , t h e

i n cl u s i o n o f t h e S E PARATION DEVICE h e l ps t o a v o i d HAZARDS t h r o u g h m alfu n ct i o n o f e q u i p m e n t
caused b y u nwanted c u rrents fl owi n g t h r o u g h c a b l e s .
T h e n e e d fo r a S E PARATION DEVICE d e p e n ds o n t h e confi g u rati o n of t h e ME SYSTEM.
S u bclause 1 6. 6 - LEAKAGE CURRENTS
R e l ev a nt sta n d a rds for s o m e n o n-ME EQUI PMENT can have l i m its for TOUCH CURRE NTS t h at are
h i g h e r than req u i red by C l a u s e 1 6 ; these h i g h e r l i m its are accepta b l e only o u ts i d e t h e PAT I E NT
E NVIRONMENT. It is esse nti a l to r e d u ce TOUCH CURRENTS w h e n n o n-ME EQUI PMENT is to be used
wit h i n t h e PAT I E NT E NV I RONMENT. LEAKAGE CURRENT red u cti o n m ea s u res c a n i n cl u d e :
additi o n a l PROTECTIVELY EARTHED parts ;
a s e pa rati n g tra nsform er;
a n additi o n a l n o n-co n d u ctive E NCLOSURE.
I nterc o n n ecti n g c a b l es a n d their c o n n ector h o u s i n g s are pa rts of t h e E NCLOS URE and t h e refo re
the LEAKAGE CURRENT l i m its with i n the PAT I E NT E NV I RONMENT, as req u i red i n 1 6 . 6 . 1 , are
applicable.
I f a M U LTIPLE SOCKET-OUTLET wit h o ut a s e p a rati n g transfo r m e r i s u s e d , t h e i nterr u pt i o n o f its

protective e a rth i n g c o u l d res u l t in TOUCH CU RRE NTS e q u a l to t h e s u m of the i n di v i d u a l EARTH
LEAKAGE CURRENTS.
S u bclause 1 6. 6 . 3 - PAT I E NT LEAKAGE CURRE NT
For ME EQUI PMENT, t h e m axi m u m a l l owed v a l u es for PAT I E NT LEAKAGE CURRENT and total
PAT I E NT LEAKAGE CURRENT ( a p p l i c a b l e with several APPLI ED PARTS co n n ected to the ME
EQUIPMENT) a re g i v e n in T a b l e 3 and T a b l e 4 ; s e e a l s o 8 . 7 . 3 . An ME SYSTEM i s to prov i d e t h e
e q u ival e nt l ev e l o f safety as prov i d e d b y ME EQUI PMENT with i n t h e PATI ENT ENVIRONMENT (see
1 6 . 1 ) . T h e refo re, t h e same m axi m u m v a l u es for PAT I E NT LEAKA G E CURRENT and total PAT I E NT
LEAKAGE CURRENT a p pl y , regardl ess whether t h e APPLI ED PARTS are co n n ected to t h e s a m e
e l e m e n t o f t h e ME SYSTEM o r n ot. T h i s h o l ds f o r t h e o p e rati o n o f t h e ME SYSTEM i n NORMAL
CONDI TION, as the s i n g l e fa u l t c o n ce pt is n ot a pp l i c a b l e to a n ME SYSTE M .
I t s h o u l d b e n oted t h at c o m bi nati o ns o f e q u i pm ent o r o f APPLIED PARTS , m ade b y t h e

RESPONSIBLE ORGANIZATION o r OPERATO R, that a r e outs i d e t h e r a n g e o f c o m b i n at i o n s i n d i cated
by the MANUFACTURER, co u l d l e a d to HAZARDOUS S I TUATI ONS. T h i s wa r n i n g h ol ds in parti c u l a r
w h e n c o m bi n at i o n s o f e q u i p m e n t are u s e d f o r m ed i c a l p u r poses o n t h e s a m e PATI E NT, w h i c h
have n ot been i nt e n d e d b y t h e i r MANUFACTU RER(s) t o be u s e d i n s u c h c o m bi n ati o n s .
6060 1 - 1 © I EC : 20 0 5 - 607 -
S u bclause 1 6. 7 - P rotecti o n ag a i n st M ECHANICAL HAZARDS
Att e nti o n s h o u l d be p a i d to t h e effects of i nterrupti o n s c a u s i n g u n pl a n n e d m ov e m e nts ,

r e m ov a l of com pres s i o n forces , a n d t h e safe re m ov a l of PAT I E NTS from t h e PAT I E NT
E NV I RONMENT w h e n a HAZARDOUS SI TUATION occurs.
S u bclause 1 6. 9 . 2 . 1 - M ULTIPLE SOCKET-OUTLET
The s e c o n d editi o n of this sta n d a rd used t h e defi n e d term " a ux i l i a ry m a i ns socket- o utlet
(AMSO)" to descri be a socket- o ut l et i nt e n d e d for provi s i o n of m a i ns s u pply to oth e r
ME EQUIPMENT o r t o oth e r s e pa rate pa rts o f t h e ME EQUIPM ENT. T h e syst e m s col l ateral
sta n d a r d , I EC 606 0 1 - 1 - 1 [ 1 3 ] , d efi n e d a term " m u lt i p l e porta b l e s ocket-o utl et ( M PS O ) " . T h e
two t e r m s h a v e been co m bi n ed i nto a new term , " M U LTIPLE SOCKET-OUTLET ( Mso) . " S u bc l a use
57 . 2 e) of t h e second editi o n req u i red that a n A M S O be des i g n e d so t h at it co u l d not accept a
MAINS PLUG . An except i o n for EMERGENCY TROLLEYS was a l l owed . With t h e co m bi n at i o n of t h e
two d efi niti o n s a n d t h e c h a n g e to 8 . 1 1 . 2 to req u i re a n y M S O o n M E EQUIPMENT to c o m pl y with
1 6 . 9 . 2 . 1 , the need for rapid ex c h a n g e in an e m e rg e n cy s i t u ati o n is reco n c i l e d with the n eed to
restri ct LEAKAGE CURRENT.
Reass i g n m e n t of t h e MAINS CONNECTI ON for the ME SYSTEM i s a d a n g e ro u s practice a n d

beyo n d t h e s c o pe o f t h i s c l a u s e . S e e 1 6 . 2 for discl os u re re q u i re m e nts.
Excess ive TOUCH CURRENTS can occur u n l ess casual access for additi o n a l e q u i p m e nt
co n n e cti o n s is i m peded o r prev e nted.
S u bclause 1 6. 9 . 2 . 1 c), 3 'd dash
M E EQUI PMENT with a n o n-DETACHABLE POWER SUPPLY CORD h as a n i m pe d a nce betwe e n t h e

protective eart h pi n i n t h e M A I N S P L U G a n d a n y part t h at is PROTECTIVELY EARTHED that d o e s
not e x c e e d 2 0 0 m O . S i m i l arly, t h e M U LTIPLE SOCKET-OUTLET has a n i m pe d a n c e t h at d o e s n ot
exceed 200 mQ betwee n its MAINS PLUG a n d its socket-o utlets . T h i s resu lts i n an i m pedance
t h at does n ot exceed 4 0 0 m Q between t h e M ULTI PLE SOCKET-OUTLET MAINS PLUG and a ny part
of ME EQUIPM ENT that is PROTECTIVELY EARTHED.
T h e i m pedance of PROTECTIVE EARTH CONNECTIONS is a l l owed to exceed 2 0 0 m Q w h e n the

relevant circu its have l i m ited c u rrent c a p a b i l ity (see 8 . 6 . 4 b ) ) . In such cases in ME EQUIPMENT,
t h i s res u lts i n a n i m pedance between t h e protective e a rth p i n in t h e MAINS PLUG and a n y part
t h at is PROTECTIVELY EARTHE D that exceeds 4 0 0 m Q .
S u bclause 1 6. 9 . 2 . 1 d)
T h e TOUCH CURRENT of t h e ME SYSTEM m ust be l ess than 5 0 0 �-tA in S I NGLE FAULT CONDI T I O N . A
separat i n g transfo r m e r c a n be used as a m eas u re to reduce t h at TOUCH CURRE NT. T h e refo re a
separati n g transfo r m e r with BAS I C I NS ULATION is s uffi ci ent. T h e DOUBLE or REI NFORCED
I NS ULATION as req u i red fo r i s o l ati n g transfo r m e rs is n ot n e e d e d .
T h e CLASS 1 req u i re m e n t f o r t h e tra nsfo r m e r asse m bly is n e c essary to prov i d e co n n ected

e q u i pm ent with a PROTECTIVE EARTH CONN E CTI O N .
I so l ati o n m o n itori n g o f the s e pa rati n g tra nsfo r m e r i s not n ecess a ry. S I NGLE FAULT CONDI TION
can be detected d u ri n g rout i n e m a i nt e n a nce a n d t h e occurrence of two i n d e p e n d ent S I NGLE
FAULT CONDITIONS i s of n o concern . The tra nsfo r m e r constr u cti o n can be of a type with or
wit h o ut a PROTECTIVELY EARTHED ce ntre tapped s e c o n d a ry wi n d i n g .
6060 1 - 1 © I EC : 20 0 5 - 609 -
S u bclause 1 6. 9 . 2 . 2 - P ROTECTIVE EARTH CONNECTIONS i n ME SYSTEMS
All PROTECTIVE EARTH CONDUCTORS and POWER SUPPLY CORDS s h o u l d be ro uted to gether.
Wit h i n t h e PAT I E NT E NV I RONMENT it is i m portant to l i m it pote ntial d i ffe r e n ces between diffe rent
pa rts of a n ME SYSTEM, and a n a d e q u ate c o n n ecti o n with a protective earth i n g system pl ays
an i m portant r o l e i n l i m iti n g that pote ntial diffe r e n c e . It is t h e refore i m portant to prevent
i nterr u pt i o n of t h at protective m ea n s to any part of t h e ME SYSTE M .
T h e additi o n a l protective earth i n g c o u l d b e u s e d w h e n t h e TOUCH CURRENT i n S I NGLE FAULT
CONDI TION exceeds the a l l owa b l e l i m its.
The additi o n a l protective eart h i n g i s n ot n ecess a ry for ME EQUI PMENT co m plyi n g with t h i s
sta n da r d . H owev e r , i n t h e c a s e o f n o n-ME EQUI P M E NT t h i s wi l l prev ent TOUCH CURRENTS
exceedi n g a l l owa b l e l i m its.
The use of a TOOL i s n ot req u i red to d i s c o n n ect the MAINS PLUG because t h e MAINS PLUG
wi l l discon n ect both the m ai n s a n d the protective earth.
Cla use 1 7 - E l ectromag netic c o m pati b i l ity of M E EQU I P M E N T and M E SYSTEMS
I EC 606 0 1 - 1 -2 s pe cifies e l e ctr o m a g netic i m m u n i ty test l evels to m i n i m ize t h e effect of the

e l ectro m a g n eti c envi r o n m ent on the ME EQUIPMENT and ME SYSTEMS covered by this sta n da r d .
I t s pecifies e l ectro m a g n etic e m issi o n s l i m its to m i n i m ize t h e effect o n oth e r e q u i p m e nt of
e l ectro m a g n et i c d i stu rbances t h at c o u l d be e m itted, i ntenti o n a l l y or u n i ntenti o n a l l y , by
ME EQUIPMENT a n d ME SYSTEMS. It a l s o s pecifies req u i re m e nts for i d e ntifi cati o n , m a r ki n g a n d
d o c u m e nts S O t h a t t h e MANUFACTURER o f t h e ME EQUI PMENT o r ME SYSTEM p rovides i nfo r m at i o n
to t h e RESPONSIBLE ORGANIZATION t h at is ess ential i n determ i n i n g t h e s u it a b i l ity o f t h e
ME EQUIPMENT o r ME SYSTEM f o r t h e e l ectro m ag n etic e n v i r o n m ent o f u s e , a n d i n m a n a g i n g t h e
el ectro m a g n et i c e nv i r o n m ent o f use to p e r m i t t h e ME EQUIPMENT o r ME SYSTEM to m a i ntai n
BAS I C SAFETY a n d prov i d e its ESSE NTIAL PERFORMANCE wit h o ut d i st u rbi n g oth e r e q u i p m e nt .
E l ectro m a g netic e m i ssi o n req u i re m e nts a r e n ecessary fo r t h e protecti o n of:

safety s e rvices ( e . g . p o l i c e , fire and a m b u l a nce com m u n i cati o n s ) ;
oth e r ME EQUIPMENT a n d ME SYSTEMS;
n o n-ME EQUIPMENT ( e . g . c o m puters ) ;
- teleco m m u n i cati o n s ( e . g . radi o/TV, tel e p h o n e , radio-navi gati o n ) .
M o re i m portantly, el ectr o m a g n et i c i m m u n ity re q u i re m e nts a r e n eces s a ry t o ass u re t h at

ME EQUI PMENT a n d ME SYSTEMS m a i nt a i n BAS I C SAFETY a n d co nti n u e to prov i d e t h e i r ESSENTIAL
PERFORMANCE in t h e presence of t h e el ectr o m a g n et i c distu rba nces to which they c a n be
expected to be exposed d u ri n g NORMAL U S E .
6060 1 - 1 © I EC : 20 0 5 - 61 1 -
A n nex G P rotect i o n a g a i nst HAZARDS of i g n it i o n of flammable a n aesthetic

-
m ixtu res (see a lso the rati o nale fo r 1 1 .4)
S e cti o n six of t h e s e c o n d editi o n of t h i s sta n dard has been m ov e d to a n o r m ative a n n ex . T h i s

was d o n e i n reco g n i t i o n o f t h e fact t h a t fl a m m a b l e a n aest h et i cs a re rarely used a n d t h e i r u s e
is ex pected to cease entirely with i n a s h o rt peri o d . H owever, i t is also reco g n ized t h at t h e
practice o f m ed i ci n e c h a n ges fre q u e ntly a n d t h at e v e n now s o m e MANUFACTURERS m i g ht sti l l
want to offer ME EQUIPM ENT for s u c h a p pl i cati o n s . I n order t o ass u re t h at t h e m aterial
conta i n ed in S e cti o n six along with t h e associated CATEGORY AP a n d CATEGORY APG RATI NGS
re m a i n ava i l a bl e w h i l e i m prov i n g t h e readabil ity of t h e sta n d a rd for m ost users, t h e m aterial
has been m oved to A n n ex G .
S u bclause G . 1 . 3 - Req u i rements fo r M E EQUIPMENT
T h e m ost devastati n g a c c i d e nts with fl a m m a b l e a n aesth etic a g e nts occ u r w h e n t h e m ixture of

t h e a g e nt with oxy g e n n o r m a l l y used is t h at w h i c h wi l l cause t h e m ost rapid c o m busti o n , a
state that s o m eti m es is descri bed as " deto n ati o n o pti m u m . " T h e worst exa m p l e of s u c h a n
a g e nt is cycl opropa n e , wh i l e t h e oxyge n/et h e r m ixtu r e n o r m a l l y u s e d i s far below t h at poi nt.
S u bclause G . 5. 3 - Low-e nergy c i rcu its
The graphs of F i g u re G . 1 , F i g u re G . 2 and F i g u re G . 3 a re g i v e n to assist in the des i g n of

circu its t h at fulfil t h e req u i re m e nts for a l l owa b l e l i m its stated for CATEGORY AP ME EQUIPMENT
wit h o ut perform i n g t h e i g n i t i o n test.
Extrapolat i o n fo r h i g h e r v o ltages is not val i d because the i g n i t i o n c o n d i t i o n of gases c h a n ges

at h i g h e r voltages. The l i m it for i n d u ct a n ces is i ntroduced because h i g h i n d u cta n c e v a l ues
g e n e r a l l y p r o d u ce h i g h e r voltages.
S u bclause G . 5. 4 - External ve nti lation with i n ternal overp ress u re
T h e a m o u nt of a i r or i n e rt gas escapi n g from t h e ME EQUIPMENT by l e a ka g e is ass u m ed to be

l i m ited so t h at hyg i e n i c c o n d iti o n s i n t h e m e d i c a l l y u s e d room are not d i st u r bed a pp reci a bl y .
For t h e p u r poses o f G . 5 . 4 a n d G . 5 . 5 t h e t e r m " e n c l o s u re" c a n represent either t h e E NCLOS URE

as defi n e d in 3 . 26 o r a di sti n ct com part m e n t o r h o u s i n g .
S u bclause G . 5 . 5 - ENCLOS URES w i t h restricted b reat h i ng
S u bclause G . 5 . 5 a)
T h i s re q u i re m ent is regarded as s uffi ci e nt to prev ent i g n it i o n i n NORMAL USE d u ri n g a n

o p e rati o n a l p e r i o d o f several h o u rs s i nce average c o n d iti o n s i n NORMAL USE a r e l ess stri n g e nt.
S u bclause G . 6 . 2 - Power s u pply
T h i s req u i re m e n t preve nts t h e i ntrod u ct i o n of v o ltages h i g h e r th a n those permitted by G . 6 . 3 .

S u c h voltages c a n exist o n earth wi ri n g .
S u bclause G . 6 . 3 - Tem perat u res a n d low-energy c i rcu its
The graphs of F i g u re G . 4 , F i g u r e G . 5 and F i g u re G . 6 are g i v e n to assist in the desi g n of

circu its t h at fu lfi l t h e re q u i re m e nts fo r a l l owable l i m its stated for CATEGORY APG ME E Q U I PMENT,
wit h o ut perform i n g t h e i g n i t i o n test.
6060 1 - 1 © I EC : 20 0 5 - 613 -
A nnex 8
(info rmative)
S e quence of testing
8.1 G e nera l
Tests s h o u l d , if a pp l i c a b l e , be perfo r m e d i n t h e s e q u e n c e i n d i c ated below, u n l ess otherwise

state d by parti c u l a r sta n d a rd s . See also 5 . 8 .
H owever, t h i s does n ot precl u d e t h e poss i bi l ity o f c o n d u cti n g a test t h at p re l i m i n a ry i ns pecti o n

s u g g ests m i ght c a u s e fai l u re.
T h e tests for radiati o n HAZARDS in Clause 1 0 , b i o c o m pati b i l ity in 1 1 . 7 , USAB I L I TY in 1 2 . 2 , alarm

syst e m s in 1 2 . 3 , PEMS in C l a use 1 4 and el ectr o m a g n eti c c o m pati b i l ity in Clause 1 7 c a n be
perfo r m e d i n d e pe n dently from t h e tests in t h e fo l l ow i n g s e q u e n c e .
T h e tests specifi e d f o r M E SYSTEMS i n C l a u s e 1 6 s h o u l d be perfo r m e d i n t h e s a m e s e q u e n c e

as t h e tests f o r ME EQUIPM ENT.
8.2 R I S K MANAG E M E N T P ROCESS fo r M E EQUI PMENT o r M E SYSTEMS a n d ESSENTIAL

PERFORMANCE
S e e 4.2 and 4 . 3 .
8.3 G e nera l re q u i reme nts
See 4 . 1 , 4 . 5 to 4 . 1 0 ( i n c l usive) a n d 5 . 1 to 5 . 7 ( i n c l u s i v e ) .
8.4 C lassificat i o n of M E EQUI PMENT a n d M E SYSTEMS
S e e C l a u s e 6.
8.5 Determ i nat i o n o f APPLI ED PARTS a n d ACC ESSIBLE PARTS
See 5 . 9 .
8.6 M E EQU I PMENT i d e ntificat i o n , m a rk i n g a n d d o c u m e nts
S e e 7 . 2 to 7 . 8 . 2 ( i n c l u s i v e ) , A n n ex C .
8.7 E n e rg y c o n s u m pt i o n ( p owe r i n p ut)
See 4 . 1 1 .
8.8 Lim itat i o n of volta g e , c u rrent o r e n ergy
See 8 . 4 .
8.9 Separat i o n o f parts
S e e 8 . 5 . 1 to 8 . 5 . 4 ( i n c l u s i v e ) .
6060 1 - 1 © I EC : 20 0 5 - 615 -
8.1 0 CREEPAGE DISTA NCES a n d AIR C LEARANCES
See 8 . 9 .
8.1 1 HAZARDS assoc iated with moving parts
S e e 9 . 2 except 9 . 2 . 2 . 4 . 1 .
8.1 2 HAZARD asso c i ated with s u rfa ces, corners a n d ed g es
See 9 . 3 .
8 . 1 3 Servicea b i l ity
See 1 5 . 2 .
8 . 1 4 A c c u racy o f c o ntro l s a n d i n strume nts a n d p rotect i o n agai nst hazard o u s

o ut p uts
See 1 2 . 1 a n d 1 2 . 4 .
8 . 1 5 I nsta b i l ity HAZARDS
See 9 . 4 .
8.1 6 Noise, vibrati o n a n d acoust i c e n ergy

See 9 . 6 .
8.1 7 I nte rru pti o n o f t h e powe r s u p p l y I SU PPLY MAINS t o M E EQUI P M E NT

See 1 1 . 8 .
8.1 8 P rotective eart h i n g , fu n ct i o n a l earth i n g a n d pote n t i a l e q u a l izat i o n of

ME EQUI PMENT
See 8 . 6 .
8.1 9 Excess ive te m p e ratu res i n M E EQUI PMENT

See 1 1 . 1 .
8.20 LEAKAGE CU RRENTS a n d PATIENT AUXILIARY CU RRENTS at o p e rati n g

te m p e ratu re
S e e 8 . 4 . 2 a n d 8. 7 .
8.21 H u m i d ity p reco n d it i o n i n g t reatm ent
See 5. 7.
6060 1 - 1 © I EC : 20 0 5 - 617 -
8.22 Dielectric stre n gt h (COLD CON DITION)
See 8 . 8 . 3 .
8 . 2 3 Defi b r i l lat i o n p rote cti o n
See 8 . 5 . 5 .
8 . 2 4 Expelled parts HAZARD
See 9 . 5 .
8.25 P ress u re vessels a n d parts s u bj e ct to p n e u mat i c a n d hyd ra u l i c p ress u re
S e e 9. 7 .
8.26 HAZARDS assoc iated with s u p p o rt systems
See 9 . 8 .
8 . 2 7 M e c h a n ical stre n gt h
See 1 5. 3 and 9 . 2 . 2 . 4 . 1 .
8.28 HAZARDOUS SITUATIONS a n d fa u lt c o n d it i o n s
See Clause 1 3 .
8.29 MAINS SU PPLY TRANS FORM ERS of M E EQUI P M E NT a n d t ra n sformers p rovi d i n g

separat i o n i n accordance with 8 . 5
See 1 5 . 5 .
8.30 M E EQUI PMENT c o m p o n e nts and g e n e ra l asse m b l y
See 1 5. 4 and 8. 1 0.
8.31 M A I N S PARTS, c o m p o n e nts a n d layo ut
See 8. 1 1 .
8.32 I ns u lati o n o t h e r t h a n wire i n s u lat i o n
See 8. 8.4.
8.33 F i re p reve nt i o n a n d c o n struct i o n a l re q u i reme nts for fire ENCLOSURES o f

M E EQUI PMENT
See 1 1 . 2 and 1 1 . 3.
6060 1 - 1 © I EC : 20 0 5 - 619 -
8.34 Ove rflow, s p i l lage, leaka g e , i n g ress of water, clea n i n g , d i s i nfect io n ,

ste ril izat i o n a n d com pati b i l ity with s u bsta n ces used with t h e M E EQUI PMENT
See 1 1 .6.
8.35 CAT EGORY A P a n d CATEGORY A PG M E EQUI PMENT
S e e 1 1 . 4 a n d A n n ex G.
8.36 VERI FICATION of markings
S e e 7 . 2 to 7 . 8 . 2 ( i n c l u s i v e ) , An n ex C a n d 7 . 1 .
6060 1 - 1 © I EC : 20 0 5 - 621 -
A nnex C
(info rmative)
G uid e to mark ing and labelling requirements for M E EQU I P M E N T and

M E SYSTE M S
C.1 M a rk i n g o n t h e o utside o f M E EQUIPM ENT, M E SYSTE M S o r t h e i r parts
The re q u i re m e nts for m a rki n g o n the o u ts i d e of M E E Q U I P M E NT a n d its parts a re fo u n d in 7 . 2 .

Additi o n a l req u i re m e nts fo r m a rki n g o n t h e o utsi d e o f M E E Q U I P M E NT, M E SYSTEMS a n d t h e i r
pa rts a r e fo u n d i n t h e s u bc l a uses l isted i n T a b l e C . 1 . Sym bols a n d s afety s i g n s u s e d i n
m a rki n g o n t h e o uts i d e o f M E E Q U I P M ENT are fo u n d i n An n ex D .
Table C . 1 - M a r k i n g on t h e outside o f M E EQU I P M E NT, M E S YSTEMS or t h e i r parts 20)
Description of m arking S u bclause
CATEGORY APG ME EQU I PM E N T : m a rking of G.3.1

CATEGORY A P M E EQU I P M ENT: m a rking of G .3.2
CATEGORY A P and A P G : m a rking of m a j o r parts G .3.3
CATEGORY A P and APG M E EQU I PM E NT: m a rking of pa rts G .3.5
Depress u rizing pressure system elements: warn i n g about 9.7.2
E m e rgency stop device actuator: m a rking of 9.2.4
Hazardous volta g e : warn i n g of 8 . 1 1 . 1 i)
Mass of PATI E N T , if designed for less than 1 35 kg : marking of 9.8.3.1
Moving parts: warn i n g of 9.2.1
M U L T I P L E SOCKET-O UTLET: m a rking of 1 6. 9 . 2 . 1 b)
Ove rbalancing during transport: warning about 9.4.2.2
POTENTIAL EQUA LIZATION CON D U CTOR term i n a l : m a rking of 8.6.7
Prohi bition agai nst p u s h i n g , l e a n i n g , resting: warning of 9.4.2.3
Reservoir o r liquid storage c h a m be r : m a r k i n g of overflow HAZARD 1 1 .6.2
MECHANICA L PROTECT IVE DEVICE intended to function only o nce: m a rking o f 9.8.4.3
S e parating transformer assem bly: m a rking o f 1 6. 9 . 2 . 1 d )
S u rfaces where a pplication of force results i n a R I S K of ove rbalancing: m a r k i n g of 9.4.2.3
Transport conditions: warn i n g for 9.4.2.2
20) See 7.2.1 f o r t h e m i n i m u m req u i re m e nts f o r m a rking o n M E EQU I P M E N T and o n interchangeable parts.
6060 1 - 1 © I EC : 20 0 5 - 623 -
C.2 M a rk i n g o n t h e i n s i d e o f M E EQUI P M E NT, M E SYSTEMS o r t h e i r parts
The req u i re m e nts fo r m a rki n g on the i n s i d e of M E E Q U I P M E NT a n d its parts a re fo u n d in 7 . 3 .

Additi o n a l req u i re m e nts for m a r ki n g o n t h e i ns i d e o f M E E Q U I P M E NT, M E SYSTEMS a n d t h e i r
pa rts a r e fo u n d i n t h e s u bc l a uses l i sted i n T a b l e C . 2 . Sym bols u s e d i n m a rki n g o n t h e i n s i d e
o f M E E Q U I P M ENT a r e fo u n d i n A n n ex D .
Table C . 2 - M a r k i n g on t h e i n s i d e of M E EQUIPMENT, M E S YSTEMS or t h e i r parts
Hazardous energ i e s : m a rki ng of capacitors o r the con nected c i rc u it parts 8.4.4

Hazardous volta g e : m a rking of parts 8 . 1 1 . 1 i)
MA I N S T E R M I NAL DEVICES: m a rking of term i nals other than terminal blocks 8. 1 1 . 4 . 1
S e parating transformer assem bly: m a rking of 1 6. 9 . 2 . 1 d)
C.3 M a rk i n g of c o ntro ls a n d i n strume nts
T h e req u i re m e nts for m a rki n g of controls a n d i n stru m e nts a re fo u n d i n 7 . 4 . Additi o n a l

req u i re m e nts fo r m a rki n g o f controls a n d i nstr u m e nts a r e fo u n d i n t h e s u bc l a uses l isted i n
Table C . 3 .
Table C . 3 - M ar k i n g of contro l s a n d i n st r u m en ts
Contro l s : scale m a rking of 1 5. 4 . 6 . 1 b)

Varying the tem perature setting of T H E R M OSTATS: clear i ndication of 1 5.4.2.2 a)
C.4 ACCO MPANYING DOC UM ENTS, g e n e ra l
T h e req u i re m e nts fo r g e neral i nfo r m at i o n t o be i n cl u d e d i n t h e ACCOMPANY I NG DOCU M E NTS are

fo u n d in 7 . 9 . 1 . Additi o n a l req u i re m e n ts for g e n eral i nfo r m a t i o n to be i n c l u d e d in the
ACCOMPANY I NG DOCU M E NTS are fo u n d in the s u bc l a u s es l isted in Table C . 4 .
6060 1 - 1 © I EC : 20 0 5 - 625 -
Table C . 4 - ACCOMPANYING DOCUMENTS, g e n e ra l
Des cription of req u i rement Clause
CATEGORY A P and CATEGORY APG M E EQU I P M ENT and parts G.3.4

Defi brillation vo ltage, any necessary recovery time 8.5.5.1 b)
Fixing of structures to floor, wa l l , ceiling, etc. 9.8.1
I nsta bility excluding transport: placement and loading of doors, drawers and s h e lves 9.4.2.2 e)
Lifting points: i n dication of 9.4.4 a)
Mass of PATI E N T , if support syste m s designed fo r less than 1 35 kg 9.8.3.1
Mass of PATI E N T , if support syste m s designed fo r m o re than 1 35 kg 9.8.3.1
M E SYST E M S : addition req u i re m e nts 1 6.2
M E EQU I P M ENT: placement of SAFE WORKING LOAD 9.4.2.4 c )
Noise: protective means 9.6.2 b)
SAFETY DEVICE intended to function only o nce: instruction to call SERVICE PERSO N N E L 9.8.4.3
C.5 ACCO MPANYING DOC UM ENTS, I n struct i o n s fo r u s e
T h e req u i re m e nts for i nfo r m ati o n to be i n c l u d e d i n t h e i nstru cti o n s for u s e are fo u n d i n 7 . 9 . 2 .

Additi o n a l req u i re m e nts f o r i nfo r m at i o n t o b e i n c l u d e d i n t h e i nstruct i o n s f o r u s e a r e fo u n d i n
t h e s u bc l a uses l i sted i n T a b l e C . 5 .
Table C . 5 - ACCOMPANYI NG DOCUMENTS, i nstruct i o n s fo r use
Description of req u i rement S u bclause
AccESS I BLE PARTS: instruction not to touch them and the PATIENT s i m u ltaneously 8.4.2 c)
ACCESS I BLE PARTS: instructions to the OPERATOR to open ACCCESS COVERS 8.4.2 c)
A P P L I E D PARTS (hot o r cold) : tem peratures and c l i n ical effects of 1 1 . 1 .2 . 1
A P P L I E D PARTS not intended t o deliver heat: tem perature exceeding 4 1 ' C 1 1 . 1 .2 . 2
Cleaning o r disinfection PROCESSES: specification of 1 1 .6.6
Foot-operated contro l s : intended f o r use i n a r e a s w h e r e l i q u ids a r e l i kely to be fo u n d 1 5.4.7.3 b)
Mass of ACCESSORIES 9.8.3.2
M E SYST E M S : other e q u i pm e nt i ntended to provide power to ME EQU I PM E NT 1 6.3
MoBI L E M E EQU I PM E NT: requirement t h a t m o re than o n e pers o n is n e e d e d to m ove 9.4.2.4 a)
Moving parts: warn i n g of 9.2.1
POTENTIAL EQUA LIZATION CON D U CTOR term i n a l : information o n the function a n d u s e of 8.6.7
Reservoir o r liquid storage c h a m be r : i nformation o n overflow HAZARD 1 1 .6.2
Transport conditions: warn i n g for 9.4.2.2
6060 1 - 1 © I EC : 20 0 5 - 627 -
C.6 ACCO MPANYING DOC UM ENTS, te c h n ical descri pt i o n
T h e req u i re m e nts f o r i nfo r m ati o n to be i n c l u ded i n t h e tec h n ical descri pt i o n a r e fo u n d i n 7 . 9 . 3 .

Additi o n a l re q u i re m e nts for i nfo r m at i o n t o be i n c l u d e d i n t h e tech n i cal descri pti o n are fo u n d i n
t h e s u bc l a uses l i sted i n T a b l e C . 6 .
Table C . 6 - ACCO M PANYING DOCUMENTS, tec h n ical description
Des cription of req u i rement Clause
CLASS 1 1 ME EQU I P M ENT with isolated i nternal screens: explanation of 8.6.9

External means of isolati o n : description o f 8 . 1 1 . 1 b)
Non-automatic discharging device for internal capac itors : specification of 8.4.4
Network req u i re m e nts f o r P E M S intended to be con nected to a n outside network 14.13
6060 1 - 1 © I EC : 20 0 5 - 629 -
A nnex D
(info rmative)
S y mbols on mark ing

(see Clause 7)
Sym bols are fre q u e ntly used o n ME EQUIPM ENT in p refe r e n c e to words with t h e i nte nti o n of
o bvi ati n g l a n g u a g e d ifferen ces and perm itti n g easier c o m p r e h e n s i o n of a m a rki n g o r
i n di cati o n , s o m et i m e s i n a restri cted s pace. N ew a n d i m proved s y m b o l s a n d s afety s i g n s h av e
been i ntroduced s i nce t h e p u b l i cati o n o f t h e s e c o n d editi o n o f I E C 6 06 0 1 - 1 w h i c h necessitates
c h a n ges in t h e l i st of a p p roved sym bols a n d s afety s i g n s for use on ME EQUI PMENT.
C h i ef a m o n g th ese c h a n ges i s t h e rev i s i o n of the usage of symbol 24 in Table 0 . 1 . T h i s

symbol w a s fo r m a l l y u s e d to i n d i cate a warn i n g as we l l as a n i nf o r m ative m a rki n g ( e . g . t h i s i s
w h e re t h e H I G H VOLTAGE i s c o n n ecte d ) . A n ew s afety s i g n ( 3 ) i n T a b l e 0 . 2 has been a d d e d t o
i n di cate, "Warn i n g : D a n gerous Volta g e . " I n t h i s editi o n o f t h e sta n da r d , t h e safety s i g n s of
T a b l e 0 . 2 are req u i red w h e re a wa r n i n g is i nt e n d e d wh i l e t h e sym bols i n T a b l e 0 . 1 a re u s e d
w h e n t h e i nte nti o n is s o l ely to i nform .
S i m i l arly is t h e rev i s i o n of t h e usage of symbol 1 0 i n T a b l e 0 . 1 , w h i c h was formerly used to

i n d i cate " attenti o n : c o n s u l t ACCOMPANYING DOCUM E NTS " . T h at sym bol is n ow used to i n d i cate
cauti o n . A new sym bol ( 1 1 ) i n T a b l e 0 . 1 has been a d d e d to i n d i cate, "fo l l ow ope rati n g
i nstr u cti o n s " . Addit i o n a l l y , a new s afety s i g n ( 1 0) i n T a b l e 0 . 2 has been a d d e d t o m a r k
ME EQUIPMENT w h e re fa i l u re to fol l ow o pe rati n g i n structi o n s c o u l d p l a c e t h e PAT I E NT o r
OPERATOR a t R I S K .
C o n s istent use o f these sym bo l s a n d s afety s i g n s i n a l l fi e l ds o f u s e ( e . g . , m ed i c a l , co n s u m e r

products , a n d g e n e ral transportati o n ) wi l l h e l p M E EQUIPMENT OPERATORS t o beco m e fa m i l i a r
with t h e i r m ea n i n g . Conversely, a n y i n co n s istent u s e wi l l l ead t o confu s i o n a n d m ista kes a n d
j e o pardize safety.
I EC 60878 provides a u s eful co m pe n d i u m of g r a p h i c a l sym bols a n d s afety s i g n used o n

e l ectrical e q u i p m e n t i n m ed i c a l practice t h at were co m pl i ed f r o m relevant I SO a n d I EC
sta ndards. S e e a l s o 7 . 5 a n d 7 . 6 .
F o r symbol req u i re m e nts n ot m et b y t h e sym bols i n I E C 6 0 8 7 8 , refe r i n t h e fi rst i nsta n c e to

p u b l i s h e d I E C o r I SO sym bols, n oti n g t h at, where n ecess a ry, two o r m o re sym bols can be
g ro u pe d toget h e r to co nvey a parti c u l a r m ea n i n g a n d th at, prov i d e d the essential
com m u n i cative c h a racte ristics of t h e bas i c sym bol are m ai ntai ned, some l atitude i n g r a p h i c
des i g n i s perm iss i bl e . T h e co l o u rs o f sym bols are not specifi e d , except for t h e backgro u n d o f
t h e AP a n d A P G sym bols (see C l a u s e G . 3) . T h e co l o u rs o f s afety s i g n s are s pecifi ed i n
I SO 3864- 1 .
I n t h e foll owi n g t a b l e s , t h e symbol g r a p h i c a n d titl e are prov i d e d for i nfo r m ati o n .

6060 1 - 1 © I EC : 20 0 5 - 631 -
Table D . 1 - Ge n e ral sym bols
No. Sym bol Reference Title
I I
�
1 I E C 6041 7-5032 Alternating c u rrent
L _j
I I
3�
2 I E C 6041 7-5032-1 Three-phase alternating c u rrent
L _j
I I
3 N "'
3 I E C 6041 7-5032-2 Three-phase alternating c u rrent with ne utral cond uctor
L _j
I I
4 I E C 6041 7-5031 Direct c u rrent

- - -
L _j
I I
�
5 I E C 6041 7-5033 Both d i rect and alternating cu rrent
L _j
I I
-
6
�� I-
-
-
I E C 6041 7-50 1 9 Protective e a rth (gro u nd)
L _j
6060 1 - 1 © I EC : 20 0 5 - 633 -
Table D . 1 (continued)
No. Symbol Reference Title
I I
j_-
-
I E C 6041 7-501 7 E a rth (g ro u nd)
L _j
I I
8 I E C 6041 7-5021 E q u i pote ntiality
L
v _j
I I
[gJ
9 I E C 6041 7-51 72 CLASS I I equ ipment
L _j
I I
10
L
& _j
I S O 7000-0434A Caution
In case of a p plication as a safety sign, the rules
according to ISO 3864- 1 are to be adhere d to. See
safety sign I S O 701 O-W001 (Table 0.2, safety sign 2).
r --,
ern
11 I S O 7000-1 641 Operati ng instructions
L _j
I I
12 I E C 6041 7-5007 "ON" (power)
L _j
6060 1 - 1 © I EC : 2005 - 6 35 -
13 I E C 6041 7-5008 "OFF" (power)
L _j
14 I E C 6041 7-50 1 0 "ON" I "OFF" (push-push)

NOTE Each posit i o n , "ON" or "OFF", is a sta bl e posit i o n .
L _j
15 I E C 6041 7-501 1 "ON" I "OFF" (push button)

NOTE " O F F" is a stable posit i o n , w h i l st th e " O N " position
only re m a i n s d u r i n g t h e t i m e th e button i s d e pressed.
16 I E C 6041 7-5264 "ON" for part of equipment
L _j
17 I E C 6041 7-5265 "OFF" for part of the e q u ipment
L _j
18 I E C 6041 7-5638 E m e rgency stop
L _j
6060 1 - 1 © I EC : 20 0 5 - 637 -
•
I I
�
19 I E C 6041 7-5840 TYPE B A P P L I E D PART
NOTE S u bc l a u se 7 . 2 . 1 0 re q u i res that, for c l ear
differe n tiation wi th symbol 20, symbol 1 9 i s not to be appl i ed
i n s u c h a way a s to give t h e i m press i o n of b e i n g i n scribed
with i n a s q u a re .
L _j
I I
[!]
20 I E C 6041 7-5333 TYPE B F A P P L I E D PART
L _j
I I
21 I E C 6041 7-5335 TYPE C F A P P L I E D PART
L _j
22 I E C 6041 7-5331 CATEGORY A P e q u i pm e nt
L _j
I I
w
23 I E C 6041 7-5332 CATEGORY APG e q u i p m e nt
L _j
I I
24 I E C 6041 7-5036 Dangerous voltage
L _j
6060 1 - 1 © I EC : 20 0 5 - 639 -
•
I I
�
� �
25 I E C 6041 7-5841 DEFIBRI LLATION- PROOF TYPE B A P P L I E D PART
L _j
I I
�
[!}
26 I E C 6041 7-5334 DEFIBRI LLATION- PROOF TYPE BF A P P L I E D PART
L _j
��
I I
27 I E C 6041 7-5336 DEFIBRI LLATION- PROOF TYPE C F A P P L I E D PART
L _j
r -,
®
28 I S O 7000-1 051 Do not reuse
L _j
6060 1 - 1 © I EC : 20 0 5 - 641 -
Table D . 2 - Safety s i g n s
Tem plate for constructing a warning sign

I S O 3864-1 ,
Figure 3
NOTE Backgro u n d col ou r: y el l ow
Tria n g u l a r b a n d : B l ac k
S y m b o l o r text: Black
2 I S O 701 0-W001 General warning s i g n
3 I E C 60878 Warn i n g : dangero u s voltage

ISO 3864-8 .3.6 "
ISO 701 0-P001 General prohibition s i g n
and and
4
I S O 3864-1 , Tem plate for constructing a p ro h i bition sign
Figure 1
NOTE Backgro u n d col ou r: wh ite
C i rc u l a r b a n d and s l a s h : red
S y m b o l o r text: black
5 Pushing pro h i bited

ISO 701 0-P01 7
6 ISO 701 0-P0 1 8 S itting pro h i bited

6060 1 - 1 © I EC : 20 0 5 - 643 -
No. Safety sign Reference Title
7 Stepping p ro h i b ited
ISO 701 0-P0 1 9
8 I S O 3864-1 Tem plate for constructing a m a ndato ry action sign

Figure 2
NOTE Backgro u n d col ou r: blue

S y m b o l o r text: white
9 ISO 701 0-M001 General m a ndatory action sign
10 IEC 60878 Fol low operating instructions

Safety 01 b
NOTE O n ME EQU I PM E NT "Follow instructions for use"
• The description of this commonly used safety sign appeared i n Annex B of I S O 3864: 1 984. When the safety
signs were col lected in I S O 701 0, this sign was not m i g rated to the new sta ndard. I S O 3864 : 1 984 was
s u perseded by I S O 3864-1 a n d I S O 701 0 in January 2003. It is expected t h at this s afety sign will be added to
I S O 701 0 in a n upcoming a m e n d m e nt.
This safety sign is under cons ideration for sta ndardization i n ISO 701 0.
6060 1 - 1 © I EC : 20 0 5 - 645 -
Table D . 3 - G e n e ral codes
N IEC 60445 Con nection point for the neutral cond uctor on
P E R M A N E NTLY I N STA L L E D e q u i p m e nt
N1 = 0 N on -protected
1 Protected agai nst s ol i d fore i g n objects of 50 mm 0 and
greater
2 Protected a g a i n st s ol i d fore i g n objects of 1 2 , 5 mm 0
a n d greater
3 Protected a g a i n st s ol i d fore i g n objects of 2 , 5 mm 0
a n d greater
4 Protected a g a i n st s ol i d fore i g n objects of 1 , 0 mm 0
a n d greater
I P N 1 N2
5 Du st-protected
6 Dust-tight
N, = 0 N on -protected
2 IEC 60529 1 Protection a g a i n st verti c al l y fa l l i n g water drops
2 Protect i o n agai nst verti c a l l y fa l l i n g water drops w h e n
ENCLOSURE tilted u p to 1 5 '
3 Protected a g a i n st spray i n g water
4 Protected agai nst splas h i n g water
5 Protected a g a i n st water jets
6 Protected a g a i n st powerful water jets
7 Protected a g a i n st the effects of temporary i m m ersion
i n water
8 Protected a g a i n st th e effects of conti n u o u s i m m ersion
i n water
NOTE W h e n a c h a racteristic n u m e ra l i s not req u i red to be
specified, it is replaced by th e letter "X" ("XX" if both n u m e ral s
are o m itted ) .
6060 1 - 1 © I EC : 20 0 5 - 647 -
A nnexE
(info rmative)
E xamples of the conne ction of the measuring d e vice ( M D) for

measurement of the PATIENT LEAKAGE C U RRENT and PATI E N T AUXI LIARY
C U RRENT
(see 8 . 7)
1
(i)
..
® - MD -
T M E EQUIPMENT with TYPE B APPLIED PART

From all PATIENT CONNECTIONS con nected
--
-
together.
For legends, see Table 5 IEC 2442105
F i g u re E . 1 - TYPE 8 APPLIED PART
(i)
® MD
M E EQUIPMENT with TYPE BF APPLIED PART

From and to all PATIENT CONNECTIONS of
a single function connected together.
For legends, see Table 5 IEC 2443105
F i g u re E . 2 - TYPE BF APPLIED PART

6060 1 - 1 © I EC : 20 0 5 - 649 -
® MD
ME EQUIPMENT IMth TYPE CF APPLIED PART

From and to every PATIENT CONNECTION
For legends, see Table 5
IEC 2444!V5
F i g u re E . 3 - TYPE CF APPLIED PART
1 0
®
MD -
T ME EQUIPMENT with TYPE B APPLIED PART,

TYPE BF APPLIED PART or TYPE CF APPLIED PART
Between any single PATIENT CONNECTION
and all other PATIENT CONNECTIONS
For legends, see Table 5 IEC 2445!V5
F i g u re E . 4 - PATIENT AUXILIARY CURRE NT
® MD
ME EQUIPMENT with MANUFACTURER

specified loading of the PATIENT CONN ECTIONS
of the APPLIED PART
From and to every PATIENT CONN ECTION IEC 2446!V5
For legends, see Table 5
F i g u re E . 5 - load i n g of the PATI ENT CONNECTIONS if s pecified by t h e MANUFACTURER

6060 1 - 1 © I EC : 20 0 5 - 651 -
A nnex F
(info rmative)
S uitable measuring supply circuits
CD
, - ---,
P1
0
----- - -0 I I
I I
I I
Mains
I I
I I
P1
e- �
I�
�o
I
I
0
L _ __j
IEC 2447105
F i g u re F . 1 - M eas u ri n g s u p p l y c i rcu it with o n e s id e of t h e S UPPLY MAINS

at approx i m ately earth potential
(see 8 . 7 . 4 . 2)
�
CD
S1 P1 �-I
0
--____-
_, -------- -- � � I
I I
I I
Mains I I
I I
I I
0
__ _
__j_ _____ ____.,� � � �
L _ __j
I
IEC 2448/0c
F i g u re F . 2 - M eas u r i n g s u p p l y c i rcu it with S UPPLY MAINS

approx i m ately s y m m etrical to earth potential
(see 8 . 7 . 4 . 2)
6060 1 - 1 © I EC : 20 0 5 - 653 -
CD
L1
v1
,-,
0
0
L2
t
� I
I
¢I v2 3�
0
I
Mains
L3
+
� I
0v
0
I
t
I
� -L
(Ne utral) I
I
-
0
L _j _
IEC 2449105
F i g u re F . 3 - M eas u ri n g s u p p l y c i rcu it fo r polyphase M E EQU I P M E NT

s pecified fo r con nection to a polyphase S UP PLY MAINS
(see 8 . 7 . 4 . 2)
(Neutral)
0 )-----�
IEC 2450105
F i g u re F . 4 - M eas u r i n g s u p p l y c i rcu it for s i n g le-phase M E EQU I P M E NT

s pecified fo r con nection to a polyphase S UP PLY MAINS
(see 8 . 7 . 4 . 2)
6060 1 - 1 © I EC : 20 0 5 - 655 -
Mains
IEC 2451105
F i g u re F . 5 - M eas u ri n g s u pply circuit fo r M E EQU I P M E NT hav i n g a separate power s u pply

u n it or i nte n d ed to receive its power from another eq u i p m e n t i n an M E SYSTEM
(see 8 . 7 . 4 . 2)
6060 1 - 1 © I EC : 20 0 5 - 657 -
A nnex G
(normative)
P rotection ag ainst HAZARDS of ig nition

of flammable anaesthetic mixtur es
NOTE T h i s a n nex replaces t h e fo rmer Section S ix : "Protection agai nst HAZARDS o f ignition o f fla m m able
ana esthetic m ixtures" of the second edition.
G.1 I nt ro d u ct i o n
G.1.1 A p p l ica b i l ity

Where M E E Q U I PMENT i s used in areas in w h i c h fl a m m a b l e a n a est h et i cs or fl a m m a b l e age nts
for d i s i nfecti o n or ski n cl e a n i n g are a p p l i e d , an ex plosi o n R I S K c a n exist if s u c h a n aest h et i cs
or a g e nts are m ix e d with a i r , or with oxy g e n or n itrous oxide.
I g n it i o n of such a m ixture c a n be caused by s pa rks o r by cont act with parts h av i n g a h i g h

s u rface tem pe ratu re.
S parks c a n be caused w h e re e l e ctrical circu its are o pe n e d o r closed by o pe rati o n of switc h e s ,

co n n ectors, f u s e s o r OVER-CURRENT R E LEAS E S a n d t h e l i ke .
I n H I G H VOLTAGE parts , s p a rks can be c a u s e d b y coro n a . Stat i c d i s c h a rges c a n c a u s e s pa rks.
The probabil ity of occurr e n ce of the i g n it i o n of s u c h a n aesth eti c m ixtu res d e p e n ds on t h e i r

conce ntrati o n , t h e a p propriate m i n i m u m i g n it i o n e n e rgy, t h e pres e n c e o f h i g h s u rface
tem peratures a n d the e n e rgy of s p a rki n g .
G.1 .2 I n d u strial eq u i p m e n t a n d co m po n e n ts
The constructi o n a l re q u i re m e nts of I EC 60079-0 are generally n ot a p pro pri ate fo r
ME E Q U I P M E N T for several reas o n s :
a) t h e y l ead to constructi o n s o f a s i z e , we i g ht o r d e s i g n t h at are not a p p l i c a b l e f o r m edi cal

reas o n s o r that c a n not be ste r i l iz a b l e ;
b) s o m e constructi o n s a l l ow a n ex p l os i o n i ns i d e a n E NCLOS U R E , but prevent propagat i o n
o u ts i d e i t . S u c h a constructi o n , w h i c h m i g ht be i n h e re ntly s afe, wo u l d be u n accepta b l e i n
a n ope rati n g t h eatre w h e re co nti n u ity o f o p e rati o n of M E E Q U I P M E NT i s esse nti a l ;
c ) i n d ustri a l req u i re m e nts were m ade for fl a m m a b l e a g e nts m i x e d with a i r . T h ey c a n n ot be
a p p l i e d to m ixtu res with oxy g e n o r n itrous oxide used in m ed i ca l practice;
d) in m ed i c a l practice fl a m m a b l e a n aest h et i c m ixtures occ u r only in r e l atively s m a l l
q u a ntiti e s .
H oweve r s o m e of t h e c o n struct i o n s described i n I EC 6 0 0 7 9 - 0 are accepta b l e for CATEGORY A P
ME EQUIPMENT (see G . 5 . 1 ).
G . 1 .3 * Req u i re m e nts fo r ME EQU I P M E NT

I n t h i s a n n ex , t h e l ocati o n of fl a m m a b l e a n aest h et i c m ixtures is d e s c r i b e d :
as m u ch as n ecess a ry f o r t h e constructi o n o f M E E Q U I P M E N T , as m i n i m u m f o r s pecifi ed
con diti o n s of ex h a ust and a bs o r pti o n ;
6060 1 - 1 © I EC : 20 0 5 - 659 -
as m u ch as n ecessary for t h e a l l ocati o n of ME EQUIPMENT a n d t h e c o n structi o n of t h e

e l ectrical i nsta l l at i o n i n t h e I EC 6 0 3 6 4 series.
T h e reco m m e n d at i o n s , l i m its and tests of t h i s a n n ex are based o n t h e resu lts of stati sti cal
c o n s i d e rati o n s o btai n e d from experi m e nts with t h e m ost re a d i l y fl a m m a b l e m ixtu res of eth e r
v a p o u r with a i r a n d with oxyg e n , u s i n g t h e test apparatus d e s c r i b e d i n C l a u s e G . 7 . T h i s is
j ustifi e d because c o m bi nati o n s with eth e r h av e t h e l owest i g n i t i o n te m pe ratu res and t h e
l owest i g n i t i o n e n ergies o f c o m m o n l y used age nts.
Where tem peratu res o r ci rcuit param eters of ME EQUIPMENT used in a FLAMMABLE ANAESTHETIC
M I XTURE WITH AIR exceed a l l owa ble l i m its and s pa r k i n g c a n not be avo i ded the r e l ev a nt parts
a n d circu its can be e n closed i n E NCLOS URES with p ress u rized i n e rt gas or c l e a n a i r or i n
E NCLOS URES with restricted breat h i n g .
ENCLOS URES with restricted breat h i n g d e l ay t h e b u i l d - u p o f a n i g n it a b l e c o n c e ntrati o n . T h ey

are recognized because it is ass u m ed t h at a period i n w h i c h ME EQUIPM ENT is used i n a
FLAMMABLE ANAESTHETIC M I XTURE WITH A I R is fol l owed by a p e r i o d of venti l ati o n d u ri n g w h i c h
s u c h a c o n c e ntrati o n wi l l disa ppear.
For ME EQUIPM ENT conta i n i n g o r used in a FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR
NI TROUS OXI DE, req u i re m e nts, l i m its a n d tests a re fa r m o re stri n g e nt.
T h ese rec o m m e n dati o n s a p ply n ot o n ly to NORMAL CONDI TION but, additi o n a l ly , in t h e S I NGLE
FAULT CONDI TION, as i n d i cated in 4 . 7 . O n l y two ex e m pti o n s from a n act u a l i g n i t i o n test are
reco g n iz e d , these be i n g either t h e a bs e n ce of s pa rks and l i m ited tem perature o r l i m ited
tem perature and restricted circuit param eters.
G.2 Locat i o n s a n d bas i c req u i reme nts
G.2.1 Parts of CATEG ORY APG M E EQUIPMENT

P a rts of CATEGORY APG ME EQUIPMENT in w h i c h a FLAMMABLE A NAESTHETIC MIXTURE WITH A I R
occ u rs s h a l l be CATEGORY AP o r A P G ME EQUIPMENT a n d s h a l l c o m ply with t h e req u i re m e nts of
C l a use G . 3 , G . 4 a n d G . 5 .
G.2.2 FLAM MABLE ANAESTHETIC M IXTURE WITH AIR

Where a FLAMMABLE ANAESTHETIC MIXTURE WITH A I R occurs beca u s e of a l eakage o r d i s c h a rge
of a FLAMMABLE ANAESTHETIC MIXTURE WITH OXYG E N OR NI TROUS OXI DE from a n E NCLOS URE, it i s
c o n s i d ered to propagate to a vol u m e s u rro u n d i n g t h e l eakage o r discharge poi nt a t a d i sta n c e
f r o m 5 em to 2 5 em f r o m s u c h a poi nt.
G.2.3 FLAM MABLE ANAESTHETIC M IXTURE WITH OXYG EN OR NITROUS OXIDE

A FLAMMABLE ANAESTHETIC MIXTURE WITH OXYG E N OR NITROUS OXIDE m ay be conta i n ed in a
'
co m pl etely or partly e n closed ME EQUIPMENT part a n d i n t h e PATI E NT s respi ratory tract. S u c h a
m ixture is c o n s i dered to propagate to a dista n c e of 5 em from an E NCLOS URE part where
l eakage o r discharge occ u rs .
G.2.4 M E EQUIPMENT s pecified for use w i t h F LAMMABLE ANAE STHETIC M IXTURE WITH AIR
M E EQUI PMENT o r pa rts t h e reof s pe cifi e d for use with FLAMMABLE A NAESTHETIC M I XTURE WITH A I R
( i n a locati o n defi n e d i n G . 2 . 2 ) s h a l l be CATEGORY AP o r A P G ME EQUIPMENT a n d s h a l l com ply
with t h e re q u i re m e nts of Clause G.4 and G . 5 .
6060 1 - 1 © I EC : 20 0 5 - 661 -
G.2.5 M E EQUIPMENT s pecified for use w i t h F LAMMABLE ANAE STHETIC M IXTURE WITH
OXYGE N OR NITROUS OXIDE
M E EQUI PMENT o r pa rts t h e reof s pecifi ed for use with FLAMMABLE ANAESTHETIC M IXTURE WITH
OXYGEN OR NI TROUS OXIDE ( i n a l ocati o n defi n e d in G . 2 . 2) s h a l l be CATEGORY APG
ME EQUIPMENT and s h a l l c o m ply with t h e req u i re m e nts of G . 4 and G . 6 .
Compliance with the requirements o f G . 2. 3 through G . 2. 5 (inclusive) is checked b y inspection
and by the appropriate tests of Clause G . 3, G . 4 and G . 5.
These tests shall be perform ed after applicable tests according to 1 1 . 6. 6 and 1 1 . 6. 7.
G.3 M a rk i n g , ACCO M PANYING DOC UM ENTS
G.3.1 CATEGORY APG m a r k i n g

CATEGORY A P G ME EQUIPM ENT s h a l l be m a rked o n a pro m i n ent l o cati o n w i t h a green-coloured
b a n d at l east 2 em wi de i m pri nted with t h e c h a racters "APG" (see sym bol I E C 6 0 4 1 7-5332
( 0 8 : 2002- 1 0) (Table 0 . 1 , sym bo l 23) ) . The l e ngth of t h e green-coloured band s h o u l d be at
l east 4 em. The size of t h e m a rki n g s h o u l d be as l a rge as poss i b l e for the parti c u l a r case. If
this m a rki n g is i m poss i bl e , the relevant i nform ati o n s h a l l be given in the i n structi o n s for u s e .
Compliance is checked by inspection a n d b y application of the tests a n d criteria in 7. 1 . 2 and

7. 1 . 3.
G.3.2 CATEGORY A P m a r k i n g
CATEGORY AP ME EQUI P M E NT s h a l l be m a rked o n a pro m i n e nt l ocati o n w i t h a green-coloured
ci rcl e of at l east 2 e m d i a m eter, i m pri nted with t h e c h a racte rs "AP" (see sym bo l I EC 604 1 7-
5 3 3 1 ( 0 8 : 2002-1 0) ( T a b l e 0 . 1 , symbol 22) ) .
T h e size o f t h e m a rki n g s h o u l d b e a s l a rge a s possi b l e for t h e p a rti c u l a r cas e . If t h i s m a rki n g

is i m poss i bl e , t h e r e l ev a nt i nfo r m at i o n s h a l l be g i v e n i n t h e i nstructi o n s f o r u s e .
Compliance is checked by inspection a n d b y application of the tests a n d criteria in 7. 1 . 2 and

7. 1 . 3.
G.3.3 P lace m e n t o f m a r k i n g s
T h e m a rki n g accord i n g to G . 3 . 2 a n d G . 3 . 3 s h a l l be p r e s e n t o n t h e m aj o r part o f t h e
ME EQUIPMENT if t h i s part i s CATEGORY AP o r CATEGORY APG . I t n e e d n ot be re peated o n
detach a b l e pa rts t h at c a n o n l y be used toget h e r w i t h t h e m a rked M E EQUI P M E NT.
G.3.4 ACCO M PANYI NG DOCUMENTS

ACCO MPANY I NG DOCU ME NTS s h a l l c o nta i n a n i n di cati o n to e n a b l e the RESPONSIBLE
ORGANIZATI ON to disti n g u i s h t h e pa rts of ME EQUI PMENT (see G . 3 . 5) that are CATEGORY AP a n d
CATEGORY APG .
G.3.5 M ar k i n g when parts o f M E EQUIPMENT a re CATEGORY A P o r CATEGORY APG

On ME EQUIPMENT i n w h i c h o n l y certa i n ME EQUI PMENT pa rts a re CATEGORY AP o r CATEGORY
APG , t h e m a rki n g s h a l l clearly i n d i cate w h i c h parts are CATEGORY AP o r CATEGORY APG .

6060 1 - 1 © I EC : 20 0 5 - 663 -
G .4 C o m m o n re q u i reme nts fo r CATEGORY AP a n d CAT EGORY APG ME EQUI PMENT
G . 4. 1 E lect rical co n n ect ions
a) CRE EPAGE DISTANCES and A I R CLEARANCES betwe e n t h e co n n e ct i o n poi nts of POWER S UPPLY
CORD s h a l l be acco rd i n g to THE T a b l e 1 2 v a l ues for o n e MEANS OF PATIENT PROTECTION.
b) C o n n ecti o n s , except t h o s e in t h e ci rcu its descri bed in G . 5 . 3 and G . 6 . 3 , shall be protected

agai nst acci d e ntal disco n n ecti o n in NORMAL USE o r s h a l l be so des i g n e d t h at c o n n ecti o n or
disco n n ecti o n can be perfo r m e d o n l y with the use of a TOOL.
c) CATEGORY AP a n d CATEGORY APG ME EQUIPMENT s h a l l n ot be provi d e d with a DETACHABLE

POWER S U PPLY CORD u n l ess the circuit c o m p l i e s with the req u i r e m e nts of G . 5 . 3 a n d G . 6 . 3 .
Compliance is checked b y inspection o r measurement.
G.4.2 Construction d eta i l s
a) O pe n i n g o f a n E NCLOSURE provi d i n g protect i o n agai nst t h e p e n etrati o n o f g ases o r v a po u rs

i nto t h e ME EQUIPMENT or i nto parts t h e re of s h a l l be poss i bl e o n l y with t h e a i d of a TOOL.
b) To m i n i m ize arci n g a n d sparki n g d u e to fore i g n o bj e cts p e n etrat i n g t h e E NCLOS URE:

- to p cov e rs of E NCLOSURES s h a l l h av e no o p e n i n gs ; o pe n i n gs for controls are permitted
if th ese o p e n i n gs are covered by t h e control k n o b ;
o p e n i ngs i n s i de-covers s h a l l h a v e s u c h d i m e ns i o n s t h at p e n etrati o n b y a s o l i d
cyl i n drical o bj e ct o f m o re t h a n 4 m m d i a m eter i s prev e nted;
o p e n i ngs in base p l ates shall have s u c h d i m e n s i o n s t h at p e n etrati o n by a s o l i d
cyl i n d r i c a l o bj ect o f m o re t h a n 1 2 m m d i a m eter is prev e n t e d .
Compliance i s checked by m e a n s of a cylindrical test rod of 4 mm diameter for side-covers

and 1 2 mm diameter for base plates. The test rod is not to enter the ENCLOSURE when
applied in all possible directions without appreciable force.
c) Where i ns u l at i o n of e l ectrical co n d u ctors e q u a l to o n e MEANS OF PAT I E NT PROTECTION m ay

contact a part c o ntai n i n g a FLAMMABLE ANAESTHETIC M I XTURE WITH OXYG E N OR NI TROUS OXI DE
o r i g n it a b l e gases a l o n e o r oxyg e n , a s h o rt circuit of these c o n d u ctors o r a s h o rt circuit of
o n e co n d u ctor to a c o n d u ctive part conta i n i n g the gas o r m ix t u re s h a l l not res u l t in l oss of
i ntegrity of s u c h a part o r res u lt in a n i n a d m i ssi b l e t e m p e ratu re o r in a HAZARD in s u c h a
part (see G . 6 . 3 a ) ) .
Compliance is checked b y inspection. I n case of doubt, a short-circuit test (without

explosive gases) should be perform ed and the temperature in the relevant part should be
measured if possible. The short-circuit test need not be perform ed if the product of the
open-circuit voltage in volts and the short-circuit current in amperes does not exceed 1 0.
6060 1 - 1 © I EC : 20 0 5 - 665 -
G.4.3 P revention o f electrostatic c h a rg es
a) E l e ctrostatic c h a rges s h a l l be preve nted on CATEGORY AP a n d CATEGORY APG ME EQUI PMENT

by a c o m b i n at i o n of a ppropri ate m easu res such as:
t h e use of a ntistat i c m aterials with a l i m ited el ectrical resista n c e as s pecifi e d i n
G . 4 . 3 b ) , and
provi s i o n o f el ectrically c o n d u ctive paths from ME EQUIPMENT o r its parts t o a
co n d u ctive floor or to t h e p rotective e a rth syst e m or t h e pote ntial e q u a l izat i o n system
o r v i a wheels to a n a ntistatic fl oor of the m ed i c a l l y used ro o m .
b ) T h e e l ectrical resista n c e l i m its o f a n aestheti c t u b i n g , m attresses a n d pads, castor tyres

a n d oth e r a nti stati c m aterial s h a l l c o m ply with I SO 2 8 8 2 .
Compliance with the allo wable resistance limits given in ISO 2882 i s checked by
measurem ents according to ISO 1 853, ISO 2878 and ISO 23529.
G.4.4 C o ro n a
P a rts a n d c o m p o n e nts o f ME EQUI PMENT o pe rati n g a t m o re t h a n 2 0 0 0 V a . c. o r m o re t h a n
2 4 0 0 V d . c. t h at are n ot i n c l u ded i n E NCLOSURES i n co m pl i a n c e with G . 5 . 4 o r G . 5 . 5 s h a l l be s o
des i g n e d t h a t c o r o n a ca n n ot be produced.
Compliance i s checked by inspection a n d m easurement.
G.5 Req u i reme nts a n d tests fo r CATEGORY AP M E EQU I P M ENT, parts a n d

c o m p o n e nts t h e re of
G.5.1 General
M E EQUI PMENT, its pa rts o r c o m p o n e n ts s h a l l n ot i g n ite FLAMMABLE ANAESTHETIC MIXTURES WITH
A I R i n NORMAL USE a n d NORMAL CONDITI O N .
M E EQUI PMENT, i t s parts o r com pon e n ts c o m plyi n g w i t h o n e o f S u bc l a uses G . 5 . 2 to G . 5 . 5

( i ncl usive) are c o n s i d e re d t o c o m pl y with t h e re q u i re m ent of this s u bc l a u s e .
M E EQUI PMENT, its pa rts o r c o m p o n e n ts com plyi n g with t h e req u i re m e nts of I EC 60079-0 for
press u rized E NCLOSURES ( I EC 60079-2), for s a n d-fi l l ed E NCLOSURES ( I EC 60079-5) o r for o i l
i m m e rsed e q u i p m e nt ( I EC 6 0 079-6) as wel l as with t h e req u i re m e nts o f t h i s sta ndard
( excl u d i n g those of G . 5 . 2 to G . 5 . 5) , are c o n s i d ered to comply with t h e re q u i re m e nts for
CATEGORY AP ME EQUIPMENT.
G . 5. 2 Tem perat u re l i m its

M E EQUI PMENT, its pa rts o r c o m p o n e n ts not prod u c i n g s pa rks a n d n ot pro d u c i n g o pe rati n g
tem peratures o f s u rfaces , i n co ntact with g a s m ixtu res i n NORMAL USE a n d NORMAL CONDI TION,
exceedi n g 1 5 0 oc in case of restricted vertical a i r c i r c u l at i o n by convecti o n , o r exceedi n g
2 0 0 oc i n case o f u n restricted vertical a i r c i r c u l ati o n , i f m ea s u r e d a t a n a m b i e nt tem perature
of 25 o c , are c o n s i dered to com ply with t h e re q u i re m e nts of G . 5 . 1 .
The operating temperatures are m easured during the tests m entioned in 1 1 . 1 .

6060 1 - 1 © I EC : 20 0 5 - 667 -
G . 5. 3 * Low-energy c i rcu its

ME EQUI PMENT, its parts or c o m p o n e nts t h at m ay produce s p a rks i n NORMAL USE a n d NORMAL
CONDI TION of the ME EQUI PMENT (for ex a m pl e , switch es , rel ays, p l u g c o n n e cti o n s t h at can be
deta c h e d wit h o ut the use of a TOOL, i n c l u d i n g c o n n ecti o n s i ns i d e ME EQUI PMENT t h at are n ot
s uffi c i e ntly l o cked or s e c u r e d , a n d b r u s h m otors) s h a l l co m pl y with t h e tem perature
req u i r e m e nts of G . 5 . 2 and additi o n a l l y the voltage Umax a n d t h e c u rrent lmax. w h i c h can occ u r
i n th e i r ci rcuits, taki n g i nto a cco u n t t h e capacitance Cmax a n d t h e i n d u ctance L m ax s h a l l c o m ply
with t h e fol l owi n g :
Umax :s; uzR with a g i v e n c u rrent lzR, s e e F i g u re G . 1 '
Umax :s; Uc with a g i v e n ca pacita nce Cmax. s e e F i g u re G . 2 ,
I m ax :s; lzR with a g i v e n voltage Uz R , s e e F i g u re G . 1 , a n d
lmax :s; lzL with a g i v e n i n d u ctance L m ax a n d a Umax :s; 2 4 V , s e e F i g u re G . 3 .
T h e graphs o f F i g u re G . 1 , F i g u re G . 2 a n d F i g u r e G . 3 h ave b e e n o bta i n e d with t h e test
o-3
a p pa ratus accord i n g to G . 6 with the m ost readily fl a m m a b l e m ixtu res of eth e r v a po u r with
a i r (ether v o l u m e percentage 4 , 3 ± 0 , 2 % ) for an i g n it i o n pro b a b i l ity (wi t h o ut s afety factor)
of 1
Extrapolat i o n of t h e g ra p h of F i g u re G . 1 is a l l owed for c o m b i n at i o n s of cu rre nts a n d
corres p o n d i n g v o ltages with i n t h e l i m itati o n s lzR UzR :s; 5 0 W .
·
Extrapolat i o n fo r voltages o f m o re t h a n 4 2 V is n o t val i d .
�
Extrapolat i o n o f t h e graph o f F i g u re G . 2 i s a l l owed for c o m bi n ati o n s o f ca pacita nces a n d
corres p o n d i n g v o ltages with i n t h e l i m itati o n s :
u2 :s; 1,2 mJ
Extrapolat i o n fo r voltages of m o re t h a n 242 V is n ot v a l i d .

I f t h e e q u i v a l e nt resista n ce R i s l ess t h a n 8 0 0 0 Q , Umax is a d d i ti o n a l ly dete r m i n e d with t h e
act u a l resista n c e R.
�
Extrapolat i o n of t h e g ra p h of F i g u re G . 3 i s a l l owed for c o m b i n at i o n s of cu rre nts a n d
corres p o n d i n g i n d u ct a n ces wit h i n t h e l i m itat i o n s
12 :s; 0,3 mJ
Extrapolat i o n fo r i n d u ct a n ces l a rger t h a n 900 m H is n ot val i d .

Voltage Umax is taken as t h e h i g h est s u pply voltage occu rri n g i n the circuit u n d e r
i nvesti gati o n with t h e s parki n g contact o p e n , taki n g i nto acco u n t t h e M A I N S VOLTAGE
variati o n s re q u i red i n 4 . 1 0 .
C u rre nt lmax is taken as t h e h i g h est c u rrent fl owi n g i n t h e ci rcuit u n d e r i nvesti gati o n with
the sparki n g co ntact c l o s e d , taki n g i nto acco u nt the MAINS VOLTAGE variati o n s req u i red i n
4. 1 0 .
Ca pacita n c e Cmax a n d i n d u ct a n ce Lmax. are taken a s t h e v a l ues t h at occ u r a t t h e
com p o n e nt u n d e r i nvesti gati o n that produces s p a rks i n t h e ME EQUI PMENT.
I f t h e circuit is s u ppl i e d with a . c. , t h e peak v a l u e i s taken i nto acco u nt.
I f t h e circuit i s c o m p l i cated and c o n s i sts of m o re t h a n one c a pacita n c e , i n d u cta n c e and
resista n c e , o r a c o m bi n ati o n t h e re of, a n e q u i v a l e nt c i r c u it is cal c u l ated to determ i n e the
e q u ival e nt m ax i m u m capacita n c e , t h e e q u i v a l ent m ax i m u m i n d u ct a n c e and a d d iti o n a l l y the
e q u ival e nt Umax a n d lmax. either as d. c. val ues o r as a . c . p e a k v a l u e s .
6060 1 - 1 © I EC : 20 0 5 - 669 -
Compliance is checked either by temperature measurem ent and determination of Umax. I max. R,
Lmax and Cmax and application of Figure G. 1 , Figure G . 2 and Figure G . 3, or by examination of
the design data.
I
R
-
10
-
f �= -
<(
-
u
"'' '
Test apparatus
"
'V 'zR · UzR = 50 W
""
1\
'
Non-allowable combinations
\
\
\
\
\
\
0,5
f- Allowable combinations
\
) I
0,2
L zR = 42 V
I u
I
I
0,1 I
10 20 50 1 00
IEC 2452105
F ig u re G . 1 - M axi m u m al lowable cu rrent /z R as a fu nction of t h e m axi m u m al lowable

voltage Uz R m eas u red i n a pu rely res i stive c i r c u i t with the m ost fla m m able m ixt u re of
ether vapo u r with a i r
6060 1 - 1 © I EC : 20 0 5 - 671 -
I I II
II
500
Uzc = 242 V R ;> 8 000 Q '
utc l G
-�
��
>
() -
:!)
Test apparatus
1 00 ....... t---
t---
I I I I I I I -
"".....
t---
-
t---
�
["..
50 -t---
I I II
/f- 1/2 cu2 1 ,2 mJ =
Allowable combinations
.(
' '
20
""
,,
t'- ,
-...,
2
10
0,05 0,1 0,2 0,5 5 10 20
Cmax flF --
lEG 2453105
• 8 000 0 o r the actual resista nce, if R is less than 8 000 0
F i g u re G . 2 - Maxi m u m al lowable voltage Uzc as a f u n ction of t h e capacitance Cm ax

m eas u red i n a capac itive c i rc u i t with the m ost fla m m able m ixt u re
of ether vapo u r with a i r
1 000
R
'" l�t
I ,I I I I I
r--:::::- 1/2 Ll
2
- = 0,3 mJ
� 500
!'-...
r--�
........
. ..
r-....
Test apparatus
�I'---
200
.......
Allowable combinations Non-allowable combinations
'
1 00 I'-...
.....,
�
.....,
50
.....
......
r-.......
.. .,
=
i'"--
Lmax 900 m H
t-t-
2 1 000
20
5 10 20 50 1 00 200 500
Lmax mH --
lEG 2454105
F ig u re G . 3 - M ax i m u m al lowable cu rrent /zL as a fu nction of t h e i n d u ctance L m a x

m eas u red i n an i n d uctive c i r c u i t with the most fla m mable m ixtu re
of ether vapo u r with a i r
6060 1 - 1 © I EC : 20 0 5 - 673 -
G . 5. 4 * External venti lation with i nternal overpress u re

Where ME EQUIPM ENT, its parts or com pon e n ts are e n c l os e d i n an E NCLOS URE with exte r n a l
venti l ati o n b y m e a n s o f i nt e r n a l overpres s u re t h e fol l owi n g req u i r e m e nts s h a l l a p ply.
a) FLAMMABLE ANAESTHETI C M I XTURES WITH A I R that m i ght h av e p e n etrated i nto t h e E NCLOS URE
of ME EQUIPMENT o r of an ME EQUIPM ENT part s h a l l be removed by v e nti l at i o n before t h e
ME EQUIPMENT o r t h e ME EQUIPMENT part c a n be e n ergized, a n d s u bs e q u e ntly t h e
p e n etrati o n o f s u c h m ixtu res d u ri n g o pe rati o n s h a l l be preve nted b y m a i nt e n a n c e of
ove r press u re with i n t h e ME EQUIPM ENT or t h e ME EQUIPMENT part by m ea n s of a i r n ot
conta i n i n g fl a m m a b l e gases or v a po u rs or by m e a n s of a p h ysi o l og i c a l l y acce pta b l e i n e rt
gas (for ex a m pl e n itro g e n ) .
b) T h e ove rpress u re i ns i d e t h e E NCLOS URE s h a l l be a t l e ast 75 P a i n NORMAL CONDITI O N . T h e

over pres s u re s h a l l be m a i nta i n e d a t t h e s i t e o f pote nti al i g n it i o n eve n if t h e a i r o r i n e rt gas
can escape t h r o u g h o p e n i n gs in the E NCLOS URE that are n ecess a ry for t h e n o r m a l
o p e rati o n o f ME EQUIPMENT o r i t s parts.
E n ergizi n g ME EQUIPM ENT s h a l l o n l y be poss i bl e after the re q u i re d m 1 n 1 m u m ove rpress u r e

has been present f o r a ti m e s u ffi c i e nt to venti l ate t h e r e l ev a nt E NCLOS URE so t h a t t h e
d i s p l aced vol u m e o f a i r o r o f i n e rt g a s is a t l east five ti m es t h e vol u m e o f t h e E NCLOSURE .
( H owev e r , ME EQUIPM ENT m ay be e n e rgized at a n y ti m e or repeatedly if t h e ove rpress u re i s
conti n u o u s l y pres e nt. )
c) If t h e over pres s u re d r o ps b e l ow 50 Pa d u ri n g operati o n , i g n i t i o n s o u rces s h a l l be de

e n e rgized a u t o m at i c a l l y by means t h at either s h a l l be l o cated in a place w h e re t h e
req u i re m e nts a n d tests o f C l a u s e G . 4 do not apply, o r c o m ply w i t h t h e re q u i re m e nts of
C l a use G . 5 .
d ) T h e exte r n a l s u rface of t h e E NCLOS URE i n w h i c h t h e i nternal ove rpress u re i s m a i ntai n e d

s h a l l not atta i n i n NORMAL CONDI TION a n d NORMAL USE a n o pe r ati n g tem perature exce edi n g
1 5 0 o c , m easu red i n a n a m b i e nt tem perature o f 2 5 o c .
Compliance with the requirements of G. 5. 4 a) to G . 5. 4 d) is checked by temperature,

pressure and flow measurements and inspection of the pressure m onitoring device.
G.5.5 ENCLOSURES w i t h restricted b reat h i ng

Where ME EQUI PMENT, its parts or com pone nts are e n c l o s e d i n a n E NCLOS URE with restricted
breat h i n g the fol l owi n g re q u i re m e nts s h a l l a p pl y :
a) * ENCLOSURES w i t h restricted breat h i n g s h a l l be so desi g n e d t h at t h e fo r m ati o n o f a

FLAMMABLE ANAESTHETIC MIXTURE WITH A I R i n s i d e t h e E NCLOSURE does n ot occur w h i l st t h e
E NCLOS URE is s u rr o u n ded b y a FLAMMABLE ANAESTHETIC M IXTURE W I T H A I R o f a h i g h
c o n c e ntrati o n f o r a period o f a t l east 30 m i n b u t wit h o u t a n y press u re diffe rence t o t h e
s p a c e i ns i d e t h e E NCLOSURE.
b) I f t h e req u i re d t i g htness i s o bta i n e d by gas kets o r sea l i n g , t h e m ate rial u s e d s h a l l t h e refore

be resistant to agei n g .
Compliance is checked b y application o f test B-b o f IEC 60068-2-2, Clause 1 5, temperature

70 "C ± 2 "C, duration 96 h.
c) I f t h e E NCLOS URE conta i n s i n l ets for flex i b l e cords , their gas-ti g htn ess s h a l l be m a i nt a i n e d
w h e n t h e cords a re stressed b y be n d i n g o r p u l l i n g . T h e cords s h a l l be fitted w i t h a d e q u ate
a n c h o rages to l i m it these stresses (see 8 . 1 1 . 3 . 5) .
6060 1 - 1 © I EC : 20 0 5 - 675 -
Compliance with the requirements of G. 5. 5 a), G. 5. 5 b) and G. 5. 5 c) is checked by

application of the following tests:
After completion of the test of G . 5. 4 b) if relevant, an internal overpressure of 400 Pa is

created and 30 pulls of the value shown in Table G. 1 are applied to each flexible cord
alternately, in the axial direction of the cord inlet and in the least favourable perpendicular
direction, each pull without jerks and of 1 s duration. At the end of the test the
overpressure is not be reduced to less than 200 Pa.
Table G . 1 - Gas-t i g h tness of cord i n l ets
Mass (m) of M E EQUIPMENT Pull

kg N
m ,s; 1 30
1 < m ,s; 4 60
m>4 1 00
When the ENCLOSURE of ME EQUIPMENT parts or components is sealed or gas-tight and no

doubt exists that the ENCL OSURE complies with the aforem entioned requirement, the
ENCLOSURE is tested by inspection only.
The operating temperature of the external surface of the ENCLOSURE shall not exceed
1 50 "C m easured at an ambient temperature of 25 °C. The steady state operating
temperature of the ENCLOSURE is also m easured.
G.6 Req u i reme nts a n d tests fo r CATEGORY APG M E EQU I P M E NT, parts a n d
c o m p o n e nts t h e re of
G.6.1 General
M E EQUI PMENT, its parts o r c o m p o n e nts s h a l l not i g n ite FLAMMABLE ANAESTHETIC MIXTURE WITH
OXYGEN OR NITROUS OXI D E . This req u i re m e n t a p pl i es both in NOR MAL USE and in t h e event of
a n y a p pl i ca b l e S I NGLE FAULT CONDI TION, as descri bed in 4 . 7 .
ME EQ UIPMENT, its parts o r components that d o not comply with the requirements o f G . 6 . 3 are
tested by a CONTINUOUS OPERA TION test over a period of 1 0 min in an ether/oxygen mixture
(ether volume percentage 1 2, 2 % ± 0, 4 %) after the thermal steady state condition has been
attained, b ut not longer than 3 h after switching on.
G.6.2 * Power s u pp l y
P a rts o r co m po n e nts o f CATEGORY APG ME EQUIPMENT that operate i n a FLAMMABLE
ANAESTHETIC MIXTURE WITH OXYGEN OR NI TROUS OXIDE s h a l l be s u p p l i e d from a s o u rce t h at is
isol ated from earth by at l east i ns u l ati o n e q u a l to one MEANS OF PATI ENT PROTECTION a n d from
el ectrical pa rts by i ns u l at i o n e q u a l to two MEANS OF PAT I E NT PROTECTION.
Compliance is checked by inspection of circuit diagrams and measurement.
G.6.3 * Tem peratu res and low-energy ci rcu its

M E EQUI PMENT, a n d its pa rts o r c o m p o n e nts are c o n s i dered to c o m ply with the req u i r e m e nts of
G . 6 . 1 wit h o ut bei n g tested accord i n g to G . 6 . 1 if, in NORMAL USE, NORMAL CONDITION a n d S I NGLE
FAULT CONDITIONS (see 4 . 7):
a) n o s pa rks a re produced a n d n o tem peratu res exceed i n g 9 0 o c occur, o r

6060 1 - 1 © I EC : 20 0 5 - 677 -
b) a t e m perature l i m it of 90 oc is n ot exc e e d e d , ME EQUI PMENT or its parts c o nta i n

co m po n e nts t h at m ay prod u c e s p a rks i n NORMAL U S E , NORMAL CON DITION a n d a p pl i ca b l e
S I NGLE FAULT CONDI TIONS, but t h e v o l t a g e Umax a n d t h e c u rrent lmax that c a n occur i n t h e i r
ci rcu its, taki n g i nto acco u n t t h e ca pacita n ce Cmax a n d t h e i n d u ctance L m ax , c o m ply with
the fol l owi n g :
Umax :s; LzR with a g i v e n lz R , s e e F i g u re G . 4 , a n d
Umax :s; Uzc with g i v e n Cmax. s e e F i g u re G . 5 , a s we l l as
lmax :s; lzR with a g i v e n voltage uz R , see F i g u re G . 4 , a n d
lmax :s; lzL with a g i v e n i n d u ctance Lmax a n d Umax :s; 24 V, s e e F i g u re G . 6 .
T h e graphs i n F i g u re G . 4 , F i g u re G . 5 a n d F i g u re G . 6 have been o bta i n e d with t h e test

a p pa ratus accordi n g to F . 8 with the m ost readily fl a m m a bl e m ixture of eth e r v a p o u r
3
w i t h oxyg e n ( eth e r v ol u m e percentage 1 2 , 2 ± 0 , 4 % ) for a n i g n i t i o n probabil ity o f 1 0-
T h e m ax i m u m a l l owa b l e v a l u es of lzR ( F i g u re G . 4 ) , Uzc ( F i g u re G . 5) a n d lzL ( F i g u re G . 6 )
i n cl u d e a s afety factor o f 1 , 5 .
Extra polati o n o f t h e c u rves o f F i g u re G . 4 , F i g u r e G . 5 a n d F i g u r e G . 6 is l i m ited t o t h e
areas i n d i cated.
Voltage Umax is taken as the h i g h est n o - l o a d voltage occu rri n g i n the ci rcuit u n der
i nvesti gati o n , taki n g i nto acco u nt MAINS VOLTAGE v a ri at i o n s as re q u i re d in 4 . 1 0 .
C u rre nt lmax is taken as t h e h i g h est cu rrent fl owi n g in th e circuit u n d e r i nvestigati o n ,
taki n g i nto acco u nt MAINS VOLTAGE v a r i at i o n s a s re q u i re d i n 4 . 1 0 .
Ca pacita n c e Cmax a n d i n d u ct a n ce Lmax are taken as v a l u es t h at occ u r in the relevant
ci rcuit.
I f t h e e q u ival e nt resistance R in F i g u re G . 5 is l ess than 8 000 Q , U m a x i s additi o n a l l y
dete r m i n e d with t h e act u a l res i sta n c e R.
I f t h e circuit is s u p p l i e d with a . c. , t h e p e a k v a l u e i s taken i nto account.
I f t h e c i r c u it i s c o m p l i cated and consists of m o re th a n one capacit a n c e , i n d u ctance a n d
resista n c e o r a c o m b i n at i o n t h e re of a n e q u i v a l ent circuit i s cal c u l ated t o d eterm i n e t h e
e q u ival e nt m ax i m u m ca pacita n c e , t h e e q u i v a l e nt m ax i m u m i n d u ct a n ce a n d ,
additi o n a l ly, t h e e q u i v a l ent Umax a n d lmax either a s d . c . v a l u es o r a . c. p e a k v a l u e s .
I f t h e e n e rgy produced i n a n i n d u ct a n ce o r capacita n c e i n a circuit i s l i m ited b y voltage
l i m iti n g o r cu rrent- l i m iti n g d evices prev e nti n g t h e l i m its of F i g u re G . 4 , F i g u re G . 5 a n d
F i g u re G . 6 bei n g exc e e d e d , two i n de p e n d ent co m po n e nts s h a l l be a p p l i e d , s o t h at t h e
req u i red l i m itati o n o f voltage o r c u rrent is o bta i n e d even i n t h e case o f a fi rst fa u l t
( s h o rt ci rcuit o r o p e n ci rcu it) i n o n e o f these c o m pon e nts .
T h i s re q u i re m ent does not a pply to transform ers des i g n e d a n d m ade accord i n g to t h i s

sta n dard a n d to wi re-wo u n d c u rrent-l i m iti n g resi stors prov i d e d w i t h a protecti o n agai nst
u n wi n d i n g of the wi re in the event of r u pt u re .
Compliance i s checked b y inspection, temperature m easurem ents, comparison with design

data or by measurement of Umax, lmax, R, L max and C max and using Figure G . 4, Figure G . 5
and Figure G. 6.
6060 1 - 1 © I EC : 20 0 5 - 679 -
<(
'" • 0,75 A
R
I\
\
___L
I\
" ll = �
Test apparatus
1\
-
1\
0,5
\
1\
0,2 1\
0,1
\ \'\
'\
\
I
0,05 I
-!
!
UzR = 30 V
I
0,03 I
3 5 10 20 I 50
l
I
UzR V�
IEC 2455105
F ig u re G . 4 - M ax i m u m al lowable cu rrent /zR as a fu nction of the maxi m u m al lowable

voltage UzR m eas u red i n a pu rely res i stive circuit with the m ost fla m m able m ixt u re of
ether vapo u r with oxygen
6060 1 - 1 © I EC : 20 0 5 - 681 -
1 00 I
R > 8 ooo o•
>
0
50
� + [=c + ��-�
\Uzc = 17 V
II lI lI
:!)
Test apparatus -
r-- - j_ -------
1---
20
10
t----. Non-allowable combinations
---
---
---
r-
j---C- max = 1 f.!F

5
I
1
I
2 I
0,02 0,05 0,1 0,2 0,5 2 4
• Cmax f.!F -�
IEC 2456105
• 8 000 0 o r the actual resista nce, if R is less than 8 000 0

F ig u re G . 5 - M axi m u m al lowable voltage Uzc as a f u n ction of t h e capacitance Cm a x
m eas u red i n a capac itive c i rcu it with the m ost fla m m able m ixt u re of ether vapo u r
/
with oxyg en
/ zL = 55 mA
1 00
R
T �
L..
<( "'50
....... 24 V
YLV•
.......
E
t--
........___
j--...
Test apparatus
20 ......
10
r...r-...
... .
I'-- Non-allowable combinations
t--r--.
....�"""-
. --...
.......
.......
.......
Lmax = 900
......
5 r......
......
mH-r---
10 � 1 000
I
2 I
2 5 20 50 1 00 200 500
Lmax mH �
IEC 2457105
F ig u re G . 6 - M ax i m u m al lowable cu rrent /z L as a fu nction of t h e i n d u ctance L m a x
m eas u red i n an i n d uctive c i r c u i t with the most fla m mable m ixtu re
of ether vapo u r with oxygen
6060 1 - 1 © I EC : 20 0 5 - 683 -
G.6.4 H eat i n g e l e m e n ts
ME EQUI PMENT, its parts a n d c o m p o n e nts t h at h eat a FLAMMABLE ANAESTH ETIC M I XTURE WITH
OXYGEN OR NI TROUS OXI DE s h a l l be prov i ded with a n o n-SELF-RESETTING THERMAL CUT -OUT, as
a n addit i o n a l protect i o n agai n st overh eati n g .
Compliance is checked b y the corresponding test o f 1 5 . 4 . 2. 1 .
T h e c u rre nt-ca rry i n g part o f t h e h eati n g e l e m ent s h a l l n ot be i n d i rect conta ct with t h e

FLAMMABLE ANAESTHETIC M I XTURE W I T H OXYG E N O R N I TROUS OXI D E .
G.7 Test a p pa ratus f o r fla m m a b l e m ixtu res

NOTE Formally Appendix F of the second editio n .
3
The test apparatus comprises a n ignition space with a volum e of at least 250 cm , which
contains the prescribed atm osphere or mixture and a contact arrangement (see Figure G. 7)
providing sparks by opening and closing.
The contact arrangement consists of a cadmium disk with two groves and a second disk with
four tungsten wires having a diameter of 0, 2 mm that slides o ver the first disk. The free length
of the tungsten wires is 1 1 mm. The shaft to which the tungsten wires are connected rotates
with a speed of 80 rlmin. The shaft connected to the cadmium disk turns in opposite direction
to the shaft connected to the disk with wires.
The ratio of the rotation speed of the shaft connected to the wires and the other shaft is 50: 1 2.
Both shafts are isolated from each other and from the frame.
The ignition space must be able to support an internal overpressure of 1,5 MPa.
With the contact arrangement, the circuit to be tested is closed or opened and it is checked if
the sparks will ignite the atm osphere or mixture under test.
6060 1 - 1 © I EC : 20 0 5 - 685 -
IEC 2458105
Dimensions i n m i l l i m etres
1
Legend
I g n ition space
2 Cad m i u m disk
3 Tungste n wire
4 S haft of wire disk
5 S haft of disk with g rooves
F ig u re G . 7 - Test apparatus
6060 1 - 1 © I EC : 20 0 5 - 687 -
An n e x H
(info rmative)
P E M S stru ctu re, P E M S D EV E L O P M E N T L I F E-CY C L E a n d d o c u m e ntati o n
H.1 Exa m p les fo r PE MS/PESS stru ct u res
A PEMS can be a very s i m pl e piece of ME EQUI P M E NT o r a c o m p l ex ME SYSTEM o r a n yt h i n g i n

betwe e n .
F i g u re H . 1 s h ows s o m e possi b l e exa m pl es o f a PEMS.
F i g u re H . 1 a) s h ows a com p l ex syste m . T h e PEMS breaks down i nto a n u m be r of m aj o r

s u bsyste m s , w h i c h i n t u r n a re m a d e u p o f s u bsyste m s , w h i c h i n c l u d e a P E S S .
F i g u re H . 1 b) s h ows a s i m pl e r i m pl e m e ntati o n . I n t h i s c a s e t h e i ntermedi ate m aj o r s u bsystem

l ev e l is m issi n g and the PESS is a s u bsystem of the PEMS itself.
F i g u re H . 1 c) i l l ustrates the s i m pl est i m pl e m e ntati o n of a PEMS. I n t h i s case the PEMS a n d t h e

P E S S are t h e s a m e .
T h e structure o f t h e PEMS i s extre m e l y i m porta nt for i m pl e m e nti n g s afety req u i re m e nts . A n

arch itect u re s h o u l d b e d o c u m e nted f o r t h e PEMS t h at descri bes t h e structure o f t h e PEMS a n d
t h e r e l ati o n s h i p betwee n each P E S S a n d t h e P E M S as a w h o l e . T h e arch itect u r e s h o u l d
i n d i cate:
- t h e divisi o n of t h e PEMS i nto co m po n e nts, especi a l l y those i m pl e m e nted i n each PESS a n d
i n cl u d i n g s oftware c o m p o n e n ts ;
- t h e fu n cti o n s t o b e perfo r m e d b y each PESS a n d its c o m p o n e nts ( i ncl u d i n g w h e re
a p propriate safety- r e l ated fu n cti o n s ) ;
- t h e i nterfaces betwe e n s oftware c o m p o n e n ts ;
- t h e i nterfaces betwe e n s oftware c o m p o n e nts a n d c o m p o n e nts exte r n a l to t h e s oftware.
H.2 P E M S DEVELO P M E NT LIFE-CYC LE m o d e l
C o m p l i a n c e with t h e PEMS c l a u s e o f t h i s sta n d ard ( C l a use 1 4) requi res that a PEMS

DEVELOPMENT LIFE-CYCLE be s pecifi e d and then fol l owe d ; it does n ot req u i r e t h at a n y parti c u l a r
PEMS DEV E LOPMENT LIFE-CYCLE is u s e d , b u t it d o e s req u i re t h at t h e P E M S DEVELOPMENT LIFE
CYCLE h as certa i n attri butes. T h e s e req u i re m e nts can be fo u n d in 1 4 . 4 .
T h e PEMS DEVELOPMENT LIFE-CYCLE i s a part o f t h e overall product l ife-cycl e .
F i g u re H . 2 i s a v i ew o f t h e P E M S DEVELOPMENT LIFE-CYCLE w h i c h s h ows activities g r o u ped i nto

two m a i n PROCES S E S . On the l eft i s decom pos i t i o n PROCESS a n d on the r i g ht i s the i nteg rati o n
PROCESS.
F i g u re H . 2 i l l ustrates:
l ayered des i g n activities;
- for each l ayer of d es i g n , a corres p o n d i n g l ayer of i nteg rati o n a n d VERI F I CATI O N ;
- verifi ed pa rts are i nteg rated to ass e m bl e t h e n ext h i g h e r l ay e r ;
pro b l e m reso l uti o n PROCESS i nte racti o n s .
6060 1 - 1 © I EC : 20 0 5 - 689 -
a) Example of a complex system
b) Example of a simpler implementation
c) Example of the simplest implementation

IEC 2459105
F ig u re H . 1 - Exa m p les of P E M S/ P E SS structu res

/
(J)
0
(J)
0
User
needs Validated PEMS
a1I I
@
PEMS m
7
PEMS
requirements capture
PEMS VALIDATION plan PEMS VALIDATION nm
VALIDATION 0
----------------- . results N
0
0
PEMS (]1
'TI Verified PEMS
requirements specifications
(Q
1::
... PEMS test specification
CD PEMS PEMS
:::c PEMS VERIFICATION plan �� VE Rl FICATIION ��
architecture des1gn
1\) results
I
PEMS
:t>
architecture specification, Verified subsystem
1J
m subsystem (e.g. PESS)
s: requirements specifications
(/)
0 Su bsystem
m
< Su bsystem test specification �� VERIFICATIION ��
m results (J)
r <D
0 Requirements
1J decomposition Subsystem architecture specification,
s: PEMS
m RISK ANALYSIS component (e.g. sw) Verified component
_
VERIFICATIN of
z requirements specifications
-1 RISK CONTROL
r
,
m Component
0 �� VERIFICATIION ��
Component test specification
-< results
(')
r
m Component architecture specification,
unit (e.g. sw module)
3 Verified unit
0 requirements specifications
a. '
CD
Component (e.g. sw Component (e.g. sw
¢::::J
Unit design Unit
f-- (e.g. sw code),
y
system) integration sytem) integration �� VERIFICATIION��
and VERIFICATION unit VERIFICATION plan and VERIFICATION results
Key:
Boxes repesent typical PEMS DEVELOPMENT LIFE-CYCLE activities
¢::::J Output to the problem resolution PROCESS
Solid arrows indicate typical deliverables into/out of activities

Dashed arrows indicate deliverables just to the RISK MANAGEMENT FILE
c:::::::) Input from the problem resolution PROCESS
IEC 2460!V5
6060 1 - 1 © I EC : 20 0 5 - 693 -
As t h e d e s i g n is decom posed from t h e re q u i re m e nts, t h e f u n cti o n a l b u i l d i n g bl ocks,

arch itect u re and tech n o l ogy are deci d e d . The decom pos iti o n P ROCESS c o n cl u des when t h e
des i g n i nfo r m ati o n e n a b l es t h e co m po n e n ts of t h e P E M S to be b u i lt ( ex a m ples o f s u c h des i g n
i nfo r m at i o n a r e circuit d i a g ra m s a n d s oftwa re code) . T h e d e c o m positi o n c o m p o n e nts are
i ntegrated toget h e r . VERI F I CATI ON i s perfo r m e d as t h e co m po n e nts are i ntegrated to d eterm i n e
w h et h e r o r n ot t h e i m pl e m e ntati o n satisfi es t h e req u i r e m ents. At t h e concl u s i o n o f t h e
i nteg rati o n PROCESS, a P E M S VALI DATION is perfo r m e d to determ i n e whet h e r o r n ot t h e PEMS
works as i nt e n d e d .
H.3 Software PROCESSES
H.3.1 P E M S DEVE LOPMENT L I F E -CYCLE

A PEMS DEV E LOPMENT L I FE-CYCLE, s u c h as the o n e i l l ustrated in F i g u re H . 2 , cons ists of a
n u m be r of PROCESSES t h at are c o m posed of activities. E a c h activity is perfo r m e d to
acco m pl i s h s pecific g o a l s . To apply RISK MANAG EMENT, confi d e n c e i n t h e e n g i n e e ri n g activities
o n w h i c h the RISK MANAG E M E NT i s based is n e e d e d . I n parti c u l a r , this is a re q u i re m ent for the
software l ife-cycl e .
I EC 62304 [26] ( u n d e r d eve l o p m e nt) descri bes t h e pro cesses to be i n c l u d e d i n t h e softwa re

devel o p m ent l ife-cycl e fo r t h e dev e l o p m e n t of s afe m ed i c a l device s oftwa re.
H.3.2 Req u i re m e nts s pecification

To determ i n e w h i c h fu n cti o n s create o r control RISKS , it is n e cess a ry to f u l l y i d e n tify t h e
req u i re m e nts o f t h e PEMS/PESS. I t i s n ot poss i bl e to do a n a d e q u ate RISK ASSESSMENT with o ut
a c o m pl ete req u i re m ent s pecifi cati o n a n d a n a rchitectural des i g n that m eets that spe cificati o n .
T h e re q u i re m e nts s h o u l d i n cl u d e , a s a p p ro p ri ate t o t h e PEMS softwa re:
- f u n cti o n a l and c a p a b i l ity req u i re m e nts , i n cl u d i n g ESSENTIAL PERFORMANCE, phys i ca l
c h a racte ristics, a n d envi ro n m e ntal c o n diti o n s u n d e r w h i c h t h e s oftware i s to perform ;
i nterfaces exte r n a l to t h e softwa re;
safety re q u i re m e nts i n cl u d i n g RISK CONTROL m eas u res for h a rdware fa i l u res and potenti a l
softwa re defects a n d s pecifi cati o n s r e l ated to m eth ods o f operati o n a n d m ai nt e n a n c e ,
envi r o n m e ntal i nfl u e nces, a n d RISK CONTROL;
softwa re driven a l a r m s i g n a l s , wa r n i ngs a n d OPERATOR m essages;
secu rity re q u i re m e nts, where l ack of secu rity wo u l d c o m pro m i se s afety;
h u m a n-factors e n g i n eeri n g req u i re m e nts related to the use of the PEMS , i n cl u d i n g those
related to s u pport for m a n u al o pe rati o n s , h u m an-eq u i p m e n t i nte racti o n s , co nstrai nts o n
pers o n n e l , a n d areas n e e d i n g c o n c e ntrated h u m a n att e nti o n t h at are s e n sitive t o h u m a n
errors a n d trai n i n g ;
data defi n it i o n a n d database req u i re m e nts ;
i nsta l l at i o n a n d accept a n ce re q u i re m e n ts for t h e PEMS softwa r e ;
doc u m e ntati o n to be dev e l o p e d ;
o p e rati o n a n d ex e c uti o n re q u i re m e nts;
m a i nt e n a n c e re q u i re m ents.
RISK ASSESSMENT s h o u l d be used to d eterm i n e t h e extent to which t h e arch itecture design c a n

be used to m iti gate t h e RISKS.
6060 1 - 1 © I EC : 20 0 5 - 695 -
H.3.3 T h i rd-party and off-th e-shelf (OTS) software

To have t h e a b i l ity to i d e ntify k n own or fo resee a b l e HAZARDS , it is a l s o n ecessary to
c h a racterise any t h i rd-pa rty o r OTS s oftwa re used in the P E M S . The dev e l o p e r s h o u l d
establ i s h s oftware req u i re m e nts for t h i rd- party o r OTS softwa re. T h e s e req u i re m e nts s h o u l d
i n cl u d e t h e fol l owi n g :
- title a n d m a n ufact u re r , vers i o n l ev e l , rel e ase date , patch n u m be r a n d u pgrade d e s i g n ati o n ;
- t h e syst e m h a rdwa re a n d software n ecess a ry to s u pport proper o pe rati o n ( e . g . processor
type and speed, m e m o ry ty pe and size, and syste m , com m u n i cati o n and d i s p l ay softwa re
req u i r e m e nts) ;
i nterfaces t o t h e s oftware c o m po n ent;
safety criti cal a n d RISK CONTROL m eas u re fu n cti o n s d e pe n de n t o n t h e software c o m pone nt.
H.3.4 I nteg ration

T h e d eve l o per s h o u l d esta b l i s h a n i nteg rati o n plan to i nteg rate t h e c o m p o n e nts of each PESS
and of t h e PEMS . The plan s h o u l d i n cl u d e t h e approac h , res pons i bi l ities and s e q u e n c e , a n d
i n cl u d e a l l s oftware c o m p o n e nts. If t h e PESS s oftwa re i s b u i l t usi n g i n c re m e ntal i ntegrat i o n
m ethods, s uffi c i e n t regres s i o n testi n g s h o u l d be perfo r m e d to e n s u re t h at prev i o u s
VERI F I CATI ON i s sti l l s uffi c i ent. I nteg rati o n tests s h o u l d i n c l u d e test cases w h i c h expose
softwa re b e h av i o u r n ot only in res p o n s e to t h e n o r m a l cas e , but also in response to
exce pti o n a l , stress or wo rst case c o n diti o n s .
H.3.5 Confi g u ration m a n ag e m e n t

Because t h e RISK ANALYS I S rel i es o n t h e re q u i re m e nts of t h e s oftware, co nfi g u rati o n
m a n ag e m ent a n d c h a n g e co ntrol a re n ecess a ry t o e n s u r e t h at additi o n a l softwa re
f u n cti o n a l ity is not added d u ri n g devel o pm e nt without bei n g c o n s i dered by t h e RISK
MANAG E M E NT PROCESS . A confi g u rati o n m a n a g e m ent p l a n s h o u l d be esta b l i s h e d t h at
descri bes:
- t h e i te m s to be contro l l e d ;
- t h e c o nfi g u rati o n m a n a g e m ent activities;
PROCEDURES and s c h e d u l e for perfo r m i n g th ese activiti e s ;
res p o n s i b i l ities for perfo r m i n g these activities;
PROCEDURES to control t h e recei pt, i nstal l ati o n , and acce pta n c e of each s oftwa re
co m po n e nt.
A s c h e m e s h o u l d be establ i s h e d for t h e u n i q u e i d e ntifi cati o n of softwa re confi g u rati o n items

and vers i o n contro l . This sch e m e s h o u l d i n cl u d e a n y t h i rd - pa rty and OTS software
co m po n e nts.
H.3.6 M od ification/c h a n g e control

For m o difi cati on/c h a n g e control , t h e fo l l owi n g s h o u l d be perfo r m e d :
i d e ntifi cati o n a n d recordi n g o f c h a n g e r e q u ests ;
a n alysis a n d eval u ati o n of t h e c h a n ge s ;
a p proval o r d i s a p prov a l o f t h e requ est;
i m pl e m e ntati o n , VERI F I CATION a n d rel e ase of the m odifi ed s oftware.
6060 1 - 1 © I EC : 20 0 5 - 697 -
An a u d it trail s h o u l d be m a i ntai n e d , w h e r e by each m odifi cati o n , t h e reason for t h e

m odifi cati o n , a n d a u t h o rizat i o n o f t h e m o d ifi cati o n c a n be t r a c e d . RECORDS o f t h e h isto ry of
control l e d ite m s s h o u l d be retri evabl e .
H.4 Des i g n a n d i m p leme ntat i o n
D u r i n g a p pl i cati o n o f t h e P E M S DEVELOPMENT LIFE-CYCLE m od e l , d e s i g n a n d i m pl e m e ntati o n wi l l

i n cl u d e t h e s e l ecti o n of:
a) the d e s i g n e n v i r o n m ent, for ex a m pl e :

software d ev e l o p m e n t m ethods;
c o m puter a i d e d s oftwa re e n g i n e e ri n g ( CAS E) tools;
progra m m i n g l a n g u a g e ;
h a rdware a n d s oftware deve l o p m ent pl atfo r m s ;
- s i m u l at i o n tools;
des i g n and codi n g sta n d a rd s ;
b) el ectro n i c c o m p o n e n ts ;
c ) red u n d a nt h a rdwa r e ;
d) h u m a n-PEMS i nterface;
e) e n e rgy s o u rces;
f) e n v i r o n m e ntal c o n d i t i o n s ;
g) t h i rd- party s oftwa re;
h ) n etworki n g o pti o n s .
T h ese e l e m e nts o f t h e des i g n e n v i r o n m ent can be c h a racterized i n g e n e ra l a n d i n t h e s pecific

m a n n e r of t h e i r use in t h e des i g n and i m pl e m e ntati o n PROCESS.
H.5 Docu me ntat i o n
F i g u re H.3 i n cl udes a l l o f t h e docu m e ntati o n req u i red b y C l a use 1 4 a n d I SO 1 4 9 7 1 : 20 0 0 . I t i s

i ntended to s h ow a n exa m p l e structure o n ly. P a rti c u l a r d o c u m e ntary refe rences c a n b e
cons o l i d ated o r d istri b uted a m o n g several d o c u m e nts . T h e c l a u s e n u m bers proceeded b y a
"#" are refe ren ces to t h e c l a u s e n u m be rs i n I S O 1 497 1 : 2 0 0 0 . Other n u m be rs refe r to t h e
s u bc l a uses o f t h i s sta n d a rd .
6060 1 - 1 © I EC : 20 0 5 - 6 99 -
ACCOMPANYING
RISK MANAGEMENT FILE
NETWORK/DATA COUPLING info 1 4 . 1 3
Acceptable RISK policy #3.3

RISK MANAGEMENT PROCESS #3.2
DEVELOPMENT LIFE-CYCLE 1 4.4

RISK MANAGEMENT plan #3.5 and 1 4.3
RISK ANALYSIS results #4.1
Problem resolution PROCESS 1 4. 5
Safety related characteristics #4.2
INTENDED USE/INTENDED PURPOSE #4.2
PEMS arch itecture specification 1 4. 8

Requirement specification 1 4.7
Design environment 1 4.9
list of HAZARD #4.3 and 1 4. 6 . 1
Reference with
Subsystem specification 1 4. 7 a "#" are references
Estimated RISK o f HAZARD #4.4 to ISO 1 4971 2000,
otherwise references
RISK EVALUATION resutts # 5 are to subclauses
RISK categorization system #4.4 in this sta ndard.
VERIFICATION plan 1 4 . 1 0
RISK CONTROL measures #6.2 and #6.3
RESIDUAL RISK evaluation #6.4

VERIFICATION results #6.3
PEMS VALIDATION plan 1 4. 1 1

PEMS VALIDATION results 1 4. 1 1
HAZARD review of RISK CONTROL #6.6

RisK/benefit analysis results #6.5
Overall RESIDUAL RISK evaluation #7

Completeness assessment #6.7
Review of RISK MANGEMENT #3.3
Post-producton information #9
RISK management report #8
RISK CONTROL VERIFICATION

#6.2 and #6.3 #6.3
IEC 2461105
F i g u re H . 3 - PEMS docu mentation req u i rements from C lause 1 4 a n d I S O 1 4971 : 2000

6060 1 - 1 © I EC : 20 0 5 - 701 -
H.6 N ETWORK/ DATA COU PLI NG
H.6.1 General
I n t h e co ntext of t h i s sta n dard, t h e i nfo r m ati o n transm itted as a part of NETWORK/DATA
COUPLI NG is t h at i nt e n d e d by t h e MANUFACTURER to be transm itta b l e ( i . e . n ot t h r o u g h i l l egal o r
i l l i cit a cti o n s o f u n a ut h o rized pers o n s ) .
N E TWORK/DATA COUPLING as used i n t h i s sta n d ard d o e s n ot i n c l u d e i nfo r m at i o n t ra nsfe rred

across user i nterfaces . The MANUFACTU RER sti p u l ates the poss i b l e i nformati o n ty pes and t h e i r
tra n s m issi o n protocols i n t h e tec h n i cal descripti o n ( s e e 1 4 . 1 3) .
H.6.2 System i n teg ration res pon s i b i l ities

ME EQUI PMENT a n d ME SYSTEMS wi l l s o m eti m es be used toget h e r to create a syst e m . T h i s is
l i ke l y to beco m e m o re fre q u ent with t h e i n creas i n g use of c o m pute rs to a n a lyze cl i n ical data
and co ntrol treatm ent.
S o m eti m es ME EQUIPMENT wi l l h ave been desi g n e d by t h e MANUFACTU RER to work with oth e r
ME E Q U I PMENT, h owev e r , it wi l l oft e n be t h e c a s e t h at t h e se pa rate ME EQUIPMENT wi l l n ot h ave
been des i g n e d to work with each oth e r . S o m e o n e h as to be res p o n s i b l e for e n s u r i n g t h at all
t h e s e pa rate ME EQUI P M E NT work toget h e r s atisfacto r i l y in t h e i nteg rated syste m ; i n oth e r
words, s o m e o n e h as to be res p o n s i b l e for des i g n i n g t h e i nteg rated syste m .
I t i s reco g n i z e d t h at t h e system i nteg rator oft e n has t o com ply with parti c u l a r r e g u l atory
req u i re m e nts .
I n order to perform its fu n cti o n , t h e syst e m i nteg rator n eeds to kn ow:

how t h e i ntegrated syste m i s i nt e n d e d to be u s e d ;
- t h e re q u i red perfo r m a nce of t h e i nteg rated syste m ;
- t h e i nt e n d e d c o nfi g u rati o n of t h e syste m ;
- t h e co nstrai nts on t h e exte n d i b i l ity of t h e syste m ;
- t h e s pecifi cati o n s of a l l ME EQUIPMENT a n d other e q u i pm ent to be i nteg rated;
- t h e perfo r m a n c e of each ME EQUI PMENT a n d ot h e r e q u i pm ent; a n d
- t h e i nfo r m at i o n fl ow i n a n d a ro u n d t h e syste m .
T h i s i nfo r m at i o n wi l l n ot b e avai l a b l e t o t h e i n d i v i d u a l MANUFACTU RERS , a n d fo r t h i s reas o n

each i n d i v i d u a l MANUFACTURER c a n not ca rry out t h e r o l e o f system i nteg rator. I n a n y c a s e t h e
syste m i nteg rator has to be a s i n g l e pers o n o r o r g a n i sati o n t h at h as overa l l res p o n s i b i l ity, t h i s
ove r a l l res pons i bi l ity c a n n ot be s h a red betwee n several diffe rent MANUFACTURERS . T h e
res p o n s i b i l ity o f a MANUFACTURER is l i m ited to provi d i n g t h e req u i red i nfo r m at i o n o n thei r
e q u i pm ent (see 1 4 . 1 3) .
O bv i o u s l y a RESPONSIBLE ORGANIZATI ON c a n e m pl oy a MANUFACTURER t o i nteg rate t h e i r

syst e m . I n t h i s c a s e t h e w h o l e system c a n beco m e a n ME SYSTEM a n d it wi l l be t h e
'
MANUFACTURER s res p o n s i b i l ity to prov i d e a co rrectly i ntegrated syste m . I n t h i s c a s e t h e
syste m co u l d be separately reg u l ated.
T h e system i nteg rator s h o u l d be c o m pete nt to assess a n d a d d ress t h e HAZARDS t h at are l i ke l y

to a ri s e f r o m i nteg rati n g a system a n d to e n s u re that t h e RESI DUAL RISKS o f t h e i n d i v i d u a l P E M S
are m a i ntai n e d .
6060 1 - 1 © I EC : 20 0 5 - 703 -
Ty pical l y a syst e m i nteg rator wo u l d :

p l a n t h e i nteg rati o n o f a n y ME EQUI PMENT o r M E SYSTEM a n d n o n - m edical e q u i p m e nt i n
accord a n c e with t h e i nstr u cti o n s prov i d e d b y t h e various MANUFACTURERS;
perform RISK MANAGEMENT o n the i nteg rated syste m ; a n d
'
pass o n a n y MANUFACTURER S i nstructi o n s t o t h e RESPONS I B L E ORGANIZATION w h e re these
are re q u i re d for t h e safe o pe rati o n of t h e i nte g rated syste m . T h e s e i nstru cti o n s s h o u l d
i n cl u d e wa r n i ngs a b o ut t h e HAZARDS o f a n y c h a n g e o f confi g u rati o n .
H.7 Des i g n c o n s i d e rati o n s f o r NETWORK/ DATA COUPLING
H.7.1 I n trod uction
From t h e v i ewpoi nt of a PEMS MANUFACTURER, a n y ty pe of a N E TWORK/DATA COUPLING i s a

s o u rce of additi o n a l c a u ses for HAZARDS. I n p r i n c i p l e a n y NETWORK/DATA COUPLI NG that is
o u ts i d e t h e control of t h e PEMS MANUFACTURER s h o u l d never be pres u m ed to be 1 00 %
rel i a b l e .
H.7.2 Cau ses o f HAZARDS associated w i t h N E TWORK/DATA C O U P L I N G

In NETWORK/DATA COUPLED syst e m s , l i ke l y c a u s es for HAZARDS a r e :
l oss o f data;
i n a ppropriate data i nterch a n g e ;
corr u pted data;
i n a ppropriate ti m i n g of data ;
u n ex pected rece i pt of d ata;
u n a uth orized access to d ata.
S u pp l e m e nti n g A n n ex A of I SO 1 4 97 1 : 20 0 0 when i d e ntifyi n g t h e c a u s es of HAZARDS

ass ociated with NETWORK/DATA COUPLI N G , at l east the fol l owi n g s h o u l d be c o n s i d e r e d :
r e m ote s e rvi c i n g ( exte r n a l access to t h e n etwork);
o p e rati n g syste m (com pati b i l ity of o pe rati n g syste m s ) ;
m odificat i o n/u pgrades o f s oftwa re ( o pe rati n g syste m s , a p p l i cati o ns , etc. ) ;
i nterface c o m pat i b i l ity ( d ata col l i s i o n s , d ata fo r m ats) :
co n n ecti o n s ( m odificat i o n o f h a rdwa r e , n etwo rk co n n ectors ) ;
n etwo rk i nterface boards (com pati b i l ity ) ;
n etwo rk protocols ( D I C O M , H L7 , etc . ) ;
packet add ress str u ctu re/ti m i n g ;
n o r m a l n etwork l o ads/ba n dwi dt h ;
peak n etwo rk l o a d ;
data m ed i a ( l o n gevity a n d retri eva b i l ity) ;
secu rity (viruses, wo r m s , u n a ut h o rized s oftware u pdates or u pgrades);
m ax i m u m acceptable res ponse ti m e ;
6060 1 - 1 © I EC : 20 0 5 - 705 -
accepta b l e fai l u re rate of t h e n etwo rk;

ava i l a b i l ity of the n etwo rk ( p l a n n e d and u n pl a n n e d m a i nt e n a n c e ) ;
i n co n s ist e n cy i n i nterfaces/fo rm ats res u l ti n g i n l o s s o f fi d e l ity d u r i n g i nform ati o n transfe r ;
h eterog e n e o u s n etwo rk topo l og i e s .
S u pp l e m e nti n g A n n ex D o f I SO 1 49 7 1 : 20 0 0 w h e n c o n s i d e ri n g t h e pote nti al c a u s e s for

HAZARDS l i sted above, the fol l owi n g q u esti o n s s h o u l d be taken i nto accou nt:
a) R e as o n a bly fores e e a b l e m i s u s es
I s co n n ecti o n to t h e n etwork i n co n s istent with t h e I NTENDED USE of e a c h co nsti t u e nt PEMS?
b) I n correct d ata flow to o r from each co nstit u e nt PEMS
What are t h e d ata transferred by t h e n etwo rk used for, and to which tasks are t h ey
related? What are t h e conseq u e n ces of a breakdown of t h e N E TWORK/DATA COUPLI NG?
c) Devi ati o n from t h e specifi ed o p e rati o n a l c h a racteri sti cs of a ny co nsti t u e nt PEMS
What are the o pe rati o n a l c h a racteri sti cs of t h e PEMS and to w h at deg ree are they affected
by t h e NETWORK/DATA COUPLI NG?
d) I n com pl ete c h a racterizat i o n of NETWORK/DATA COUPLING parameters
I s t h e n etwork topol ogy, confi g u rati o n , param ete rs ( e . g . o p e n or c l o s e d , b a n dwidth,
tra n s m i s s i o n protoc o l ) c o m p l etely c h a racterized? Are there a n y brea kdown
characteristi cs/c o n c e pts a n d w h at are these?
e) Excessive us e/l o a d of t h e NETWORK/DATA COUPLI NG by t h e n etwo rk n o des
What i s the p l a n n e d n u m be r of n etwork n o d es and t h e i r ass u m ed d e g ree of use? Are the
reso u rces s uffi c i e nt to m eet t h e n eeds of both t h e NETWORK/DATA COUPLING itself and the
devices c o n n ected to it?
f) Use e rrors
What s ki l ls are re q u i re d by t h e OPERATOR for t h e effective o pe rati o n of t h e syst e m ?
g) I n a d e q u ate c o nfi g u rati o n m a n a g e m ent
'
Do periodic service tasks alter t h e n etwo rk s c h a racteristics ( e . g . after rem ote access ,
u pdates or u pgrades)? Does t h e RESPONSIBLE ORGANIZATION e n s u re that m odifi cati o n s to
each co nstit u e nt PEMS are revi ewed a n d a p p rov e d ?
h ) I nfo r m ati o n i n wro n g place
Does data a rrive at a conve n i ent and predict a b l e l o cati o n ? I s it acco m p a n i e d by i r re l evant
data that co u l d confuse t h e OPERATOR o r o bs c u re t h e wanted d ata? W h e n it a rrives , i s its
s o u rce a d e q u ately i n d i cate d?
H.7.3 N etwork class ificat ion based o n t h e con seq u e nce t o t h e PAT I E N T
H. 7.3. 1 Con seq uence to the PATI E N T

In order to r e l ate t h e c a u s es in H . 7 . 2 to t h e c o n s eq u e n ces fo r t h e PAT I E NT, it m ay be u s efu l to
cl assify NETWORK/DATA COUPLINGS both by the conse q u e n ces a n d the reacti o n t i m e , w h e re
reacti o n ti m e is t h e ti m e d e l ay between a NETWORK/DATA COUPLING fai l u re a n d t h e o n s et of
HARM to t h e PATI E NT.
T a b l e H . 1 conta i n s an exa m pl e of a NETWORK/DATA COUPLING c l assifi cati o n based o n th ese

cons i d e rati o n s .
6060 1 - 1 © I EC : 20 0 5 - 707 -
H . 7.3.2 C lass C NETWORK/DATA COUPLING (PATIENT vital d ata, t i m e critical)

This is t h e NETWORK/DATA COUPLING for all ti m e critical a p p l i cati o n/PROCESSES. I t i s n ot l i n ked
to a n y oth e r n etwork, because a l i n k could res u l t i n u n contro l l a bl e RISKS . Al l res o u rces a re
ava i l a b l e o n l y for t h e n o d es of this n etwo rk. T h e av a i l a b i l ity n e eds to be cl ose to 1 0 0 % .
D i s r u pt i o n s n e e d t o b e avoi d e d a n d l ast for o n l y a few m i n utes per year. Respo n s i b i l ity i s
ass i g n ed to a s i n g l e P E M S MANUFACTURE R/system co ntractor o n l y . N etwo rk n o d es c o m ply with
t h e re q u i re m e nts esta b l i s h e d by this MANUFACTU RER/co ntractor. An ex a m p l e of this cl ass is a
PAT I E NT m o n itori n g n etwo rk.
Table H . 1 - N E TWORK/DATA COUPLING c lass ification
Consequence Reaction time Class Example(s)

Second(s) c I nfusion (closed loop) ; false control of a s u rgical
robot
Death/serious injury
M i n ute(s) c Suppressed a l a r m transmission
Hou r(s) C/ B False therapy data to ventilator
Second(s) c Wrong a l a rm tra ns m ission, false control of a

s u rgical robot
Medium injury M i n ute(s) C/ B Wrong alarm tra ns m ission, false control of a

s u rgical robot
Hou r(s) C/ B Falsified image; loss of a therapy report
Second(s) B
M i n o r i nj u ry M i n ute(s) B Loss of a ra diograph
Hou r(s) B /A
Second(s) A
Negligible M i n ute(s) A
Hou r(s) A
H . 7.3.3 C lass 8 NETWORK/DATA COUPLING (PATIENT v ital data, n o n -ti m e c ritical)

This is t h e NETWORK/DATA COU PLING for n o n-ti m e critical a p p l i catio n/PROCESSES t h at h a n d l e
t h e r a p e ut i c o r d i a g n osti c PAT I E NT data . T h i s NETWORK/DATA COUPLI NG c a n b e l i n ke d t o a n ot h e r
o n e b y a defi n e d a n d co ntrol l a b l e/se c u re d i nterfac e . T h e avai l a bi l ity n e e ds t o be very h i g h ,
a n d because o f a l ack o f a lte rnatives, disru pt i o n s s h o u l d l ast o n l y f o r s h o rt periods.
T h e res p o n s i b i l ity i s ass i g n e d to t h e RESPONSIBLE ORGANIZATI O N o r system i ntegrato r. I n
t h e case of m u lti p l e PEMS, t h e c o nte nti o n of d ata pri o rity n ee d s to be d efi n e d .
T h e n etwo rk n o des s h o u l d fo l l ow s e l ected criteri a/m i n i m u m s et o f p a r a m eters. A radi o l o gy
n etwo rk can s e rv e as a n ex a m p l e .
H . 7.3.4 C lass A NETWORK/DATA COUPLING

This is t h e NETWORK/DATA COUPLI NG for any a pp l i cati o n s ( i n c l u d i n g PAT I E NT a d m i n istrative/
d e m o g r a p h i c data) that o p e rate on v a l i d ated PAT I E NT d ata o n l y a n d are not ass i g n e d to class
" C " o r " B" n etworks. Al s o , it c a n be accepted t h at these a p p l i c ati o n s a re u n avai l a b l e for a
l o n ge r period because t h e re are a l te r n atives. An exa m pl e is a g e neral h o s pital a d m i n istrati o n
n etwo rk w h e r e :
6060 1 - 1 © I EC : 20 0 5 - 709 -
- t h e res p o n s i b i l ity is ass i g n e d to t h e RESPONSIBLE O RGANIZATI O N ;

- there are m a ny types of n etwo rk n o d e s .
H.7.4 N E TWORK/DATA COUPLING parameters

The use of a NETWORK/DATA COUPLING fo r ex c h a n g e of d ata eith e r betwee n PEMS or betwe e n
P E M S a n d o t h e r i nform ati o n tec h n ol ogy e q u i p m e nt req u i res t h e k n owl edge a b o ut both t h e
structure o f t h e NETWORK/DATA COUPLING a n d t h e PROCESS ES/fu n cti o n s r u n n i n g i ns i d e th e m .
T h i s i s i m portant because MANUFACTURERS of PEMS o r NETWORK/DATA COUPLINGS s h o u l d s e l ect
the c o nfi g u rati o n of t h e i r prod u cts s u c h t h at:
- they co m pl y with i nternati o n a l l y reco g n ized n etwo rk sta n d ards ( Et h e r n et, F ast Eth e r n et,
G i g a B itEt h e r net, F O O l , etc . ) and u s e t h e ava i l a bl e b a n dwidth a p p ro priately accord i n g to
t h e I NTENDED USE;
- they a c h i ev e t h e o pti m a l perfo r m a n c e for t h e i r a p pl i cati o n
A m ixt u re o f d iffe rent NETWORK/DATA COUPLI NGS co nfi g u rati o ns/pa ram eter s etti n gs c a n e m e rge
which are not always c o m pati b l e for t h e d iffe rent NETWORK/DATA COUPLINGS n o des in s pite of
t h e fact that they com ply to v a l i d i nternati o n a l sta n dards.
To avoid o r at l e ast to m i n i m ize t h e res ulti n g pote ntial of disru pti o n , a m atch of a m i n i m u m s et
of NETWORK/DATA COUPLI NGS param eters derived from t h e r e l ev a nt sta n d a rds is re q u i re d .
To e n s u re a r e l i a b l e i nsta l l at i o n o f NETWORK/DATA COUPLED P E M S a n d m i n i m ize t h e RISK t o

PAT I E NTS , t h e P E M S MANU FACTURER, t h e RESPONSIBLE ORGANIZATI O N , a n d t h e syst e m i nteg rator
n e e d to c o m m u n i cate a l l r e l ev a nt tec h n i c a l param eters to each other. T h i s l ev e l of deta i l is
n ecess a ry to avo i d i n a p propriate ass u m pt i o n s t h at res u l t in u n accepta b l e RISK.
F i g u re H.4 conta i ns a l ist of p a r a m eters potenti a l l y req u i red to b e s pecifi e d . D u e to t h e rapid

evo l ut i o n of NETWORK/DATA COUPLING tec h n o l ogy, t h i s t a b l e s h o u l d be s e e n as a starti n g poi nt.
I t s h o u l d be c l e a r if t h e table s h o u l d be m a i ntai n e d and w h o s h o u l d be res p o n s i b l e for
m a i nta i n i n g it.
6060 1 - 1 © I EC : 20 0 5 - 71 1 -
Objects Description Value/C o m m e n t
Application a n d Operating System:
Operating System I Vers i o n :
Network proto c o l s :
Detailed data for specific application I tra n sport protocol (if used)
HL7 H L 7 vers i o n
Formats of m e s s a g e types used
Free fields (wh i c h are used)
Ports
HL7 P rotocol (TCP/I P Lower Layer)
DICOM Service classes A) T e s t : Verification
B ) Transfer: Storage
Q u e ry/Retrieve
C ) D o c u m e ntatio n : P ri n t m a n a g e m e n t
D ) O r g a n i zati o n : Moda lity work l i st man agement
Performed proced u re step
E ) Informati o n : S t u d y contents notification

Patient m a n a g e m e n t
Storage com m it m e nt
Study c o m p o n e n t man agement
Resu lts m a n ag e m e nt
F) External Storage: Media storage
D I C O M Objects e g C O M P U T E R RADIOGRAPHY I MA G E
Other M o d a lity Objects
DICOM host n a m e
D I C O M AET c a l l e d
D I C O M AET c a l l i n g
DICOM Port called
DICOM Port calling
Detailed Parame ters with respect t o t h e lower protocol /ayers
Network data Physical c o n nection
Network inte rface card parameters
Net work-Administration
Port n u m be r of c o n n ected Switch I H U B I Router
IP-Address
S u b n e t mask
Host-Name
IT-Domain
Active-Directory I LDAP Serve r
Default G ateway
(Access via Router)
Remote Con trol
Remote M o n itoring
M o d e m C o n n ection
Remote S e r v i c e I P -
Ad d r e s s
Other Parameters
F ig u re H . 4 - Exa m p l e of potential parameters req u i red to be s pecified for

NETWORK/DATA COUPLING
6060 1 - 1 © I EC : 20 0 5 - 713 -
An n e x I
(info rmative)
M E SYSTE M S aspects
1.1 Com b i n at i o n s o f M E EQUI PMENT a n d n o n -M E EQUI P M E NT
1.1.1 I n trod uction

T h i s a n n ex prov i d es a s u m m a ry of situati o n s t h at could occ u r w h e n d iffe rent com bi n ati o n s of
e q u i p m e nt are used in various m ed i c a l e n v i r o n m e n ts . To kee p this s u m m a ry s h o rt , n o m o re
t h a n two ite m s of e q u i p m e n t (A a n d B) are used per s i t u ati o n .
1 . 1 .2 Local ities i n a m ed i cal e n v i ron ment
T h e fol l owi n g l o c a l ities are fo reseen (see a l s o T a b l e 1 . 1 ):

- t h e PAT I E NT ENVIRONMENT as part of a m ed i c a l l y used roo m ;
a m ed i c a l l y used ro o m , excl u d i n g t h e PAT I E NT ENVIRONMENT;
- t h e n o n- m ed i c a l l y used room (a room not desi g n e d for m e d i c a l treat m e nt, for exa m pl e , a n
office o r a storage roo m ) .
A protective e a rth c a n be dedi cated t o each o f t h e three l ocal ities l i sted above.
NOTE A potential difference (V) c a n exist between t h e protective earths i n different localities. I n c a s e o f a n
interrupti o n of protective e a rthing (fa ult condition) f o r e q u ipment i n the PATI ENT ENVI RON M E N T , this potential
difference can appear o n the ENCLOS U R E of the equipm ent causing a HAZA R D for the OPERATOR o r for the PATIENT if
the OPERATOR s i m u ltaneously touches the e q u ipment and the PATI E N T , o r for the PATIENT if the ME EQU I P M ENT is of
TYPE B.
1 . 1 .3 Basic p r i n c i p l es
PATIE NTS s h o u l d o n l y be co n n ected to APPLI ED PARTS of ME EQUIPM ENT c o m plyi n g with t h i s

sta n d a r d . Oth e r e q u i pm ent s h o u l d com ply w i t h rel evant I E C o r I S O sta n d a rd s .
I n fa u l t c o n d i t i o n t h e a l l owa b l e TOUCH CURRENT i s 500 J.LA.
- All e q u i pm ent c o m plyi n g with t h e s afety sta n dard a p p l i c a b l e to t h e o r i g i n a l ly i nt e n d e d ,
n o n- m ed i c a l u s e , h e rei n c a l l e d I EC XXXXX, a n d pl aced i n t h e PAT I E NT E NV I RONMENT n eeds
m e as u res to l i m it the TOUCH CURRENT, if this exceeds t h e val u es s pecifi e d in 1 6 . 6 . 1 .
1 . 1 .4 E xa m p les of M E SYSTEMS
Two ite m s of e q u i p m e n t are placed wit h i n t h e PATIENT E NVI RO N M E NT (see s it u ati o n No. 1 i n
Table l . 1 ) .
T h e re are several poss i b i l ities des i g n ated 1 a t h r o u g h 1 f:

1 a: Items A and B both c o m pl y with I EC 6060 1 : S u bc l a use 1 6 . 6 is sati sfi e d .
1 b: I t e m s A a n d B both c o m ply w i t h I EC 606 0 1 a n d are powe red t h ro u g h a M U LTIPLE
SOCKET-OUTLET: LEAKAGE CURRE NTS m i g ht be too h i g h w h e n t h e e a rt h c o n d u ctor in the
M U LTIPLE SOCKET-OUTLET i s broke n .
6060 1 - 1 © I EC : 20 0 5 - 715 -
1 c: Item A co m pl i es with I E C 6 0 6 0 1 a n d item B co m pl i es with I E C XXXXX: o n l y t h e TOUCH

CURRENT of item B has to be l i m ited w h e n any s i n g l e PROTECTIVE EARTH CONDUCTOR or
the e q u ival e nt co n d u ctor of the e q u i p m e nt, is i nterrupte d , if n ecess a ry , by a p plyi n g an
additi o n a l protective e a rth o r a s e p a rati n g transfo r m e r to ite m B .
1 d: S a m e a s 1 c , with both ite m s powe red t h r o u g h a M U LTI P L E SOCKET-O UTLET: LEAKAGE
CURRE NTS m i ght be too h i g h for c a u s es as l i sted u n der 1 b a n d 1 c.
1 e: Item A is powered from item B with item A com plyi n g to I E C 6060 1 a n d bei n g an i n s e rt
to ite m B, com plyi n g to I EC XXXXX. Item B n e e ds t h e m e a s u res fo r a power s u pply as
descri bed by t h e MANUFACTU R E R a n d n e e ds to fulfil t h e re q u i re m ent of 1 6 . 3. I f
n ecess a ry, a pply a n additi o n a l protective earth o r a s e parat i n g transfo r m e r to i t e m B .
1.1 a re not i ntended to be a n exhaustive list.

1 f: S a m e as 1 e , with item A n ot bei n g an i ns e rt to item B: s e e 1 e .
S i t u at i o n s 2 a n d 3 c a n be d e rived from s i t u ati o n 1 of T a b l e 1 . 1 .
NOTE The practical means of compliance ind icated i n Table
6060 1 - 1 © I EC : 20 0 5 - 717 -
Table 1 . 1 - So m e exam p les of ME SYSTEMS for i l l ustration
M e d i c a l ly u s e d room E x a m p l e s of
Practical means
poss i b le
Non- of c o m p l i a n c e
c a u s e s for
Situation N o . Outside the medically
I n s i d e the exceeding
PATIENT used room A p p l y 16.5 i n all
PATIENT ENVIRONMENT LEAKAGE
ENVIRONMENT situations
CURRENT l i m its
M u lti pl i ed
Mains Mains A P P L I E D PARTS
Plug Plug of t h e same
A B - Verify total
1a Items A a n d lEG 60601 lEG 60601 type c an c au s e
PATIENT
B a re th e total
LEAKAGE
ME E Q U I P M ENT PATIENT LEAKAGE
CURRENT
CURRENT to
exceed l i m its
See Note 1 .
cf?··· ·�
- Additi o n a l
1b Items A and Earth conductor PROTECTIVE
B a re of the MULTIPLE EARTH
ME E Q U I P M ENT SOCKET-OUTLET is CONNECTION
powered via MULTIPLE SOCKET-OUTLET broken (for A or B) or,
a MULTIPLE
SOCKET-OUTLET See also 1 a. - Separating
transform e r
Mains Mains - Additi o n a l

Plug Plug PROTECTIVE
A B
1c Item A i s lEG 60601 IEC xxxxx EARTH
Due to high CONNECTION
ME E Q U I P M ENT
TOUCH CURRENT (for B) or,
and B is N o n -
of B
ME E Q U I P M ENT
- Separating
1 transform e r
(for B )
cf?""" "9J
The earth
1d Item A i s - Additi o n a l
conductor of the
PROTECTIVE
ME E Q U I P M ENT MULTIPLE SOCKET-
EARTH
and B is n o n - OUTLET is broken
CONNECTION
ME E Q U I P M ENT
MULTIPLE SOCKET-OUTLET or,
(for A or B) or,
powered via
a MULTIPLE Due to high
- Separating
SOCKET-OUTLET TOUCH CURRENT
transform e r
of B
Mains
1e Item A i s Plug
ME E Q U I P M ENT
powered from
specified
� B
lEG xxxxx
r- - Additi o n a l
PROTECTIVE
power su pply
EARTH
i n item B Due to high CONNECTION
TOUCH CURRENT (for B) or,
1f Item A is Mains of B
ME E Q U I P M ENT Plug
A B - Separating
powered from lEG 60601 IEC xxxxx transform e r
NON- DC/AC
(for B)
ME E Q U I P M ENT
power su pply
in B
6060 1 - 1 © I EC : 20 0 5 - 719 -
Table 1 . 1 (continued)
M e d i c a l ly u s e d room E x a m p l e s of
Practical means
poss i b le
Non- of c o m p l i a n c e
c a u s e s for
Situation N o . Outside the medically
I n s i d e the exceeding
PATIENT used room A p p l y 16.5 i n all
PATIENT ENVIRONMENT LEAKAGE
ENVIRONMENT situations
CURRENT l i m its
Mains Mains No causes of

2a Items A and Plug Plug - No f u rt h e r
A B excee d i n g
B a re m e a s u re s are
lEG 60601 lEG 60601 LEAKAGE
ME E Q U I P M ENT necessary
CURRENT
�-·· · · · · · · · · · · · · ·�
- Additi o n a l
2b Items A and PROTECTIVE
item B are Earth conductor EARTH
ME E Q U I P M ENT of the MULTIPLE CONNECTION
powered via � SOCKET-OUTLET is (for A o r B) or,
a MULTIPLE MULTIPLE SOCKET-OUTLET broken
SOCKET-OUTLET - Separating
transform e r
2
Mains Mains - Do not use

2c Item A i s Plug Plug Due to high
A B metal
TOUCH CURRENT
ME E Q U I P M ENT co n n ector
lEG 60601 IEC xxxxx of B
and item B is h o u s i n g or,
non- See rat i o n a l e
ME E Q U I P M ENT - SEPARATION
for 1 6 . 5 .
DEVICE
2d Item A is
� . . .�
- Additi o n a l
ME E Q U I P M ENT PROTECTIVE
and item B is The earth EARTH
non- .................................
conductor o f the CONNECTION
ME E Q U I P M ENT
� MULTIPLE SOCKET- (for A or B) or,
powered via MULTIPLE SOCKET-OUTLET OUTLET is broken
a MULTIPLE - Separating
SOCKET-OUTLET transform e r
Mains
g:
Plug
A
No causes of
3a Items A a n d lEG 60601 1 - No f u rt h e r
excee d i n g
B a re m e a s u re s a r e
LEAKAGE
I I
ME E Q U I P M ENT Common protective earth necessary
CURRENT
- Do not use
Mains Mains metal
Plug Plug Due to high co n n ector
3b Item A is A B
TOUCH CURRENT h o u s i n g for
ME E Q U I P M ENT lEG 60601 IEC xxxxx
of B SIGNAL
a n d item B i s
I N P UT/OUTPUT
I I
non- Common protective earth See rat i o n a l e PART o r ,
ME E Q U I P M ENT
for 1 6 . 5 .
3 - SEPARATION
DEVICE
a) Pote ntial - Additio n a l

d iffe re n ce PROTECTIVE
§=
betwee n EARTH
Mains PROTECTIVE CONNECTION for
3c Item A i s Plug
A 1 EARTH (A), or
I I
ME E Q U I P M ENT ' CONNECTIONS
lEG 60601
xxxx
and item B i n of A a n d B - SEPARATION
is DEVICE, o r
ME E Q U I P M ENT Pcotect;ve earth b) D u e to h i g h
I I
or non- Common prctective earth with potential TOUCH - Do not use
ME E Q U I P M ENT ifference CURRENT metal
d
of B co n n ector
h o u s i n g in t h e
See rat i o n a l e PATIENT
for 1 6 . 5 . ENVIRONMENT
6060 1 - 1 © I EC : 20 0 5 - 721 -
Table 1 . 1 (continued)
NOTE 1 No causes of TOUCH CURRENT or EARTH LEAKAGE CURRENT exceeding limits.

NOTE 2 I EC 60601 M E D ICAL ELECTRICAL E Q U I PMENT i n c o m p l i a n c e with I EC 60601
NOTE 3 I EC xxxxx: N o n -medical e q u i pm e nt i n c o m p l i a n ce wi th relevant I E C safety sta n d ards.

NOTE 4 Separat i n g transformer: see 1 6 . 9 . 2 . 1
NOTE 5 If e q u i p m e n t " B" is outside the PATIENT ENVIRONMENT a n d if e q u i pm e n t "A" is a CLASS 11 e q u i p m e n t a n d h as accessible
c o n d u ctive parts con nected to the PROTECTIVE EARTH CONNECTION of e q u i pment "B " t h e n a d d iti o n a l safety m e a s u res could be
necessary, for example: additi o n a l protective earth for " B " o r separat i n g transformer o r SEPARATION DEVICE.
1.2 Exa m p les o f a p p l icat i o n o f M U LT I P L E SOCKET-OUTL ETS ( MSO)
F i g u re 1 . 1 s h ows a n ex a m pl e of the constructi o n of a M U LTI P L E SOCKET-OUTLET. F i g u re 1 . 2

s h ows s o m e exa m ples of a pp l i cati o n of MUPTILE SOCKET-OUTLETS.
Male plug for M E EQUIPMENT
Cover
Spacers
Plate fixed on MSO
MSO
View from A-A (male plug connected)
IEC 2463105
F ig u re 1 . 1 - Exam p l e of the construction of a MULTIPLE SOCKET-OUTLET (MSO)

(acces s i b l e o n l y with t h e u s e of a TOOL)
6060 1 - 1 © I EC : 20 0 5 - 723 -
I C:J C:J C:J C:J

MULTIPLE SOCKET-OUTLET
f-------jlt IDL
Transformer assembly with
special socket-outlet
Transformer assembly with

permanently connected
M U LTIPLE SOCKET-OUTLET
Outlets
Transformer assembly incorporating Circuit diagram of an integral MSO

M U LTIPLE SOCKET-OUTLET and transformer assembly
IEC 2464105
F ig u re 1 . 2 - E xam p les of appl icat ion of MULTIPLE SOCKET-OUTLETS (MSO)

6060 1 - 1 © I EC : 20 0 5 - 725 -
An n e x J
(info rmative)
S u rvey of i n s u lati o n paths
1 MOOP
I
(see 8 . 5 . 1 )
,-----
MAINS SECONDARY
PART CIRCUIT
-==-
- 1
®
MOOP -
L PROTECTIVELy
EARTHED ENCLOSURE
IEC 2465105
I
F ig u re J . 1 - I n s u lation exam ple 1
,----- 2 MOOP
MAINS SECONDARY
PART CIRCUIT
0
_L_
l ENCLOSURE that is not

-
2 MOOP -
IEC 2466105
�,� :
�� :::: ::
SUPPLEM ENTARY INSULATION -'+'< > < > <<
ONE MEANS OF PROTECTION
1 ::;:: ::
0
� I ntermediate
MAIN S
PART I' \" : part
��:�,��meom' �J-cJ i
:::::::::::::::::::::::::::::::::::
IEC 2467105

6060 1 - 1 © I EC : 20 0 5 - 727 -
SIGNAL I NPUT/OUTPUT
PART
MAINS PATIENT
PART CONN ECTION (s)
IEC 2468105
2 MOPP
1
0
MAINS SECONDARY PAT lENT
T
PART CIRCUIT CON NECTION(s)
I I
0
I
-==-
2 MOPP
IEC 2469105
PATIENT
CONN ECTION(s)
,- - - - -
1
I
I
Voltage within I
a floating circuit I
I
I
I
L _ _
2 MOPP IEC 2470105

6060 1 - 1 © I EC : 20 0 5 - 729 -
PATIENT
� � � �
CONNECTION(s)
I
! IT
I
L��
1 MOPP _______ _j
IEC 2471105
NOTE WOR K I N G VOLTAGE is the MAXI M U M M A I N S VOLTAGE.
F ig u re J.7 - I n s u lation exam ple 7

6060 1 - 1 © I EC : 20 0 5 - 731 -
An n e x K
(info rmative)
S i m p l ifi e d PATI E N T LEAKAGE C U RRENT d i a g ra m s
F i g u re K . 2 , F i g u re K . 4 a n d F i g u re K. 5 i l l ustrate a s pe c i a l test c o n diti o n i n T a b l e 4 , w h i c h i s

n e i t h e r a NORMAL CONDITION n o r a S I NGLE FAULT CONDI TION.
Current i n f.!A
APPLIED NOR MAL SINGLE
l
PART CON DITION FAU LT
TY P E CON DITION
CF 10 50
PATIENT
CONN ECTION (s) BF 1 00 500
MAINS
PART B 1 00 500
o------;.-__j1
I EUT mounting surface
IEC 2472105

F i g u re K . 1 - M E EQUIPMENT with an E NCLOSURE made of i n s u l at i n g m aterial
(si m plified F i g u re 1 5)
(see 8 . 7 . 4 . 7 a ) )
Current in f.!A
APPLIED S pecial
PART test
,--- - - - TY P E condition
1
I CF 50
I PATIENT
BF
CONN ECTION(s)
5 000
I
SIGNAL I NPUT/OUTPUT I B -
PART I
I
�--
�--- IEC 2473105

F i g u re K . 2 - M E EQUIPMENT with an F -TYPE APPLI E D PART
(see 8 . 7 . 4 . 7 b))
6060 1 - 1 © I EC : 20 0 5 - 733 -
Current i n f.!A
APPLIED NOR MAL S I N G LE
PART CON DITION FAU LT
TY P E CON DITION
CF 10 50
PATIENT
CONN ECTION (s) BF 1 00 500
SIGNAL I NPUT/OUTPUT B 1 00 500

PART
IEC 2474105

F i g u re K . 3 - M E EQUIPMENT with an APPL I E D PART a n d a S IG NAL INPUT/OUTPUT PART
(see 8 . 7 . 4 . 7 c))
Current in f.!A
S pecial
1
APPLIED
PART test
TY P E condition
CF -
PATIENT
CONN ECTION (s) BF -
B 500
Not PROTECTIVELY
EARTHED part
IEC 2475105

F i g u re K . 4 - M E EQUIPMENT with a PATIENT CONNECTION of a TYPE 8 APP L I E D PART that is not
(see 8 . 7 . 4 . 7 d ) )
6060 1 - 1 © I EC : 20 0 5 - 7 35 -
:� [fo
Current i n f.!A
APPLIED S pecial
PART test
, - - - TY P E condition
CF -
I PATIENT
BF 500
CONN ECTION(s)
B -
Not PROTECTIVELY
EARTHED part I
L _ _ _
IEC 2476105

F i g u re K . 5 - M E EQUIPMENT with a PATIENT CONNECTION of a TYPE BF APP L I E D PART that is not
(see 8 . 7 . 4 . 7 d ) )
6060 1 - 1 © I EC : 20 0 5 - 737 -
An n e x L
(normative)
I n s u lated w i n d i n g w i res fo r use w i t h o u t i nterl eaved i n s u lati o n

(see 8 . 8 . 2 )
L.1 I nt ro d u ct i o n
T h i s a n n ex s pecifies wi n d i n g wi re whose i ns u l ati o n m ay b e u s e d t o prov i d e BAS I C I NS ULATION,

SUPPLEMENTARY I NS ULATION, DOUBLE I NS U LATI ON o r REI NFORCED I NS U LATION in wo u n d
co m po n e nts wit h o ut i nterleaved i ns u l ati o n .
T h i s a n n ex cov e rs ro u n d wi n d i n g wi res h av i n g d i a m eters between 0 , 0 5 m m a n d 5 , 00 m m .
L.2 Wire c o n struct i o n
I f t h e wi re is i ns u l ated with two o r m o re s pi ra l l y wrapped l ayers of t a p e , t h e overl a p o f l ayers

s h a l l be a d e q u ate to e n s u re conti n u ed ove r l a p d u ri n g m a n ufact u r e of t h e wo u n d co m po n e nt.
The l ayers of s pi ra l l y wrapped wi re i ns u l ati o n s h a l l be s uffi c i e ntly secured to m a i nta i n t h e
a m o u nt o f overl a p .
l.3 TYPE TEST
T h e wi re s h a l l pass t h e tests of L. 3 . 1 to L . 3 . 4 , carried out at a te m perature betwe e n 1 5 oc a n d

35 o c a n d a r e l ative h u m i dity betwe e n 4 5 % a n d 75 % , u n l ess specified otherwi s e .
L. 3 . 1 D ielectric strength
The test sample is prepared according to IEC 6085 1 -5: 1 996, Subclause 4. 4. 1 (for a twisted
pair) . The sample is then subjected to the test of 8. 8. 3 for the appropriate type and number of
MOP(s) . The test voltage is at least twice the appropriate voltage in Table 6 and Table 7 (see
8. 8. 3), with a minimum of:
- 3 000 V for BASIC INSULA TION or SUPPLEMENTARY INSULA TION; or
6 000 V for REINFORCED INSULA TION.
L.3.2 F lexi b i l ity a n d ad h e re n ce

The sample is subjected to test 8 of IEC 6085 1 -3: 1 996, Subclause 5. 1 . 1 , using the m andrel
diameters of Table L. 1 . The test sample is then examined in accordance with IEC 60851-
3: 1 997, Subclause 5. 1. 1 . 4, follo wed by the test of 8. 8. 3, for the appropriate type and num b er
of MOP(s). except that the test voltage is applied between the wire and the mandrel. The test
voltage is at least the appropriate voltage in Table 6 and Table 7 (see 8. 8. 3) with a minimum
of:
1 500 V for BASIC INSULA TION or SUPPLEMENTARY INSULA TION; or
- 3 000 V for REINFORCED INSULA TION.
6060 1 - 1 © I EC : 20 0 5 - 7 39 -
Table L . 1 - M a n d rel d i a m eter
NoMINAL c o n d u ctor d i ameter M a n d rel d i a m eter

mm m m ± 0,2 m m
0 , 05 - 0 , 34 4,0
0 , 35 - 0 , 49 6,0
0 , 50 - 0 , 74 8,0
0 , 75 - 2 , 49 1 0,0
2 , 50 - 5 , 00 fo u r times the cond uctor dia meter a

a
I n accordance with I E C 6031 7-43 [9] .
The tension to be applied to the wire during winding on the m andrel is calculated from the
wire diameter to be equivalent to 1 1 8 MPa ± 1 1 , 8 MPa (1 1 8 Nlmm 2 ± 1 1 , 8 Nlmm 2) .
L.3.3 H eat s hock

The sample is subjected to test 9 of IEC 6085 1-6: 1 996, followed by the dielectric strength test
of 8. 8. 3 for the appropriate type and number of MOP(s), except that the test voltage is applied
between the wire and the mandrel. The voltage is not less than the appropriate voltage in
Table 6 and Table 7 (see 8. 8. 3) with a minimum of:
The oven temperature is the relevant temperature for the therm al class of insulation in Table
L. 2.
The mandrel diameter and tension applied to the wire during winding on the m andrel are as in
L. 3. 2.
The electric strength test is conducted at room temperature after removal from the o ven.
Table L . 2 - Oven tem peratu re
A E 8 F H
Th ermal class
( 1 05) (1 20) (1 30) ( 1 55) (1 80)
O v e n tem perature
200 215 225 240 260
· c ± 5 ·c
L.3.4 Retention o f elect ric strength after ben d i n g

Five samples are prepared a s in L. 3. 2 above and tested a s follo ws. Each sample is removed
from the m andrel, placed in a container and positioned so that it can be surrounded by at
least 5 mm of m etal shot. The ends of the conductor in the sample are to be sufficiently long
to avoid flash over. The shot is to be not m ore than 2 mm in diam eter and consists of balls of
stainless steel, nickel or nickel plated iron. The shot is gently p oured into the container until
the sample under test is covered by at least 5 mm of shot. The shot is cleaned periodically
with a suitable solvent (for example, 1 , 1 , 1-trichloroethane).
6060 1 - 1 © I EC : 20 0 5 - 741 -
NOTE The above test PROC E D U R E is reprod uced from 4 . 6 . 1 .c) of I EC 6085 1 -5 : 1 988 (second edition including
a m e nd m e nt 1), now withdraw n . I t i s not included i n the third e d ition of that sta ndard.
The test voltage is at least the appropriate test voltage in Table 6 and Table 7 (see 8. 8. 3) for
the appropriate type and number of MOP(s), with a minimum of:

The test voltage is applied b etween the shot and the conductor.
The mandrel diameter and tension applied to the wire during winding on the m andrel are as in
L. 3. 2.
L.4 Tests d u ri n g m a n ufact u re
L.4. 1 General
The wire is subjected by the wire m anufacturer to electric strength tests during m anufacture
as specified in L . 4 . 2 and L. 4. 3.
L.4.2 Rou t i n e testi n g

The test voltage for routine testing i s to be the appropriate voltage in Table 6 a n d Table 7
(see 8. 8. 3) for the appropriate type and number of MOP(s), with a minimum of:
1 500 V r. m . s. or 2 1 00 V peak for BASIC INSULA TION or SUPPLEMENTARY INSULA TION; or
3 000 V r. m . s. or 4 200 V peak for REINFORCED INSULA TION.
L.4.3 Sam p l i n g tests

Twisted pair samples are tested in accordance with IEC 6085 1-5: 1 996, Subclause 4 . 4. 1 . The
minimum breakdown voltage is twice the appropriate voltage in Table 6 and Table 7 (see
8. 8. 3) for the appropriate type and number of MOP(s), with a minimum of:
3 000 V r. m . s. or 4 200 V peak for BASIC INSULA TION or SUPPLEMENTARY INSULA TION; or
6 000 V r. m . s. or 8 400 V peak for REINFORCED INSULA TION.
6060 1 - 1 © I EC : 20 0 5 - 743 -
B i b l i o g ra p h y
[1] I E C 60050- 1 5 1 : 2 0 0 1 , International Electrotechnica/ Vocabulary (lE V) - Part 151:

Electrical and magnetic devices
[2] I EC 60050- 1 95 : 1 9 9 8 , International Electrotechnica/ Vocabulary (lE V) - Part 1 95:

Earthing and protection against electric shock
Am e n d m ent 1 (20 0 1 )
[3] I EC 6 0 0 5 0-44 1 : 2 0 0 1 , International Electrotechnica/ Vocab ulary (lE V) - Chapter 44 1 :

Switchgear, contra/gear and fuses
[4] I EC 60 050- 826 : 2004, International Electrotechnica/ Vocabulary (lE V) - Part 826:
Electrical installations
[5] I E C 60073, Basic and safety principles for m an-m achine interface, marking and
identification - Coding principles for indication devices and actuators
[6] I EC 60086- 1 , Prim ary batteries - Part 1: General
[7] I EC 6 0 1 27-6, Miniature fuses - Part 6: Fuse holders for miniature fuse links
[8] I E C 60309- 1 , Plugs, socket-outlets and couplers for industrial purposes - Part 1 :
General requirements
[9] I EC 6 0 3 1 7-4 3 , Specifications for particular types of winding wires - Part 43:Aromatic
po/yimide tape wrapped round copper wire, class 240
[1 0] I EC 6 0364-7-7 1 0 , Electrical installations of b uildings - Part 7- 7 1 0: Requirements for

special installations or locations - Medica/ locations
[1 1 ] I E C 60479- 1 : 1 99 4 , Effects of current on human beings and livestock - Part 1 : General

aspects
[ 1 2] I E C 605 1 3 : 1 994, Fundamental aspects of safety standards for medical electrical

equipment
[ 1 3] I EC 6060 1 - 1 - 1 : 20 0 0 , Medical electrical equipment - Part 1 - 1 : General requirements for

safety - Collateral standard: Safety requirements for m e dical electrical systems
[ 1 4] I EC 6060 1 - 1 -4 : 1 99 6 , Medical electrical equipm ent - Part 1 : General requirements for

safety - 4. Collateral standard: Programm able electrical m e dical systems
Am e n d m ent 1 ( 1 9 99) 2 1 )
[ 1 5] I E C 6060 1 -2-4 , Medical electrical equipm ent - Part 2-4: Particular requirements for the
safety of cardiac defibrillators
[ 1 6] I EC 6060 1 -2-4 9 : 2 00 1 , Medical electrical equipment - Part 2-49: Particular requirements

for the safety of m ultifunction patient monitoring equipment
[ 1 7] I EC 60695- 1 - 1 , Fire hazard testing - Part 1 - 1 : Guidance for assessing the fire hazard of
e/ectrotechnica/ products - General guidelines
[ 1 8] I EC 6 072 1 ( a l l parts ) , Classification of environmental conditions
2 1 ) There exists a conso lidated edition 1 . 1 (2000) i nc l u d i n g I E C 6060 1 - 1 -4 ( 1 996) and its A m e nd m e nt 1 ( 1 999).
6060 1 - 1 © I EC : 20 0 5 - 745 -
[ 1 9] I EC 6 0 7 8 8 : 2 0 0 4 , Medical electrical equipment - Glossary of defined terms
[20] I E C 6 0 9 9 0 , Methods of m easurement of touch current and protective conductor current
[2 1 ] I EC 6 1 0 0 0-4- 1 1 , Electromagnetic compatibility (EMC) - Part 4-1 1 : Testing and

measurem ent techniques - Voltage dips, short interruptions and voltage variations
immunity tests
[22] I EC 6 1 0 1 0- 1 : 2 00 1 , Safety requirements for electrical equipment for measurement,

control, and laboratory use - Part 1 : G eneral requirements
[23] I EC 6 1 1 4 0 : 2 0 0 1 , Protection against electric shock - Common aspects for installation

and equipment
[24] I E C 6 1 25 8 , Guidelines for the developm ent and use of m edical electrical equipm ent
educational m aterials
[25] I EC 6207 9 : 20 0 1 , Preparation of instructions - Structuring, content and preparation
[26] I E C 62304, Medical device software - Software life-cycle processes 22)
[27] I SO 407, Small medical gas cylinders - Pin-index yoke-type valve connections
[28] I SO 5 8 0 5 , Mechanical vibration and shock - Human exposure - Vocab ulary
[29] I SO 804 1 , Human response to vibration - Measuring instrumentation
[30] I SO 1 34 8 5 , Medical devices - Quality m anagem ent systems - Requirements for

regulatory purposes
[3 1 ] I SO 1 47 0 8- 1 , Implants for surgery - Active implantable medical devices - General

requirements for safety, marking and for inform ation to be provided by the manufacturer
[32] I EV- D B : 2 0 0 2 , International Electrotechnical Vocab ulary
[33] I SO/I E C G u i d e 5 1 : 1 99 9 , Safety aspects - Guidelines for their inclusion in standards
[34] AC G I H T h re s h o l d L i m it Val u es and B i o l o gi c a l Ex posure I n d ices (2000 h a n d bo o k)

I S B N : 1 -88241 7-36-4
[35] ASTM STP 1 26 2 , Environmental Toxicology and Risk A ssessm ent, 4th Volume,
Editor(s): T.W. La P o i nt , F. T . P r i c e , E . E . Litt l e , P u bl i s h e d 1 99 6 , I S B N : 0-803 1 - 1 998-4
[36] ASTM STP 1 26 7 , Flammability and Sensitivity of Materials in Oxygen-Enriched

Atm ospheres: lth Volume, E d ito r(s ) : J a n off/Royals/G u n aj i , P u bl i s h ed 1 99 6 , I S B N : 0-
8 0 3 1 -2004-4
[37] ASTM STP 1 39 5 , Flammability and Sensitivity of Materials in Oxygen-Enriched

Atmospheres, N i nth Vo l u m e , E d itor( s ) : T.A. Stei n berg; B . E . N ewto n ; H . D . B e es o n ,
P u bl i s h ed 2 0 0 0 , I S B N : 0-803 1 -287 1 - 1
[38] E N 563, Safety of m achinery - Temperatures of touchable s urfaces - Ergonomic data to

establish temperature limit values for hot surfaces
22l To be published.
6060 1 - 1 © I EC : 20 0 5 - 747 -
[39] I C R P P u bl i cati o n 60 : 1 9 9 0 Recommendations of the International Commission on

Radiological Protection, A n n a l s of t h e I C R P Vol u m e 2 1 /1 -3 , I nternati o n a l C o m m i s s i o n
o n R a d i o l o g i c a l Protecti o n , 1 9 92
[ 40] M I L-H D B K-2 1 7 : 1 9 9 5 , Reliability prediction of electronic equipm ent
[4 1 ] N F PA 5 3 : 1 9 9 9 , Recommended practice on materials, equipm ent and systems used in

oxygen-enriched atmospheres
[42] N F PA 9 9 : 2002, Standard for Health Care Facilities
[ 43] U L 1 4 39 : 1 9 9 8 , Test for sharpness of edges on equipm ent
[44] UL 2 6 0 1 - 1 : 1 997, Medical Electrical Equipment, Part 1: General Requirements for Safety
[45] DALZ I E L , C F . , Re-ev a l u at i o n of lethal el ectric c u rre nts. IEEE Transactions on Industry
and General Applications, S e pte m be r/Octo ber 1 96 8 , Vol . 1 GA-4 , N o . 5
[46] D O LAN , AM . , H O RA C E K, B M . , RAUTAHARAJ U , PM . , Medical Instrum entation

( a bstract ) , J a n u a ry 1 2 , 1 95 3 , 1 97 8
[47] G R E E N , H L . , Electrical Safety Symposium Report. D e pa rtm ent of H ealth a n d S o c i a l

Secu rity, U n ited Ki n g d o m , O cto ber 1 97 5
[48] K E E S EY , J C . a n d LETC H E R , F S . , H u m a n th res h o l ds of e l e ctric s h o c k at power

tra n s m issi o n fre q u e n ci es . Arch. Environ. Health, O ctober 1 97 0 , Vol . 2 1
[49] ROY, OZ . , 6 0 H z Ve ntri c u l a r fi bri l l ati o n a n d rhyt h m t h re s h o l ds a n d t h e n o n-paci n g

i ntraca rdiac cath ete r . Medical and Biological Engineering, M a rch 1 97 5
[50] RAF F E RTY, E B . , G R E E N , H L . , YAC O U B , M H . , Distu r b a n c es of h e a rt rhyt h m produced

by 5 0 Hz l eakage cu rre nts i n h u m a n s u bj ects . Cardiovascular Research, M a rch 1 97 5 ,
Vol . 9 , N o . 2 , p p . 263-265
th
[5 1 ] SAN D E R S , M S . a n d M c CO R M I C K, EJ . , Human Factors In Engineering and Design, " 7
E d . , M c G raw- H i l l , I n c. , I S B N 0-07-0549 0 1 -X
[52] SC HWARTZ, S l . , S H I R E S , G T . , S P E N C E R , F C . , STO R E R , E H . , Principles of Surgery,

7th E d . , M c G raw- H i l l , I n c. , I S B N 0-07-054256-2
[53] STA R M E R , C F . and WHAL E N , R E . , C u rrent d e n s ity a n d e l ectri cal l y i n d u c e d ventri c u l a r

fi bri l l ati o n . Medica/ Instrumentation, J a n u a ry- F e b r u a ry 1 97 3 , Vo l . 7 , N o . 1 .
[54] WATSO N , AB. a n d WR I G H T , J S . , E l ectrical t h re s h o l ds for v e ntri c u l a r fi bri l l at i o n in m a n .

Medical Journal of Australia, J u n e 1 6 , 1 973
6060 1 - 1 © I EC : 20 0 5 - 749 -
INDEX
277, 3 1 1 ' 361 ' 391 ' 397, 431 ' 439, 441 ' 471 '
.'
A 479, 521 , 523, 527, 529, 531 , 543, 561 , 575 '
61 5, 663
Abnormal condition • 73 75
Complying with I EC 60950-1 • 21 3 ' 481
ACCESS COVER • 95, 1 39 1 43, 245, 257 D E F I B R I LLAT I O N - P R OO F A P P L I E D PART s • 221
Definition • 41
ACCESS I B L E PART • 49, 1 35 , 1 41 , 1 47, 1 73, 251 ,
527
Definition • 4 1
427, 429, 443 , 455 , 467, 469, 477
H i g h altitude • 21 5
Actuating mechanisms • 99
I nterpolation • 21 5, 527
Defi b r i l lation protection • 491 M EANS O F O P E RATOR P R O T E C T I O N • 1 45
Definition • 41 M EANS OF PAT I E N T P R OT E CT I O N • 1 45
Determ i n ation of · 95, 1 37 , 455 , 471 , 61 3
Short circuit of · 1 35
Fuse-hol d e r • 1 1 1
L EAKAGE C U R R ENTS • 1 39 473
Values • 21 3
M AXI M U M M A I N S VOLTAGE � n • 473
Am bient h u m i d it y • 91 , 1 1 1 , 367, 465, 737
M EANS O F PROTECT I O N • 1 45 479
Ambient i l l u m i na nce · 1 03
. Am bient pressure • 65, 91 , 437 , 465
Metal · 1 49 , 1 97 , 243, 493, 51 5
Am bient tem perat u re • 49, 91 , 21 1 , 309, 31 3,
Moving • 341
381 , 465, 563, 599 , 665, 673, 675
of E N C L O S U R E S • 41 1 A P P L I AN C E CO U P L E R • 43, 5 1 , 57, 1 27, 247 , 251 ,
T O U C H C U R R E N T • 477
533
Voltage l i m its fo r • 339
ACCESSORY • 93, 1 05, 1 57 , 273, 295, 461 , 539 ,
Definition • 4 1
A P P L IANCE I N L E T • 41 , 5 7 , 1 1 5, 1 63 , 1 93, 237,
563
ACCO M PA N Y I N G DOC U M E NTS d efi nition • 4 1
273
Definition • 43
Biocompat i b i l ity • 333 A P P L I E D PART • 41 , 5 1 , 53, 6 1 , 65, 73, 77, 79,
Cleaning • 1 29, 331
83, 99, 1 09, 1 35, 1 39, 1 47, 1 49, 1 51 , 1 53,
Definition • 41
1 55, 1 57, 1 67 , 1 71 , 1 73, 1 93, 1 97, 1 99, 307,
Disposal • 1 3 1
309, 331 , 337 , 339, 395, 41 1 , 41 9, 421 , 423,
List of · 1 3 1
M E E Q U I P M ENT defi nition • 6 1
449, 467, 473, 507, 525, 575, 605, 7 1 3, 731 ,
733
Means of attach m e nt • 291
Classification • 1 01 , 1 37
M i n i m u m m arking • 1 05
M O D E L OR TYPE R E FE R ENCE d efi nition • 63
Cold · 309
Definition 43 •
Multiple cleanings/d i s i nfections • 331
Determ i n ation of • 95 61 3
D I R ECT CAR D I AC A P P L I � A T I ON • 51 , 1 37 , 425
O perating i nstructions • 1 29
Other power source • 1 09 H A N D - H E L D • 593
Pneumatic and hydra u l i c parts • 285
I ntended to s u p p l y heat • 307
S i n g l e use • 1 05
Marking of • 1 09
Start-up P R O C E D U R E • 1 29
Maxi m u m surface tem perature • 563
Sterile • 1 1 1
Maxi m u m t e m perature • 337
Ster i l izat i o n • 331 M EANS O F P R O T E CT I O N • 1 45
ACCO M PA N Y I N G DOC U M E NT • 59, 69, 93, 95, 1 05,
Moving • 341
1 07, 1 1 3, 1 1 5 , 1 23, 1 25, 1 35, 1 37, 261 ' 273,
Multiple • 1 49 , 483
277, 279, 283 , 291 , 295, 301 , 329, 363, 389,
Not i ntended to s u p p l y heat • 307, 563
395, 399, 403 , 447, 457, 463, 465, 491 , 51 5,
Specified in the i n structions for use • 1 27
539, 625, 661
8
C O M P O N E N T W I T H H I G H- I N T E G R ITY
:
CHARACT E R I S I TCS • 425
Consult • 1 05 , 459, 629 49, 5 1 , 73, 201 , 203 , 389,
B A S I C I NS U LA T I ON •
Defi b r i l lation voltage and any recovery t i m e • 399, 423, 425, 433, 441 , 451 473 , 479 ' 495 '
1 53 51 7, 521 , 525, 607, 737, 739 741
Definition • 41 Definition • 43
I nspection · 87, 1 37, 279, 295, 301 , 367 , M EANS OF P R O T E CT I O N • 469
:
379 B A S I C SAFETY • 29, 31 , 41 , 1 57, 351 , 353 , 357,
I nstructions for use • 1 23 ' 625 401 , 407, 409, 423, 433, 443 , 445 , 447 , 449 ,
M E SYSTEM • 389, 603 451 , 453, 457 , 461 , 463, 467 477 , 491 ' 543 '
M O D E L OR TYPE R E FE R ENCE • 433 561 ' 563, 579, 599, 603, 605 609
Recovery t i m e • 1 57 Defi b r i l lation protection • 1 53
Surface te m perature • 405 Definition • 49
Technical d escri ption • 1 23 , 627 Biocompat i b i l ity • 333, 443, 593, 61 3
Active i m p l a ntable medical device • 6 1
A I R C L EARANCE • 6 1 , 1 35, 1 4 1 , 1 45, 1 47, 1 49,
1 5 1 ' 1 53, 21 1 ' 21 3, 21 5, 21 7, 221 ' 223, 227,
229, 231 , 233 , 235, 237, 247, 253, 255, 257,
6060 1 - 1 © I EC : 20 0 5 - 751 -
Diagnostic or t h e rapeutic rad iation • 335, 337

c D I R ECT CAR D I AC A P P L ICAT I O N • 77, 1 37 , 425, 443,
475, 499, 603
CATEGORY AP • 329, 569 , 6 1 1 , 6 1 9, 621 , 625,
Definition • 5 1
657, 659, 661 , 663, 665
4 9 , 8 5 , 1 35, 1 51 , 425, 451 ,
D O U B L E I N S U LAT I O N •
Definition • 49
471 , 479, 481 , 521 , 525, 535, 737
Symbol · 637
CATEGORY APG • 329, 569 , 6 1 1 , 6 1 9, 621 , 625,
Definition • 5 1
M EANS O F PROTECT I O N • 51 , 469
659, 661 , 663 , 665 , 675
Short circuiting • 1 67, 497
Definition • 49 W O R K I N G VOLTAGE • 489
Symbol · 637 D UTY CYC L E • 1 23, 309 , 347, 425, 563
C LASS I • 69, 99, 1 01 , 1 25 , 1 95, 257, 391 , 397,
Definition • 5 1
399, 451 , 463 , 473, 493, 507, 533, 607
Marking of · 1 1 1
Definition • 49
C LASS II • 49, 99, 1 0 1 , 1 07, 1 67, 257 , 429, 497,
E
627, 633, 721
Definition • 49 E ARTH LEAKAGE C U R R E N T • 57, 1 67 , 1 7 1 , 1 95,
Class I l l • 457 435, 501 ' 721
C LEARLY L E G I B LE • 1 03, 1 1 1 , 1 1 5 , 275, 457 Definition • 5 1
Definition • 49 Measurement • 1 73, 1 95, 5 1 3
C O L D C O N D I T I O N • 343, 61 7 M U L T I P L E SOC KET - OU T L E T • 605
Definition • 49 Total · 393
Com parative tracking i ndex · 2 1 7 Value • 1 67 , 1 69
C O M P O N E N T W I T H H I G H - I NT E G R ITY Value for a M U LT I P L E SOCKET - OU T L E T • 393
CHARACT E R I ST I CS • 83, 85, 87, 1 35, 355, 381 , Electrical e q u i p m e nt • 39, 1 25, 1 35 , 1 37, 1 91 ,
425, 451 , 587 399, 405, 455, 599 , 601
Definition • 49 ACCESS C OV E R definition • 41
1 0 1 , 1 1 1 , 31 1 , 349,
C O N T I N U O U S O P E RA T I O N • ACCESS I B L E PART d efi nition • 41
393, 425, 457 , 577, 675 A P P L I AN C E CO U P L E R definition • 41
Definition • 51 A P P L IANCE I N L E T definition • 43
D UTY CYC L E • 425 C LASS I I defi n it i o n • 49
Non- · 1 0 1 , 1 1 1 , 3 1 1 , 345 , 347, 351 , 393 , C O L D C O N D I T I O N d efi nition • 49
425, 457, 577 D ETAC H A B L E P O W E R S U P PLY C O R D definition •
C R E E PAGE DI STANCE • 61 , 1 35, 1 41 , 1 45, 1 47, 51
1 49, 1 51 ' 1 53 , 203, 21 1 ' 21 3, 21 5, 223, 225, H A N D - H E L D d efinition • 55
233, 235, 237 , 247, 253, 255, 257, 277, 31 1 , I N T E R N A L E L EC T R I CAL POW E R SOURCE definition
361 , 391 , 397 , 431 , 439, 471 , 479, 485, 521 , • 57
523, 527, 529 , 531 , 543, 561 , 575, 6 1 5, 663 I N T E R N A L L Y POWE R E D definition • 57
Complying with I EC 60950-1 • 21 3, 481 M A I N S C O N N ECTOR definition • 57
D E F I B R I L LATION- PROOF A P P L I E D PARTS • 221 , M A I N S PLUG d efi nition • 57
527 M A I N S TRAN S I E N T VOLTAGE d efi nition • 59
Definition • 51 M E E Q U I P M E N T defi nition • 61
H i g h altitude • 21 5 P EAK WOR K I N G VOLTAGE defi nition • 65
I nterpolation • 21 5, 527 P OTENTIAL E QU A L I ZAT I O N C O N D U CT OR definition
M EANS O F O P E RATOR P R O T E C T I O N • 1 45, 221 • 67
M EANS O F PAT I E N T P R OTECT I O N • 1 45 P OW E R S U P P L Y C O R D definition • 67
Short circuit of · 1 35 S E L F - R E S E T T I N G T H E R MA L CUT-OUT definition •
Values · 21 3 73
W O R K I N G VOLTAG E above 1 000 V • 527 S I G NAL I N P U T / O U T P U T PART d efi nition • 73
T E R M I NA L DEVICE definition • 75
D T H E R MAL C U T -OUT definition • 75
W O R K I N G VOLTAGE definition • 79
D E F I B R I LLAT I O N - PROOF A P P L I E D PART • 1 53, 425, ENCLOSURE • 57, 77, 1 43 , 1 49, 1 51 , 1 53, 1 67,
461 , 489, 491 , 493
1 91 , 1 95, 1 97 , 201 , 205, 237, 247, 263, 321 ,
Classification • 1 01 , 1 49, 1 53
323, 41 1 ,427 , 443, 469, 471 , 475, 491 , 50 1 ,
C o m m o n-mode test • 1 53
521 , 523, 525, 539, 545, 605, 61 1 , 657, 659,
C R E E PAG E DI STANCES and A I R C L EARANCES •
663, 665, 673, 675, 71 3
221 ACCESS COVER • 41 , 455
Definition • 51 ACCESS I B L E PART • 41 1
Diffe re ntial-mode test • 1 55
Ball-pressure test • 21 1
Energ y reductio n test • 1 57
Definition • 5 1
Marking of · 1 09
W O R K I N G VOLTAG E • 1 53, 489
Deformation of • 337
F i re • 31 3, 323, 325, 339 , 543, 569, 575, 6 1 7
D ETAC H A B L E POWER S U P PLY CORD • 1 93, 273, H A N D H E L D switches and footswitches • 531
425, 485, 663 H I G H VOLTAG E parts • 463
Definition • 51
I m pact • 363, 593
Non- • 1 33, 1 63 , 255, 533 , 607
6060 1 - 1 © I EC : 20 0 5 - 753 -
I m pairment o f coo l i ng · 3 4 1 ME E Q U I P M E N T • 1 03, 1 95, 271 ' 275, 325 ,

I P Classification • 1 01 , 1 09, 331 , 379, 409, 361 , 593
455, 571 POWER S U P P L Y CORD • 67
Main • 1 95 , 497 PROTECTIVE EARTH CONDUCTOR • 1 6 1
ME SYSTEM • 391 , 599 S u p p l y cond uctors • 1 61
M i n i m u m m arking • 1 05 S U P P LY MAINS • 53
Moulded • 367 Term inals • 257
MULTIPLE SOCKET -OUTLET • 397 Wiring · 257
Opening in • 1 4 1 , 663 F LAM MABLE ANAESTHETIC M IXTUR E WITH AIR • 49,
R i g i d ity • 363, 593 569, 659, 673
Separate • 1 37 Definition • 53
TOUCH CURRENT • 77, 51 3 F LAM MABLE ANAESTHETIC M IXTUR E WITH OXYGEN
E q u i p m e nt • 39, 1 05, 1 09 , 1 27 , 1 31 , 359, 387, OR NITROUS OXI DE • 49, 659 , 661 , 663, 675,
389, 391 , 393 , 397, 399, 41 1 , 433, 435, 441 , 683
451 , 457, 525 , 533, 539, 541 , 559, 571 , 59 1 , Definition • 53
597, 599, 603 , 605, 607, 703, 71 3 F l a m m able a naesthetic m ixtu res · 405 , 61 1 ,
ACCESSORY definition • 41 657
ACCOMPANYI NG DOC U M E NTS d efi nition • 4 1 F-TYPE APPLIED PART • 65, 77, 1 49 , 1 51 , 1 97,
Class I l l • 457 41 3, 4 1 5, 483, 485, 505, 523
GUARD d efi nition • 53 Classificati o n • 53
MAI NS S UPPLY TRANSFO R M E R d efi nition • 57 Definition • 53
ME SYSTEM definition • 61 F-TYPE ISOLATED ( FLOATING) APPLIED PART • See
M O B I L E • 77 F-TYPE A P P L I E D PART
M O B I L E definition • 61 Function · 41 , 43, 49, 8 1 , 1 03, 1 1 3, 1 1 7, 1 23 ,
MODEL OR TYPE R E FER ENCE d efi nition • 63 1 25, 1 27, 1 29 , 1 33 ,
1 49, 1 53, 1 65, 1 99, 203,
N ETWORK/DATA COU P L I N G • 359 261 , 297, 299, 301 ,
32 1 , 333, 339, 355, 357,
N ETWORK/DATA COU P L I N G defi nition • 63 369, 371 , 375, 395 ,
403, 41 3, 41 7, 41 9, 421 ,
PER MANENTLY I NSTAL LED • 645 423, 427, 437 , 451 ,
473, 483, 491 , 495, 505,
Polyp hase • 487 509, 5 1 7, 539, 541 ,
585, 589, 591 , 621 , 625,
PORTABLE • 77 687, 693, 695, 709701 ,
PROTECTIVE EARTH T E R M I NAL d efi nition • 69 F UNCTI ONAL CON NECTION • 6 1 , 391 , 393, 427
SAFE WORKING LOAD definition • 71 Definition • 53
Separate power s u p p l y • 93 F UNCTI ONAL EARTH CONDUCTOR • 49, 1 21
SERVICE PERSONNEL definition • 73 Definition • 53
STAT IONARY definition • 73 FUNCTIONAL EARTH T E R M I NAL • 49, 53, 1 57 , 1 65,
TRANSPORTABLE definition • 67, 77 1 67, 1 91 , 429
TRAPP I N G ZONE definition • 77 Definition • 53
TYPE TEST definition • 79 Marking of • 1 1 3, 1 1 5
USAB I L I TY E N G I N E E R I N G defi n ition • 79 Fuseholder • 95, 1 39, 455
ESSENTIAL P E R FO R MANCE • 29, 31 , 41 , 81 , 1 57 ,
351 , 353, 355 , 357, 401 , 407, 409, 425, 427, G
433, 445, 447 , 451 , 453, 461 , 49 1 , 543, 545,
G UARD • 261 , 539
579, 583, 585 , 609, 61 3, 693
ACCESS COVER • 41
d . c . SUP PLY MAINS • 1 37
Definition • 53
Defi b r i l lation protection • 1 53
F IXED • 263
Definition • 51
Hot or cold access i b l e surfaces • 31 3
VERI FICAT I O N • 357, 589
Mova b l e • 267
EXPECTED SERVICE L I FE • 49, 73, 81 , 83, 85, 99,
TRAP P I N G ZONE • 263
1 03, 1 23, 1 37 , 1 63, 21 1 ' 291 ' 303, 331 ' 367,
447, 449, 451 , 493, 51 9, 555 H
Definition • 53
Disposal • 1 3 1 HAND- H E L D
APP L I E D PART • 593
F Control device • 245 , 377, 379
Definition • 55
F i re • 1 1 3, 259, 3 1 3, 321 , 323, 325, 327, 329,
M E E Q U I P M E N T • 89, 271 ' 309, 343, 351 ' 361 '
373, 401 , 477 , 533, 551 , 565, 567, 569, 575,
363, 593
601 , 6 1 7
Part • 245 , 363
FIXED
Switches and footswitches • 531
APPLIANCE I NLET • 43
HARM • 55, 71 , 1 1 1 , 267, 269, 277, 361 , 427,
Connections • 493
429, 447, 449, 537, 543, 545, 549, 551 , 559,
Definition • 53
563, 575, 705
GUARD • 263
Definition • 55
I nsta l lations • 435
HAZARD • 29, 49, 55, 61 , 63, 7 1 , 73, 77, 81 ,
Mains socket-outlets • 435
1 1 1 ' 1 1 3, 1 33 , 1 35, 261 ' 267, 269, 271 ' 279,
291 , 309, 353, 369, 371 , 373, 387 , 395, 401 ,
6060 1 - 1 © I EC : 2005 - 75 5 -
405, 41 1 ,
425 , 429 , 433, 439, 445, 447, 449,
451 , 453,455 , 459, 461 , 463, 465, 467, 485,
487, 501 ,
507 , 529, 533, 537, 539, 541 , 549, I nstructions for use · 63, 89, 91 , 93, 95, 1 0 1 ,
551 , 553,565 , 571 , 573, 575, 585, 587, 593, 1 09, 111'1 21 ' 1 23 , 1 25, 1 27, 1 33, 1 39, 1 4 1 '
595, 597,601 , 603, 605, 61 3, 621 , 625, 663, 1 57, 1 65,
1 93 , 1 99 , 203, 261 ' 273, 275, 297,
695, 701 ,
703 , 705, 71 3 307, 329,331 , 391 , 403, 437, 449, 455, 459,
Definition • 55 463, 491 ,
601 , 625 , 661
Excessive tem perat ures • 305, 561 I nspectio n · 1 31 , 1 41 , 309
Expelled parts • 261 , 281 , 545, 61 7 I N S U LA T I ON CO- O R D I NAT I O N
I m pairment of coo l i ng • 341 Definition • 55
I nsta bility • 271 , 543, 6 1 5 I EC 60950-1 • 1 45, 1 47 , 201 , 2 1 3, 441 , 445
Moving parts • 6 1 5 I NTENDED U S E • 4 1 , 67, 263 , 283 , 359, 367, 427,
Roug h surfaces, corners and edges • 271 , 431 , 437, 465, 493, 529, 539, 569, 595, 705,
541 , 6 1 5 709
Sup port systems • 291 , 551 , 61 7 Definition • 55
Tem peratu re of A P P L I E D PARTS • 563 N O R MAL U S E d efi nition • 63
U nwanted and excessive radiation • 301 , I N T E R N A L E L E CT R I CAL POW E R SOURCE • 57, 7 1 ,
561 87, 1 27, 373, 375, 463
• 85, 1 35 , 1 37, 1 75, 259,
H AZA R D O U S S I TUAT I O N Definition • 57
323, 337, 339 , 429 , 447, 569, 573, 579, 605, I N T E R N A L L Y POW E R E D • 99, 1 01 , 1 5 1 , 1 93, 1 95,
607, 6 1 7 21 9, 221 , 489
Adj ust m e nt of controls • 375 Definition • 57
Battery replacement • 373 IP Cla ssification • 1 01 , 1 09, 379, 397
Damage d uring assem bly • 245
Damage to i nsulation • 245 L
Definition • 55
La mpholder • 1 1 3, 1 39 , 3 1 3
Detach m e nt of cond uctors and connectors •
Layperson • 69, 435
1 37, 243, 245 L EAKAGE C U R R E N T • 57, 77, 1 39, 1 41 , 1 49, 1 67,
Exhaustion of a batte ry • 597
1 69, 1 91 ' 1 93 , 339, 391 ' 393, 41 1 ' 439, 453,
F a i l u re of any one com ponent at a t i m e • 337
469, 473, 479, 483, 485, 487, 497, 499, 501 ,
F a i l u re of components • 85
505, 507, 51 1 , 51 3, 533, 605, 607, 6 1 5, 71 3,
F a i l u re of the NETWORK/ DATA CO U P L I N G • 359
71 5
Heaters • 373
Definition • 57
I ncorrect connect i o n • 395
Measurement • 1 37, 1 49, 1 65, 1 73 , 1 93,
I ng ress of water and particulate m atter •
329, 331 , 395, 455, 473, 499, 51 1 , 5 1 3
331 ' 571 T Y P E B A P P L I E D PART • 485
I nterruption of S UPPLY MAINS • 333
I nterrupti o n of the power supply • 395, 571 M
Lim itation of movem ent • 377
Marking of supply term i n a l s • 1 1 5 M A I N S C O N N ECTOR • 41 , 57, 251 , 253 , 485, 487,
Overflow • 329 533
Overheati ng of transform ers • 381 , 383 Definition • 57
Poor contact • 243 M A I N S PART • 51 , 93, 1 67 , 201 , 205, 207, 2 1 1 ,
Prolonged operation • 373 21 7, 2 1 9, 223, 227, 229, 233, 245, 247, 257,
Short circuiting of a battery • 371 259, 431 , 441 , 453, 467, 51 7, 523, 525, 529,
Short circuiting of C R E EPAGE D I STANCES or AIR 535, 6 1 7
CLEAR ANCES • 233 Definition • 57
Speed of m ove ment • 269 Overvoltage catego ry • 21 9
S p i l l a g e • 329, 331 Separation from S E C O N DARY CI RC U I T • 71
T H ER MAL CUT -OUTS and OVER-CURRENT M A I NS PLUG • 1 35, 1 63, 1 67, 247, 249, 397,
R E LEASES • 369 399, 431 , 479, 607 , 609
Transformer fai l u re • 385 Definition • 57
Health care professional • 435 M A I N S S U P P LY TRANS FO R M E R • 379, 399 , 597,
H I G H VOLTAG E • 111 599, 6 1 7
Defi b r i l lation protection • 491 Definition • 57
Definition • 55 M A I N S T E R M I NAL DEVICE • 255, 259, 397, 535,
Part • 463 , 657 623
Part, Marking of · 1 1 3, 629 Definition • 57
H u m i d ity preco nditioning • 93, 1 67 , 203, 235, M A I N S TRAN S I E N T VOLTAGE • 21 7, 21 9, 227, 247
385, 455, 521 , 61 5 Definition • 59
H YDRAU L I C TEST P R E S S U R E • 287, 289 M A I N S VOLTAG E 1 5 1 , 1 73, 1 91 , 227, 229 , 41 5,
•
Definition • 55 431 , 505, 507, 51 1 , 51 5, 525, 667, 677

Defi nition • 59
N OM INAL • 63, 2 1 7
R ATED • 1 67 , 2 1 7, 303, 393 , 487 , 489
6060 1 - 1 © I EC : 20 0 5 - 757 -
M A N U FACT U R E R • 55, 61 , 6 3 , 69, 71 , 81 , 1 01 , Test vo ltage for solid i nsulation • 207

1 27, 1 31 , 1 33 , 1 35, 1 49, 1 63, 1 95, 2 1 5, 237, • 1 49
T Y P E B A P P L I E D PART
253, 281 , 283 , 287, 289, 291 , 295, 303, 305, M EANS OF P R O T E CT I O N• 43, 51 , 57, 59, 1 45,
309, 321 , 329 , 331 , 333, 335, 337, 351 , 353, 251 , 257, 737 , 739, 741 , 763
357, 359, 367 , 371 , 375, 399, 405, 409, 41 9, A I R C L EARANCE • 233
423, 425, 445 , 451 , 453, 457, 459, 461 , 463, Ball-pressure test • 345
465, 481 , 483 , 487, 493, 51 3, 535, 549, 551 , Classification • 1 45 , 1 47
555, 563, 569 , 571 , 575, 579, 581 , 583, 585, Coat i n g s , etc. not considered as • 1 45
591 , 593, 595 , 609, 70 1 , 71 5 Components and wiring • 1 45
Definition • 59 Components used as · 85
Equ ivalent safety • 83, 447 C R E E PA G E DI STANCE or A I R C L EARANCE not
E XPECTED S E R V I C E L I FE • 53, 81 , 447 considered as • 1 45
F l a m m able a naesthetic m i xt u res · 61 1 C R E E PA G E DI STANCE or A I R C L EARANCE • 1 45,
Identification of ESSENTIAL P E R FO R MANCE • 81 237, 255
I N T E N D E D U S E • 1 25 Definition • 6 1
Marking of name or t rade-name • 1 05, 1 23 DO U B L E I N S U L A T I O N • 1 51
M E SYSTEM • 387, 389, 433, 445, 599 , 601 , I nsulating characteristics and mechanical
605 strength • 2 1 1
P E M S • 703, 707, 709 I nsulating m aterial in which heat i n g
Qual ificatio n of S E R V I C E P E R SON N E L • 1 33 cond uctors a r e em bedded • 2 1 3
Reasonably foreseeable m isuse • 445 I nternal screens and i nternal wiring • 1 67
R I S K accepta b i l ity · 8 1 Op posite pola rity of the MAI N S PART • 201
S i n g l e use · 1 29 Pollution degree 4 • 2 1 7
Specificati o n of overvoltage category • 89 R E I N FO R C E D I NS U LA T I ON • 69, 201
System i ntegration • 701 S E C ON DARY C I RC U I T • 71
U SAB I L I TY E N G I N E E R I N G • 1 0 1 Separation from M A I N S P A R T • 245
Mate rial group classificatio n • 21 7 Sheath of a fl exible cord • 247
M AXI M U M M A I N S VOLTAGE • 1 35, 1 49, 1 51 , 1 67, Short circuit of · 1 35 , 255, 257, 31 1
1 73, 1 97, 391 ' 431 ' 473, 487, 505, 5 1 5, 729 Short circuit of C R E EPAGE D I STANCE or AIR
Definition • 59 CLEARANCE • 1 35
M AXI M U M P E R M I S S I B L E W O R K I N G P R E S S U R E • 285, S U P P L E M ENTARY I N S U LA T I O N • 73, 201
287, 289, 291 , 431 , 549, 551 Test vo ltage fo r • 385 , 523
Definition • 59 Test vo ltage for solid i nsulation • 207
M E E Q U I P M ENT Transfo rmers fo r m i n g • 387
P E R MAN ENTLY I N STAL L E D • 535 Wetting of · 329
See M E D ICAL E L EC T R I CAL E Q U I P M E N T • 61 W O R K I N G VOLTAGE for • 1 51
M E SYSTEM M E C HA N I CAL HAZARD • 259, 263, 267 , 339, 343,
See M E D ICAL E L EC T R I CAL SYSTEM • 61 395, 405, 537 , 607
M EANS O F O P E RATOR P R O T E C T I O N • 1 45, 221 , Definition • 61
381 , 391 , 433 , 479 , 481 , 527, 763 M E C HA N I CAL P R OTECTIVE DEVICE • 83, 293 , 297,
Add itional AIR C L EARNACE • 229 299, 301 , 559, 621
Capacitors • 1 47 Definition • 61
Classification • 1 45 , 1 47 When not req u i red • 301
Definition • 59 Medical d evice 29, 59, 79, 405, 581 , 693
•
I EC 60950-1 • 1 47, 1 61 , 201 , 2 1 3, 21 5 M E D I CAL E L E CT R I CAL E Q U I P M E NT • 379

M i n i m u m A I R C L EARANCE • 227, 231 a . c S U P P LY M A I N S • 93
M i n i m u m C R E EPAGE D I STANCE • 221 , 233 Accessi b i l ity of connections • 257
P ROTECTIVE EA RTH C O N N E C T I O N • 1 47 Acoustic energy and vibrat i o n • 281
Solid i nsulation for m i ng • 1 45 Ada pting • 59
Test vo ltage fo r • 209 Applicabi lity of req u i re m e nts · 29
Test vo ltage for solid i nsulation • 207 Arrangement of controls and i n d i cators • 359
M EANS O F O P E R T O R P R OTECT I O N Automatica l l y or remotely contro l l e d • 341
Coat i n g s , e t c . com plying with I EC 60950-1 Battery • 1 27, 371
1 45 Battery replacement • 373
M EANS OF PAT I E N T P R OTECT I O N • 1 6 1 , 21 5, 323, Biocompat i b i l ity • 333
41 3, 4 1 5, 433 , 479, 481 , 663, 675, 763 C ATEGORY AP • 657, 659, 661 , 663, 665
Capacitors • 1 45, 1 47 C ATEGORY APG • 659, 661 , 663 , 665, 675
Classification • 1 45 , 1 47 C LASS I • 1 25, 1 95, 257
Coat i n g s , etc. com plying with I EC 60950-1 C LASS II • 1 07 , 1 67, 257
1 45 Classificati o n • 99
Definition • 59 Cleaning • 1 29, 331
F- TYPE A P P L I E D PART • 1 49, 483 Compat i b i l ity with substances · 333
P A T I E N T C O N N E C T I O N • 1 49 Com ponent • 81 , 85, 327
P ROTECTIVE EA RTH C O N N E C T I O N • 1 45 C O M P O N E N T W I T H H I G H - I NT E G R ITY
Solid i nsulation for m i ng • 1 45 CHARACT E R I ST I CS • 49, 85
Spacing • 225, 525 Condition fo r a p p l ication • 79
6060 1 - 1 © I EC : 20 0 5 - 759 -
Cond uctors and con nectors • 243 Multiple cleanings/d i s i nfections • 331
Connection to S U P PLY M A I N S • 1 35 Multiple PAT I E N T C O N N E C T I O N • 1 99
Connectors • 369 M U L T I P L E SOC KET - OU T L E T • 1 09, 1 25, 249
C O N T I N U O U S O P E RA T I O N • 1 0 1 , 1 1 1 , 31 1 Non- • 85, 389, 391 , 397
Contraind ication • 1 25 Non-SI U nits • 1 1 9
Controls • 375 Oi l-fi l led • 1 33 , 379
Coo l i n g provisions • 1 1 1 O perating i n structions • 1 29
d.c. • 1 51 Overbala nci n g • 275
d . c . S U P PLY M A I N S • 93, 1 37 Overcharging • 373
Definition • 61 Overtravel • 269
Descri ption • 1 27, 1 33 Overvoltage catego ry • 21 9
Diagnostic or therapeutic rad iation • 337 O XYG E N R I C H ENVI R O N M E N T • 1 01
Disa b l i ng of controls • 347 Part • 49, 59, 73, 93, 95, 99, 1 01 , 1 03, 1 05,
Disposal • 1 3 1 1 09, 111, 1 1 7, 1 27, 1 29, 1 35, 1 37, 1 43,
D UTY CYC L E • 51 , 347 1 47, 1 63, 1 65 , 243, 267, 269, 273, 275,
Educational materials • 1 25 279, 291 , 295, 305, 307, 309, 327, 337,
E m e rgency sto p • 267, 269, 271 359, 361 , 379, 659, 661 , 665, 667, 673,
Equ ivalent safety • 83 675, 677, 683
Excessive rad iation • 335 Part biocom pat i b i l ity • 333
E XPECTED S E R V I C E L I FE • 81 , 83, 85, 99, 1 03, Part cleaning • 1 29, 331
1 37, 1 63, 21 1 ' 291 ' 303, 367 Part ster i l izat i o n • 331
Expelled parts • 281 Part, HAN D - H E L D • 363
F IXED • 1 03, 1 95, 275, 325 Part, heating • 347
F IXED or HAND- H E L D • 271 Part, m u lt i p l e cleanings/d isi nfections • 331
Fixing of co m ponents • 243 Parts that contact the PAT I E NT · 83
Fluid reservo i r • 329 P A T I E N T ENVI R O N M E N T • 65
Foot-operated control device • 377, 379 P E R MA N E N T L Y I N STAL L E D • 1 05,1 07, 1 1 5, 1 33,
Function · 43, 1 27 , 1 33 1 37, 1 57, 1 63 , 1 69, 1 93, 247, 255, 257
G u i d i ng rol l e rs • 245 Physiolog ical effects · 1 1 1
Hand loaded • 351 Physiolog ical fu nction • 29
H A N D- H E L D • 89, 309, 343, 351 , 363 Platen g lass 363 •
H A N D- H E L D control device • 377 Pneumatic and hydra u l i c parts • 285

Heating e l e m ents • 309, 345, 347 Polyp hase · 1 37 , 1 51 , 351
Identification • 1 05, 1 23 P ORTABLE • 279, 281 , 365, 379
Identification of ESSENTIAL P E R FO R MANCE • 81 P ORTABLE p a rt • 365
I n vitro d i a g nostic e q u i p m ent · 29 Power i n p ut • 89
I nd icator l i g hts • 373 Pressure control device • 289
I nput s u p p l y vo ltage • 1 51 Pressure rel i ef device • 289
I nspectio n · 1 43, 379 P ROTECTIVE EARTH C O N N E C T I O N • 1 2 1
I nsta b i l ity · 273 R ATED altitude • 21 5
I nsta l lation • 1 27 R ATED voltag e • 93
I N T E N D E D U S E • 1 25, 263, 283 , 367 Ready fo r N OR MAL USE • 373
I NTER N ALLY POWE R E D • 99, 1 51 , 1 93, 1 95, Rechargeab l e battery • 1 31
21 9, 221 Reci p rocal i nterference • 1 25
I nterruption and short circuiting of m otor Release of PAT I E NT • 271
capacitors • 341 R E S P O N S I B L E ORGAN IZAT I O N • 69
I nterruption of S U P P LY MAINS • 333 R ISK
I P Classification • 331 , 379 of fire • 31 3
I so lation from S U P P LY M A I N S • 1 33, 247 R I S K M A NA G E M E N T P ROCESS • 79
Large · 367 Roug h surfaces, sharp corners and edges ·
Lit h i u m batte ries • 373 271
Load-reducing device • 351 Routine m a i n tenance • 1 31
Mains operated • 1 27 Separate power s u p p l y • 93, 1 05, 1 25 , 1 31 ,
Manual M O B I L E • 277 1 37, 391
Manually switched on • 351 Shutdown P R O C E D U R E • 1 29
Maxi m u m supply pressure • 285 Sl Un its • 1 1 7
M ECHA N I CAL P R OTECTIVE DEVICE • 299 S I N G L E FAU L T C O N D I T I O N • 83
M E D I CAL E L EC T R I CAL SYSTEM • 61 S I N G L E FAU L T SAFE • 83
MO B I L E • 275 , 277, 279, 365 , 367 , 379 S i n g l e use · 1 05
MO B I L E Part • 365 , 367 Sing le-p hase · 1 93
M o B I L E , power-d riven • 277 Source of power • 87
Mod ificati o n • 1 33 Spark source • 31 5
Motor · 347 S p i l l a g e • 329
Motor operated • 309 , 343 Stand-by or a warm -up state • 373
Motor-d riven M O B I L E • 277 Start-up P R O C E D U R E • 1 29
Moving parts · 261 , 267 , 271 S TAT I O NARY • 253, 325
6060 1 - 1 © I EC : 2005 - 761 -
Sterile • 1 1 1 N
Ster i l izat i o n • 331
S U P P LY M A I N S • 89 1 27, 353, 357, 359,
N ETWORK/ DATA C O U P L I N G •
Surface • 307 435, 591 , 701 , 703, 705, 707, 709
Surface coating • 1 65 Definition • 63
Therm ostatically contro l l e d • 345 N O M I NA L
T i m e r · 351 Capacitance • 1 45, 1 47
Transformer • 379, 383, 387 Conductor d i a m eter • 739
T RANSPORTABLE • 1 03, 325, 329 Cross-sectional a rea of cond uctors • 249,
U npacki ng • 111 25 1 , 255
M E D I CAL ELECTRICAL SYSTEM 73, 75, 1 27 , 1 31 ,
• Definition • 63
1 37, 1 65 , 323 , 329 , 387, 389, 391 , 393 , 395, Frequency • 89, 1 07
399 M A I N S VOLTAGE • 63, 89, 21 7, 2 1 9 , 227, 229,
Ada pting • 59 231
App l ica b i l ity or req u i rem ents • 29 Supply voltag e · 1 07
Biocompat i b i l ity • 333 N O R MAL C O N D I T I O N • 49, 65, 83, 1 1 5, 1 35, 1 41 ,
Cleaning • 331 1 45, 1 47, 1 51 , 1 67, 1 69, 1 7 1 , 1 75, 1 99, 247,
Com ponent • 81 269, 283, 285, 305, 31 3, 321 , 331 , 339, 347,
Components · 85 387, 393, 401 , 435, 439, 467, 469, 471 , 473,
Condition fo r a p p l ication 79 • 479, 497, 499, 501 , 503, 505, 507, 5 1 5, 525,
Creation of • 1 25 549, 567, 571 , 573, 575, 605, 659, 665, 667,
Definition • 61 673, 675, 677, 731
Equ ivalent safety 83 • Definition • 63
E XPECTED S E RV I C E L I F E 81 •
N ORMAL U S E 43, 49, 51 , 55, 61 , 65, 71 , 75, 77,
•
Function • 43 79, 9 1 , 95, 1 03 , 1 1 1 , 1 1 5 , 1 1 7, 1 27, 1 29,

Identification of E S S E N T I A L P E R FO R MANCE • 81 1 39, 1 41 , 1 43 , 1 51 , 1 65, 1 97, 1 99, 201 , 203,
I N T E N D E D U S E • 263 245, 247, 249, 263, 269, 271 , 273, 275, 277,
I P Classification • 331 279, 281 , 283, 289, 295, 297, 303, 305, 309,
Multiple cleanings/d i s i nfections • 331 31 1 , 323, 329, 331 , 35 1 , 363, 365, 369, 373,
O XYG E N RICH ENVI R O N M E N T • 1 01 375, 377, 379, 381 , 383, 385, 393, 397, 401 ,
Part · 393 41 3, 4 1 7, 41 9 , 421 , 423, 429, 451 , 489, 491 ,
Parts that contact the PAT I E NT • 83 539, 541 , 543, 551 , 563, 565, 567, 571 , 575,
P A T I E N T ENVI R O N M ENT 65 • 595, 597, 603, 609, 61 1 , 663, 665, 667, 673,
Physiolog ical fu nction 29 • 675, 677
Power i n p ut • 89 Definition • 63
R E S P O N S I B L E ORGAN IZAT I O N 69 •
I N T E N D E D U S E definition 55 •
R I S K MANAGEM ENT PROCESS 79 •
R ISK of fire • 31 3 0
S p i l l a g e • 329 O BJ ECTIVE EV I D E NC E • 69, 79, 81 , 601
Ster i l izat i o n • 331
S U P P LY M A I N S • 89
Definition • 63
Operating te m p e rature • 1 1 5 , 1 67, 1 73 , 203,
Total PAT I E N T LEAKAG E C U R R ENT • 393
T O U C H C U R R E N T • 393
305, 393, 521 , 565, 61 5, 665, 673, 675
O P E RATOR • 41 , 63, 77, 79, 1 03, 1 05, 1 1 1 , 1 1 9 ,
M O B I L E • 277 , 545, 595, 625
1 23, 1 25, 1 29 , 1 31 , 1 39, 1 53, 1 65, 267, 271 ,
Definition • 61
E Q U I P M E NT • 77
295, 299, 321 , 335, 343, 359, 373, 375, 387,
M E E Q U I P M ENT • 275, 277, 279, 361 ' 365 ,
391 , 401 , 403, 405, 407, 41 1 , 41 9, 427, 429,
433, 435, 449, 453, 455, 457, 459, 461 , 463,
379, 593
M E E Q U I P M ENT parts 365 , 367
477, 479, 481 , 493, 501 , 523, 537, 539, 543,
•
545, 573, 577, 595, 597, 60 1 , 605, 625, 693,
M ODEL OR TYPE REFER ENCE 1 05, 1 23, 433, 459,
•
705, 7 1 3
46 1
Contact with · 1 95 , 391 , 469, 471 , 477, 49 1 ,
Definition • 63
565
MOOP
Contact with PAT I E NT • 1 39
See M EANS O F O P E RATOR P R OTECT I O N • 59 Definition • 63
MOP
E m e rgency sto p • 269
See M EANS O F PROTECT I O N • 61
Expected position of · 1 27 , 283, 561
MOPP
Exposure to hazard o u s m aterials • 1 27
See M EANS O F PAT I E N T P R OTECT I O N • 59
H o m e use · 69
MS O
Mass of • 295, 555
See M U L T I P L E SOCKET- OUTLET • 63
Moving parts • 263, 269
M U L T I P L E SOCKET- OUTLET • 6 1 , 1 09 , 1 25,
249, R I S K to • 629
389, 391 , 393 , 397, 399, 433, 435, 533, 603,
Sensitivity to acoustic energy and vibration •
605, 607, 621 , 71 3, 71 5, 72 1 , 763
283
Definition • 63
Sensitivity to vibration 283 •
S p u rious X-rad iation 303 •

6060 1 - 1 © I EC : 20 0 5 - 763 -
Support • 295, 297, 301 , 551 Definition • 65

U nwanted or excessive rad iation • 335 L i m it · 77
O V E R - C U R R E N T R E L EASE • 1 1 3, 201 , 257, 259, Measurement • 1 73, 1 99, 439
339, 369, 371 , 373, 449, 463 ' 473 ' 529 ' 535 ' Value • 1 67 , 1 69, 507
657 Values · 477 , 479 , 499
Definition • 63 PA T I E N T C O N N E C T I O N • 43, 53, 65, 77, 1 39 , 1 49,
O XYG E N R I C H ENVI R O N M E N T • 1 01 , 31 3, 31 7, 3 1 9, 1 53, 1 57, 1 71 , 1 91 , 1 97, 1 99, 205, 4 1 1 , 41 3,
321 , 323, 343 , 437 , 565, 567, 569, 601 41 7, 4 1 9, 421 , 423, 439, 453, 461 , 469, 477,
Definition • 65 479, 501 ' 507 , 51 1 ' 51 3, 51 7
D E F I B R I LLAT I O N - P R OO F A P P L I E D PART • 1 53 '
p 1 55, 491
Definition • 65
43, 5 1 , 59, 61 , 65, 77,
PA T I E N T • 79, 83, 1 1 1 ,
Energ y red uction test • 1 57
1 1 7, 271 ' 295 , 359, 375, 401 ' 403, 405, 407,
F- TYPE A P P L I E D PART • 1 5 1 , 1 73, 483, 505 ,
41 1 , 423, 427 , 433, 435, 443, 449, 453, 493,
523, 525
501 , 505, 537 , 543, 597, 605, 659
Multiple • 1 99 , 51 7
Ad ult h u m a n • 295
S i n g l e • 1 99 , 5 1 7
A P P L I E D PARTS i ntended to s u p p l y heat to •
T Y P E B A P P L I E D PART • 1 97 , 443, 483, 51 5
307 T Y P E BF A P P L I E D PART • 443 ' 51 5
A P P L I E D PARTS not i ntended to supply heat to T Y P E CF APP L I E D PART • 443 , 469, 505
• 307 W O R K I N G VOLTAGE • 1 5 1
Cable · 1 09, 1 93, 395 , 4 1 3, 41 7, 423, 461 , P A T I E N T ENVI R O N M E N T • 387, 389, 391 , 393 , 395 ,
491 , 5 1 3
439, 601 , 603, 605 , 607, 609, 71 3
C i rcuit · 41 3, 4 1 5
Definition • 65
Condition • 51 1 P A T I E N T LEAKA G E C U R R E N T • 57, 1 71 , 1 73, 1 99,
Contact with • 83, 1 29 , 1 39 , 1 49, 1 95, 1 97,
41 3, 4 1 7, 439, 501 , 503
1 99, 269, 307 ,391 , 405, 41 1 , 41 3, 41 7,
Definition • 65
41 9, 425, 437 ,439 , 449, 471 , 475, 477,
L i m it · 53, 77 , 1 39, 1 49 , 1 65, 505, 5 1 3 , 5 1 5 ,
479, 481 , 485 ,493 , 499, 501 , 505, 51 3,
51 7
51 7, 525, 539 ,565 , 599, 625, 71 3 M E SYSTEM • 393, 605
Current flowing in • 65, 439, 443, 487, 51 7
Measurement • 1 73, 1 97, 1 99, 5 1 3 , 5 1 7
Defi b r i l lation of • 1 53 , 461 , 491 M U L T I P L E SOC KET - OU T L E T • 393
Definition • 65
Total · 1 7 1 , 1 73, 1 99 , 393, 505, 507 , 605
Disconnection from • 1 99 5 1 7
:
Earthing of · 65, 1 5 1 , 43 sl , 485 , 505, 525
T Y P E B A P P L I E D PART • 483
T Y P E B F A P P L I E D PART • 507 ' 51 5
Electric shock to • 59 457 T Y P E CF APP L I E D PART • 443 503
Expected position of ; 1 27 , 1 29, 283
Value · 1 67 , 1 69, 1 73, 503 507
Exposure to hazard o u s m aterials • 1 27 P EAK W O R K I N G VOLTAG E • 201 , 207, 209, 21 7,
Exposure to toxic gases • 321
221 , 229, 431 , 441 , 445
Heart • 51 , 425, 469 , 603
Definition • 65
Home use • 69, 435
I nterpolation • 21 5
I ncorrect d e l i very of energy or substances · PEMS
335, 575
See P R O G R A M M A B L E E L E CT R I CAL M E D I CAL
Lead · 1 49 , 1 53, 369, 395 , 4 1 3 , 485
SYSTEM • 67
Mass of • 295, 555 , 621 , 625
PEMS DEVELO P M E NT L I F E-CYC L E • 351 , 353, 581 ,
Moving of • 261 , 297
585, 591 , 687 , 693 , 697
Moving parts • 261 , 263 , 271
Definition • 65
N u m ber of APPLIED PARTS • 505 P E M S VA L I DA T I ON • 65, 591 , 693
P A T I E N T ENVI R O N M ENT • 65
Definition • 67
Release of • 271 , 541
R I S K to • 427, 509, 629, 705 , 709
Plan • 353, 357, 581
Results • 357, 359
Sensitivity to acoustic energy • 545
Team • 357, 359
Sensitivity to acoustic energy and vi b ration •
P E R MA N E N T L Y I N STAL L E D
281 , 283
Definition • 67
Sensitivity to vibration • 283 ' 545 ME EQUIPMENT . 1 05, 1 07, 1 1 5 , 1 33, 1 37 ,
Special needs • 269, 575
1 57, 1 63, 1 69 , 1 93, 247, 255, 257, 467,
Support • 275, 295, 297 , 301 , 41 3, 439, 455,
535
475, 537, 551 M E D I CAL E L E C T R I CAL E Q U I P M E NT • 1 1 5
Support of • 559
Non- • 247, 393
Transfer of energy • 1 39 , 477 P ESS
U n i ntended voltage on • 275, 295, 297 , 301 ,
See P R O G R A M M A B L E E L E CT R O N I C S U BSYSTEM •
41 3, 439, 455 , 475, 537, 551
67
U nwanted or excessive rad iation • 335 561
1 39, 1 67, 1 7 1 ,
P A T I E N T AU XIL IARY CURRENT •
Pollution d e g re e classification • 217
P ORTABLE
1 93, 1 99, 4 1 3 , 4 1 7 , 437, 439, 505, 51 7, 61 5,
Definition • 67
649
E q u i p m e nt • 77
6060 1 - 1 © I EC : 20 0 5 - 765 -
ME E Q U I P M ENT • 279, 281 ' 361 ' 365, 379 , 593 Thermoform i ng • 595
ME E Q U I P M ENT part • 365 USAB I L I TY E N G I N E E R I N G • 1 0 1 , 333, 445, 573
POTENTIAL EQUALIZAT I O N CONDUCTOR • 1 2 1 , 1 65, VERI FICAT I O N • 79, 583
497, 621 , 625 PROGRAMMABLE E LECT R I CAL M E D I CAL SYSTEM
Definition • 67 (PEMS) • 67, 1 05, 351 , 353, 355, 357 , 359,
POWER SUPPLY CORD • 57, 251 , 253, 533, 535, 405, 577, 763
565, 609 PROG RAM MAB LE E LECT R O N I C SUBSYSTEM (PESS) •
C l a m p i ng means · 1 6 1 67, 351 , 355, 763
CLASS I I ME E Q U I P M ENT • 1 67 Definition • 67
Colour of cond uctors • 1 23, 429 PROPERLY I NSTALLED • 1 1 1 , 261
Cond uctors • 251 , 253 Definition • 69
Cord anchorage • 251 , 253 PROTECTIVE EARTH CONDUCTOR • 51 , 57, 67, 69,
Cord con nectio n • 245, 255, 663 77, 1 2 1 , 1 37, 1 57, 1 61 , 1 63 , 1 91 , 1 95 , 251 ,
Cord g ua rd • 253 255, 257, 393, 397, 435, 451 , 463, 501 , 533,
Cross-sectional area of cond uctors • 249 , 603, 609, 71 5
259 Definition • 69
Definition • 67 ME SYSTEM • 399
I ncorporating switches · 247 Non-PERMAN E NTLY I NSTALLED • 393
I nsulation of · 251 PROTECTIVE EARTH CONNECTION • 61 , 1 37 , 1 45,
MAI NS PLUG • 249 1 47, 1 61 , 1 63 , 1 65, 1 67, 397, 433, 435, 471 ,
MULTIPLE SOCKET -OUTLET • 397, 435 473, 485, 491 , 493, 495, 497, 51 3, 5 1 7, 521 ,
Neutral cond ucto r • 1 2 1 529, 535, 571 , 607, 721
POTENTIAL EQUALIZAT I O N CONDUCTOR • 1 65 Colour of · 1 2 1
PROTECTIVE EARTH CONDUCTOR • 1 6 1 Definition • 69
Replaceable • 1 33, 257 ME SYSTEM • 399
Sheathing • 249 PROTECTIVE EARTH T E R M I NAL • 69, 1 1 5 , 1 61 , 1 63,
Stra i n relief · 251 1 9 1 , 255, 397 , 479 , 493
Testing with · 1 93 , 237 , 273 Definition • 69
PROCEDURE • 71 , 479, 501 , 567, 579, 585 , 589 , PROTECTIVELY EARTHED • 49, 77, 1 49 , 1 53, 1 57,
695 1 63, 1 65, 1 91 ' 1 95 , 21 9, 443, 479, 485, 493,
Cleaning • 331 , 391 605, 607
Definition • 67 Definition • 69
Docu m e nt control • 353 Non- • 1 67, 1 73 , 1 95, 1 97 , 251 , 443, 471 ,
Energ y reductio n test • 1 57 491
LEAKAGE CURRENT measure m ent • 1 73
M a i ntena nce • 501 R
Measuring X-radiation • 561
RATED
Mod ificati o n/change • 359
Altitude • 21 5
RISK CONTROL • 355
CATEGORY AP • 569
RISK MANAG E M E NT • 445
CATEGORY APG • 569
Shutdown • 1 29
Characterist i cs • 247
Start-up • 1 29, 41 1
Components • 397
Ster i l ization • 203 , 331
Current • 1 33 , 1 63, 251 , 383
Test · 1 95, 303, 329, 331 , 491 , 523 , 741
Definition • 69
Thermal cyc l i ng • 235
DUTY CYCLE • 347
PROCESS • 43, 55, 81
F i re protect i o n d evice • 373
Assessm e nt of APPLIED PARTS • 41 1
Frequency • 93, 1 67, 381 , 385, 523, 597
Cleaning • 625
I nput · 89
Cleaning or disi nfection • 331
I nput power · 89, 1 07
Definition • 67
I P Classificat ion · 455
Desi g n • 445
Load • 289
H a n d l i n g of PAT I E N T • 297
MAINS VOLTAGE • 21 7, 229, 303 , 487, 489
Manufacturing • 1 65, 291 , 451 , 575
Ma rked · 1 09
PEMS DEVELOPMENT LI FE-CYCLE • 351 , 353,
Maxi m u m s u p p l y pressure • 285
577, 579, 581 , 583, 585, 587, 687, 693,
Non-CONT I NUOUS OPERATION • 345, 347 , 351
697
On and off p eriods • 31 1 , 393
PEMS VAL I DATION • 67
Operating t i m e • 347
R I S K ASSESSMENT • 71
Operation • 425, 457, 577
R I S K CONTROL • 71
Output cu rrent or power • 1 09
RISK MANAG E M E NT • 71 , 77, 79, 81 , 83, 85,
Output powe r · 397 , 399
95, 1 23, 1 37, 1 39, 1 45 , 1 51 ' 1 53, 283,
Output vo lta g e • 1 09
303, 305, 309 , 321 , 329, 331 , 333, 335,
Phase to neutral supply voltage • 1 51
337, 341 , 351 , 353, 359, 375, 379, 399,
Pressure • 1 1 1
403, 4 1 1 , 4 1 5 , 427, 429, 445, 447, 449,
Protect i o n agai nst particulate m atter • 571
453, 463, 475 , 543, 545, 565, 571 , 579,
Supply fre q u e ncy • 1 07
593, 595, 6 1 3 , 695
6060 1 - 1 © I EC : 20 0 5 - 767 -
S u p p l y freque ncy ra nge • 1 07 Disconnection • 535

S u p p l y voltage • 93, 1 07, 1 5 1 , 347, 393, Disposal • 1 3 1
489, 5 1 1 ' 51 3 Earthing the PAT I E N T • 483
S u p p l y voltage range • 1 07 Electric shock • 61
Tem perature • 249 Electric shock to others than the PAT I E N T · 59
Total W O R K I N G VOLTAG E • 1 45, 1 47 Electric shock to PAT I E NT · 59
Voltage • 89, 93, 1 31 , 1 43, 1 51 , 309, 343, Electromag netic compat i b i l ity · 399
349, 351 , 381 , 385 , 483 Equ ivalent safety • 83
Voltage (maxi m u m ) • 31 1 Expelled parts • 281
Voltage ( m i n i m u m ) • 31 1 Explanation • 391
Voltage ra nge • 1 07 , 1 51 , 351 F a i l u re of com ponent • 85
Reasonably foreseeable m i suse • 49, 79, 85, Fault · 535
261 , 263, 269 , 31 3, 357, 401 , 445, 457, 577, F l a m m able a gent • 569
593, 595 H I G H VOLTAG E • 463
R ECO RD • 71 , 351 , 445, 593 , 697 I dentified • 355
Definition • 69 I g nition • 323
R E I N FO R C E D I NS U LATION • 49, 83, 85, 201 , 203, I ncorrect d e l i very of energy or substances ·
21 1 , 2 1 3, 277 , 361 , 425, 441 , 469, 471 , 479, 335
481 , 5 1 7, 521 , 525, 535, 607, 737, 739, 741 I nco rrect o ut put • 335
Definition • 69 I nfra- and ultrasound • 283
Removable protective means • 1 1 3 I nfrared rad i ation • 305
R ESI DUAL R I S K I nitial m ovem ent • 279
Accept a b i l ity of · 81 , 427, 481 , 493, 537, I nsulation b re akdown • 453, 481
601 I ntentional exceeding of safety l i m its • 333
Definition • 69 Mechanical rupture • 549
Equ ivalent safety • 447 Microwave ra d iation • 303
I d e ntifi a b l e safety req uirements • 585 Mitigation • 693
I nd ication of · 273, 539 Mix-up • 593, 595
J u stificati o n of · 83 M o u l d i ng and mechanical stress • 361
Moving parts • 261 Moving part • 537
of fire • 321 Moving parts • 261
SERVICE PERSONNEL • 437 Multiple PAT I E N T C O N N EC T I O N S • 51 1 , 51 7
System i ntegrator • 701 New · 359
• 41 , 59, 73, 1 23,
R E S P O N S I B L E ORGAN IZAT I O N of accum ulat i o n and ig nition • 371
1 25, 1 31 ' 1 33 , 1 41 ' 359, 387, 389, 391 ' 393, of contact • 485
447, 455, 461 , 463, 499, 561 , 563, 567, 601 , of exp losion 657 •
605, 609, 661 , 701 , 703, 705, 707, 709 of fire • 3 1 3 , 533
Definition • 69 Overbala nci n g • 275, 621
H o m e use · 69 Overtravel • 269
I nstructions for use • 1 25 Particular · 8 1
Period ic i nspect i o n and m a i ntenance • 595 P A T I E N T ENVI R O N M E N T • 603
RISK P A T I E N T support • 295
Accepta b i l ity of · 81 PEMS • 581
Acceptab l e • 61 , 7 1 , 8 1 , 83, 269 , 271 , 355, PEMS Problem reso l ution • 353
429, 447, 579 , 593 Poor USAB I L I T Y • 1 0 1 , 333
Accepta ble levels • 81 Pre-set controls • 375
Accidental d isconnection • 1 65 Previ o usly u n i d e ntified • 359
Accidental selection of excessive output Radiotherapy • 335
values · 335 Reci p rocal i nterference • 1 25
Accuracy of contro ls and i nstrum ents • 333 Reduction • 73, 83, 549, 585
Alarm systems as a means of a d d ressing • Replacem ent of lithium batteries or fue l cells
333 • 113
Al p h a , beta, g a m m a and neutron rad iation • Safety sign • 1 1 9
303 Servicing • 437
Arrangement of controls and i n d i cators • 359 Sharp edge • 541
Burn • 477, 499 , 51 1 to PAT I E N T • 4 1 1 , 427, 449, 487, 505 , 509
Compat i b i l ity with substances · 333 to PAT I E N T o r O P E RATOR • 629
C O M P O N E N T W I T H H I G H- I N T E G R ITY TY P E B A P P L I E D P A R T • 1 49
CHARACT E R I ST I CS • 587 Ultraviolet rad iation • 305
Conseq uent • 585 U naccepta b l e • 49, 5 1 , 73, 81 , 85, 1 05, 1 1 1 ,
Control • 693 1 1 7, 1 27, 1 35 , 1 37, 1 51 ' 21 1 ' 243, 263,
Definition • 71 267, 269, 271 , 275, 277, 279, 281 , 285,
Diagnostic or therapeutic acoustic pressure • 287, 289, 291 , 293, 297, 299, 31 3, 329,
337 331 , 341 , 351 , 359, 361 , 363, 365, 367,
Diagnostic or therapeutic rad iation • 337 369 , 371 , 373, 377, 379, 387, 427 , 449,
Diagnostic X-rays • 335
6060 1 - 1 © I EC : 2 0 05 - 769 -
459, 541 , 543 , 545 , 555, 575, 593, 601 , Alternative m eans of co m p l iance • 323
709 Alternative m ethods of t e m p e rature
U ncontro l lable • 707 m easurem ent · 31 3
U n i ntended X-rad iation • 303 Cleani ng/d i s i nfect i o n • 331
U SAB I L I TY E N G I N E E R I N G • 573 Contents of · 357 , 445 , 529, 531 , 571 , 579,
Ventricular fi bril lation • 499, 503 581 , 593
Vibration • 545 Definition • 7 1
Visi b l e electro mag netic rad iation • 303 Docu m e nts p rod uced by a p p l ication o f
R I S K ANALY S I S Clause 1 4 • 351
C O M P O N ENTS W I T H H I G H - I NT E G R ITY Equ ivalent safety • 447
CHARACT E R I ST I CS • 451 E XPECTED S E R V I C E L I FE • 81
Definition • 71 Fuses and OVER-CU R R E N T R E L EASES • 259
Identification of fai l ures • 573 I nspection · 8 1 , 83, 87, 99, 1 41 , 1 49, 1 63,
I nterruption of any one power-carrying 21 1 , 243, 245, 259, 267, 269, 271 , 277,
cond uctor • 1 37 281 , 283, 285, 287, 289, 291 , 293, 295,
Least favo u rable working conditions • 9 1 297, 299, 301 , 303, 305, 309, 321 , 329,
P E M S DEVE L O P M E N T L I FE-CYC L E • 579 331 , 333, 335, 337, 341 , 35 1 , 359, 363,
Results of · 85, 9 1 365, 367, 369, 371 , 373, 375, 379, 399,
Revision of · 9 1 447
R I S K ASS E S S M E N T • 71 Methods of P E M S VALDAT I O N • 359
R I S K EVALUATION • 71 Om ission of OV E R -C U R R E N T R E LEASES • 373
Second fault • 451 Proba b i l ity and d urat i o n of contact • 309
Shorting of gaps • 575 Professional relationships of P E M S VA L I DA T I ON
S I N G L E FAU L T C O N D I T I O N • 507 TEAM m e m bers • 359
Software • 695 Tem perature l i m its • 307
Sup port system • 291 Tem perature test corner · 309
T O U C H C U R R E N T • 501 Worst case l i m its of oxyg en concentration of
R I S K ASS E S S M E N T fla m m able fue l s · 31 5
Definition • 71
H A N D- H E L D A P P L I E D P A R T S • 593 s
P E M S DEVE L O P M E N T L I FE-CYC L E • 579, 581 , S A FE W O R K I N G LOAD • 75, 277, 279, 295, 297,
587, 693
301 , 363, 365, 625
Source of ignition • 321
R I S K CO N TR OL
Definition • 7 1
Safety sign · 1 03 , 1 05 , 1 09 , 1 1 1 , 1 1 3, 1 1 9,
Alarm systems as means of · 333
1 2 1 ' 1 25, 1 33 , 275, 301 ' 397, 459, 463, 621 '
Definition • 71
629, 633, 641 , 643
Measure • 81 , 351 , 355, 357, 453, 459 , 579, S E C ON DARY C I R C U I T • 207, 2 1 9, 221 , 231 , 441 ,
583, 585, 587 , 589 , 693, 695
P E M S DEVE L O P M E N T L I FE-CYC L E • 355, 579
471 ' 5 1 1 ' 523
R I S K EVALUATION
Definition • 7 1
S E L F - R E S E T T I N G T H E R MAL CUT-OUT • 371
Definition • 71
Definition • 73
R I S K ASS E S S M E N T • 71
R I S K MANAG E M E NT
Non- • 347, 369, 683
S EPARAT I O N D E V I C E • 391 , 393, 441 , 603, 605,
Activities • 353
71 9, 721
Application of · 403, 4 1 3, 4 1 7, 4 1 9 , 421 ,
Definition • 73
423, 445, 507 , 601 S E R V I C E P E R S O N N E L • 75, 9 1 , 1 05 , 1 1 3, 1 31 ,
Contents of • 71
1 33, 1 35, 1 39 , 1 65, 255, 301 ' 437, 455, 463,
Definition • 71
467, 531 , 533, 535, 597, 625
Methods • 387 , 601
P E M S DEVE L O P M E N T L I FE-CYC L E • 351 , 579,
Definition • 73
Qual ificatio n of · 1 33
693
Roug h surfaces, corners and edges · 541
Plan • 353, 581
P ROCESS • 43, 7 1 , 77, 79, 8 1 , 83, 85, 95,
S p u rious X-rad iation • 303
Servicing • 361 , 437 , 533, 539, 703
1 23, 1 37, 1 39 , 1 45, 1 5 1 ' 1 53, 283, 303, S EVE R I TY • 71 , 427, 429, 449, 491 , 545
305, 309, 321 , 329, 331 , 333, 335, 337,
Definition • 73
341 , 351 , 353 , 359, 375, 379, 399, 403, S I G NAL I N P U T/ O U T P U T PART • 1 27, 1 35, 1 53, 1 71 ,
41 1 , 4 1 5, 427 , 429, 445, 447, 449, 453,
1 83, 1 91 ' 1 97 , 205, 443, 491 ' 51 5, 605, 71 9,
463, 475, 543 , 545, 565, 571 , 579, 595,
733, 763
61 3, 695
Definition • 73
Report • 591 S I N G L E FAU L T C O N D I T I O N • 49, 61 , 65, 73, 81 , 83,
Resu lts of · 583
S I N G L E FAU L T C O N D I T I O N • 85
85, 1 35, 1 41 , 1 43, 1 47 , 1 65 , 1 67, 1 69, 1 71 ,
1 73, 1 75, 1 77 , 1 79, 1 83, 1 87, 1 9 1 , 1 95, 243,
Sup port systems • 555
267, 269, 285, 31 3, 321 , 323, 331 , 337, 339,
System i ntegration • 703
341 , 343, 381 , 401 , 435, 449, 467, 469, 471 ,
Tem perature l i m its • 565
R I S K MANAG E M E NT F I L E
473 , 479, 491 , 497, 499, 501 , 503 , 505, 507,
6060 1 - 1 © I EC : 20 0 5 - 771 -
51 5, 529, 549 , 551 , 559, 565, 567, 569, 571 , TOOL • 41 , 53, 67, 75, 95, 99, 1 03, 1 1 1 , 1 1 3 ,
575, 577, 607 , 609, 659, 675, 677, 731 1 37, 1 39, 1 41 , 1 43, 1 6 1 , 1 65, 243, 255, 263,
Definition • 73 267, 289, 299, 303, 31 3, 369, 375, 391 , 395,
S I N G L E FAULT SAFE • 83, 341 , 449, 567 397, 399, 455, 477, 539, 593, 597, 609, 663,
Definition • 73 667, 721
SI P/SOP Definition • 75
See S I G NAL I N PUT/OUTPUT PART • 73 TOTAL LOAD • 75 , 291 , 293, 297, 553
STAT IONARY Definition • 75
Definition • 73 TOUCH CURRENT • 57, 1 71 , 477, 501 , 503, 607,
E q u i p m e nt • 539 71 7, 721
ME E Q U I P M ENT • 1 03, 253, 279, 325, 361 Definition • 77
SUPPLEM ENTARY I N S U LATION • 51 , 201 , 203, 21 1 , L i m it · 1 39, 1 65, 393, 443, 473, 605 , 7 1 3,
21 3, 277, 361 , 425 , 433, 479, 521 , 737, 739, 71 5
741 Measurement • 1 73, 1 77, 1 95, 51 3
Definition • 73 M U LT I P L E SOC KET -OUTLET • 393, 605
S U P P LY MAINS • 57, 59, 61 , 63, 67, 87, 89, 1 0 1 , S I N G L E FAULT CONDITION • 435, 609
1 07, 1 27, 1 33 , 1 35, 1 37, 1 57, 1 65, 1 91 , 1 93, Value • 1 67 , 1 69, 607
201 , 2 1 9, 259 , 273, 385, 391 , 393, 395, 431 , Transport and storage
433, 435, 443 , 457, 463, 485, 487, 491 , 51 1 , Conditions • 1 1 1 , 1 33 , 367, 391 , 465, 467
523, 651 Covers used during • 93
a.c. • 93, 21 9, 489 Data for • 1 3 1
Apparent i m pedance of · 1 33, 467 Protective packag ing • 1 1 1
Characte ristics of · 89, 499 TRANSPORTABLE
d . c . • 93, 1 37, 489 Definition • 77
Definition • 75 E q u i p m e nt • 6 1 , 67
I nterruption of · 333 , 571 , 6 1 5 ME E Q U I P M E N T • 1 03, 279, 325, 329
I solation from • 1 33, 247 , 465, 467 , 531 TRAP P I N G ZONE • 261 , 263, 267 , 541
Overvoltage category • 21 9, 523 Definition • 77
Polyp hase • 1 51 , 247 , 351 , 653 TYPE B A P P L I E D PART • 77, 1 49 , 1 97, 1 99, 443,
Sing le-p hase · 1 5 1 475, 485, 51 5 , 5 1 7 , 733
Socket-outlet • 53 Classification • 77, 1 0 1 , 1 39 , 475, 499
Switch · 247 D E F I B R I LLATIO N-PROOF sym bol • 639
Symbol • 77, 1 05 , 1 07, 1 09, 1 1 1 , 1 1 3, 1 1 5, Definition • 77
1 1 7, 1 1 9, 1 21 , 1 25 , 1 29, 1 43, 1 65, 249, 271 , Marking of · 77, 1 09
463, 5 1 1 , 621 , 623 , 629, 661 Measurement • 1 89
PAT I E N T LEAKAGE CURRENT • 503
T Symbol · 637
Tech nical description • 59, 89, 9 1 , 95, 1 1 5,
TYPE BF APPLIED PART • 77, 1 97 , 1 99, 443, 475,
1 23, 1 25, 1 27, 1 3 1 ' 1 33 , 1 43 , 1 67, 247, 359 ,
485, 505, 51 5 , 5 1 7 , 735
437, 627, 701
Classification • 53, 77, 1 0 1 , 1 39, 1 49, 475,
Am bient tem peratu re • 21 1
499
I nspectio n · 1 43, 379
D E F I B R I LLATIO N-PROOF sym bol • 639
I nsta l lation i nstructions · 309
Definition • 77
Operating te m perature • 305, 3 1 3
Marking of · 77, 1 09
TEN S I L E SAFETY FACTOR • 83, 85, 291 , 293, 297,
M EAS U R E M E N T • 1 89
301 , 549, 551 , 553 , 555, 559
PAT I E N T LEAKAGE CURRENT • 503, 505
Definition • 75
Symbol · 637
TEN S I L E STRENGTH • 75, 293
Definition • 75
TYPE CF APP L I E D PART • 1 37, 1 73, 1 99, 443 , 469 ,
TER M I NAL DEVICE
475, 485, 501 , 503, 51 5, 51 7
Definition • 75
Classification • 53, 1 01 , 1 39 , 1 49, 475 , 499
H I G H -VOLTAGE • 1 1 1 , 463
D E F I B R I LLATIO N-PROOF sym bol • 639
MAI NS T E R M I NAL DEVICE • 57
Definition • 77
THER MAL CUT -OUT • 1 1 3, 305 , 3 1 3 , 339, 343 ,
Marking of · 77, 1 09
347, 369, 371 , 463
M EAS U R E M E N T • 1 89
Definition • 75
PAT I E N T LEAKAGE CURRENT • 505
Manual reset • 371
Symbol · 637
SELF-RESETTING T H E R MAL CUT-OUT • 73
Total PAT I E N T LEAKAG E C U R R ENT • 505, 507
THER MAL STABI LITY • 31 1 , 343, 347, 349 , 351 ,
TYPE TEST • 91 , 203, 453, 737
381 , 383, 393
COMPONENTS WITH H I G H - I NTEGR ITY
Definition • 75
CHARACT E R I STICS • 451
THER MOSTAT • 345 , 371 , 623
Definition • 79
Definition • 75
Samples · 91 , 455
F a i l u re of · 339, 341 , 369
6060 1 - 1 © I EC : 2005 - 773 -
Results • 357, 583

u R I S K CONTROLmeasures • 589
Strategies • 357, 693 , 695
U SAB I L I TY • 79, 1 01 , 333, 405, 457, 573, 61 3
Tools • 357 , 589, 593
Definition • 79
w
U SAB I L I TY E N G I N E E R I N G • 1 0 1 , 333, 445, 573
Definition • 79
Warning • 1 03, 1 1 1 , 1 1 3, 1 1 9, 1 23 , 1 25, 1 27,
v 1 29, 1 33, 1 35 , 249 , 261 , 273, 275, 285, 389,
459, 461 , 463, 533 , 539, 543, 603, 605, 621 ,
V E R I F ICAT I O N
625, 629, 641 , 693 , 703
Coverage criteria • 357, 5 7 9 , 583 , 5 8 5 , 587
WORKING VOLTAGE • 65, 1 45, 1 47, 1 49, 1 51 ,
Defi nition • 79
1 53, 201 , 205, 221 , 223, 225, 227, 231 , 233,
Methods • 353
385, 387, 391 , 431 , 441 , 445, 471 , 481 , 489,
M i lestones • 357
523, 525, 527, 729
of Markings • 61 9
P E M S • 357, 687
Definition • 79
I nterpolation • 21 5, 527
Plan • 357, 589
Polymer properties • 595
6060 1 - 1 © I EC : 20 0 5 - 775 -
I N D EX O F A B B R EVIATI O N S AN D ACRO NYMS
Abbreviation Term
a.c. Alternating c u rrent
AMSO Auxiliary mains socket-outlet
AP Anaesthetic-proof
A PG Anaesthetic-proof category G (gas)

CASE Com puter aided software engineering
CAT Com puter assisted tomo graphy
CRT Cathode ray tube
CTI Comparative tracking index
d.c. Direct c u rrent
DICOM Digital i m aging and c o m m u nication i n medicine
E LV Extra-low voltage
EUT E q u i p m ent u nder test
FDDI F i bre distributed data interface
F M EA F a i l u re modes a n d effects ana lysis
HL7 Health Level 7
ICRP I nternational c o m m ission f o r radiation protection
l EV I nternational E lectrotechnical Vocabulary
IP I nternational protection i n relation t o the protection req u i re m e nts o f I E C 60529 o r I nternet

protocol in re lation to N ETWORK/DATA COU P L I N G
IT I nformation technology
LDAP Light weight d i rectory access protocol
LED L i g h t e m itting d i o d e
MAR Minimum angle resolvable
MD Measuring device, s e e 8 . 7 . 4 . 4
ME M ED I CAL ELECTRICAL, see 3 . 63 and 3 . 64
M OO P MEANS OF OPERATOR PROTECT I O N , see 3 . 58
MOP M EA N S OF PROTECT I O N , see 3 . 60
MOPP M EA N S OF PATI ENT PROTECTI O N , see 3 . 59
MPSO M u ltiple portable socket-outlet
M SO M U LT I P L E SOCKET-OUTLET, see 3.67
OTS Off the shelf
PEMS PROGRA M M A B L E E L ECTRICAL M E DICAL SYST E M , see 3 . 90
PESS PROGRA M M A B L E E L ECTRO N I C SU BSYSTE M , see 3 . 9 1
PTC Positive tem perature coeffic i e nt device
r.m.s. Root m e a n square
S E LV S afety extra-low voltage
Sl System international
S I P/SOP SIGNAL I N PUT/OUTPUT PART, see 3 . 1 1 5 .

6060 1 - 1 © I EC : 20 0 5 - 777 -
Abbreviation Term
TCP Tra nsport con nection protocol
TENS Transcuta neous electro n i c nerve stim ulator
UPS U n i nterruptible power supply
VDU Video d isplay u n it

I SBN 2-831 8-8400-4
9 782831 884004
ICS 1 1 .040
Typeset and printed by the I EC Central Office

GE NEVA, SWITZERLAND
Corrigendum to EN 6060 1 - 1 :2006
English version
Foreword
Add a DOW of 201 2-06-0 1 .
Delete the sentences:
However, EN 6060 1 - 1 : 1 990 remai ns valid u ntil all the parts 2 that are used in conj u nction with it have been
withdrawn. No date of withdrawal of confl i cti ng national standards (dow) has therefore been fixed. However,
when Part 1 is used for appliances not covered by a part 2, EN 6060 1 - 1 : 1 990 is not to be used after 2009-09-
1 2.
March 20 1 0
EUROPEAN STANDARD EN 60601-1/A11
NORME EUROPEENNE
EUROPAISCHE NORM October 201 1
ICS 1 1 .040
English version
Medical electrical equipment -

Part 1: General requirements for basic safety and essential performance
Appareils electromedicaux - Medizinische elektrische Gerate -

Partie 1 : Exigences generales pour Ia Teil 1 : Allgemeine Festlegungen fU r d ie
secu rite de base et les performances Sicherheit einschliel11ich der wesentlichen
essentielles Leistungsmerkmale
This amendment A1 1 modifies the European Standard EN 60601 -1 :2006; it was approved by CENELEC on
201 1 -1 0-01 . CENELEC members are bound to comply with the CEN/CENELEC I nternal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CEN ELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CENELEC member into its own language and notified to the
CEN-CENELEC Management Centre has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotech nical Standardization
Cornite Europeen de Normalisation Electrotechnique
Eu ropaisches Kornitee fUr Elektrotechnische Norrn ung
Management Centre: Avenue Marnix 1 7, B - 1 000 Brussels
© 201 1 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601 - 1 :2006/A1 1 :201 1 E

EVS-EN 6060 1 - 1 :2006/A1 1 :201 1 -2 -
F o reword
This docum ent (EN 6060 1 -1 :2006/A1 1 :201 1 ) has been prepared by CLC/TC 62 " Electrical equipm ent
in m edical practice".
The followi ng dates are fixed:
• l atest date by which this document has (dop) 201 2-1 0-0 1
to be i m plemented at national l evel by
publicati on of an identical national
standard or by endorsement
• l atest date by which the national (dow) 201 4-1 0-0 1
standards confl i cti ng with this
docu m ent have to be withdrawn
Attention is drawn t o t h e possi bi lity that s o m e o f t h e elements o f this docum e nt m ay b e t h e s u bject of

patent rights. CEN ELEC [and/or CEN] shall not be held responsi bl e for identifyi ng any or all such
patent rights.
- 3 - EVS-EN 6060 1 - 1 :2006/A1 1 :201 1
Replace Annex ZZ of EN 60601-1 :2006 by:
Annex ZZA
(informative)
Coverage of Esse ntial Req u i rements of EC Directives
relevant essential requirements as given i n Annex I of the EC Di rective 93/42/EEC except the
followi ng:
Essential Requi rement 6a
Essential Requi rement 7.4
Essential Requi rement 7.5 paragraph 2 & 3
Essential Requi rement 1 3.6 (q)
Annex ZZB
(informative)
Coverage of Esse ntial Req u i rements of EC Directives
relevant essential requirem ents as given in Annex I of the EC Directive 90/385/EEC except the
followi ng:
Essential Requi rement 5a
Essential Requi rement 7
Essential Requi rement 8 bullet 5
Essential Requi rement 1 0
[Blank page]
Aru 1 0
1 03 1 7 Tallinn
Eesti
standard @evs.ee
www.evs.ee
EES T/ S TANDARDIKESKUS
ESTONIA N CENTRE FOR STANDARDISA TION
£i'C

IEC 60601-1 2006 (Original) PDF

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

IEC 60601-1 2006 (Original) PDF

Uploaded by

Copyright:

Available Formats

Elektrilised meditsiiniseadmed.

Osa 1: Oldised nouded

Medical electrical equipment - Part 1: General

Euroopa standard imisorganisatsioonid on teinud Date of Availability of the European standard is

Standardite reprodutseerimise ja levitamise iii gus kuulub Eesti Standardikeskusele

ICS 1 1 .040 Supersedes EN 60601-1 : 1 990 + amendments

Medical electrical equipment

Appareils electromedicaux Medizinische elektrische Gerate

Central Secretariat: rue de Stassart 35, B 1 050 Brussels

Ref. No. EN 60601-1 :2006 E

T h e followi ng date was fixed:

- latest date by which the EN has to be i m plem ented

I n this standard the foll owi ng print types are used:

requirements and defi nitions: i n rom an type;

test specifications: in italic type;

I n referri ng to the structure of this standard, the term

Annexes ZA and ZZ have been added by CEN ELEC.

I E C 60073 NOTE Harmonized as EN 60073:2002 (not m odified) .

I E C 60086-1 NOTE Harmonized as E N 60086- 1 :2001 (not mod ified).

IEC 60309-1 NOTE Harmonized as E N 60309- 1 : 1 999 (not mod ified).

IEC 60601 - 1 - 1 NOTE Harmonized as E N 6060 1 - 1 - 1 : 2001 (not modified) .

I E C 6060 1 - 1 -4 NOTE Harmonized as E N 6060 1 - 1 -4 : 1 996 + A 1 : 1 999 (not modified) .

I EC 60601 -2-49 NOTE Harmonized as EN 6060 1 -2-49:2001 (not modified) .

I E C 60695- 1 - 1 NOTE Harmonized as E N 60695- 1 - 1 : 2000 (not modified) .

I E C 60721 series NOTE Harmonized i n E N 6072 1 series (not modified) .

I E C 60990 NOTE Harmonized as E N 6099 0 : 1 999 (not m odified) .

I E C 6 1 000-4- 1 1 NOTE Harmonized as E N 6 1 000-4- 1 1 :2004 (not modified) .

I E C 6 1 0 1 0- 1 NOTE Harmonized as E N 6 1 0 1 0-1 :2001 (not mod ified).

IEC 6 1 1 40 NOTE Harmonized as E N 6 1 1 40: 2002 (not m odified) .

I E C 62 079 NOTE Harm o n i ze d as EN 62079:2001 (not modified) .

I E C 62304 NOTE Harmonized as EN 62304:2006 (not m odified) .

I S O 407 NOTE Harmonized as EN ISO 1 3407: 2004 (not modified).

ISO 8041 NOTE Harmonized as E N I S O 804 1 : 2 005 (not mod ified) .

I S O 1 3485 NOTE Harmonized as EN ISO 1 3485:2003 (not modified).

N ormative references to international publications

Publicatio n Year Title EN/H D Year

I EC 60068-2-2 1 974 Enviro n m e ntal testi ng EN 60068-2-2 1 993

I EC 60079-0 El ectrical apparatus for explosive gas EN 60079-0 2006

I EC 60079-2 El ectrical apparatus for explosive gas EN 60079-2 2004

I EC 60079-5 El ectrical apparatus for explosive gas

I EC 60079-6 El ectrical apparatus for explosive gas

I EC 60083 Plugs and socket-outlets for dom estic and

Publicatio n Year Title EN/H D Year

I EC 60227-1 1 993 Polyvinyl chl oride insulated cables of rated

I EC 60245-1 2003 Ru bber insulated cables - Rated voltages u p ­

I EC 60252-1 AC m otor capacitors EN 60252-1 2001

I EC 60320-1 Appli ance couplers for household a n d EN 60320-1 2001

I EC 60364-4-41 2005 Low-voltage el ectrical i nstallations HD 60364-4-4 1 2006

I EC 60384- 1 4 2005 Fixed capacitors for use in el ectronic EN 60384- 1 4 2005

I EC 604 1 7 Data Graphical sym bols for use on equipm ent

Publicatio n Year Title EN/H D Year

I EC 6060 1 - 1 -2 M edical electrical equ i pm ent EN 6060 1 - 1 -2 2001

I EC 6060 1 - 1 -3 M edical electrical equ i pm ent EN 6060 1 - 1 -3 1 994

I EC 6060 1 - 1 -6 M edical electrical equ i pm ent EN 6060 1 - 1 -6 2004

I EC 6060 1 - 1 -8 M edical electrical equ i pm ent EN 6060 1 - 1 -8 2004

I EC 60695- 1 1 - 1 0 Fire hazard testi ng EN 60695-1 1 -1 0 1 999

I EC 60825-1 1 993 Safety of laser products EN 60825-1 1 994

I EC 6085 1 -3 1 996 Wi nding wires - Test m ethods EN 6085 1 -3 1 996

I EC 6085 1 -5 1 996 Wi nding wires - Test m ethods EN 6085 1 -5 1 996

I EC 6085 1 -6 1 996 Wi nding wires - Test m ethods EN 6085 1 -6 1 996

I EC/TR 60878 2003 Graphical sym bols for electrical equipment -

I EC 6 1 558-2-1 Safety of power transformers, power su pply EN 6 1 558-2-1 1 997

I EC 6 1 965 M echanical safety of cathode ray tubes EN 6 1 965 2003

I EC 60245-1 2003 Ru bber insulated cables - Rated voltages u p