Iec 60601-2-57 - 2023

IEC
====·
IEC 60601-2-57
Ill
Edition 2.0 2023-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment -

Part 2-57: Particular requirements for the basic safety and essential performance
of non-laser light source equipment intended for therapeutic, diagnostic,
monitoring, cosmetic and aesthetic use
Appareils electromedicaux -
Partie 2-57: Exigences particulieres pour la securite de base et les performances
essentielles des appareils a source de lumiere non laser destines a des usages
therapeutiques, de diagnostic, de surveillance, cosmetiques et esthetiques
�
Ln
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IEC
=====·
IEC 60601-2- ®7
lil
Edition 2.0 2023-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE colour
inside
Medical electrical equipment -

Part 2-57: Particular requirements for the basic safety and essential
performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring, cosmetic and aesthetic use
Appareils electromedicaux -
Partie 2-57: Exigences particulieres pour la securite de base et les
performances essentielles des appareils a source de lumiere non laser destines
a des usages therapeutiques, de diagnostic, de surveillance, cosmetiques et
esthetiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11. 040.50, 11.040.60 ISBN 978-2-8322-7296-1
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agree.
® Registered trademark of the International Electrotechnical Commission

Marque deposee de la Commission Electrotechnique Internationale
-2- I E C 6060 1 -2-57: 2023 © I E C 2023
CONTENTS
F O R EWO R D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
I NT R O D U C T I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
201 . 1 Scope, o bject a n d re l ated sta ndards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
201 .2 Normative refe ren ces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
201 .3 Te rms a n d defi n itions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
201 .4 General requ i re m e n ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2
201 .5 General requ i re m e n ts for testing M E EQUI P M ENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
201 .6 Classification of M E EQUI P M ENT a n d M E SYSTE M S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
201 .7 M E EQUI P M ENT i d e ntification , m a rk i n g a n d docume nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3
201 .8 P rotection agai nst e l ectrical HAZARDS from M E EQUI P M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
201 .9 P rotection agai nst M ECHAN I CAL HAZARDS o f M E EQUI P M ENT and M E SYST E M S . . . . . . . . . . . 18
201 . 1 0 P rotection a g a i nst u nwa nted and excess ive rad i ation HAZARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
201 . 1 1 P rotection a g a i nst excessive te m pe ratu res a n d other HAZARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
201 . 1 2 Accuracy of controls a n d i n stru me nts and p rotecti on a g a i nst HAZARDOUS
outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1
201 . 1 3 HAZARDOUS SI TUAT I O N S a n d fa ult co nditions fo r M E EQUI P M ENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
201 . 1 4 P RO G RAMMABLE E L E C T R I CAL M E D I CAL SYSTEMS ( P EMS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
201 . 1 5 Construction of M E EQUI P M ENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
201 . 1 6 ME SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
201 . 1 7 E lectromag netic com pati b i l ity of M E EQUI P M ENT and M E SYST E M S . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
An n exes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
An nex AA ( i nformative) P a rti c u l a r g u ida nce and rati o n a l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
An nex BB ( i nformative) S u m mary of MAN UFACTURER'S requ i re ments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
An nex C C ( i nformative) Symbols on m a rk i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
B i b l iography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
I n dex of d efi ned terms used i n this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
F i g u re 2 0 1 . 1 0 1 - Exa m p l e of explan atory label fo r a device with m u l t i p l e h aza rd

s pectral reg i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4
F i g u re 2 0 1 . 1 02 - Exa m p l e of explan atory label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4
F i g u re 2 0 1 . 1 03 - Re prod uction of the O P T I CAL RADIAT I O N warn i n g symbol
( I S O 70 1 O:W027:20 1 1 -0 5 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5
Ta ble 2 0 1 . 1 04 - Requ i re m e n ts for m a rk i n g of LS EQUI P M ENT accord i n g to risk g ro u p

classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4
Ta ble B B . 1 - S u m m a ry of MAN UFACTURER'S requ i reme nts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 6
Table C C . 1 - Symbols, refe rences a n d descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
I E C 6060 1 -2-57 : 2 023 © I E C 2023 -3-
INTERNATIONAL ELECTROTECHNICAL COMMISSION
MEDICAL EL ECTRICAL EQUIP M ENT -
FOREWORD
1) The I nternational Electrotechnical Commission ( I E C) is a worldwide organization for standardization comprising

all national electrotechnical committees ( I E C National Committees). The object of I E C is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, I E C publishes I nternational Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and G uides (hereafter referred to as " I E C Publication(s)"). Their
preparation is entrusted to technical committees; any I E C N ational Committee interested in the subject dealt with
may participate in this preparatory work. I nternational, governmental and non-governmental organizations liaising
with the I E C also participate in this preparation. I E C collaborates closely with the I nternational Organization for
Standardization (I SO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of I EC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested I E C N ational Committees.
3) I E C Publications have the form of recommendations for international use and are accepted by I E C N ational
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of I E C
Publications i s accurate, I E C cannot b e held responsible for the way i n which they are used o r for any
misinterpretation by any end user.
4) In order to promote international uniformity, I EC N ational Committees undertake to apply I EC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any I EC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) I E C itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to I EC marks of conformity. I E C is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to I E C or its directors, employees, servants or agents including individual experts and
members of its technical committees and I E C N ational Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this I E C Publication or any other I E C
Publications.
8) Attention is drawn to the N ormative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) I E C draws attention to the possibility that the implementation of this document may involve the use of
(a) patent(s). I E C takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, I E C had not received notice of (a) patent(s),
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
https://patents. iec.ch. I EC shall not be held responsible for identifying any or all such patent rights.
I E C 6060 1 -2-57 has bee n pre p a red by I E C tech n i c a l com m ittee 76 : Optical rad iation safety a n d
l a s e r equ i p m e n t . I t is a n I n te rnati o n a l Sta n d a rd .
T h i s second edition cancels a n d re p l aces the fi rst edition published i n 2 0 1 1 . T h i s edition

constitutes a tec h n ical revisio n .
Th is edition i n cl udes t h e fol lowi n g s i g n ificant tec h n ical c h a n ges with respect t o the p rev ious
editi o n :
a ) T h i s e d i t i o n con stitutes a m ajor review o f the previous ed ition a n d covers t h e rece nt

d eve lopment of LS EQUI P M E NT. I t now i n c l udes the RISK G ROUP 1 c (RG-1 C). L S EQUI P M ENT
of RG-1 C i n corporates tech n i cal means w h i ch i n h ibit e m ission i n to free space when the
A P P L I CATO R i s n ot i n G O O D CONTACT with the target tiss u e .
-4- I E C 6060 1 -2-57: 2023 © I E C 2023
b) It now exc l u d es LS EQUI P M E N T of RG-1 and RG-2 as these are assumed to re p resent no
haza rd . RG-1 C i s only i n cl uded if the i n corporated l ig ht source i s of RG-3.
c) It c l a rifies its re lation to the concept of Risk G ro u p s ( R G s ) , as i ntrod uced in I E C 62471 .
d ) Altho u g h the p revious edition was a p p l i cable to LS EQUI P M ENT conta i n i n g UV sources , more
e m p h asis is g iven to UV a p p l i cations of the equ i p m ent i n this e d i t i o n .
e ) T h i s e d i t i o n exc l u d es L S EQUI P M ENT which i s i ntended t o b e used o n a n i m a l s .
T h e text o f this I nternati o n a l Sta n d a rd i s based on t h e fo l low i n g documents:
Draft Report on voting
76/734/F D I S 76/737/RVD
F u l l i nform ation on the vot i n g fo r its a p prova l can be fo u n d in the re port on voti n g i n d i cated i n
t h e above tab l e .
The l a n g u a g e u s e d for the deve l o p m e n t o f this I nternational Sta n d a rd i s E n g l i s h .
T h i s docu m e n t was d rafted i n accorda n ce with I S O/I E C D i rectives , Part 2 , a n d d eve loped i n
a ccord a n ce with I S O/ I EC D i rective s , P a rt 1 a n d I SO/I E C D i rectives , I E C S u pplement, ava i l able
at www . i ec . ch/membe rs_ex perts/refdocs . The m a i n document types d eve loped by I E C a re
described i n g reater deta i l at www . i e c . c h/publications .
I n t h i s document, the fo l l ow i n g print types a re used :
Requ i re m e n ts a n d defi n itions : ro m a n ty pe.

- Test s pec ificati ons: italic type.
I nfo rmative material a p peari n g outs i d e of tables , such as notes , exa m p les a n d references:
N orm ative text of tables i s also i n a s m a l l e r ty pe.
i n smaller type.
- Terms defi ned i n Cla use 3 of IEC 606 0 1 - 1 :2005, I E C 6060 1 - 1 : 2 005/AM D 1 : 2 0 1 2 and
IEC 606 0 1 - 1 :2005/AM D 2 : 2 0 2 0 , in t h i s document or as note d : S M A L L CAP I TALS.
In referring to the struct u re of t h i s docu m e n t , the term
"cl a use" means one of the seventeen n u mbered d ivisions with i n the table of contents ,
i n cl usive of a l l subd ivis i o n s ( e . g . C l a u s e 7 i nc l u d e s subcla uses 7. 1 , 7 . 2 , etc . );
"s ubc l a u se" mea n s a n u m be red subd ivision of a clause ( e . g . 7. 1 , 7.2 and 7.2 . 1 a re a l l
subcla uses o f Clause 7) .
Referen ces to clau ses with i n t h i s document a re preceded by the term "C la use" fo l l owed by the
clause n u mber. References to subcl auses with i n this document a re by n u m be r o n l y .
I n this document, the conju nctive "or" i s u s e d as a n "inclus ive or" so a state m e n t i s t r u e if any
combination of the conditi ons i s tru e .
The verba l fo rms u s e d i n t h i s document conform t o u s a g e desc ribed i n C l a use 7 o f t h e

I S O/ I E C D i rective s , Part 2 : 202 1 . For the p u rposes o f t h i s document, t h e a u xi l i a ry verb:
"s h a l l" means th at com p l i a nce with a requ i rement or a test is m a n d atory for com p l i ance with
this docum ent;
- "s h o u ld" means that com p l i a n ce with a requ i re m e n t or a test is reco m m e n ded but is not
m a n d atory for com p l i a n ce with t h i s document;
- "may" is used to describe a perm issible way to ach ieve com p l ia nce with a requ i rement or
test.
I E C 6060 1 -2-57 : 2 023 © I E C 2023 -5-
An asterisk (*) as the fi rst c h a ra cter of a title or at the beg i n n i n g of a p a ragraph or table title
i nd i cates that there i s g u i d a nce or rati o n a l e related to t h at item i n A n n ex AA .
A l ist of a l l pa rts of the I E C 6060 1 series, p ublished u n d e r the g e n e ra l title: Medical electrical
equipment, can be fo u n d on the I E C webs ite.
The comm ittee has decided that the conte n ts of this doc u me n t will re m a i n u n changed until the
stabi l ity d ate i n d i cated o n the I E C webs ite under webstore . i ec.ch i n the d ata rel ated to the
specific docu ment. At this date, the document will be
• reconfi rmed ,
• withdrawn ,
• re p l a ced by a rev ised editi o n , or
• amended .
IMPO RTANT - The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.
-6- I E C 6060 1 -2-57: 2023 © I E C 2023
INTRODUCTION
T h i s document a m e n d s and s u p p l e ments I E C 6060 1 - 1 : 2 0 0 5 , I EC 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2

a n d I E C 6060 1 - 1 :2005/AM D 2 : 2 0 2 0 , Medical electrical equipment - Part 1 : General
requirements for basic safety and essential performance.
The requ i re m ents of this document s h o u l d be take n as the m i n i m u m to comply wit h , i n o rd e r to

achieve a reaso n a b l e level of safety a n d re l i a b i l ity d u r i n g ope ratio n and a p p l ication of n o n - l aser
light source equ i p ment i ntended fo r thera peuti c , d i ag n osti c , m o n itori n g and cos metic or
aesthetic use.
An asterisk (*) notes clauses fo r which there is rati o n a l e comment i n A n n ex AA. I t i s con s i d e red
that knowledge of the reaso n s for these requ i re m e nts will fa ci l itate the proper a p p l ication of this
document and be of use in a n y rev ision t h at may be n ecess itated by c h a n g e s i n c l i n i cal pract i ce
or as a result of developme nts i n tech nology.
I E C 6060 1 -2-57 : 2 023 © I E C 2023 -7-
MEDICAL EL ECTRICAL EQUIP M ENT -
201 .1 Scope, object and related standards
C l a use of I E C 6060 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

I E C 6060 1 - 1 : 2 00 5/A M D 2 : 2 02 0 a p p l i e s , except as fo l l ows:
201.1.1 *Scope
Replacement:
T h i s part of I E C 6060 1 -2 a p p l i es to BASIC SAFETY a n d ESSENTIAL P E RFO RMAN C E of equ i p ment

i n corporat i n g one or more sources of O P T I CAL RAD I A T I O N i n the wave length ra n g e 200 n m to
3 000 n m , with the exception of laser rad iation , a n d i nte nded to create p h oto b i olog ical effects
i n h u m a n s for thera pe u tic, diag nostic, m o n itori n g , and cos metic or aesthetic a p p l ications;
h e reafte r refe rred to as l i g h t source equ i p m ent ( LS EQ U I P M E N T ) .
T h i s document a p p l ies to LS E Q U I P M ENT of RISK G RO U P 1 C if the i n corporated source of O P T I CAL

RAD IAT I O N i s of RG-3, and of Risk Group 3 .
NOTE 1 For classification rules for Risk Groups, see 201.6.1.102.
T h i s document does n ot a p p l y to equ i p m e n t fo r s u n ta n n i ng such as s u n l a m p p rod ucts , for

ophth a l m i c i n stru ments, for l i g h t i n g p u rposes i n medica l or cosmetic e nviron ments , for
photog ra phy/video, for equ i p m e n t w h i c h produces visual or no n-visual effects such as c i rca d i a n
entra i n ment, o r fo r i nfant p h ototherapy a n d i nfa n t rad i a n t warmers . T h i s doc u m e n t does not
apply to steril ization equ i p m e n t .
T h i s d o c u m e n t d o e s not a p p l y t o h ome-use a p p l i a n ces . I t does n o t a pply t o home l i g h t thera py

equ i p m ent, such as equ i pment which is i ntended to be used i n the H O M E H EALTHCARE
E N V I R O N M E N T a n d is ty pically used by a LAY OP ERATOR.
NOTE 2 Home-use appliances are covered by I EC 60335-2-113:2016 [1] 1. Appliances for skin exposure to OPT ICAL
RADIATION, such as sunlamp products, are covered by I EC 60335-2-27 [2]. H ome light therapy equipment providing
light therapy by means of eye-mediated photobiological effects, which can be visual or non-visual, and skin-mediated
photobiological effects, possible applications including pain relief, psoriasis treatment, and treatment of winter
depression (SAD), are also covered by I E C 60601-2-83:2019 [3].
NOTE 3 Safety requirements in this document are intended to address only HAZARDS to the eye and superficial
tissues including skin or mucosa. As OPTICAL RADIATION does not penetrate more than a few millimetres in tissue,
HAZARDS to underlying tissues are not considered.
N umbers in square brackets refer to the Bibliography.

- 8 - I E C 6060 1 -2-57: 2023 © I E C 2023
201.1 .2 Object
Replacement:
The objects of t h i s document are:
- to esta b l i s h the risk fro m O P T I CAL RADIAT I O N , spec i fy basic s afety a n d essential perfo rm a n ce
requ i re m e nts fo r LS EQ U I P M ENT;
- to s pec ify requ i re m ents for the MAN U FACT U R E R to s u p p ly i nform ation a n d esta b l i s h
proce d u res so t h at p roper preca utions can be adopted;
- to provide warn i n g to i n d iv i d u a l s of risks associated with acces s i b l e O P T I CAL RAD I AT I O N from
LS EQ U I PM E N T t h rou g h s i g n s , labels a n d i n stru ctions;
- to red u ce the p oss i b i l ity of adverse effects a n d i n ju ries by m i n i m i z i n g u n n ecessary

acces s i b l e O P T I CAL RAD IATION; to p rov i d e means of i m p roved control of the HAZARDS re lated
to O P T I CAL RAD IATION through e n g i neeri n g controls;
- to specify requ i re m e nts for protecti on agai nst ot h e r HAZARDS res u lt i n g from the operation
and use of LS EQU I P M ENT.
201.1.3 Collateral standards
Addition:
T h i s document refers to the a p p l i ca b l e col lateral sta n d a rd s that are l i sted i n C l ause 2 of
I E C 606 0 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 0 0 5/A M D 1 : 2 0 1 2 a n d I E C 606 0 1 - 1 : 2005/A M D 2 : 2 0 2 0 .
A l l coll atera l sta n d a rds a p p l y , except I E C 6060 1 - 1 - 1 1 .
201.1.4 Particular standards
Replacement:
I n the I E C 6060 1 series , part i c u l a r sta n d a rd s m ay mod ify, re p l ace or d e lete requ i reme nts
conta i ned in I E C 606 0 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and
I E C 6060 1 1 : 2 0 05/AM D 2 : 2020 and coll ateral sta n d a rd s as a p p rop riate for the particu l a r
M E E Q U I P M E N T u n der con s i d e rat i o n , a n d may add o t h e r b a s i c safety a n d essential perform a n ce
requ i rements .
A requ i rement o f a part i cu l a r sta ndard takes priority over I E C 6060 1 - 1 : 2 005,
IEC 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 a n d IEC 6060 1 - 1 : 2 005/AM D2 : 2 0 2 0 .
The n u m b e r i n g o f c l a uses a n d s u b c l auses o f this d o c u m e n t corres ponds t o t h at o f

I E C 606 0 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 005/AM D 1 : 20 1 2 a n d I EC 6060 1 - 1 : 2005/A M D 2 : 2020 with the
prefix "2 0 1 " (e . g . 2 0 1 . 1 i n this document addresses the co nte nt of C l a u s e 1 of
I E C 606 0 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 0 05/A M D 1 : 2 0 1 2 a n d I E C 6060 1 - 1 : 2 005/A M D 2 : 2 0 2 0 ) or
a p p l icable co l l atera l sta n d a rd with the p refix "2 0x" wh ere x is the fi n a l d i g it(s) of the co l l atera l
sta ndard document n u m be r ( e . g . 2 0 2 . 4 i n t h i s document add resses the content of Clause 4 of
the I E C 6060 1 - 1 -2 co l l ateral sta n d a rd , 2 0 3 . 4 in t h i s document a d d resses the content of Clause
4 of the I E C 6060 1 - 1 -3 col l ate ra l sta n d a rd , etc . ) . The changes to the text of I E C 6060 1 - 1 : 2 0 0 5 ,
I E C 606 0 1 - 1 : 2 0 05/A M D 1 : 2 0 1 2 a n d I E C 60601 - 1 : 2 00 5/A M D 2 : 2020 are s pecifi ed b y the u s e of
the fo l l owi n g word s :
"Re p l ace m e n t" means that the c l a use or s u bc l a use of I E C 606 0 1 - 1 : 2 0 0 5 ,

I E C 606 0 1 - 1 : 2 0 05/A M D 1 : 2 0 1 2 a n d I E C 6060 1 - 1 : 2 005/A M D 2 : 2 020 or a p p l i ca b l e collateral
sta ndard is re place d com p l etely by the text of this docu ment.
"Ad d ition" means that the text of t h i s document i s additional to the requ i re m e nts of
IEC 606 0 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 :2 005/AM D 1 : 2 0 1 2 a n d I E C 6060 1 - 1 :2 005/AM D 2 : 2020 or
a p p l ica b l e co l l ateral sta n d a r d .
I E C 6060 1 -2-57:20 23 © I E C 2023 -9-
"Am e n d m e nt" means that the c l a use or subc l a use of I E C 606 0 1 - 1 : 2 0 0 5 ,

I E C 6060 1 - 1 : 2005/AM D 1 : 2 0 1 2 a n d I E C 6060 1 - 1 : 2 0 05/AM D2 : 2 020 or a p p l i cable collateral
sta ndard is a m e n d e d as i n d icated by the text of this document.
S ubcl a uses , fi g u res or tables which a re add itional to those of I E C 606 0 1 - 1 : 2 0 0 5 ,

I E C 6060 1 - 1 : 2005/AM D 1 : 2 0 1 2 a n d I E C 606 0 1 - 1 : 2 005/A M D 2 : 2020 are n u mbe red starting from
201 . 1 0 1 . However, due to the fact that defi n itions in I E C 606 0 1 - 1 : 2 0 0 5 ,
I E C 6060 1 - 1 : 2005/AM D 1 : 2 0 1 2 a n d I E C 606 0 1 - 1 : 2 005/A M D 2 : 2 020 are n u mbered 3 . 1 t h ro u g h
3 . 1 3 9 , add ition a l defi n itions i n this docu m e n t a re n u m be red beg i n n i n g fro m 2 0 1 . 3 . 20 1 .
Add i t i o n a l a n nexes a re lettered AA , B B , etc . , a n d ad d it i o n a l items a a ) , bb) , etc.
S ubcl a uses , fi g u res or tables w h i c h are add itional to those of a coll ateral sta n d a rd a re
n u m be red sta rt i n g fro m 20x, w h e re "x" is the fi n a l d i g it(s) of the co l l ate ral sta ndard document
n u mber, e . g . 202 fo r I E C 6060 1 - 1 -2 , 203 fo r I E C 606 0 1 - 1 -3 , etc.
The term "th is sta ndard" i s used to make refe rence to I E C 606 0 1 - 1 : 2 0 0 5 ,
I E C 6060 1 - 1 : 2005/AM D 1 : 2 0 1 2 a n d I E C 6060 1 - 1 : 2 0 0 5/AM D 2 : 2 0 2 0 , a n y a p p l i cable col latera l
sta ndards and this document taken togeth er.
Where there i s no corres pond i n g clause or s u bcla use i n t h i s doc u m e nt , the c l a use o r subc l a use
of I E C 6060 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 0 05/AM D 1 : 2 0 1 2 and I E C 6060 1 - 1 : 2 0 0 5/AM D 2 :2020 or
a p p l i cable coll atera l sta nd a rd , although poss ibly not releva nt, a p p l ies without mod ification;
where it is i nte n d ed t h at any p a rt of I E C 6060 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 0 0 5/AM D 1 : 2 0 1 2 a n d
I E C 6060 1 - 1 : 2005/AM D 2 :2020 or a p p l icable coll atera l sta n dard , a l t h o u g h possibly releva nt, i s
not t o b e a p p l ie d , a state ment t o t h at effect is g iven i n t h i s docu ment.
20 1 .2 Normative references
NOTE I nformative references are listed in the Bibliography.
C l a use 2 of I E C 6060 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

I E C 6060 1 - 1 : 2 00 5/A M D 2 : 2 02 0 a p p l i e s , except as fo l l ows :
Addition:
I E C 60947-3, Low-voltage switchgear and contra/gear - Part 3: Switches, disconnectors,

switch-disconnectors and fuse-combination units
I E C 624 71 , Photobiological safety of lamps and lamp systems
I S O 3864-2 , Graphical symbols - Safety colours and safety signs - Part 2: Design principles
for product safety labels
2 0 1 .3 Terms and definitions

Replacement:
201.3.18
CONTINUOUS OPERATION
operation with a conti n u o u s OPTI CAL RAD I A T I O N output for a d u ration equ a l to or g reater t h a n
0 , 2 5 s f o r wavelengths i n the ra n g e 400 n m t o 7 0 0 n m a n d 1 0 s fo r a l l oth e r wave l e ngths
- 10 - I E C 6060 1 -2-57: 2023 © I E C 2023
201.3.73
OPERATOR
person h a n d l i n g the LS E Q U I P M E N T
N ote 1 t o entry: I n general, the O P E RATOR controls the delivery of optical radiation. The O P E RATOR can appoint one
or more other persons who assist with the selection and/or setting of the parameters. The more general term "user"
is interpreted in its generic meaning. The meaning of "user" may include the definition of "OPERATOR".
201.3.76
PATIENT
person u n d e rg o i n g the treatment or diag nostic proce d u re
Addition:
201.3.201
APPLICATOR
mecha n i cal or optical means of transferri n g O PT I CAL RAD I A T I O N from the source to the h u m a n
tissue
201.3.202
EMERGENCY STOP
device i ntended to sto p the LS EQU I P M ENT O U T P U T i m m ed i ately in case of e m e rg e n cy
201.3.203
EMISSION APERTURE
o p e n i n g or wi ndow thro u g h which the O P T I CAL RAD I AT I O N is e m i tted
201.3.204
EXPOSURE DURATION
d u rati o n of a P U LS E , o r series, or tra i n of P U LSES or of conti nuous e m ission of OPT I CAL RAD IAT I O N
i n cident upon the human body d u ring o pe rati on , m a i nte n a n ce or servi c i n g of L S E Q U I P M E N T
N ote 1 t o entry: For a single P U LSE, this i s the duration between the half-peak power point o f the leading edge and
the corresponding point on the trailing edge. For a train of P U LS E S (or subsections of a train of P U LS E S ), this is the
duration between the first half-peak power point of the leading P U LS E and the last half-peak power point of the last
PULSE.
N ote 2 to entry: EXPOS U R E DURATION is measured in seconds (s).
201.3.205
GOOD CONTACT
state that is established when the A P P L I CATOR of the LS EQ U I P M ENT w h i c h is class ifi ed RG-1 C i s
pos i tioned at the target tissue so as t o effectively p reve nt HAZARDOUS eye exposu re t o STRAY
O P T I CAL RAD IAT I O N
201.3.206
LS EQUIPMENT
ME EQ U I PMENT which i n corpo rates one or more sou rces of O PTI CAL RAD IATI ON i n the wave l e n g t h
ra n g e 200 n m t o 3 000 n m , w i t h the exce ption o f l a s e r rad i ation , a n d which i s i ntended to create
ph otobiological effects for therapeutic, diag nostic, m o n itori n g , a n d cosmetic or aesthet i c
a p p l ications
201.3.207
LS EQUIPMENT OUTPUT
rad i a nt power, rad i a n t e n e rgy, i rrad i a nce or rad i a n t exposure e m i tted by a n d as relevant to the
LS EQU I PM E N T
I E C 6060 1 -2-57 : 2 023 © I E C 2023 - 11 -
201.3.208
OCULAR EXPOSURE LIMIT
maxi m u m level of expos u re to the eye that is not ex pected to res u lt i n adverse biolog ical effects
N ote 1 to entry: O C U LAR EXPOS U R E L I M ITS can be found in I C N I R P G uidelines:

https://www. icnirp. org/cms/upload/publications/I C N I R PVisible_I nfrared2013. pdf [ 4]
https : //www. icni rp.org/cms/upload/publications/I CN I RP UV2004. pdf [5] .
201.3.209
OCULAR HAZARD DISTANCE
OHO
shortest d i stance fro m an E M I SSION APERTURE at w h i c h the projected rad i a nt expos u re or
i rrad i a n ce for a g iven EXPOSU R E D U RAT I ON equ a ls the a p p l i cable O C U LA R EXPOSU RE L I M IT
N ote 1 to entry: OCU LAR HAZARD DISTA N C E is measured in metres (m).
201.3.210
OPTICAL RADIATION
e l ectro m ag n etic rad iation with wave lengths between 1 0 0 n m a nd 1 m m
201.3.211
PULSE
PULSED
e m i ss i o n with the d u ration shorter t h a n 0 , 2 5 s in the ra n g e 400 nm to 700 nm a n d shorter than
1 0 s at a l l ot her wavelengths
201.3.212
PULSE DURATION
t i m e i n cre m e n t m ea s u red between the h a lf-peak ( 5 0 %) powe r points at the l e a d i n g a n d tra i l i n g
edges o f a P U LSE
N ote 1 to entry: P U L S E DURATION is measured in seconds (s).
201.3.213
PULSE INTERVAL
t i m e betwee n the e n d of one P U LSE a n d the on set of the fol l owi n g P U LSE, meas u red at the 50 %
tra i l i n g a n d l e a d i n g edges, res pectively
N ote 1 to entry: P U L S E I N T ERVAL is measured in seconds (s).
201.3.214
PULSE TRAIN
series of P U LSES where the total o n time of the P ULSES i n a n y series of P U LSES i n a n y s i n g l e
expos u re sequ ence d o e s not exceed 0 , 2 5 s fo r wave l e n gths i n the ra n g e 400 n m t o 700 n m a n d
does n o t exceed 1 0 s for a l l other wave l e n gths
201.3.215
READY
co n d ition i n which the LS EQ U I P M E N T is capable of e m itti n g O P T I CAL RADIAT I O N a n d e m i s s i o n
takes p l a ce w h e n the control switch is activated
201.3.216
READY IN DICATOR
visible or a u d ible s i g n a l that i n d i cates w h e n LS E Q U I P M ENT is i n the READY condition
N ote 1 t o entry: The purpose o f the READY I N DI CATOR i s t o make all persons present i n the vicinity aware o f the need
to take precautions against HAZARDOUS OPTICAL RADIATION.
- 12 - I E C 6060 1 -2-57: 2023 © I E C 2023
201.3.217
RISK GROUP 1C
RG-1C
classification of LS EQU I P M E N T that conta i n s a source of u p to R i sk G ro u p 3 , that is used i n
con tact with t h e ski n , a n d that h a s e n g i neering con trols which conta i n t h e optical rad i ation s o
that a n y leakage does n o t exceed R G - 1 i n a n y of t h e haza rd spectral reg ions, w h e n assessed
at 0 , 5 m fro m the A P P L I CATOR
201.3.218
SET VALUE
i nte n d ed LS E Q U I P M ENT O U T P U T i n c i d e nt on the T R EATM ENT AREA, as set by the O P E RATOR
201.3.219
STAND-BY
co n d ition in which the power s u pply ( S U P P LY M A I N S or battery ) is conn ected , a n d the S U P PLY
MAINS switch activate d , and the LS EQ U I P M ENT is n ot capable of e m itting the O PT I CAL RAD I AT I O N
eve n if the control sw itch is activated
201.3.220
STRAY OPTICAL RADIATION
OPTI CAL RAD IATI O N that is u n i ntenti ona l ly e m itted from the E M I SS I O N APERTURE or fro m the target
tiss u e , i n c l ud i n g scatte red , reflected a n d leakage rad i at i o n
201.3.221
TREATMENT AREA
extent of the fi eld over which the O P T I CAL RADIAT I O N is i n tended to p rod uce a therapeutic
res ponse
N ote 1 t o entry: F o r LS E Q U I P M E N T where OPTI CAL RADIATION exposure i s carried out i n contact with the surface to
be treated, this is equivalent to the device aperture.
201.3.222
ULTRAVIOLET
UV
OPTI CAL RADIAT I O N havi n g wave lengths between 1 0 0 n m a n d 400 n m
N ote 1 to entry: For UL TRAV I O LET (UV) radiation, the range between 100 nm and 400 nm is commonly subdivided
into: UV-A, from 315 nm to 400 nm; UV-B, from 280 nm to 315 nm; and UV-C, from 100 nm to 280 nm. These
designations for the UV are not precise limits, particularly for photobiological effects. In some fields of photobiology
the wavelength bands are taken from 200 nm to 290 nm, from 290 nm to 320 nm, and from 320 nm to 400 nm.
Sometimes these are (incorrectly) called by the names UV-A, UV-B and UV-C, respectively.
201.3.223
VISIBLE
VIS
OPTI CAL RAD I AT I O N havi n g wave lengths between 380 n m a n d 780 n m
N ote 1 to entry: There are no precise limits for the spectral range of V I S I B LE radiation since they depend on the
amount of radiant power reaching the retina and the responsivity of the observer, The lower limit is generally taken
between 360 and 400 nm and the upper limit between 7 60 and 830 nm.
2 0 1 .4 General requirements
C l a use 4 of I E C 6060 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

I E C 606 0 1 - 1 : 2 005/AM D2 : 2 02 0 a p p l i e s .
T h e requ i re m e nts for m a n ufactu rers are s u m m a ri zed i n Annex B B .

I E C 6060 1 -2-57: 2023 © I E C 2023 - 13 -
20 1 .5 General requirements for testing ME EQUIPMENT

I E C 606 0 1 - 1 : 2005/AM D2 : 2 02 0 a p p l i e s .
20 1 .6 Classification of ME EQUIPMENT and ME SYSTEMS

201.6.1 General
Addition:
201.6.1.101 Classification responsibilities
The LS E Q U I P M E N T s h a l l be classified by the m a n ufa cturer accord i n g to the cl assification rules

as d efi ned i n I E C 62471 , if the Risk G ro u p is not 1 C .
201.6.1.102 Classification rules
LS E Q U I P M ENT is d iffe re nt fro m l a m ps used i n general l i g h t i n g , as the rad i ation is used fo r

treatment or d i ag nosis p u rposes o n h u m a n s rather t h a n g e n e ra l expos u re pu rposes such as
g e n e ra l l i g h t i n g , i l l u m i n ation or d i s i nfecti o n . To be able to attribute a Risk G ro u p to LS E Q U I P M EN T ,
i t s h a n d p ieces, A P P L I CATORS or its i n co rporated freely e m itti ng sources s h a l l b e considered as
"l a m ps" as covered by I E C 62471 .
201 .7 ME EQUIPMENT identification, marking and documents

201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Addition:
201.7.2.101 Labels and marking of LS EQUIPMENT
201.7.2.101.1 Specification of labels and marking
The MAN U FACT U R E R of LS EQU I PM E N T s h a l l p rovide risk g ro u p m a rki n g . The l abe l s h a l l i n clude
the desig n ated risk g ro u p a n d word i n g accord i n g to Table 2 0 1 . 1 04 .
Word i n g that conveys a n equ ivalent mea n i n g i s acceptable.

- 14 - I E C 6060 1 -2-57: 2023 © I E C 2023
Table 201.104 - Requirements for marking o f L S EQUIPMENT

according to risk group classification
HAZARD RISK GROUP 1 C Risk Group 3
WAR N I N G
Actinic UV CAUT I O N UV emitted from this device may b e hazardous
180 nm to 400 nm UV emitted from this device Avoid non-intended skin exposure and avoid eye
exposure
WAR N I N G
N ear UV CAUT I O N
UV emitted from this device may be hazardous
315 nm to 400 nm UV emitted from this device
Avoid eye exposure
Blue-light
Not required WAR N I N G
300 nm to 700 nm
The light emitted may result i n eye injury
Retinal thermal
Not applicable Do not look at the light source
380 nm to 1 400 nm
Retinal thermal,
Not applicable WAR N I N G
weak visual stimulus
IR emitted from this device may cause eye injury
Corneal and lens I R CAUT I O N
Avoid eye exposure
> 780 nm I R emitted from this device
When LS EQU I P M ENT e m its O P T I CAL RAD IATI O N i n more than one hazard s pectra l reg i o n , it s h a l l
b e c l assified fo r t h e most restrictive case. If t h e O PT I CAL RAD I A T I O N i n oth e r s pectra l regions
exceeds the E M I SS I O N L I M I TS fo r the Exempt G ro u p , a p p ro p ri ate wa r n i n g shall be i n c l uded in the
prod uct ex p l a n atory label. See I E C 62471 fo r the e m iss ion l i m its of the Exem pt G ro u p a n d fo r
the h azard spectra l reg ions.
RISK G ROUP 3
WARNING IR emitted from this device may cause eye injury.
Avoid eye exposure
CAUTION UV emitted from this device. Eye irritation may result
Figure 201.101 - E xample of explanatory label for a device

with multiple hazard spectral regions
RISK GROUP 1 C
CAUTION Optical radiation - follow instructions
Figure 201.102 - E xample of explanatory label

I E C 6060 1 -2-5 7 : 2 0 2 3 © I E C 2023 - 15 -
201.7.2.1 01.2 Product label design and labelling information
LS EQU I PM E N T s h a l l carry a n ex p l a n atory labe l ( F i g u re 2 0 1 . 1 0 1 for RG-3, or F i g u re 2 0 1 . 1 02 fo r

RG-1 C ) and the O P T I CAL RADIAT I ON warn i n g symbo l , as defi ned i n I S O 7 0 1 O : W027 : 2 0 1 1 -05
( F i g u re 2 0 1 . 1 03 ) in accorda nce with the requ i rements of this sta n d a rd and ISO 3864- 2 . The
l abels s h a l l be d u rabl e , p e r m a n e n tly affixed , l e g i b l e , and clearly vis ible d u ri ng o pe rat i o n ,
m a i nte n ance or service, accord i n g t o the i r pu rpos e . T h ey s h a l l b e positioned so that they ca n
be read without the necessity for h u m a n expos u re to O P T I CAL RADIAT I O N e m itted fro m this
equ i p ment. Text bo rd e rs a n d symbo l s s h a l l be black on a ye l l ow backg ro u n d .
If t h e size or d es i g n of t h e L S EQU I P M ENT makes l abe l l i ng i m p ractica l , t h e labe l s h a l l b e i n c l uded

with the user i nform ation or on the packa g e .
D i rect p r i n t i n g or e n g raving o f equ ivalent l abels o n the LS E Q U I P M E N T o r p a n e l s i s acce ptable.
The exp l a n atory label may be of a n y s ize n ecessa ry to co nta i n the requ i re d l ettering a n d bo rd e r .
The m i n i m u m w i d t h of e a c h bord e r d i m e n s i o n s h o u l d b e 0 , 06 times the l e n gth o f the s h o rter
side of the labe l .
Figure 201 .103 - Reproduction of the OPTICAL RADIATION warning symbol

(ISO 701 O:W027:201 1 -05)
201.7.2.1 01.3 EMISSION APERTURE label
LS EQU I PM E N T c l assified RG-1 C , a n d RG-3 s h a l l h ave a label affixed close to each EM ISSION
A P E RTU RE. The l abe l(s) s ha l l bear the word s :
OPTICAL RADIATION APERTURE
or
APERTURE FOR OPTICAL RADIATION
or (for RG-3 only)
AVOID EYE EXPOSURE - OPTICAL RADIATION I S EMITTED FROM THIS

APERTURE
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201.7.2.101.4 Radiation output and standards information
The name a n d p u b l ication d ate of the sta ndard to w h i c h the product is classified s h a l l be
i n cl uded o n the e x p l a n atory l a b e l or e l sew h e re near to the p rod uct. Each LS E Q U I P M E N T s h a l l
b e described o n t h e explanatory l a b e l b y a state m e n t o f t h e m ax i m u m output of OPT I CAL
RAD IAT I O N , the P U LSE D U RATI O N range (if a p p ro p riate) a n d the e m i tted wavelen gth ra n g e .
201.7.9 Accompanying documents
201.7.9.1 General
Addition:
MAN U FACTU RERS of LS EQ U I P M ENT s h a l l provide i n structions fo r proper ope ration , i n c l u d i ng clear
wa r n i ngs concern i n g preca utions to avo i d poss i b l e expos u re to HAZA R D O U S O P T I CAL RAD I AT I O N .
201.7.9.2 Instructions for use
201.7.9.2.13 Maintenance
Addition:
MAN U FACTU RERS of LS E Q U I P M E N T s h a l l provide i n structions for m a i ntena n ce i n c l u d i n g wa r n i ngs

conce r n i n g precautions to avoid pos s i b l e expos u re to HAZARDOUS O P T I CAL RADIAT I O N .
201.7.9.2.17 ME EQUIPMENT emitting radiation
Addition:
201.7.9.2.17.101 Specific information for LS EQUIPMENT
201.7.9.2.17.101.1 Information on output
The MAN U FACT U R E R of LS EQ U I P M E N T s h a l l provide the fo l low i n g i nfo rmati o n :
s pectra l i rrad i a nce or spectral rad i a nt expos u re measured at t h e T REATM ENT A R EA for a l l
i nte n d ed confi g u rations o f L S EQU I P M ENT;
max i m u m LS EQU I P M E N T OUTPUT for a l l intended confi g u rati o n s of LS E Q U I P M EN T, measured
at the T R EATM ENT AREA. I f the LS E Q U I P M E NT is des i gned fo r p rovi d i n g treatm ent in d iffe rent
TREAT M E N T A R EAS, th ese para meters s h a l l be specified for each of the T REAT M E N T AREAS;
max i m u m variation of the LS E Q U I P M E N T O U T P U T from the mean v a l u e across the T R EAT M E NT

AREA for a l l i ntended confi g u rati o n s of the LS EQ U I P M ENT;
O C U LAR HAZARD D I STAN C E w h e n the LS EQ U I P M E N T is cl assified Risk G ro u p 3 .
For P U LSED L S EQ U I P M E N T , fo r a l l intended operation a l SET VAL U E S of the equ i p ment, the
s h a l l prov ide a n additional state ment of:
MAN U FACT U R E R
P U LSE D U RATI O N of i n d iv i d u a l P U LSES;

- d u ration of a P U LSE TRAI N;
P U LSE I N T E RVAL;
P U LSE repeti tion rate;

n u m be r of P U LSES i n a P U LSE TRA I N .
I E C 6060 1 -2-57 : 2 023 © I E C 2023 - 17 -
201.7.9.2.17.101.2 Safety information
MAN U FACTU RERS of LS EQ U I P M E N T s ha l l p rovide the fo l l owi n g i nfo rmation i n the user i nstructions,
if a p p l i cable:
i n structions fo r i n sta l lation , m a i nte n a n ce, p re-use ch ecks and safe use , i n c l ud i n g clear
wa r n i ngs con cern i n g p recautions to avo i d possible expos u re to HAZARDOUS radiation or risk
of fi re;
description of the proce d u res of the i nte nded use, i n d icati ons , p re-treatment eva l u at i o n s ,
cou nte r- i n d icati o n s . When the L S EQU I P M ENT e m its U V-A, UV- B or U V - C , warn i n g about t h e
risks t h a t PATI ENTS w i l l suffe r from future potential carci nogenic occurrences.
recom m e n d ations for tra i n i ng;
leg ible re p rod uctions (colour option a l ) of all requ i red labels a n d HAZARD warn i n gs affixed to
the LS EQ U I P M ENT;
a clear i n d i cation of a l l locations of EM ISSI ON A P E RT U R ES;
a l ist of contro l s , adjustments a n d proce d u res for o pe rati on and m a i nte nance, i n c l u d i n g the
wa r n i n g "C aution - Use of controls or adjustments o r perform a n ce of proced u res other t h a n
t h o s e s pec ified h e re i n may result i n HAZARDOUS rad i at i o n expos u re";
a note , saying t h at LS E Q U I P M ENT s h o u l d be protected ag a i nst u n a uthorized u s e , fo r exa m p l e
by re moval o f t h e key fro m t h e key switch;
when tec h n ical means are i n s ufficient to p rovide a safe environ ment, e . g . when the
can freely be moved wh i le the e m ission can be triggere d , reco m m e n d ations for
A P P L I CATO R
eye and skin protection fo r the perso n n e l and fo r the PAT I ENT. This i n c l u des a tech n i cal
specification of the reco m m e n ded safety eyewear a n d a tech n i cal spec i fication of the
recom mended skin protection or c l oth;
when the L S EQU I PM E N T is RG-1 C , i n structions for reco m m e n ded use so that G O O D CONTACT
i s m a i nta i n e d . This is to i n c l u d e clear warn i n g s concern i n g poss ible expos u re to HAZARDOUS
rad i at i o n if the contact sensors a re i n a p p ropriate ly m a n i p u l ated by the O P E RATO R or
ma lfu nctio n i n g due to a tech n i cal S I N G L E FAULT C O N D I T I O N or any other fo reseeable reason;
advice about the meas u res to m i n i m ize vis u a l d i sturbances to perso n n e l , such as i n creas i n g
t h e level o f ambient l i ght, a p p l y i n g s pot l i g h t i n g o f t h e target a rea and u s e o f protective
eyewea r .
2 0 1 .8 Protection against electrical HAZARDS from ME EQUIPMENT

201.8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated control

devices
Addition:
201.8.10.4.101 Footswitch
Any foot-operated expos u re control switch s h a l l be s h rouded to p reve nt u n i ntenti o n a l ope rati o n .
The force requ i red t o actuate the switch s h a l l b e n o t l e s s t h a n 1 0 N , a p p l ied over an a rea of
625 m m 2 a nywh e re on the operati ng s u rface of the footswitc h . T h i s force s h a l l not exceed 50 N .
Compliance is checked by measurement of the actuating force.
NOTE H A N D HELD PARTS are covered in 8.10. 4 of I E C 60601-1:2005, I E C 60601-1:2005/A M D 1:2012 and
I EC 60601-1:2005/A M D2:2020.
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201.8.11 MAINS PARTS, components and layout
Addition:
201.8.11.101 Cooling liquid
Where l iqu i d is used i n LS E Q U I P M ENT for coo l i n g a n d where the l iqu i d ass u m es the task of BAS I C
I N SULAT I O N to the S U P P LY M A I N S , the con d u ctivity of the l iqu i d sha l l be such t h at the leakage
cu rrent val ues requ i red i n 8.7 of IEC 6060 1 - 1 :2005, IEC 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and
IEC 606 0 1 - 1 : 2 005/A M D 2 : 2 020 are not exceeded i n N O RMAL U S E . The c o n d u ctivity of the l iquid
s h a l l be conti n u ously mon itored by the L S EQ U I P M ENT. I n case of leakage cu rre nt exceed i n g the
values requ i red in 8 . 7 of I E C 606 0 1 - 1 :2005 , I E C 6060 1 - 1 : 2 005/A M D 1 : 20 1 2 and
I E C 606 0 1 - 1 : 2 005/A M D 2 : 2 020 a s a res u lt o f i n c reased l iquid c o n d u ctivity , t h e L S EQ U I P M E N T
shall be switched off auto m atica l ly fro m the SUP PLY MAI NS.
Compliance is checked by inspection and functional tests.
2 0 1 .9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS

I E C 6060 1 - 1 : 2005/AM D 2 :2020 a p p l i e s .
2 0 1 . 1 0 Protection against unwanted and excessive radiation HAZARDS

I E C 606 0 1 - 1 : 2 005/AM D2 : 2 02 0 a p p l ies except as fo l l ows :
Addition:
201.10.101 Means for detecting GOOD CONTACT
T h i s s u bclause a p p l ies to LS E Q U I P M ENT of RG-1 C .
o f R G - 1 C s h a l l b e fitted with a device that d isables t h e re lease o f O P T I CAL

L S EQU I PM E N T
w h e n G O O D CONTACT is not established or lost. The disabl i n g device may be in the
RAD IAT I O N
form of a n i nterlock system which is capable of detecting whether G O O D CONTACT with the
biolog ical skin tissue is estab l i s h e d .
If conti nuous action by the O P E RATO R i s n ecessary t o m a i nta i n the e n abled status (for exa m p l e ,
a n a ctivation button is cont i n uously depresse d ) t h e L S EQ U I P M ENT s h a l l keep e m itti n g , u n less
GOOD CONTACT with the ski n i s lost. Wh i l e this conti nuous action i s m a i nta i n ed by the O P E RATO R ,
any loss of G O O D CONTACT sha l l be detected by the d i sabl i n g device a n d the e m ission of O P T I CAL
RAD IAT I O N s h a l l s h u t off. For RG-1 C LS EQUIPMENT when the exposure is terminated upon loss of GOOD
CONTACT, the signal cha i n towa rds exposure termi nation or its components shall be FAIL SAFE or
red undant.
When the loss of G O O D CONTACT exceeds 2 s the LS E Q U I P M ENT s h a l l requ i re active retri g g eri n g
by the O P E RATO R to res u m e e m i ss i o n .
T h e t i m e i nterval between loss o f GOOD C O N TACT with the s k i n a n d d i sabl i n g the triggering of
l i g h t e m i ss i o n s ha l l not exceed 0, 1 s .
If t h e mea n s for d etect i n g G O O D CO NTACT conta i n s a progra m m able electro n i c c i rc u i t the

software s h a l l i n corporate measures to contro l the fa ult conditions specified in 2 0 1 . 1 3 . 1 . 1 0 1 ,
as fa r as a p p l icabl e .
I E C 6060 1 -2-57 : 2 023 © I E C 2023 - 19 -
Refer to C l a use 1 4 of I E C 606 0 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 0 0 5/AM D 1 : 2 0 1 2 and

I E C 6060 1 - 1 : 2 005/AM 02 : 2 0 2 0 , P RO G RAMMABLE E L ECTR I CAL M E D I CAL SYST E M S ( P E MS).
NOTE If the e m i s s ion is cou p l ed into the s k in by frustrated internal total reflection d ue to the match of the refractive
indices of t h e trans m itting med i u m and the s k in, and the contact sensors rely on the effect of internal total reflect ion,
t h i s device may not be safe since index matching a l s o takes p l ace w h en gel or other index match ing s u bstance sticks
to the output w indow, a l lowing e m i s s ion into free air to take p l a ce.
Compliance is checked by the following tests.
The function of the disabling device shall be tested with a cylindrical test specimen, designed
to simulate human skin, with the following properties:
a cylindrical rod with an outer diameter exceeding the maximal dimension of the A PPL/CA TOR
footprint by 40 mm and having a smooth surface, made of a flexible material with a Shore
hardness not exceeding 25;
the material shall simulate the optical properties of the skin with regard to absorption,
reflection and scattering, in order to assess the S TRA Y OPTICAL RAD/A TION;
the surface of the artificial skin used for detecting the skin contact is modified in turn as
follows:
• dry skin is simulated using the artificial skin without any modification;
• the presence of dried sweat is simulated by using a 0, 9 git saline solution on the artificial
skin surface, that is then air dried;
• the presence of sebum is simulated by using petroleum jelly on the artificial skin surface.
For LS EQUIPMENT using an auxiliary material such as a gel as specified in the instructions as
the contact means during the INTENDED USE, the test shall be performed with and without this
material.
The reaction time of the disabling device is tested by placing the output window of the L S
EQUIPMENT APPLICA TOR o n the test specimen, then subsequently removing the A PPLICA TOR from
the test specimen. The emission of radiation shall cease within a time interval of 0, 1 s.
The output window of the LS EQUIPMENT A PPL/CA TOR shall be placed on the test specimen and
rotated, tilted and raised to test whether the sensors in the interlock system correctly detect
G O OD CONTA C T with the test specimen.
201.10.102 Output uniformity
The spatial variation of the LS EQ U I P M E N T O UTPUT over the TREAT M E N T AREA s h a l l not deviate
fro m the average rad i a nt power, ra d i a n t energy, i rrad ia nce or rad i a n t expos u re as a p p ropri ate
by more t h a n ±20 %. A d ecrease of LS EQ U I P M E N T OUTPUT g reater than 2 0 % i s accepta b l e for
the edge of the TREAT M E N T A R EA (20 % of the a re a ) .
Compliance i s checked by inspection and measurements. The detector aperture of the

measuring device shall be 2 mm, unless another size is justified by the manufacturer in a risk
assessment included in the RISK MA NAGEMENT FILE.
In the risk assessment the manufacturer may take the "flattening " of the spatial radiation profile
i nto accou nt, w h i c h takes p lace by l i g ht scatte ring across a n area of the same size as the typical
penetration depth, which depends on the wavelength and tissue's absorption characteristics.
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201.10.103 Controls and indicators
For the p rotection of the PAT I E N T , the OP ERATOR, and oth e r persons present, LS E Q U I P M E NT s h a l l
i n corporate the fo l l owi n g .
1 ) Key-o perated master contro l . T h e OPTI CAL RADIAT I ON s h a l l o n ly b e acces s i b l e w h e n t h e key

is activate d . If it is a physical key, it s h a l l be rem ova b l e .
N OTE In this document the term "key" includes any control devices, such as keys, magnetic cards, cipher
combinations, digital keys, passwords, etc.
2 ) Vis i b le o r a u d i b l e READY I N D I CATOR, which s h a l l be i l l u m i n ated or a u d i b l e when e m ission of

the OPTI CAL RAD IAT I O N is poss i b le upon a ctuation of the control switc h , to a l l ow a p p ro pri ate
safety p reca utions to be take n .
3 ) OPT I CAL RAD I AT I O N i n d i cator;
4 ) I n add ition t o t h e READY I N D I CATO R , L S EQ U I P M ENT sha l l be equi p ped with a vis i b l e a n d/or a n
a u d i b l e s i g na l , which clearly i n d icates that e m ission of O P T I CAL RADIAT I O N i s tak i n g place .
5 ) If t h e i n d i cators a re o f v i s i b l e type , t h e READY I N D I CATOR a n d the O P T I CAL RAD I AT I O N i n d i cator
s h a l l be v i s i b l e t h ro u g h p rotective eyewear recom m e n d e d by the MAN U FACT U R E R.
6) STAN D-BY/READY control; LS EQU I P M ENT s h a l l be equ i p ped with a STAN D-BY/ R EADY contro l . O n
i n it i a l switch-on t h e L S EQ U I P M ENT s h a l l defa u l t t o STAND-BY co n d it i o n .
NOTE The STAN D-BY/READY control can be marked with a symbol, see Annex CC.
Compliance is checked by inspection.
201.10.104 E xposure termination
When the exposu re te r m i nation is by means of a ti mer, p rotection a g a i nst S I N G L E FAULT

CON D IT I O N S s h a l l be provided by a safety device w h i c h is i n dependent of the timer a n d is
activated w h e n the set t i m e is exceeded by 2 0 %. The safety device s h a l l te rm i n ate the O P T I CAL
RAD IAT I O N output a n d s h a l l prevent fu rth e r operation of the equ i p ment.
A second t i m e r may be a means of ach iev i n g co m p l i a nce with this requ i rement.
Compliance i s checked b y inspection and measurements.
201.10.105 *Protection against HAZARDOUS or visually disturbing STRAY OPTICAL

RADIATION
The MAN U FACT U R E R of LS EQU I PM E N T s h a l l assess the risk to the eyes of perso n n e l or the PAT I E N T ,
d u e to STRAY O P T I CAL RADIAT I O N arising from the target s i t e . The res u lts of t h e r i s k assess ment
shall be i n cluded in the R I SK MANAG E M E N T F I LE.
If expos u re to STRAY O PT I CAL RAD I AT I O N could res u l t in an u n accepta b l e risk, the user s h a l l be
i nformed a bout the s pecification of safety eyewear to be worn , refe r to 2 0 1 . 7. 9 . 2 . 1 7 . 1 0 1 . 2 .
STRAY OPTI CAL RAD IAT I O N i n t h e VISI B L E reg i o n ( V I S ) c a n cause v i s u a l d isturb a n ces, pos s i b l y
fo l l owed by afte rimages, headaches or o t h e r effects o f tra n s i e n t ada ptatio n . The MAN U FACT U R E R
s ha l l assess the risk fo r effects of STRAY OPTI CAL RAD IAT I O N wh ich com prom ise the a b i l ities of
the O P E RATO R or other person n e l , and w h i c h make the O P E RATOR suffe r from u n a ccepta b l e
v i s u a l i m pairments .
Accord i n g t o the result of the risk assess ment, the MAN U FACT U R E R s h a l l p rovide advice to the
O P E RATO R , a bout methods or means to red u ce such risks , refer to 2 0 1 .7. 9 . 2 . 1 7. 1 0 1 . 2 .
NOTE Although diffuse STRAY O P T I CAL RADIATION is believed to be non-hazardous to eyes, potentially HAZA R D O U S
specular reflection of OPTI CAL RADIATION can take place when the target skin is wet or covered with gel. A P P L I CATORS,
which are equipped with sensors which ensure that GOOD C O NTACT is maintained can have sudden gaps or cracks
between the window and the skin which allow specular reflected light to escape into free space, while the sensors
. . still to1 e.r. ate i rn perfect contact.
_
I E C 6060 1 -2-57 : 2 023 © I E C 2023 - 21 -
201 .1 1 Protection against excessive temperatures and other HAZARDS
C l a use 11 of I E C 6060 1 - 1 : 2 005, IEC 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

I E C 6060 1 - 1 : 2 00 5/A M D 2 : 2 02 0 a p p l i e s .
2 0 1 . 1 2 Accuracy o f controls and instruments and protection against HAZARDO U S

outputs

I E C 606 0 1 - 1 : 2005/AM D2 : 2 02 0 a p p l i e s , except as fo l l ows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 *In dicatio n of LS EQUIPMENT OUTPUT
s h a l l d i s p l ay the selected v a l u e of the output of the O P T I CAL RAD I AT I O N i n S I u n its

LS EQU I PM E N T
( use of submultiples, e . g . either cm 2 or m 2 , is al lowe d ) .
Compliance is checked by inspection.
201.12.4.2 *Indication relevant to safety
Addition:
201.12.4.2.101 Specific requirements for the LS EQUIPMENT
The LS E Q U I P M E NT O UT P U T and , where a p p l icabl e , P U LSE D U RAT I O N , e m itted by the equ i p ment
s h a l l not deviate fro m the i n d i cated S E T VALU ES by more than ±20 %. A measu red quantity,
e l ectrical or optica l , w h i c h is related to the LS EQU I PM E N T OUTPUT and P U LSE D U RATI O N , s h a l l be
mon itored d u r i n g operation . The m o n itori ng s h a l l be carried out at i n te rva l s shorter than the
fa i l u re tolerance t i m e .
The L S EQ U I P M E NT O U T P UT e m i tted a t the T REATM E N T A R EA s h a l l b e capable o f be i n g ch ecked

each time the LS EQ U I P M ENT i s switched to S U P P LY MAI N S. The MAN U FACT U R E R s ha l l p rovide
i nform ation about the ch eck proce d u re .
T h e L S EQU I P M ENT s h a l l n o t be able t o b e p u t i nto t h e READY state before the L S E Q U I P M ENT

OUTPUT has been ch ecked and the check has been valid ated each time the LS EQ U I P M ENT i s
switched to S U P P Ly M A I N S.
The P U LSE D U RAT I O N s h a l l be ch ecked at reg u l a r i nterva l s . T h e test methods and the i nterva ls
s h a l l be described in the i n stru cti ons for use in accord a nce with 2 0 1 .7. 9 . 2 . 1 7. 1 0 1 . 2
Compliance is checked by inspection and measurements.
Addition:
201.12.4.2.102 EMERGENCY STOP for OPTICAL RADIATION
LS EQU I PM E N T classified a s Risk G ro u p 3 s h a l l i n corporate a n E M E RG E N CY STOP. The E M E R G E N CY

STOP s h a l l i m med iate ly stop the e m i s s i o n of OPTI CAL RADIAT I O N . The EM ERG ENCY STOP s ha l l be
d es i g ned to be i n dependent of a l l other O P T I CAL RADIAT I O N contro l syste m s . The switch s h a l l be
a red push-button device a n d positioned to be read i ly visible a n d e a s i l y a n d quickly reached by
the LS E Q U I P M E N T O P E RATOR fro m the operati n g pos i t i o n . " E M ER G E N CY STO P " or the sy mbol
a ccord i n g to Table E E . 1 , symbol 1 0 1 , s h a l l be marked on or near the p u s h -butto n .
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If a n E M E R G E N CY STOP device as s pecifi ed i n IEC 6 0947-5-5 i s i n corporated i n the L S EQU I P M E N T ,

the E M E RG E N CY STO P fo r O P T I CAL RAD I AT I O N is n ot requ i re d .
NOTE The E M E R G E N CY STOP for O PT I CAL RADIAT I O N can be marked with a symbol, see Annex CC.
2 0 1 . 1 3 HAZARDOUS SITUATIONS a n d fa u l t c o n d i t i o n s for ME EQUIPMENT

I E C 606 0 1 - 1 : 2005/AM D2 : 2 02 0 a p p l i e s except as fo l l ows :
201.13.1 Specific hazardous situations
Addition:
201.13.1.101 OPTICAL RADIATION HAZARDS
When a p p l y i n g the S I N G L E FAULT CO N D IT I ON S as described i n 4 . 7 of I E C 6060 1 - 1 : 2 0 0 5 ,

I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 a n d I E C 606 0 1 - 1 : 2 0 0 5/AM D 2 :2020 and l i sted i n 1 3 . 2 of
I E C 606 0 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 0 0 5/AM D 1 : 2 0 1 2 a n d I E C 606 0 1 - 1 : 2 005/A M D 2 : 2 0 2 0 , none of
the HAZARD O US SITUAT I O N S descri bed in 1 3. 1 of I E C 6060 1 - 1 : 2 0 0 5 ,
I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 a n d I E C 6060 1 - 1 : 2 005/A M D 2 : 2020 a n d t h i s docu m e n t
( i n clus ive) s h a l l o c c u r i n the LS EQU I PM E NT.
For LS E Q U I P M E N T , a S I N G L E FAULT C O N D I T I O N s h a l l not res u l t in an i n c rease of acces s i b l e output

g reater t h a n 1 00 % a bove the n o m i n a l value, or i n a n u n i ntended re lease of O P T I CAL RAD I AT I O N .
Atte ntion should be g iven to compone nts i n the e m ission control chai n , such as e l ectro n i c
circ u i ts , opto-e l ectro n i c or m e c h a n ical m e a n s o f contro l , switches , ti mers, mon ito ring c i rcu its,
i nterlocks and contact se nsors . The choice of compone nts which a re fa i l -safe or red u n d ant may
be considered .
2 0 1 . 1 4 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)

I E C 606 0 1 - 1 : 2005/AM D2 : 2 02 0 a p p l i e s .
2 0 1 . 1 5 C o n st r u ct i o n of M E EQUIPMENT

I E C 6060 1 - 1 : 2 00 5/A M D 2 : 2 02 0 a p p l i e s .
2 0 1 . 1 6 M E SYSTEMS

I E C 6060 1 - 1 : 2 00 5/A M D 2 : 2 02 0 a p p l i e s .
2 0 1 . 1 7 E l ectro m a g n et i c c o m pati b i l ity of M E EQUIPMENT a n d ME SYSTEMS

I E C 6060 1 - 1 : 2 00 5/A M D 2 : 2 02 0 a p p l i e s .
I E C 6060 1 -2-57 : 2 023 © I E C 2023 - 23 -
Annexes
The a n nexes of I E C 6060 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

I E C 606 0 1 - 1 : 2 005/A M D 2 : 2 020 a p p ly.
- 24 - I E C 6060 1 -2-5 7 : 2 0 2 3 © I E C 2023
Annex AA
( i nfo rm ative )
Particular guidance and rationale
AA. 1 G e n e ra l g u i d a n ce
T h i s a n nex p rovi des a concise rati o n a l e for the i m porta nt requ i re m e nts of this document. Its
pu rpose i s to promote effective a p p l ication of t h i s doc u m e n t by ex p l a i n i n g the reasons for the
requ i re m e nts and provid i n g additional g u i d a n ce where a p propri ate .
AA. 2 Rat i o n a l e fo r p a rti c u l a r c l a u s e s a n d s u b c l a uses
The fo l l owi ng a re rati o n a l e s for s p ec ific clauses and s u bcl a u ses in this document, with c l a use
and subclause n u mbe rs a l i g ned with those i n the body of the document.
201.1.1 Scope
The u p pe r wave length of LS EQ U I P M ENT is l i m ited to 3 000 n m . "FI R", i . e . fa r I N F RA R E D rad iati o n ,
I R-C exceed i n g 3 0 0 0 n m is c l a i m e d by s u p p l i e rs t o have thera peutic effects , t h e thera py be i n g
called "F I R thera py". F I R medica l equ i p me n t d o e s seem to exist which w a s certified a s
com p l i a n t w i t h I E C 6060 1 - 1 . Although s u rg i c a l lasers are k n own such as CO r laser equ i p ment
e m i tting in the F I R at 1 0 600 n m , s i m i l a rly powerfu l non-co h e rent F I R sou rces a re not k n own ,
except heat radiators , warm i n g bla nkets , s a u n a ove n s , etc. However, the know n no n-co h e re n t
F I R sources do not have the rad i a nces or i rrad i a n ces h ig h e n o u g h t o b e HAZARDOUS from just
the OPTI CAL RAD I A T I O N . When F I R m e d i cal equ i p m e n t qual ifies as a medical device, it m ay fa l l
u n d e r the scope o f I E C 6060 1 - 1 . HAZARDS such a s e rythema o r burn fo l l owi n g excessive
e l evation of the body core or s u rface tem peratu res d u e to a m i s s i n g or fa i l i n g te mperature
sensation or d u e to PAT I E N T i m mobi l ity can be co n s i d e re d .
F o r more i nfo rmation s e e [6] . National reg u lation c a n a l s o exist.
201.10.105 Protection against HAZARDOUS or visually disturbin g STRAY OPTICAL RADIATION
LS E Q U I P M ENT usua l ly comp rises optical A P P L I CATORS w h i c h d i rect the O P T I CAL RAD IAT I O N o n to
the target tissue such as skin or m u cosa. A fracti on of the O P T I CAL RAD IAT I O N is e i t h e r d iffu sely
scattered or specula rly reflected - the l atte r, fo r exa m p l e , when the target tissue is kept mo ist
or is covered with g e l . When the A P P L I CATOR i s i n close conta ct with the target tissue d u ri n g the
treatment, the A P P L I CATOR i s ass u m e d to serve as a s h i e l d thus red ucing the amount of stray
e m i ss i o n . A h a lo-l ike rim of scatte red l ig ht potent i a l ly reac h i n g the eyes a n d skin of perso n n e l
or t h e PAT I E N T , m ay b e p rese nt.
S i nce the source may be as strong as RG-3 a n d e m its i n the wave length ra nges of U V , V I S or
IR, a n y u nwa nted visual effects of STRAY OPTI CAL RAD I AT I O N to perso n n e l need to be considered .
Stray e m ission i n the V I S can atta i n d isturbing leve l s , i n c l u d i n g seco n d a ry effects , such as
headaches or deterio rated visual control of the treated tissue by the O P E RATOR. I ntense flashes
may sti l l be seen at the set repeat frequency e m e rg i n g fro m the very site which needs to be
observed by the O P E RATOR d u r i n g treatm ent.
I E C 6060 1 -2-5 7 : 2 0 2 3 © I E C 2023 - 25 -
C l i n i cians u s i n g i ntense P U LS E D l i g h t equ i p m e n t may find it d iffi cult to assess the c l i n i ca l tissue
res ponse to treatment w h i l e wea ring d a rk "we l d e r" eyewear. Even the use of the au to s h utter
eyewea r does not always satisfacto r i ly neg ate the back fl ash i mage for the user because of the
i n h e rent d e l a y of the d a rke n i n g functio n . Wea ri n g a high i l l u m i na n ce overhead l i g h t may p rove
effective in the red u ction of the excess fl a s h l a m p backscatte r i n g expos u re above the
i l l u m i n ation level of the treat ment target site. A general h i g h level of a mbient l i g ht wo u l d a l s o
b e of h e l p . Eyewea r w h i c h absorbs i n the red may p rove usefu l t o fu rther red u ce the re lative
amount of excess fl ash i nte ns ity, but it also i ntroduces a colour s h ift towa rds g ree n , which
makes tissue observation d ifficult.
There does not seem to be a n y scie ntific evide nce fo r a n assertion that d iffuse STRAY O P T I CAL
RAD IAT I O N from i ncohere n t sources reaches HAZAR DOUS leve l s , neither fo r U V, nor for V I S or I R .
S i nce the level o f s pecu l a r refl ection from l iquid o r g e l s u rfaces i s down to a p prox i m ate ly 5 %
fro m the o r i g i n a l ( F re s n e l reflection ) , such spec u l a r reflection seems to be g e n e ra l ly acce pted
as be i n g non-h aza rd ous to eyes or sk i n of pers o n n e l .
STRAY O P T I CAL RADIAT I O N fro m non-cohere n t medical U V equ i p me n t seems t o b e scientifically

a ccepted as not pos i n g a HAZARD to perso n n e l . Any U V leakage that i s u n i nte nded should not
be assessed with a n e i g h t h o u rs c u m u lative expos u re to radiation i n m i n d , but o n ly the time of
a few treatme nts as expected expos u re to the PAT I E NT.
201.12.1.101 Indication of LS EQUIPMENT OUTPUT
The d i sp lay of the output is reg a rded as be i n g i m porta nt fo r com parison of treatm ent param eters
of d iffe re nt LS EQ U I PM E NT. The ph otobiological effects a lso d e p e n d on other e m ission
parameters , l ike wave l e n gth ra n g e (fi lteri n g ) a n d te m poral c h a racteristics. There a re sometimes
no n-qu antitative step controls of the output, and the associ ated S I value i s show n o n ly in the
ACC O M PAN Y I N G L I T E RATU R E.
When the LS E Q U I P M E N T is contro l l e d by sett i n g target tissue para meters , e . g . the skin type or
h a i r colour, a n d the LS E Q U I P M ENT derives the accord i n g output by an i nte rnal a l gorith m , then
i nform ation o n the a ctu a l output i s i m portant for the O P E RATO R to k n ow and needs to be
d i sp l ayed .
201.12.4.2 Indication of parameters relevant to safety
F a i l u re tolera nce t i m e :
L s E Q U I P M E N T w h i c h term i n ates e m ission d u e t o a fa ult condition requ i res t i m e t o d etect the

fa u lt and i n terrupt the e m i ssion . An excess exposu re may be tolerated by the PAT I E N T or cl ient
for a certa i n t i m e . This time i s c a l l ed fa i l u re to l e rance t i m e . The fa i l u re to l e ra n ce t i m e d e p e n d s
on both the vu l n erabil ity o f the target t i s s u e a n d the e m ission c h a racte ristics o f the
LS E Q U I P M E N T. T h e fa i l u re tolerance time should be dete r m i n e d by the MAN U FACT U R E R i n the
R I S K MANAG E M E NT F I LE.
- 26 - I E C 6060 1 -2-5 7 : 2 0 2 3 © I E C 2023
Annex B B
( i nfo rm ative )
Summary of MAN U FACT U RER ' S requirements
See Table B B . 1 .
Table 8 8 . 1 - Summary of MANUFACTURER' S requirements
Req u i rements RISK GROUP 1 C Risk Grou p 3
H i g h risk - m a y pose a HAZARD

Description of risk gro u p
Low ris k even for m o m entary or brief
(refer to 20 1 . 6 . 1 . 1 02 )
ex pos u re
Labels and marking

Req u ired Req u ired
20 1 . 7 . 2 . 1 0 1
Key control
20 1 . 1 0 . 1 0 3 1 )
E M E R G E N CY ST O P
2 0 1 . 1 2 . 4 . 2 . 1 0 2 ; Annex CC
O P T I CAL RADIATI O N indicator

Requ ired Req u ired
2 0 1 . 1 0 . 1 03 3 )
STA N D BY/READY
20 1 . 1 0 . 1 0 3 6 ) ; Annex CC
Exposure terminat ion

2 0 1 . 1 0 . 1 04
O C U LAR HAZARD D I STA N C E inform ation

Not requ ired Req u ired
2 0 1 . 7 . 9 . 2 . 1 7 . 1 0 1 . 1 fourth d a s h
Information o n LS EQU I P M E N T O UTPUT

2 0 1 . 7 . 9. 2 . 1 7 . 1 0 1 . 1
Safety inform ation

2 0 1 . 7 . 9. 2 . 1 7 . 1 0 1 . 2
I E C 6060 1 -2-57 : 2 023 © I E C 2023 - 27 -
Annex CC
( i nfo rm ative )
Sym bols on mar king
The symbols g iven in Ta b l e CC . 1 may be used on LS E Q U I PM E N T .
Table CC.1 - Symbols, references and descriptions
No. Symbol IEC reference Descri pti on
101 I E C TR 60878, E M E RG E N CY STOP for OPTICAL RADIATI O N .
@ (symbol 6 1 96)
1 02 I E C TR 60878, STAND-BY/READY (STAND-BY)
0 (symbol 5 2 6 6 )
1 03 I E C TR 60878, STAND-BY/READY ( R EADY) a
0 (symbol 5 2 64)
1 04 I E C TR 60878, C O N T I N U O U S O P E RATION . T h e LS E Q U I P M E NT is set to a mode,
J
(symbol 6 1 87 ) w h ere t h e EXPOSU R E D U RATI O N is l i m ited by T H E LS E Q U I P M E NT
I E C 604 1 7-6 1 87 O P E RATOR actuating and releasing the switch
( 2 0 1 3-03)
1 05 I E C TR 60878, Sing le exposure. T h e LS E Q U I P M E N T is set to a mode, where one
1l_
(symbol s ingle expos u re of a g iven d u ration is em itted when t h e switch is
I E C 6060 1 -2-22- activated
1 05 ( 2 0 1 9-1 1 ) )
1 06 I E C TR 60878, Repeat exposure. T h e LS EQU I P M E N T is set to a mode, w h ere a
JlJl
(symbol series of exposures of a g iven d u ration and of a g iven P U L S E
I E C 6060 1 -2-22- I N T E RVAL are e m i tted as long as the switch is activated
1 06 ( 2 0 1 9-1 1 ) )
1 07 I E C TR 60878, EXPOS U RE D U RATION
jl_
(symbol
I E C 6060 1 -2-22-
1 0 7 (20 1 9- 1 1 ) )
1 08 I E C TR 60878, Repeat exposure P U L S E repetition time
Jt{l
(symbol
I E C 6060 1 -2-22-
1 08 ( 2 0 1 9-1 1 ) )
1 09 I E C TR 60878, Special ized P U L S E D mode. A P U L S E D mode of the l i g h t source
ilil
(symbol eq u i p ment which may be used as an a lternative to t h e mode of
I E C 6060 1 -2-22- C ON T I N U O U S OP E RATION
1 09 (20 1 9- 1 1 ) )
1 13 I E C TR 60878, Optical fibre A P P L I CATOR
7u-·
(symbol
I E C 6060 1 -2-22-
1 1 3 ( 2 0 1 9-1 1 ) )
1 14 I E C TR 60878, PRF, P U L S E repetition freq u ency [rate]
WJllt
(symbol
I E C 6060 1 -2-22-
1 1 4 (20 1 9- 1 1 ) )
NOTE T h e above l ist is not a n excl u s ive l ist. Other s y m bo l s can be chosen from I E C TR 6 0 8 7 8 i f a p propriate
a
T h i s s y m bol is l i sted in Table D . 1 , No 1 6 of I E C 6 0 60 1 - 1 : 2 0 0 5 as " O N" for part of the eq u i p ment. Ls EQU I P M E N T
can m a ke u s e o f t h i s s y m bol t o indicate t h e "STA N D BY" and " R EADY" states.
- 28 - I EC 6060 1 -2-57:2023 © I E C 2023
B i b l io g ra p h y
[1 ] I EC 60335-2- 1 1 3 , Household and similar electrical appliances - Safety - Part 2- 1 1 3:

Particular requirements for cosmetic and beauty care appliances incorporating lasers
and intense light sources
[2 ] IEC 60335-2-27 , Household and similar electrical appliances - Safety - Part 2-27:
Particular requirements for appliances for skin exposure to optical radiation
[3 ] IEC 6060 1 -2-83 : 20 1 9 , Medical electrical equipment - Part 2-83: Particular requirements
for the basic safety and essential performance of home light therapy equipment
[4 ] I C N I R P G u i d e l i nes on L i m its of Expos u re to I n cohere nt Vis i b le a n d I nfra red Rad iati o n ,

H ealth P hys i cs 1 05 ( 1 ) : 76-96 ; 20 1 3
[5 ] I C N I R P G U I D E L I N E S o n l i m its of expos u re to u l trav i o let ra d i ation of wave l e n gths

between 1 80 n m a n d 400 nm ( i ncoherent optical radiation ) , p u b l i s h e d i n : H EAL TH
P H YS I C S 87(2) : 1 7 1 - 1 86 ; 2004
[6 ] I C N I R P State ment on F a r I nfra red Radiation Expos u re - P u b l is h e d i n : Health Physics

9 1 (6): 630-645; 2006
[7 ] I E C TR 60878, Graphical symbols for electrical equipment in medical practice

IEC 6060 1 -2-57:2023 © I E C 2023 - 29 -
I n d ex of defi ned terms used i n t h i s document

ACCOMPAN Y I N G D OC U M E N T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IEC6060 1 - 1 :2005, 3 . 4
A P P L I CATO R 201 . 3 . 2 0 1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BAS I C I N S U LAT I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .I E C 6060 1 - 1 :2005, 3 . 9

CONT I N U O U S O P E RAT I O N 2 0 1 .3 . 1 8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E M E R G E N CY STOP 201 .3 .202

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
E M I S S I O N APERTURE 2 0 1 .3 .203
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
EXP O S U R E D U RATI O N 2 0 1 .3 .204

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GOOD CONTACT 201 .3 .205

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HAZARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . !EC 6060 1 - 1 :2005, 3.39
LS EQU I PM E N T 201 .3 .206

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
LS EQU I PM E N T OUTPUT 201 .3 .207

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
M A I N S PART IEC 6060 1 - 1 :2005, 3.49

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MAN U FACT U R E R I E C 6060 1 - 1 :2005, 3.55

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
M E C HA N I CAL HAZARD ! E C 6060 1 - 1 :2005, 3 . 6 1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
M E EQU I P M ENT I E C 6060 1 - 1 :2005, 3.63

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
M E SYSTEM ! E C 6060 1 - 1 :2005, 3 . 64

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
N O RMAL U S E I E C 6060 1 - 1 :2005, 3. 7 1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
O C U LAR EXPOS U R E L I M IT 201 .3 .208

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
O C U LAR HAZARD D I STAN C E , OHO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201 .3 .209
O P E RATO R 201 . 3 . 73
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OPTI CAL RADIAT I O N 201 . 3 .2 1 0

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PATI ENT 201 .3 .76

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PULSE, PULSED 201 . 3 . 2 1 1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
P U L S E D U RAT I O N 201 . 3 .2 1 2
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P U L S E I NT E RVAL 201 . 3 .2 1 3
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P U L S E T RA I N 2 0 1 . 3 .2 1 4
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READY 201 . 3 .2 1 5
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READY I N D I CATO R 201 . 3 .2 1 6

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R I S K MANAG E M E NT F I LE I E C 6060 1 - 1 :2005, 3 . 1 07

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R I S K G R O U P 1 C , RG-1 C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201 . 3 .2 1 7
SET VAL U E 201 . 3 .2 1 8

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S I N G L E FAULT C O N D I T I O N I E C 6060 1 - 1 :2005, 3 . 1 1 6

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STAN D-BY 201 . 3 .2 1 9

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S U P P LY MAI N S I E C 6060 1 - 1 : 2005, 3 . 1 20

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STRAY OPTI CAL RAD IAT I O N 2 0 1 .3 .220

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TREAT M E N T A R EA 201 .3 .22 1

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U LTRAV I O L E T , UV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201 . 3 .222
V I S I B L E , V I S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201 .3 .223
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Medical electrical equipment -

ICS 11. 040.50, 11.040.60 ISBN 978-2-8322-7296-1

® Registered trademark of the International Electrotechnical Commission

F i g u re 2 0 1 . 1 0 1 - Exa m p l e of explan atory label fo r a device with m u l t i p l e h aza rd

Ta ble 2 0 1 . 1 04 - Requ i re m e n ts for m a rk i n g of LS EQUI P M ENT accord i n g to risk g ro u p

INTERNATIONAL ELECTROTECHNICAL COMMISSION

MEDICAL EL ECTRICAL EQUIP M ENT -

1) The I nternational Electrotechnical Commission ( I E C) is a worldwide organization for standardization comprising

T h i s second edition cancels a n d re p l aces the fi rst edition published i n 2 0 1 1 . T h i s edition

a ) T h i s e d i t i o n con stitutes a m ajor review o f the previous ed ition a n d covers t h e rece nt

T h e text o f this I nternati o n a l Sta n d a rd i s based on t h e fo l low i n g documents:

Draft Report on voting

The l a n g u a g e u s e d for the deve l o p m e n t o f this I nternational Sta n d a rd i s E n g l i s h .

I n t h i s document, the fo l l ow i n g print types a re used :

Requ i re m e n ts a n d defi n itions : ro m a n ty pe.

In referring to the struct u re of t h i s docu m e n t , the term

The verba l fo rms u s e d i n t h i s document conform t o u s a g e desc ribed i n C l a use 7 o f t h e

T h i s document a m e n d s and s u p p l e ments I E C 6060 1 - 1 : 2 0 0 5 , I EC 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2

The requ i re m ents of this document s h o u l d be take n as the m i n i m u m to comply wit h , i n o rd e r to

MEDICAL EL ECTRICAL EQUIP M ENT -

201 .1 Scope, object and related standards

C l a use of I E C 6060 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

T h i s part of I E C 6060 1 -2 a p p l i es to BASIC SAFETY a n d ESSENTIAL P E RFO RMAN C E of equ i p ment

T h i s document a p p l ies to LS E Q U I P M ENT of RISK G RO U P 1 C if the i n corporated source of O P T I CAL

NOTE 1 For classification rules for Risk Groups, see 201.6.1.102.

T h i s document does n ot a p p l y to equ i p m e n t fo r s u n ta n n i ng such as s u n l a m p p rod ucts , for

T h i s d o c u m e n t d o e s not a p p l y t o h ome-use a p p l i a n ces . I t does n o t a pply t o home l i g h t thera py

N umbers in square brackets refer to the Bibliography.

The objects of t h i s document are:

- to red u ce the p oss i b i l ity of adverse effects a n d i n ju ries by m i n i m i z i n g u n n ecessary

201.1.3 Collateral standards

A l l coll atera l sta n d a rds a p p l y , except I E C 6060 1 - 1 - 1 1 .

201.1.4 Particular standards

The n u m b e r i n g o f c l a uses a n d s u b c l auses o f this d o c u m e n t corres ponds t o t h at o f

"Re p l ace m e n t" means that the c l a use or s u bc l a use of I E C 606 0 1 - 1 : 2 0 0 5 ,

"Am e n d m e nt" means that the c l a use or subc l a use of I E C 606 0 1 - 1 : 2 0 0 5 ,

S ubcl a uses , fi g u res or tables which a re add itional to those of I E C 606 0 1 - 1 : 2 0 0 5 ,

NOTE I nformative references are listed in the Bibliography.

C l a use 2 of I E C 6060 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

I E C 60947-3, Low-voltage switchgear and contra/gear - Part 3: Switches, disconnectors,

I E C 624 71 , Photobiological safety of lamps and lamp systems

2 0 1 .3 Terms and definitions

C l a use 3 of I E C 6060 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

N ote 2 to entry: EXPOS U R E DURATION is measured in seconds (s).

N ote 1 to entry: O C U LAR EXPOS U R E L I M ITS can be found in I C N I R P G uidelines:

N ote 1 to entry: OCU LAR HAZARD DISTA N C E is measured in metres (m).

N ote 1 to entry: P U L S E DURATION is measured in seconds (s).

N ote 1 to entry: P U L S E I N T ERVAL is measured in seconds (s).

C l a use 4 of I E C 6060 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

T h e requ i re m e nts for m a n ufactu rers are s u m m a ri zed i n Annex B B .

20 1 .5 General requirements for testing ME EQUIPMENT

C l a use 5 of I E C 6060 1 - 1 : 2 0 0 5 , I E C 606 0 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

20 1 .6 Classification of ME EQUIPMENT and ME SYSTEMS

C l a use 6 of I E C 6060 1 - 1 : 2 0 0 5 , I E C 6060 1 - 1 : 2 005/A M D 1 : 2 0 1 2 and

201.6.1.101 Classification responsibilities

The LS E Q U I P M E N T s h a l l be classified by the m a n ufa cturer accord i n g to the cl assification rules