929.304 Popis Hrvatskih Norma...

Na temelju lanka 8. stavka 2. Zakona o medicinskim proizvodima (Narodne novine, br.
67/08), te na temelju dostavljenog popisa hrvatskih norma na podruju medicinskih proizvoda

od Hrvatskog zavoda za norme, ministar zdravstva i socijalne skrbi objavljuje
POPIS HRVATSKIH NORMA ZA MEDICINSKE PROIZVODE 2010-05-24
(Narodne novine, broj 79/10)
Aktivni medicinski proizvodi za ugradnju

Oznaka hrvatske
Naslov hrvatske norme
norme
Oznaka
Naslov engleske norme
europske norme
HRN EN 5561:2008
Sterilization
of
medical
devices Requirements for
medical devices to be
designated STERILE
EN 556-1:2001
Part 1: Requirements for
terminally sterilized medical
devices
(EN
5561:2001+AC:2006)
HRN EN 5562:2008
Sterilization
of
medical
EN 556-2:2003 designated STERILE
aseptically processed medical
devices (EN 556-2:2003)
HRN
980:2008
EN
HRN
1041:2008
EN
HRN EN ISO
11135-1:2008
EN 980:2008
Symbols for use in the

labelling of medical devices
(EN 980:2008)
EN 1041:2008
Information supplied by the

manufacturer of medical
devices (EN 1041:2008)
Sterilization of health care

products Ethylene oxide
development, validation and
EN ISO 11135routine
control
of
a
1:2007
sterilization
process
for
medical devices (ISO 111351:2007; EN ISO 111351:2007)
Sterilizacija proizvoda za
zdravstvenu skrb Zraenje
products Radiation Part 1:
1. dio: Zahtjevi za razvoj,
Requirements
for
vrednovanje
i
kontrolu
HRN EN ISO
EN ISO 11137provedbe
sterilizacijskog
routine
control
of
a
11137-1:2007
1:2006
postupka za medicinske
sterilization
process
for
proizvode
(ISO
11137medical devices (ISO 111371:2006; EN ISO 111371:2006; EN ISO 111371:2006)
1:2006)
HRN EN ISO
11137-2:2008

EN ISO 11137- Establishing the sterilization
2:2007
dose (ISO 11137-2:2006,
corrected version 2006-0801; EN ISO 11137-2:2007)
Sterilizacija
medicinskoga
Sterilization
of
medical
pribora Mikrobioloke
devices Microbiological
metode 1. dio: Odreivanje
methods
Part
1:
HRN EN ISO vrste
i
broja EN ISO 11737- Determination
of
a
11737-1:2006
mikroorganizama
na 1:2006
population
of
proizvodima (ISO 11737microorganisms on products
1:2006; EN ISO 11737(ISO 11737-1:2006; EN ISO
1:2006)
11737-1:2006)
Medicinski ureaji Sustavi
Medical devices Quality
upravljanja kvalitetom
management
systems
HRN EN ISO
EN
ISO
Zahtjevi
za
zakonsku
Requirements for regulatory
13485:2003
13485:2003
namjenu (ISO 13485:2003;
purposes (ISO 13485:2003;
EN ISO 13485:2003)
EN ISO 13485:2003)
HRN EN ISO upravljanja kvalitetom EN
ISO management
systems
13485:2003/Ispr. Zahtjevi
za
zakonsku 13485:2003/AC: Requirements for regulatory
1:2008
namjenu
(EN
ISO 2007
purposes
(EN
ISO
13485:2003/AC:2007)
13485:2003/AC:2007)
HRN
13824:2007
Sterilizacija
medicinskih
proizvoda
Sterilna
EN
priprema
tekuih EN 13824:2004
medicinskih proizvoda
Zahtjevi (EN 13824:2004)
HRN EN ISO
14155-1:2008
Sterilization
of
medical
devices Aseptic processing
of liquid medical devices
Requirements
(EN
13824:2004)
EN ISO 14155- Clinical investigation of

1:2003
medical devices for human
subjects Part 1: General

requirements (ISO 141551:2003; EN ISO 141551:2003)
HRN EN ISO
14155-2:2008
Clinical investigation of
EN ISO 14155- subjects Part 2: Clinical
2:2003
investigation plans (ISO
14155-2:2003;
EN
ISO
14155-2:2003)

products
General
zdravstvenu skrb Opi
requirements
for
zahtjevi za znaajke sredstva
characterization
of
a
za sterilizaciju i za provedbu,
sterilizing agent and the
ocjenjivanje i tijek ispitivanja
HRN EN ISO
EN
ISO
provedbe
sterilizacije
routine
control
of
a
14937:2005
14937:2000
medicinskih proizvoda (ISO
sterilization
process
for
14937:2000+Cor 1:2003; EN
medical
devices
(ISO
ISO
14937:2000+Cor 1:2003; EN
14937:2000+AC:2003+AC:2
ISO
005)
14937:2000+AC:2003+AC:2
005)
HRN EN ISO
14971:2009
Medical
devices
Application
of
risk
EN
ISO
management to medical
14971:2007
devices (ISO 14971:2007;
EN ISO 14971:2007)
HRN EN ISO
17665-1:2008

products Moist heat Part
1: Requirements for the
EN ISO 17665routine
control
of
a
1:2006
sterilization
process
for
HRN EN 45502- Aktivni

implantabilni EN
1:2000
medicinski ureaji 1. dio: 1:1997
Opi zahtjevi za sigurnost,
oznaivanje i obavijesti koje
mora dati proizvoa (EN
45502- Active implantable medical

devices Part 1: General
requirements
for
safety,
marking and information to
be
provided
by
the
manufacturer
1:1997)
45502-1:1997)
(EN
45502-
Aktivni
implantabilni
Active implantable medical
medicinski ureaji Dio 2-1:
devices Part 2-1: Particular
Posebni zahtjevi za aktivne
requirements
for
active
HRN EN 45502- implantabilne
medicinske EN
45502-2- implantable medical devices
2-1:2008
ureaje (elektrostimulatore 1:2003
intended
to
treat
srca) namijenjene lijeenju
bradyarrhythmia
(cardiac
bradiaritmija (EN 45502-2pacemakers) (EN 45502-21:2003)
1:2003)
Aktivni
implantabilni
Active implantable medical
medicinski ureaji Dio 2-2:
devices Part 2-2: Particular
Posebni zahtjevi za aktivne
requirements
for
active
HRN EN 45502- implantabilne
medicinske EN
45502-2- implantable medical devices
2-2:2008
ureaje namijenjene lijeenju 2:2008
intended
to
treat
tahiaritmija
(ukljuuje
tachyarrhythmia
(includes
implantabilne defibrilatore)
implantable
defibrillators)
(EN 45502-2-2:2008)
(EN 45502-2-2:2008)
Medicinski elektrini ureaji
1. dio: Opi sigurnosni
zahtjevi
(IEC
60601HRN EN 60601EN
1:1988+A1:1991+A2:1995,
1:1999
1:1990
prilag.;
EN
606011:1990+A1:1993+A2:1995+
A13:1996)
Medical electrical equipment
Part
1:
General
requirements for safety (IEC
60601- 606011:1988+A1:1991+A2:1995,
mod.;
EN
606011:1990+A1:1993+A2:1995+
A13:1996)

1. dio: Opi zahtjevi za
HRN EN 60601EN
osnovnu sigurnost i bitne
1:2008
1:2006
radne znaajke (IEC 606011:2005; EN 60601-1:2006)
Part
1:
General
60601- requirements for basic safety
and essential performance
(IEC 60601-1:2005; EN
60601-1:2006)
HRN
62304:2008
Programske
podrke
medicinskih
ureaja
EN Odravanje
programske
EN 62304:2006
podrke za vrijeme ivotnog
vijeka (IEC 62304:2006; EN
62304:2006)
In vitro dijagnostiki medicinski proizvodi
Medical device software

Software life-cycle processes
(IEC
62304:2006;
EN
62304:2006)
Oznaka
norme
hrvatske
Oznaka europske
Naslov europske norme
norme
EN 375:2001

manufacturer with in vitro
diagnostic reagents for
professional
use
(EN
375:2001)
EN 376:2002

manufacturer with in vitro
diagnostic reagents for selftesting (EN 376:2002)
EN 556-1:2001
Sterilization of medical
designated STERILE
terminally
sterilized
medical devices (EN 5561:2001+AC:2006)
EN 556-2:2003
Sterilization of medical
designated STERILE
aseptically
processed
medical devices (EN 5562:2003)
EN 591:2001
Instructions for use for in

vitro diagnostic instruments
for professional use (EN
591:2001)
HRN EN 592:2008
EN 592:2002
Instructions for use for in

vitro diagnostic instruments
for
self-testing
(EN
592:2002)
HRN EN 980:2008
EN 980:2008

(EN 980:2008)
HRN EN 375:2008
HRN EN 376:2008
HRN EN
1:2008
HRN EN
2:2008
556-
556-
HRN EN 591:2008
HRN
12286:2008
HRN
12287:2008
HRN
12322:2008
HRN EN
13485:2003
EN
EN
EN
EN 12286:1998
In vitro diagnostic medical

devices Measurement of
quantities in samples of
biological
origin
Presentation of reference
measurement
procedures
(EN 12286:1998+A1:2000)
EN 12287:1999

quantities in samples of
biological
origin
Description of reference
materials (EN 12287:1999)
EN 12322:1999

devices Culture media for
microbiology
Performance criteria for

culture
media
(EN
12322:1999+A1:2001)
Medicinski
ureaji
Sustavi
upravljanja
ISO kvalitetom Zahtjevi za EN
zakonsku namjenu (ISO 13485:2003
13485:2003;
EN
ISO
13485:2003)

management systems
ISO
EN ISO 13485:2003)
Medicinski
ureaji

HRN EN ISO Sustavi
upravljanja EN
ISO management systems
13485:2003/Ispr.1: kvalitetom Zahtjevi za 13485:2003/AC:2 Requirements for regulatory
2008
zakonsku namjenu (EN 007
purposes
(EN
ISO
ISO 13485:2003/AC:2007)
13485:2003/AC:2007)
HRN
13532:2008
EN
HRN
13612:2008
EN
HRN
EN
EN 13532:2002
General requirements for in

vitro diagnostic medical
devices for self-testing (EN
13532:2002)
EN 13612:2002
Performance evaluation of
in vitro diagnostic medical
devices
(EN
13612:2002+AC:2002)
EN 13640:2002
Stability testing of in vitro
diagnostic reagents
13640:2002)
13640:2008
HRN
13641:2008
HRN
13975:2008
HRN
14136:2008
HRN
14254:2008
EN
EN
EN
EN
(EN
EN 13641:2002
Elimination or reduction of
risk of infection related to
in vitro diagnostic reagents
(EN 13641:2002)
EN 13975:2003
Sampling procedures used

for acceptance testing of in
vitro diagnostic medical
devices Statistical aspects
(EN 13975:2003)
EN 14136:2004
Use of external quality

assessment schemes in the
assessment
of
the
performance of in vitro
diagnostic
examination
procedures
(EN
14136:2004)
EN 14254:2004

devices
Single-use
receptacles
for
the
collection of specimens,
other than blood, from
humans (EN 14254:2004)
EN 14820:2004
Single-use containers for

human
venous
blood
specimen collection (EN
14820:2004)
HRN
14820:2008
EN
HRN EN
14937:2005
ISO Sterilizacija proizvoda za EN

zdravstvenu skrb Opi 14937:2000
zahtjevi
za
znaajke
sredstva za sterilizaciju i za
provedbu, ocjenjivanje i
tijek ispitivanja provedbe
sterilizacije
medicinskih
proizvoda
(ISO
14937:2000+Cor 1:2003;
EN
ISO
14937:2000+AC:2003+AC
:2005)
ISO Sterilization of health care

products
General
requirements
for
characterization
of
a
sterilizing agent and the
development,
validation
and routine control of a
sterilization process for
medical
devices
(ISO
14937:2000+Cor 1:2003;
EN
ISO
14937:2000+AC:2003+AC:
2005)
HRN EN
14971:2009
HRN EN
15197:2007
HRN EN
15225:2008
EN
14971:2007
Medical
devices
Application
of
risk
ISO
management to medical
devices (ISO 14971:2007;
EN ISO 14971:2007)
Dijagnostiki
sustavi
ispitivanja in vitro
Zahtjevi
za
sustave
ISO praenja glukoze u krvi za EN
samoispitivanje
eerne 15197:2003
bolesti (ISO 15197:2003;
EN
ISO
15197:2003+AC:2005)
In vitro diagnostic test

systems Requirements for
blood-glucose monitoring
ISO
systems for self-testing in
managing diabetes mellitus
(ISO 15197:2003; EN ISO
15197:2003+AC:2005)
ISO
ISO
EN
15225:2000
Nomenclature
Specification
for
a
nomenclature system for
medical devices for the
ISO purpose of regulatory data
exchange
(ISO
15225:2000+Amd 1:2004;
EN
ISO
15225:2000+A1:2004+A2:
2005)
quantities in biological
samples Metrological
ISO
traceability
of
values
assigned to calibrators and
control materials (ISO
17511:2003;
EN
ISO
17511:2003)
HRN EN
17511:2008
ISO
EN
17511:2003
HRN EN
18153:2008
ISO
EN
18153:2003
ISO In vitro diagnostic medical

quantities in biological
samples Metrological
traceability of values for
catalytic concentration of
enzymes
assigned
to
calibrators and control
materials (ISO 18153:2003;
EN ISO 18153:2003)
HRN EN ISO
20776-1:2008
Clinical laboratory testing

and in vitro diagnostic test
systems Susceptibility
testing of infectious agents
and
evaluation
of
performance
of
antimicrobial susceptibility
EN ISO 20776- test devices Part 1:
1:2006
Reference
method
for
testing the in vitro activity
of antimicrobial agents
against rapidly growing
aerobic bacteria involved in
infectious diseases (ISO
20776-1:2006; EN ISO
20776-1:2006)
Sigurnosni zahtjevi za
Safety requirements for
mjernu,
upravljaku
i
electrical equipment for
laboratorijsku
elektrinu
measurement, control and
opremu Dio 2-101:
laboratory use Part 2-101:
HRN EN 61010-2- Posebni zahtjevi za in vitro EN
61010-2- Particular requirements for
101:2004
dijagnostiku
(IVD) 101:2002
in vitro diagnostic (IVD)
medicinsku opremu (IEC
medical equipment (IEC
61010-2-101:2002,
61010-2-101:2002,
preinaena; EN 61010-2modified; EN 61010-2101:2002)
101:2002)
Elektrina
oprema
za
mjerenje,
voenje
i
Electrical equipment for
laboratorijsku uporabu
measurement, control and
Zahtjevi
za
laboratory use EMC
elektromagnetsku
requirements Part 2-6:
HRN EN 61326-2- kompatibilnost (EMC) EN
61326-2- Particular requirements In
6:2008
Dio 2-6: Posebni zahtjevi 6:2006
vitro diagnostic (IVD)
Medicinski ureaji za in
medical equipment (IEC
vitro dijagnostiku (IEC
61326-261326-26:2005+Corr.1:2007;
EN
6:2005+Corr.1:2007; EN
61326-2-6:2006)
61326-2-6:2006)
HRN
62304:2008
EN Programske
podrke EN 62304:2006
medicinskih ureaja
Odravanje
programske
podrke
za
vrijeme

Software
life-cycle
processes (IEC 62304:2006;
EN 62304:2006)
ivotnog
vijeka
62304:2006;
62304:2006)
HRN
62366:2008
(IEC
EN
Medicinski
elektrini
ureaji
Primjena
EN prikladnog oblikovanja i
EN 62366:2008
konstrukcije medicinskih
ureaja (IEC 62366:2007;
EN 62366:2008)
Medical
devices
Application of usability
engineering to medical
devices (IEC 62366:2007;
EN 62366:2008)
Medicinski proizvodi
Oznaka hrvatske
norme
Oznaka
europske
norme
HRN EN 4551:2008
Medical gloves for single use

Part 1: Requirements and
EN 455-1:2000
testing for freedom from holes
(EN 455-1:2000)
HRN EN 4552:2008

testing for physical properties
EN 455-2:2000
(including
Technical
Corrigendum 1:1996) (EN
455-2:2000)
HRN EN 4553:2008

EN 455-3:2006
testing
for
biological
evaluation (EN 455-3:2006)
HRN EN 5561:2008
Sterilization
of
medical
medical
devices
to
be
EN 556-1:2001 designated STERILE Part
1: Requirements for terminally
sterilized medical devices (EN
556-1:2001+AC:2006)
HRN EN 5562:2008
Naslov europske norme
EN 556-2:2003 Sterilization
of
medical
medical
devices
to
be
designated STERILE Part

2:
Requirements
for
aseptically processed medical
devices (EN 556-2:2003)
Pluni ventilatori 3. dio:
Lung ventilators Part 3:
HRN EN 794- Posebni zahtjevi za prijenosne
Particular requirements for
EN 794-3:1998
3:2004
ventilatore za hitne sluajeve
emergency
and
transport
(EN 794-3:1998)
ventilators (EN 794-3:1998)
Ventilatori plua 3. dio:
Lung ventilators Part 3:
Posebni
zahtjevi
za EN
794- Particular requirements for
HRN EN 794transportne
ventilatore
i 3:1998/A1:200 emergency
and
transport
3:2004/A1:2008
ventilatore za hitnu pomo 5
ventilators
(EN
794(EN 794-3:1998/A1:2005)
3:1998/A1:2005)
HRN
980:2008
EN
HRN
1041:2008
EN
EN 980:2008

(EN 980:2008)

EN 1041:2008 manufacturer
of
medical
devices (EN 1041:2008)
EN
1:1995
Non-invasive
1060- sphygmomanometers Part 1:
General requirements (EN
1060-1:1995+A1:2002)
EN
2:1995
Non-invasive
sphygmomanometers Part 2:
1060- Supplementary requirements
for
mechanical
sphygmomanometers
(EN
1060-2:1995+AC:2002)
HRN EN 10603:2008
EN
3:1997
Non-invasive
1060- Supplementary requirements
for electromechanical blood
pressure measuring systems
(EN 1060-3:1997+A1:2005)
HRN EN 10604:2008
EN
4:2004
HRN EN 10601:2008
HRN EN 10602:2008
1060- Non-invasive
Test procedures to determine
the overall system accuracy of

automated
non-invasive
sphygmomanometers
(EN
1060-4:2004)
Prenosive plinske boce
Oznaivanje plinskih boca
HRN EN 1089EN
(osim UNP) 3. dio:
3:2008
3:2004
Oznaivanje bojom (EN 10893:2004)
Transportable gas cylinders

Gas cylinder identification
1089(excluding LPG) Part 3:
Colour coding (EN 10893:2004)
Traheostomijske cijevi 2.
HRN EN 1282- dio: Cijevi za djecu (ISO EN
2:2008
5366-3:2001,
MOD;
EN 2:2005
1282-2:2005)
Tracheostomy tubes Part 2:

1282- Paediatric tubes (ISO 53663:2001, MOD; EN 12822:2005)
HRN
1618:2008
EN
HRN
1639:2004
EN
HRN
1640:2004
EN
HRN
1641:2004
EN
HRN
1642:2008
EN
Catheters
other
than
intravascular catheters Test
EN 1618:1997
methods
for
common
properties (EN 1618:1997)
Stomatologija Medicinske
Dentistry Medical devices
naprave za stomatologiju EN 1639:2004 for dentistry Instruments
Instrumenti (EN 1639:2004)
(EN 1639:2004)
naprave za stomatologiju EN 1640:2004 for dentistry Equipment (EN
Oprema (EN 1640:2004)
1640:2004)
naprave za stomatologiju EN 1641:2004 for dentistry Materials (EN
Materijali (EN 1641:2004)
1641:2004)
EN 1642:2004 for dentistry Dental implants
(EN 1642:2004)
Conical fittings with a 6%
(Luer) taper for syringes,
EN 1707:1996 needles and certain other
medical equipment Lock
fittings (EN 1707:1996)
HRN
1707:2008
EN
HRN
1782:2004
EN Trahealne cijevi i prikljuci

Tracheal tubes and connectors
EN 1782:1998
(EN 1782:1998)
(EN 1782:1998)
HRN
1789:2008
HRN
1820:2008
HRN
1865:2004
Medicinski
automobili
i
Medical vehicles and their
EN njihova oprema Cestovni
EN 1789:2007 equipment Road ambulances
medicinski automobili (EN
(EN 1789:2007)
1789:2007)
EN
Zrani baloni za anesteziju

Anaesthetic reservoir bags
(ISO 5362:2000, MOD; EN EN 1820:2005 (ISO 5362:2000, MOD; EN
1820:2005)
1820:2005)
Specifikacije za nosila i drugu

opremu za postupanje s
EN bolesnikom
koja
se
EN 1865:1999
upotrebljavaju u cestovnome
medicinskom automobilu (EN
1865:1999)
HRN
1970:2008
EN
HRN
1985:2008
EN
Specifications for stretchers

and other patient handling
equipment used in road
ambulances (EN 1865:1999)
Adjustable beds for disabled

persons Requirements and
EN 1970:2000
test
methods
(EN
1970:2000+A1:2005)
Walking aids General
EN 1985:1998 requirements and test methods
(EN 1985:1998)
HRN EN ISO
3826-2:2008
Plastics collapsible containers

for human blood and blood
components
Part
2:
EN ISO 3826Graphical symbols for use on
2:2008
labels and instruction leaflets
(ISO 3826-2:2008; EN ISO
3826-2:2008)
HRN EN ISO
3826-3:2008
Plastics collapsible containers

for human blood and blood
EN ISO 3826- components Part 3: Blood
3:2007
bag systems with integrated
features (ISO 3826-3:2006;
EN ISO 3826-3:2007)
HRN EN ISO
4074:2008
Natural latex rubber condoms

Requirements and test
EN
ISO methods (ISO 4074:2002+Cor
4074:2002
1:2003+Cor 2:2008; EN ISO
4074:2002+AC:2004+AC:200
8)
Anestetika i respiracijska
Anaesthetic and respiratory
HRN EN ISO oprema Terminoloki rjenik EN
ISO equipment Vocabulary (ISO
4135:2008
(ISO 4135: 2001; EN ISO 4135:2001
4135:
2001;
EN
ISO
4135:2001)
4135:2001)
oprema Stoasti prikljuci
equipment
Conical
HRN EN ISO
EN ISO 53561. dio: Stoasti utikai i
connectors Part 1: Cones and
5356-1:2008
1:2004
utinice (ISO 5356-1:2004;
sockets (ISO 5356-1:2004; EN
EN ISO 5356-1:2004)
ISO 5356-1:2004)
equipment
Conical
oprema Stoasti prikljuci
HRN EN ISO
EN ISO 5356- connectors Part 2: Screw2. dio: Prikljuci na navoj
5356-2:2008
2:2007
threaded
weight-bearing
vee nosivosti (ISO 5356connectors (ISO 5356-2:2006;
2:2006; EN ISO 5356-2:2007)
EN ISO 5356-2:2007)
Niskotlani cjevovodni sklop
Low-pressure hose assemblies
HRN EN ISO za primjenu s medicinskim EN
ISO for use with medical gases
5359:2008
plinovima (ISO 5359:2008; 5359:2008
(ISO 5359:2008; EN ISO
EN ISO 5359:2008)
5359:2008)
Cjevovodni
sustavi
za
Medical gas pipeline systems
medicinske plinove 1. dio:
Part 1: Pipeline systems for
HRN EN ISO Cjevovodni
sustavi
za EN ISO 7396compressed medical gases and
7396-1:2008
komprimirane
medicinske 1:2007
vacuum (ISO 7396-1:2007;
plinove i vakuum (ISO 7396EN ISO 7396-1:2007)
1:2007; EN ISO 7396-1:2007)
Cjevovodni
sustavi
za
Medical gas pipeline systems
medicinske plinove 2. dio:
Part 2: Anaesthetic gas
HRN EN ISO Sustavi za odstranjivanje EN ISO 7396scavenging disposal systems
7396-2:2008
anestetikih plinova (ISO 2:2007
(ISO 7396-2:2007; EN ISO
7396-2:2007; EN ISO 73967396-2:2007)
2:2007)
HRN EN ISO
7886-3:2008
HRN EN ISO
7886-4:2008
Sterile hypodermic syringes

for single use Part 3: AutoEN ISO 7886disable syringes for fixed-dose
3:2005
immunization (ISO 78863:2005; EN ISO 7886-3:2005)
EN ISO 7886- Sterile hypodermic syringes
4:2006
for single use Part 4:
Syringes
with
re-use
prevention feature (ISO 78864:2006; EN ISO 7886-4:2006)
HRN EN ISO
8536-4:2008
Infusion
equipment
for
medical use Part 4: Infusion
EN ISO 8536sets for single use, gravity feed
4:2007
(ISO 8536-4:2007; EN ISO
8536-4:2007)
oprema Izmjenjivai topline
equipment Heat and
i vlage (HMEs) za ovlaivanje
moisture exchangers (HMEs)
HRN EN ISO dinih plinova za ljude 1. EN ISO 9360- for humidifying respired gases
9360-1:2004
dio: HMEs za upotrebu s 1:2009
in humans Part 1: HMEs for
minimalnim
volumenom
use with minimum tidal
udisaja od 250 ml (ISO 9360volumes of 250 ml (ISO 93601:2000; EN ISO 9360-1:2009)
1:2000; EN ISO 9360-1:2009)
oprema Izmjenjivai topline
equipment Heat and
i vlage (HMEs) za ovlaivanje
moisture exchangers (HMEs)
dinih plinova za ljude 2.
for humidifying respired gases
HRN EN ISO
EN ISO 9360dio: HMEs za upotrebu kod
in humans Part 2: HMEs for
9360-2:2004
2:2009
trahetomiranih bolesnika s
use with tracheostomized
minimalnim
volumenom
patients having minimum tidal
udisaja od 250 ml (ISO 9360volumes of 250 ml (ISO 93602:2001; EN ISO 9360-2:2009)
2:2001; EN ISO 9360-2:2009)
HRN EN ISO
10328:2008
Prosthetics Structural testing

of lower-limb prostheses
EN
ISO
Requirements
and
test
10328:2006
methods (ISO 10328:2006; EN
ISO 10328:2006)
Regulatori tlaka za uporabu s

Pressure regulators for use
medicinskim plinovima 1.
with medical gases Part 1:
dio: Regulatori tlaka i
Pressure
regulators
and
HRN EN ISO
EN ISO 10524regulatori tlaka s ureajima za
pressure regulators with flow10524-1:2008
1:2006
mjerenje protoka (ISO 10524metering devices (ISO 105241:2006; EN ISO 105241:2006; EN ISO 105241:2006)
1:2006)
HRN EN ISO Regulatori tlaka za uporabu s EN ISO 10524- Pressure regulators for use
10524-2:2008 medicinskim plinovima 2. 2:2006
dio: Regulatori tlaka baterija
Manifold and line pressure
boca i tlaka sredinjeg sustava
regulators (ISO 10524-2:2005;
opskrbe (ISO 10524-2:2005;

EN ISO 10524-2:2006)
EN ISO 10524-2:2006)
Regulatori tlaka za uporabu s

medicinskim plinovima 3.
HRN EN ISO dio:
Regulatori
tlaka EN ISO 10524- Pressure regulators integrated
10524-3:2008 integrirani s ventilima na boci 3:2006
with cylinder valves (ISO
(ISO 10524-3:2005; EN ISO
10524-3:2005; EN ISO 1052410524-3:2006)
3:2006)
Regulatori pritiska za uporabu
s medicinskim plinovima 4.
HRN EN ISO
EN ISO 10524dio: Niskotlani regulatori
Low-pressure regulators (ISO
10524-4:2008
4:2008
(ISO 10524-4:2008; EN ISO
10524-4:2008; EN ISO 1052410524-4:2008)
4:2008)
HRN EN ISO
10535:2008
Hoists for the transfer of

disabled
persons
EN
ISO
Requirements
and
test
10535:2006
ISO 10535:2006)
HRN EN ISO
10993-7:2008
Biological
evaluation
of
medical devices Part 7:
EN ISO 10993Ethylene oxide sterilization
7:2008
residuals (ISO 10993-7:2008;
EN ISO 10993-7:2008)
HRN EN ISO
11135-1:2008

products Ethylene oxide
EN ISO 11135routine
control
of
a
1:2007
sterilization
process
for
HRN EN ISO Sterilizacija proizvoda za EN ISO 11137- Sterilization of health care

11137-1:2007 zdravstvenu skrb Zraenje 1:2006
1. dio: Zahtjevi za razvoj,
Requirements
for
vrednovanje
i
kontrolu
provedbe
sterilizacijskog
routine
control
of
a
postupka
za
medicinske
sterilization
process
for
proizvode (ISO 11137-1:2006;
medical devices (ISO 11137EN ISO 11137-1:2006)
1:2006; EN ISO 11137-
1:2006)
HRN EN ISO
11137-2:2008

EN ISO 11137- Establishing the sterilization
2:2007
dose (ISO 11137-2:2006,
corrected version 2006-08-01;
EN ISO 11137-2:2007)
HRN EN ISO
111372:2008/AC:2009

products -- Radiation -- Part 2:
EN ISO 11137Establishing the sterilization
2:2007/AC:200
dose (ISO 11137-2:2006/Cor
9
1:2009; EN ISO 111372:2007/AC:2009)
HRN EN ISO
11607-2:2008
Packaging
for
terminally
sterilized medical devices
EN ISO 11607- Part 2: Requirements for
2:2006
forming, sealing and assembly
processes (ISO 11607-2:2006;
EN ISO 11607-2:2006)
Sterilizacija
medicinskoga
Sterilization
of
medical
pribora
Mikrobioloke
devices Microbiological
metode 1. dio: Odreivanje
methods
Part
1:
HRN EN ISO
EN ISO 11737vrste i broja mikroorganizama
Determination of a population
11737-1:2006
1:2006
na proizvodima (ISO 11737of microorganisms on products
1:2006; EN ISO 11737(ISO 11737-1:2006; EN ISO
1:2006)
11737-1:2006)
Optika i optiki instrumenti
Optics and optical instruments
Laseri i pridruena oprema
Lasers and laser-related
Utvrivanje
otpornosti
HRN EN ISO
EN
ISO equipment Determination of
trahealnih intubacijskih cijevi
11990:2008
11990:2003
laser resistance of tracheal
na lasersko zraenje (ISO
tube shafts (ISO 11990:2003;
11990:2003;
EN
ISO
EN ISO 11990:2003)
11990:2003)
EN
12182:1999
Technical aids for disabled

persons
General
requirements and test methods
(EN 12182:1999)
HRN
EN Cijevi za disanje namijenjene EN
12342:2004
za uporabu s anestetikim 12342:1998
Breathing tubes intended for

use with anaesthetic apparatus
HRN
EN
12182:2008
ureajima i ventilatorima (EN

12342:1998)
and
ventilators
12342:1998)
(EN
Medicinski termometri 5.
Clinical thermometers Part
dio: Zahtjevi za infracrvene
HRN
EN
EN
12470- 5: Performance of infra-red ear
une termometre (za mjerenje
12470-5:2005
5:2003
thermometers (with maximum
najvie temperature ljudskoga
device) (EN 12470-5:2003)
tijela) (EN 12470-5:2003)
upravljanja
kvalitetom
management
systems
HRN EN ISO
EN
ISO
Zahtjevi za zakonsku namjenu
13485:2003
13485:2003
(ISO 13485:2003; EN ISO
13485:2003)
EN ISO 13485:2003)
HRN EN ISO upravljanja
kvalitetom
EN
ISO management
systems
13485:2003/Ispr Zahtjevi za zakonsku namjenu 13485:2003/A Requirements for regulatory

.1:2008
(EN
ISO C:2007
purposes
(EN
ISO
13485:2003/AC:2007)
13485:2003/AC:2007)
Oprema
za
respiracijsku
Respiratory therapy equipment
HRN
EN terapiju 1. dio: Sustavi za EN
13544- Part 1: Nebulizing systems
13544-1:2008 stvaranje aerosola i njihovi 1:2007
and their components (EN
dijelovi (EN 13544-1:2007)
13544-1:2007)
Oprema
za
respiracijsku
HRN
EN
EN
13544terapiju 2. dio: Cijevi i
Part 2: Tubing and
13544-2:2004
2:2002
spojevi (EN 13544-2:2002)
connectors (EN 13544-2:2002)
Oprema
za
respiracijsku
HRN
EN terapiju 3. dio: Ureaji za EN
13544 Part 3: Air entrainment
13544-3:2004 obogaivanje zraka kisikom 3:2001
devices (EN 13544-3:2001)
(EN 13544-3:2001)
Kemijski
dezinficijensi
i
antiseptici Kvantitativni
suspenzijski
test
za
vrednovanje
fungicidne
HRN
EN djelotvornosti
kemijskih EN
13624:2005
dezinficijensa za instrumente 13624:2003
koji se upotrebljavaju u
medicini Metoda i zahtjevi
testiranja (faza 2, korak 1)
(EN 13624:2003)
Chemical disinfectants and

antiseptics Quantitative
suspension test for the
evaluation
of
fungicidal
activity
of
chemical
disinfectants for instruments
used in the medical area Test
method and requirements
(phase 2, step 1) (EN
13624:2003)
HRN
EN
13726-1:2008
Test methods for primary

EN
13726- wound dressings Part 1:
1:2002
Aspects of absorbency (EN
13726-1:2002)
HRN
EN
13726-2:2008
Test methods for primary

wound dressings Part 2:
EN
13726Moisture vapour transmission
2:2002
rate of permeable film
dressings (EN 13726-2:2002)
Kemijski
dezinficijensi
i
suspenzijski
test
za
vrednovanje
baktericidne
HRN
EN djelotvornosti
kemijskih EN
13727:2005
dezinficijensa za instrumente 13727:2003
koji se upotrebljavaju u
medicini Metoda i zahtjevi
testiranja (faza 2, korak 1)
(EN 13727:2003)

evaluation of bactericidal
activity
of
chemical
disinfectants for instruments
used in the medical area Test
method and requirements
13727:2003)
HRN
EN
13795-1:2008
Surgical drapes, gowns and

clean air suits, used as medical
devices, for patients, clinical
EN
13795staff and equipment Part 1:
1:2002
General requirements for
manufacturers, processors and
products (EN 13795-1:2002)
HRN
EN
13795-2:2008

EN
13795- devices for patients, clinical
2:2004
staff and equipment Part 2:
Test methods (EN 137952:2004)
HRN
EN
13795-3:2008

devices for patients, clinical
EN
13795staff and equipment Part 3:
3:2006
Performance requirements and
performance
levels
(EN
13795-3:2006)
HRN
EN Sterilizacija
medicinskih EN
Sterilization
of
medical
proizvoda Sterilna priprema

tekuih medicinskih proizvoda 13824:2004
Zahtjevi (EN 13824:2004)
13824:2007
devices Aseptic processing

of liquid medical devices
Requirements
(EN
13824:2004)
Sustavi za spaavanje
Rescue
systems
HRN
EN Transport inkubatora 1. dio: EN
13976- Transportation of incubators
13976-1:2008 Uvjeti
povezivanja
(EN 1:2003
Part 1: Interface conditions
13976-1:2003)
(EN 13976-1:2003)
Sustavi za spaavanje
Rescue
systems
HRN
EN Transport inkubatora 2. dio: EN
13976- Transportation of incubators
13976-2:2008 Zahtjevi za sustav (EN 13976- 2:2003
Part 2: System requirements
2:2003+AC:2004)
(EN 13976-2:2003+AC:2004)
Non-active medical devices
Performance requirements and
test methods for absorbent
cotton gauze and absorbent
cotton and viscose gauze (EN
14079:2003)
HRN
EN
14079:2008
EN
14079:2003
HRN EN ISO
14155-1:2008
Clinical
investigation
of
EN ISO 14155- subjects Part 1: General
1:2003
requirements (ISO 141551:2003; EN ISO 141551:2003)
HRN EN ISO
14155-2:2008
Clinical
investigation
of
EN ISO 14155- subjects Part 2: Clinical
2:2003
investigation
plans
(ISO
14155-2:2003; EN ISO 141552:2003)
HRN EN ISO
14160:2008
Sterilization of single-use
medical devices incorporating
materials of animal origin
EN
ISO Validation and routine control
14160:1998
of sterilization by liquid
chemical
sterilants
(ISO
14160:1998;
EN
ISO
14160:1998)
HRN
EN Kemijski
dezinficijensi
i EN
Chemical
disinfectants
and
suspenzijski
test
za
vrednovanje mikobaktericidne
djelotvornosti
kemijskih
dezinficijenasa
koji
se
14348:2005
upotrebljavaju u medicini,
ukljuujui dezinficijense za
instrumente
Metoda
testiranja i zahtjevi (faza
2/korak 1) (EN 14348:2005)
evaluation of mycobactericidal
activity
of
chemical
disinfectants in the medical
area including instrument
disinfectants Test methods
and requirements (phase 2,
step 1) (EN 14348:2005)
Kemijski
dezinficijensi
i
antiseptici Kvantitativni test
na nosau za vrednovanje
baktericidne djelotvornosti za
HRN
EN
EN
instrumente
koji
se
14561:2006
14561:2006
upotrebljavaju u medicini
Metoda testiranja i zahtjevi
(faza
2/korak
2)
(EN
14561:2006)

carrier test for the evaluation
of bactericidal activity for
instruments used in the
medical area Test methods
and requirements (phase 2,
step 2) (EN 14561:2006)
Kemijski
dezinficijensi
i
fungicidne ili djelotvornosti
HRN
EN
EN
na kvasce za instrumente koji
14562:2006
14562:2006
se upotrebljavaju u medicini
(faza
2/korak
2)
(EN
14562:2006)

of fungicidal or yeasticidal
activity for instruments used in
the medical area Test
methods and requirements
14562:2006)
Kemijski
dezinficijensi
i
mikobaktericidne
ili
HRN
EN tuberkulocidne djelotvornosti EN
14563:2008
za instrumente koji se 14563:2008
upotrebljavaju u medicini
(faza
2/korak
2)
(EN
14563:2008)

of
mycobactericidal
or
tuberculocidal activity of
chemical disinfectants used for
instruments in the medical
area Test methods and
requirements (phase 2, step 2)
(EN 14563:2008)
HRN
EN
14683:2008
EN
14683:2005
Surgical
masks
Requirements
and
test
methods (EN 14683:2005)
HRN
EN
Pressure vessels for human
14348:2005
EN
14931:2008
14931:2006
occupancy (PVHO) Multiplace

pressure
chamber
systems for hyperbaric therapy
Performance,
safety
requirements and testing (EN
14931:2006)

products
General
zdravstvenu skrb Opi
requirements
for
zahtjevi za znaajke sredstva
characterization of a sterilizing
za sterilizaciju i za provedbu,
agent and the development,
ocjenjivanje i tijek ispitivanja
HRN EN ISO
EN
ISO validation and routine control
provedbe
sterilizacije
14937:2005
14937:2000
of a sterilization process for
medicinskih proizvoda (ISO
medical
devices
(ISO
14937:2000+Cor 1:2003; EN
14937:2000+Cor 1:2003; EN
ISO
ISO
14937:2000+AC:2003+AC:20
14937:2000+AC:2003+AC:20
05)
05)
HRN EN ISO
14971:2009
Medical devices Application

EN
ISO of risk management to medical
14971:2007
devices (ISO 14971:2007; EN
ISO 14971:2007)
HRN EN ISO oprema Kompatibilnost s EN
ISO equipment Compatibility
15001:2008
kisikom (ISO 15001:2003; EN 15001:2004
with oxygen (ISO 15001:2003;
ISO 15001:2004)
EN ISO 15001:2004)
HRN EN ISO
15225:2008
Nomenclature Specification
for a nomenclature system for
medical devices for the
purpose of regulatory data
EN
ISO
exchange
(ISO
15225:2000
15225:2000+Amd 1:2004; EN
ISO
15225:2000+A1:2004+A2:200
5)
HRN
EN
15424:2008
EN
15424:2007
Sterilization
of
medical
devices Low temperature
steam and formaldehyde
Requirements
for
routine
control
of
a
sterilization
process
for
medical
devices
15424:2007)
(EN
HRN
EN
15546-1:2008
Small bore connectors for

liquids and gases in healthcare
EN
15546applications Part 1: General
1:2008
requirements (EN 155461:2008)
HRN EN ISO
15747:2008
Plastics
containers
EN
ISO intravenous injection
15747:2005
15747:2003;
EN
15747:2005)
HRN EN ISO
16061:2009
Instrumentation for use in

association with non-active
EN
ISO surgical implants General
16061:2008
requirements
(ISO
16061:2008;
EN
ISO
16061:2008)
HRN EN ISO
16201:2008
Technical aids for disabled

persons Environmental
EN
ISO
control systems for daily
16201:2006
living (ISO 16201:2006; EN
ISO 16201:2006)
HRN EN ISO
17664:2008
Sterilization
of
medical
devices Information to be
provided by the manufacturer
EN
ISO
for
the
processing
of
17664:2004
resterilizable medical devices
(ISO 17664:2004; EN ISO
17664:2004)
HRN EN ISO
17665-1:2008

products Moist heat Part 1:
Requirements
for
the
EN ISO 17665routine
control
of
a
1:2006
sterilization
process
for
HRN EN ISO Medicinski ureaji za uvanje EN
ISO Medical
devices
for
(ISO
ISO
for
18779:2008
kisika i mjeavina kisika

Posebni
zahtjevi
(ISO
18779:2005
18779:2005;
EN
ISO
18779:2005)
conserving oxygen and oxygen

mixtures
Particular
requirements
(ISO
18779:2005;
EN
ISO
18779:2005)
Pruni sustavi za uvrenje

Rail systems for supporting
HRN EN ISO medicinskih ureaja (ISO EN
ISO medical
equipment
(ISO
19054:2008
19054:2005;
EN
ISO 19054:2006
19054:2005;
EN
ISO
19054:2006)
19054:2006)
HRN
EN
20594-1:2008
Conical fittings with a 6%

(Luer) taper for syringes,
needles and certain other
EN
20594medical equipment Part 1:
1:1993
General requirements (ISO
594-1:1986;
EN
205941:1993+A1:1997+AC:1996)
HRN EN ISO
21171:2008
Medical
gloves
Determination of removable
EN
ISO
surface
powder
(ISO
21171:2006
21171:2006;
EN
ISO
21171:2006)
HRN EN ISO
21649:2008
Needle-free
injectors
for
medical use Requirements
EN
ISO
and test methods (ISO
21649:2006
21649:2006;
EN
ISO
21649:2006)
Visokotlani
fleksibilni
High-pressure
flexible
prikljuci za uporabu s
connections for use with
HRN EN ISO
EN
ISO
medicinskim
plinskim
medical gas systems (ISO
21969:2008
21969:2006
sustavima (ISO 21969:2005;
21969:2005;
EN
ISO
EN ISO 21969:2006)
21969:2006)
HRN EN ISO
22442-1:2008
Medical devices utilizing

animal tissues and their
derivatives
Part
1:
EN ISO 22442Application
of
risk
1:2007
management (ISO 224421:2007; EN ISO 224421:2007)
HRN EN ISO
EN ISO 22442- Medical
devices
utilizing

derivatives Part 2: Controls
on sourcing, collection and
handling (ISO 22442-2:2007;
EN ISO 22442-2:2007)
22442-2:2008
2:2007
HRN EN ISO
22442-3:2008
Medical devices utilizing

derivatives Part 3: Validation
of the elimination and/or
EN ISO 22442inactivation of viruses and
3:2007
transmissible
spongiform
encephalopathy (TSE) agents
(ISO 22442-3:2007; EN ISO
22442-3:2007)
HRN EN ISO
22523:2008
External limb prostheses and

external
orthoses
EN
ISO
Requirements
and
test
22523:2006
ISO 22523:2006)
HRN EN ISO
22610:2008

devices, for patients, clinical
EN
ISO staff and equipment Test
22610:2006
method to determine the
resistance to wet bacterial
penetration (ISO 22610:2006;
EN ISO 22610:2006)
HRN EN ISO
22612:2008
Clothing for protection against

infectious agents Test
EN
ISO method for resistance to dry
22612:2005
microbial penetration (ISO
22612:2005;
EN
ISO
22612:2005)
HRN EN ISO
22675:2008
Prosthetics Testing of anklefoot devices and foot units

EN
ISO
Requirements
and
test
22675:2006
ISO 22675:2006)
HRN EN ISO Sustav respiratornih filtara za EN ISO 23328- Breathing system filters for
23328-1:2008 anestetiku i respiracijsku 1:2008
anaesthetic and respiratory use
uporabu 1. dio: Ispitni

postupci sa solima za procjenu
kakvoe filtra (ISO 233281:2003; EN ISO 233281:2008)
HRN
EN
27740:2008
Part 1: Salt test method to

assess filtration performance
(ISO 23328-1:2003; EN ISO
23328-1:2008)
EN
27740:1992
Instruments
for
surgery,
scalpels
with
detachable
blades, fitting dimensions
(ISO
7740:1985;
EN
27740:1992+A1:1997+AC:19
96)
Elektroakustika Sluna
Electroacoustics Hearing
pomagala
13.
dio:
aids
Part
13:
HRN
EN Elektromagnetska
EN
60118Electromagnetic compatibility
60118-13:2008 kompatibilnost (EMC) (IEC 13:2005
(EMC) (IEC 60118-13:2004;
60118-13:2004; EN 60118EN 60118-13:2005)
13:2005)
Odreivanje veliine trajne
HRN
EN filtracije
sklopova EN
60522:2000
rendgenskih
cijevi
(IEC 60522:1999
60522:1999; EN 60522:1999)
Medicinska elektrina oprema
HRN
EN
Mjerila
radioaktivne EN
60580:2003
ozraenosti prostora (IEC 60580:2000
60580:2000; EN 60580:2000)
HRN
60601-110:2008
Determination
of
the
permanent filtration of X-ray
tube
assemblies
(IEC
60522:1999; EN 60522:1999)
Dose area product meters (IEC
60580:2000;
EN 60580:2000)

Part
1-10:
General
Dio 1-10: Opi zahtjevi za
requirements for basic safety
and essential performance
EN radne znaajke Popratna
EN 60601-1- Collateral
Standard:
norma: Zahtjevi za razvoj
10:2008
Requirements
for
the
fiziolokih
kontrolera
u
development of physiologic
zatvorenoj petlji (IEC 60601closed-loop controllers (IEC
1-10:2007; EN 60601-160601-1-10:2007; EN 6060110:2008)
1-10:2008)
HRN
EN Medicinska elektrina oprema EN 60601-1- Medical electrical equipment
60601-1-1:2003 Dio 1-1: Opi zahtjevi za 1:2001
Part 1-1: General requirements
sigurnost Popratna norma:
for safety Collateral
Sigurnosni
zahtjevi
za
standard: Safety requirements
medicinske elektrine sustave
for medical electrical systems
(IEC 60601-1-1:2000;
60601-1-1:2001)
EN
(IEC 60601-1-1:2000;
60601-1-1:2001)
EN

Part 1: General requirements
zahtjevi
(IEC
60601for safety (IEC 60601HRN
EN
EN
606011:1988+A1:1991+A2:1995,
1:1988+A1:1991+A2:1995,
60601-1:1999
1:1990
prilag.;
EN
60601mod.;
EN
606011:1990+A1:1993+A2:1995+A
1:1990+A1:1993+A2:1995+A
13:1996)
13:1996)
1. dio: Opi zahtjevi za
HRN
EN
EN
60601osnovnu sigurnost i bitne
for basic safety and essential
60601-1:2008
1:2006
radne znaajke (IEC 60601performance (IEC 606011:2005; EN 60601-1:2006)
1:2005; EN 60601-1:2006)
HRN
EN
EN 60601-1Elektromagnetska
standard:
Electromagnetic
60601-1-2:2003
2:2001
kompatibilnost Zahtjevi i
compatibility Requirements
ispitivanja (IEC 60601-1and tests (IEC 60601-12:2001; EN 60601-1-2:2001)
2:2001; EN 60601-1-2:2001)
HRN
EN
EN 60601-1Elektromagnetska
standard:
Electromagnetic
60601-12:2001/A1:200
2:2003/A1:2008
6
ispitivanja (IEC 60601-1and tests (IEC 60601-12:2001/am1:2004; EN 606012:2001/am1:2004; EN 606011-2:2001/A1:2006)
1-2:2001/A1:2006)
radne znaajke Popratna
performance Collateral
HRN
EN
EN 60601-1norma:
Elektromagnetska
standard:
Electromagnetic
60601-1-2:2008
2:2007
ispitivanja (IEC 60601-1and tests (IEC 60601-12:2007, MOD; EN 60601-12:2007, MOD; EN 60601-12:2007)
2:2007)
HRN
EN Medicinski elektrini ureaji EN 60601-1- Medical electrical equipment
60601-1-3:1999 1. dio: Opi sigurnosni 3:1994
zahtjevi 3: Popratna norma:

Opi zahtjevi za zatitu od
zraenja u dijagnostikoj
opremi s X-zraenjem (IEC
60601-1-3:1994; EN 60601-13:1994)
for safety 3. Collateral

standard:
General
requirements for radiation
protection in diagnostic X-ray
equipment (IEC 60601-13:1994; EN 60601-1-3:1994)

HRN
EN radne znaajke Popratna EN 60601-1- performance Collateral
60601-1-3:2008 norma: Zatitu od zraenja u 3:2008
Standard: Radiation protection
dijagnostikoj
rendgenskoj
in diagnostic X-ray equipment
opremi (IEC 60601-1-3:2008;
(IEC 60601-1-3:2008; EN
EN 60601-1-3:2008)
60601-1-3:2008)
zahtjevi 4: Popratna norma:
for safety 4. Collateral
HRN
EN
EN 60601-1Elektrini medicinski sustavi
standard:
Programmable
60601-1-4:1999
4:1996
koji se mogu programirati
electrical medical systems
(IEC 60601-1-4:1996; EN
(IEC 60601-1-4:1996; EN
60601-1-4:1996)
60601-1-4:1996)
HRN
EN
EN 60601-1Programabilni
standard:
Programmable
60601-14:1996/A1:199
elektromedicinski
sustavi
electrical medical systems
4:1999/A1:2003
9
(IEC
60601-1(IEC
60601-14:1996/am1:1999; EN 606014:1996/am1:1999; EN 606011-4:1996/A1:1999)
1-4:1996/A1:1999)
HRN
EN
EN 60601-1- for safety Collateral
60601-1-6:2008
6:2004
standard:
Usability
(IEC
Upotrebljivost (IEC 60601-160601-1-6:2004; EN 60601-16:2004; EN 60601-1-6:2004)
6:2004)
HRN
EN
EN 60601-1radne znaajke Popratna
60601-1-6:2009
6:2007
norma: Upotrebljivost (IEC
Standard:
Usability
(IEC
60601-1-6:2006; EN 60601-160601-1-6:2006; EN 60601-16:2007)
6:2007)

standard:
General
Opi zahtjevi, ispitivanja i
requirements,
tests
and
HRN
EN smjernice za alarmne sustave EN 60601-1- guidance for alarm systems in
60601-1-8:2008 u medicinskim elektrinim 8:2004
medical electrical equipment
ureajima i opremi (IEC
and medical electrical systems
60601-1-8:2003+am1:2006;
(IEC
60601-1EN
60601-18:2003+am1:2006; EN 606018:2004+A1:2006+Corr.:2006)
18:2004+A1:2006+Corr.:2006)
radne znaajke Popratna
norma:
Opi
zahtjevi,
standard:
General
HRN
EN
EN 60601-1ispitivanja i smjernice za
requirements,
tests
and
60601-1-8:2009
8:2007
alarmne
sustave
u
guidance for alarm systems in
medicinskim
elektrinim
medical electrical equipment
ureajima i opremi (IEC
and medical electrical systems
60601-1-8:2006; EN 60601-1(IEC 60601-1-8:2006; EN
8:2007)
60601-1-8:2007)
HRN
60601-210:2003

Part
2-10:
Particular
Dio 2-10: Posebni zahtjevi
requirements for the safety of
EN za
sigurnost
stimulatora
EN 60601-2- nerve and muscle stimulators
ivaca i miia (IEC 60601-210:2000
(IEC
60601-210:1987+am1:2001+am1:200
10:1987+am1:2001+am1:2001
1/Corr.1:2002; EN 60601-2/Corr.1:2002; EN 60601-210:2000+A1:2001)
10:2000+A1:2001)
HRN
60601-211:1999

2. dio: Posebni sigurnosni
Part 2: Particular requirements
EN
zahtjevi za terapijsku opremu EN 60601-2- for the safety of gamma beam
koja primjenjuje gama-zrake 11:1997
therapy
equipment
(IEC
(IEC 60601-2-11:1997; EN
60601-2-11:1997; EN 6060160601-2-11:1997)
2-11:1997)
HRN
60601-2Dio 2-11: Posebni zahtjevi za 11:1997/A1:20 Part
2-11:
Particular
11:1999/A1:200 sigurnost terapijske opreme s 04
8
gama zrakama (IEC 60601-2gamma
beam
therapy
11:1997/am1:2004;
EN
equipment (IEC 60601-260601-2-11:1997/A1:2004)
11:1997/am1:2004; EN 60601-
2-11:1997/A1:2004)
Dio 2-1: Posebni zahtjevi za
Part
2-1:
Particular
sigurnost
elektronskih
HRN
EN
EN 60601-2akceleratora u podruju od 1
electron accelerators in the
60601-2-1:2000
1:1998
MeV do 50 MeV (IEC 60601range of 1 MeV to 50 MeV
2-1:1998;
EN
60601-2(IEC 60601-2-1:1998; EN
1:1998)
60601-2-1:1998)
Part
2-1:
Particular
HRN
EN sigurnost
elektronskih EN 60601-2electron accelerators in the
60601-2akceleratora u podruju od 1 1:1998/A1:200
range of 1 MeV to 50 MeV
1:2000/A1:2003 MeV do 50 MeV (IEC 60601- 2
(IEC
60601-22-1:1998/am1:2002;
EN
1:1998/am1:2002; EN 6060160601-2-1:1998/A1:2002)
2-1:1998/A1:2002)
HRN
60601-212:2008

Part
2-12:
Particular
EN
sigurnost plunih ventilatora EN 60601-2lung ventilators Critical care
Ventilatori za intenzivnu njegu 12:2006
ventilators (IEC 60601-2(IEC 60601-2-12:2001; EN
12:2001;
EN
60601-260601-2-12:2006)
12:2006)
HRN
60601-213:2008

Part
2-13:
Particular
requirements for the safety and
EN sigurnost i bitne radne
EN 60601-2- essential
performance
of
znaajke anestezijskih sustava
13:2006
anaesthetic systems (IEC
(IEC
60601-260601-2-13:2003+am1:2006;
13:2003+am1:2006;
EN
EN
60601-260601-2-13:2006+A1:2007)
13:2006+A1:2007)
HRN
60601-216:2000

Part
2-16:
Particular
sigurnost
ureaja
za
EN
haemodialysis,
hemodijalizu,
EN 60601-2haemodiafiltration
and
hemodijafiltriranje
i 16:1998
haemofiltration
equipment
hemofiltriranje (IEC 60601-2(IEC 60601-2-16:1998; EN
16:1998;
EN
60601-260601-216:1998+Corr.1:1999)
16:1998+Corr.1:1999)
HRN
60601-217:2008

Part
2-17:
Particular
sigurnost
automatski
EN
kontrolirane
opreme
za EN 60601-2- automatically-controlled
brahiterapiju s naknadnim 17:2004
brachytherapy
afterloading
punjenjem (IEC 60601-2equipment (IEC 60601-217:2004;
EN
60601-217:2004;
EN
60601-217:2004)
17:2004)
HRN
60601-218:1999

EN
zahtjevi za endoskopijske EN 60601-2- for the safety of endoscopic
ureaje
(IEC
60601-2- 18:1996
equipment (IEC 60601-218:1996;
EN
60601-218:1996;
EN
60601-218:1996)
18:1996)

2. dio: Posebni zahtjevi za
for the safety of endoscopic
HRN
EN sigurnost endoskopske opreme
EN 60601-2- equipment Addition of an
60601-2 Dodatak za ponitenje
18:1996/A1:20 exclusion from subclause 56.3
18:1999/A1:200 podtoke 56.3 c), te raznih
00
c) and various amendments
3
amandmana (IEC 60601-2(IEC
60601-218:1996/am1:2000;
EN
18:1996/am1:2000;
EN
60601-2-18:1996/A1:2000)
60601-2-18:1996/A1:2000)
HRN
60601-219:1999

EN
zahtjevi za djeje inkubatore EN 60601-2- for the safety of baby
(IEC
60601-2- 19:1996
incubators (IEC 60601-219:1990+am1:1996;
EN
19:1990+am1:1996;
EN
60601-2-19:1996+A1:1996)
60601-2-19:1996+A1:1996)
HRN
60601-220:1999

EN
zahtjevi
za
prijevozne EN 60601-2- for the safety of transport
inkubatore (IEC 60601-2- 20:1996
incubators (IEC 60601-220:1990+am1:1996;
EN
20:1990+am1:1996;
EN
60601-2-20:1996)
60601-2-20:1996)
HRN
60601-221:1999

EN
zahtjevi za grijae djece koji EN 60601-2- for the safety of infant radiant
griju zraenjem (IEC 60601- 21:1994
warmers
(IEC
60601-22-21:1994+am1:1996;
EN
21:1994+am1:1996;
EN
60601-2-21:1994+A1:1996)
60601-2-21:1994+A1:1996)

Part
2-2:
Particular
HRN
EN sigurnost visokofrekvencijske EN 60601-2- requirements for the safety of
60601-2-2:2003 kirurke opreme (IEC 60601- 2:2000
high
frequency
surgical
2-2:1998;
EN
60601-2equipment (IEC 60601-22:2000)
2:1998; EN 60601-2-2:2000)
Part
2-2:
Particular
HRN
EN sigurnost visokofrekvencijskih EN 60601-2- requirements for the safety of
60601-2-2:2008 kirurkih ureaja (IEC 60601- 2:2007
high
frequency
surgical
2-2:2006;
EN
60601-2equipment (IEC 60601-22:2007)
2:2006; EN 60601-2-2:2007)
HRN
60601-222:1999

EN
zahtjevi za dijagnostike i EN 60601-2- for the safety of diagnostic and
terapijske laserske ureaje 22:1996
therapeutic laser equipment
(IEC 60601-2-22:1995; EN
(IEC 60601-2-22:1995; EN
60601-2-22:1996)
60601-2-22:1996)
HRN
60601-223:2003

Part
2-23:
Particular
requirements for the safety,
za sigurnost, ukljuivo i bitne
EN
including
essential
zahtjeve,
opreme
za EN 60601-2performance,
of
transkutano
nadziranje 23:2000
transcutaneous partial pressure
parcijalnoga
tlaka
(IEC
monitoring equipment (IEC
60601-2-23:1999; EN 6060160601-2-23:1999; EN 606012-23:2000)
2-23:2000)
HRN
60601-224:2000

Part
2-24:
Particular
EN
sigurnost infuzijskih crpka i EN 60601-2- requirements for the safety of
njihovih kontrolera (IEC 24:1998
infusion pumps and controllers
60601-2-24:1998; EN 60601(IEC 60601-2-24:1998; EN
2-24:1998)
60601-2-24:1998)
HRN
60601-225:1999

EN 2. dio: Posebni sigurnosni
EN 60601-2- for
the
safety
of
zahtjevi za elektrokardiografe
25:1995
electrocardiographs
(IEC
(IEC 60601-2-25:1993; EN
60601-2-25:1993; EN 6060160601-2-25:1995)
2-25:1995)
HRN
EN Medicinska elektrina oprema EN
60601-2- Medical electrical equipment

za
sigurnost
60601-2elektrokardiografa
(IEC 25:1995/A1:19
25:1999/A1:200
60601-2-25:1993/am1:1999; 99
3
EN
60601-225:1995/A1:1999)
Part
2-25:
Particular
electrocardiographs
(IEC
60601-2-25:1993/am1:1999;
EN
60601-225:1995/A1:1999)
HRN
60601-226:2003

Part
2-26:
Particular
EN
za
sigurnost EN 60601-2- requirements for the safety of
elektroencefalografa
(IEC 26:2003
electroencephalographs (IEC
60601-2-26:2002; EN 6060160601-2-26:2002; EN 606012-26:2003)
2-26:2003)
HRN
60601-227:2008

Part
2-27:
Particular
sigurnost, ukljuujui bitne
EN
including
essential
radne
znaajke EN 60601-2performance,
of
elektrokardiografskih ureaja 27:2006
electrocardiographic
za nadzor (IEC 60601-2monitoring equipment (IEC
27:2005;
EN
60601-260601-2-27:2005; EN 6060127:2006+Corr.:2006)
2-27:2006+Corr.:2006)
HRN
60601-228:1999

zahtjevi za sklopove izvora Xfor the safety of X-ray source
EN
zraka i sklopove medicinskih EN 60601-2- assemblies and X-ray tube
dijagnostikih cijevi za X- 28:1993
assemblies
for
medical
zraenje
(IEC
60601-2diagnosis
(IEC
60601-228:1993;
EN
60601-228:1993;
EN
60601-228:1993)
28:1993)
HRN
60601-229:2000

Part
2-29:
Particular
EN
sigurnost
radioterapijskih EN 60601-2- requirements for the safety of
simulatora (IEC 60601-2- 29:1999
radiotherapy simulators (IEC
29:1999;
EN
60601-260601-2-29:1999; EN 6060129:1999)
2-29:1999)
rpHRN
EN
60601-2-29
EN 60601-2- Medical electrical equipment

29:2008
-- Part 2-29: Particular
requirements for the basic
safety
and
essential
performance of radiotherapy
simulators (IEC 60601-229:2008;
EN
60601-2-
29:2008)
HRN
60601-230:2003

Part
2-30:
Particular
zahtjeve,
opreme
za
including
essential
cikliko
EN automatsko
EN 60601-2- performance, of automatic
neinvazivno
nadziranje
30:2000
cycling non-invasive blood
krvnoga tlaka
pressure
monitoring
equipment (IEC 60601-2(IEC 60601-2-30:1999; EN
30:1999;
EN
60601-260601-2-30:2000)
30:2000)
HRN
60601-231:2000

Part
2-31:
Particular
sigurnost
vanjskih
EN
elektrostimulatora
srca
s EN 60601-2- external cardiac pacemakers
vlastitim izvorom napajanja 31:1995
with internal power source
(IEC
60601-2(IEC
60601-230:1994+am1:1998;
EN
30:1994+am1:1998;
EN
60601-2-31:1995+A1:1998)
60601-2-31:1995+A1:1998)

HRN
EN zahtjevi
za
kratkovalne EN 60601-2- for the safety of short-wave
60601-2-3:1999 terapijske
ureaje
(IEC 3:1993
therapy
equipment
(IEC
60601-2-3:1991; EN 60601-260601-2-3:1991; EN 60601-23:1993)
3:1993)
Part
2-3:
Particular
HRN
EN
EN 60601-2- requirements for the safety of
sigurnost
kratkovalnih
60601-23:1993/A1:199 short-wave therapy equipment
terapijskih
ureaja
(IEC
3:1999/A1:2000
8
(IEC
60601-260601-2-3:1991/am1:1998;
3:1991/am1:1998; EN 60601EN 60601-2-3:1993/A1:1998)
2-3:1993/A1:1998)
HRN
60601-232:1999

EN
zahtjevi za prateu opremu EN 60601-2- for the safety of associated
ureaja za X-zraenje (IEC 32:1994
equipment of X-ray equipment
60601-2-32:1994; EN 60601(IEC 60601-2-32:1994; EN
2-32:1994)
60601-2-32:1994)
HRN
60601-2-
EN Medicinska elektrina oprema EN 60601-2- Medical electrical equipment

Dio 2-33: Posebni zahtjevi 33:2002
Part
2-33:
Particular
33:2003
za sigurnost opreme za
medicinsku dijagnostiku s
pomou
magnetske
rezonancije (IEC 60601-233:2002;
EN
60601-233:2002)

magnetic resonance equipment
for medical diagnosis (IEC
60601-2-33:2002; EN 606012-33:2002)

Part
2-33:
Particular
HRN
EN sigurnost
opreme
za
EN 60601-260601-2medicinsku
dijagnostiku
magnetic resonance equipment
33:2002/A1:20
33:2003/A1:200 pomou
magnetske
05
8
rezonancije (IEC 60601-260601-2-33:2002/am1:2005;
33:2002/am1:2005;
EN
EN
60601-260601-2-33:2002/A1:2005)
33:2002/A1:2005)
Part
2-33:
Particular
sigurnost
opreme
za
HRN
EN
medicinsku
dijagnostiku EN 60601-260601-2magnetic resonance equipment
pomou
magnetske 33:2002/A2:20
33:2003/A2:200
rezonancije (IEC 60601-2- 08
8
60601-2-33:2002/am2:2007;
33:2002/am2:2007;
EN
EN
60601-260601-233:2002/A2:2008+AC:2008)
33:2002/A2:2008+AC:2008)
HRN
60601-234:2003

Part
2-34:
Particular
including
essential
performance,
of
invasive
EN zahtjeve, opreme za invazivno
EN 60601-2nadziranje krvnoga tlaka (IEC
blood pressure monitoring
34:2000
60601-2-34:2000;
equipment
EN 60601-2-34:2000)
(IEC 60601-2-34:2000; EN
60601-2-34:2000)
HRN
60601-235:1999

EN zahtjevi za grijae deke,
for the safety of blankets, pads
EN 60601-2jastuke
i
madrace
u
and mattresses, intended for
35:1996
medicinskoj uporabi (IEC
heating in medical use (IEC
60601-2-35:1996; EN 6060160601-2-35:1996; EN 606012-35:1996)
2-35:1996)
HRN
60601-236:2000

Dio 2-36: Posebni zahtjevi za 36:1997
Part
2-36:
Particular
sigurnost
ureaja
za
izvantjelesno
induciranu
litotripsiju (IEC 60601-236:1997;
EN
60601-236:1997)
HRN
60601-237:2003
equipment for extracorporeally

induced
lithotripsy
(IEC
60601-2-36:1997; EN 606012-36:1997)

za
sigurnost
ultrazvune
Part
2-37:
Particular
EN opreme za dijagnostiku i
EN 60601-2nadzor
ultrasonic medical diagnostic
37:2001
and monitoring equipment
(IEC 60601-2-37:2001; EN
(IEC 60601-2-37:2001; EN
60601-2-37:2001)
60601-2-37:2001)

Part
2-37:
Particular
HRN
EN
sigurnost ultrazvune opreme EN 60601-260601-2ultrasonic medical diagnostic
za dijagnostiku i nadzor (IEC 37:2001/A1:20
37:2003/A1:200
60601-2-37:2001/am1:2004; 05
8
(IEC
60601-2EN
60601-237:2001/am1:2004;
EN
37:2001/A1:2005)
60601-2-37:2001/A1:2005)
Part
2-37:
Particular
HRN
EN
sigurnost ultrazvune opreme EN 60601-260601-2ultrasonic medical diagnostic
za dijagnostiku i nadzor (IEC 37:2001/A2:20
37:2003/A2:200
60601-2-37:2001/am2:2005; 05
8
(IEC
60601-2EN
60601-237:2001/am2:2005;
EN
37:2001/A2:2005)
60601-2-37:2001/A2:2005)
HRN
60601-237:2008

Part
2-37:
Particular
requirements for the basic
EN
safety
and
essential
radne znaajke ultrazvune EN 60601-2performance of ultrasonic
opreme za dijagnostiku i 37:2008
medical
diagnostic
and
nadzor
(IEC
60601-2monitoring equipment (IEC
37:2007;
EN
60601-260601-2-37:2007; EN 6060137:2008)
2-37:2008)
HRN
60601-238:1999

EN
zahtjevi za elektrine bolnike EN 60601-2- for the safety of electrically
krevete
(IEC
60601-2- 38:1996
operated hospital beds (IEC
38:1996;
EN
60601-260601-2-38:1996; EN 6060138:1996)
2-38:1996)

Part
2-38:
Particular
electrically operated hospital
HRN
EN Dio 2-38: Posebni zahtjevi
EN 60601-2beds
(IEC
60601-260601-2za
sigurnost
elektrinih
38:1996/A1:20
38:1996/am1:1999;
38:1999/A1:200 bolnikih kreveta (IEC 6060100
3
2-38:1996/am1:1999;
EN
60601-2-38:1996/A1:2000)
EN
60601-238:1996/A1:2000)
HRN
60601-239:2003

Part
2-39:
Particular
EN
za sigurnost opreme za EN 60601-2- requirements for the safety of
peritonealnu dijalizu (IEC 39:1999
peritoneal dialysis equipment
60601-2-39:1999; EN 60601(IEC 60601-2-39:1999; EN
2-39:1999+Corr.:1999)
60601-2-39:1999+Corr.:1999)
HRN
60601-239:2008

Part
2-39:
Particular
EN osnovnu sigurnost i bitne
requirements for basic safety
EN 60601-2radne znaajke ureaja za
and essential performance of
39:2008
peritonealnu
hemodijalizu
peritoneal dialysis equipment
(IEC 60601-2-39:2007; EN
(IEC 60601-2-39:2007; EN
60601-2-39:2008)
60601-2-39:2008)
HRN
60601-240:2000

Part
2-40:
Particular
EN sigurnost elektromiografa i
EN 60601-2ureaja
za
evocirane
electromyographs and evoked
40:1998
potencijale (IEC 60601-2response equipment (IEC
40:1998;
EN
60601-260601-2-40:1998; EN 6060140:1998)
2-40:1998)
HRN
60601-241:2003

za sigurnost kirurke i
Part
2-41:
Particular
opreme
za
EN dijagnostike
EN 60601-2osvjetljavanje
surgical
luminaires
and
41:2000
luminaires for diagnosis (IEC
(IEC 60601-2-41:2000; EN
60601-2-41:2000; EN 6060160601-2-41:2000)
2-41:2000)

Part
2-4:
Particular
HRN
EN
sigurnost sranih defibrilatora
60601-2-4:2003
4:2003
cardiac defibrilators (IEC
(IEC 60601-2-4:2002; EN
60601-2-4:2002; EN 60601-260601-2-4:2003)
4:2003)
HRN
60601-243:2003

Part
2-43:
Particular
EN za
sigurnost
rendgenske
EN 60601-2opreme za intervencijske
X-ray
equipment
for
43:2000
zahvate
(IEC
60601-2interventional procedures (IEC
43:2000;
EN
60601-260601-2-43:2000; EN 6060143:2000)
2-43:2000)
HRN
60601-244:2003

Part
2-44:
Particular
za
sigurnost
rendgenske
EN
opreme za kompjutoriziranu EN 60601-2- X-ray equipment for computed
tomografiju (IEC 60601-2- 44:2001
tomography (IEC 60601-244:2001+am1:2002+Corr.
44:2001+am1:2002+Corr.
1:2006;
EN
60601-21:2006;
EN
60601-244:2001+A1:2003)
44:2001+A1:2003)
HRN
60601-245:2003

Part
2-45:
Particular
za sigurnost mamografske
rendgenske
opreme
i
mammographic
X-ray
EN
mamografskih stereotaktikih EN 60601-2- equipment and mammographic
naprava
(IEC
60601-2- 45:2001
stereotactic devices
45:2001;
(IEC 60601-2-45:2001; EN
EN 60601-2-45:2001)
60601-2-45:2001)
HRN
60601-246:2000

Part
2-46:
Particular
EN Dio 2-46: Posebni zahtjevi za
sigurnost operacijskih stolova
46:1998
operating tables (IEC 60601-2(IEC 60601-2-46:1998; EN
46:1998;
EN
60601-260601-2-46:1998)
46:1998)
HRN
60601-247:2003

Part
2-47:
Particular
za
ambulantne
EN zahtjeve,
EN 60601-2- including
essential
elektrokardiografske sustave
47:2001
performance, of ambulatory
(IEC 60601-2-47:2001;
electrocardiographic systems
(IEC 60601-2-47:2001; EN
EN 60601-2-47:2001)
60601-2-47:2001)
HRN
60601-249:2003

EN Dio 2-49: Posebni zahtjevi EN 60601-2- Medical electrical equipment
za sigurnost viefunkcijske 49:2001
Part
2-49:
Particular
opreme za nadzor pacijenata
multifunction
patient
(IEC 60601-2-49:2001; EN
monitoring equipment (IEC
60601-2-49:2001; EN 606012-49:2001)
60601-2-49:2001)
HRN
60601-250:2003

Part
2-50:
Particular
EN za sigurnost opreme za
EN 60601-2fototerapiju
novoroenadi
infant phototherapy equipment
50:2002
(IEC
60601-2(IEC
60601-250:2000+Corr.1:2001;
EN
50:2000+Corr.1:2001;
EN
60601-2-50:2002)
60601-2-50:2002)
HRN
60601-251:2003

Part
2-51:
Particular
requirements
for
safety,
karakteristike, jednokanalnih i
including
essential
EN
viekanalnih
EN 60601-2- performance, of recording and
elektrokardiografa,
s 51:2003
analysing single channel and
mogunou registracije i
multichannel
analize signala (IEC 60601-2electrocardiographs
(IEC
51:2003;
EN
60601-260601-2-51:2003; EN 6060151:2003)
2-51:2003)

Part
2-5:
Particular
HRN
EN sigurnost ultrazvune opreme EN 60601-2- requirements for the safety of
60601-2-5:2003 za fizikalnu terapiju (IEC 5:2000
ultrasonic
physiotherapy
60601-2-5:2000; EN 60601-2equipment (IEC 60601-25:2000)
5:2000; EN 60601-2-5:2000)
Part
2-7:
Particular
sigurnost
visokonaponskih
HRN
EN
EN 60601-2generatora
dijagnostikih
high-voltage generators of
60601-2-7:2000
7:1998
izvora rendgenskog zraenja
diagnostic X-ray generators
(IEC 60601-2-7:1998; EN
(IEC 60601-2-7:1998; EN
60601-2-7:1998)
60601-2-7:1998)
zahtjevi
za
terapijske
HRN
EN
EN 60601-2- for the safety of therapeutic Xgeneratore X-zraka (IEC
60601-2-8:1999
8:1997
ray generators (IEC 60601-260601-2-8:1987+am1:1997;
8:1987+am1:1997; EN 60601EN
60601-22-8:1997+A1:1997)
8:1997+A1:1997)
HRN
EN Dijagnostika
rendgenska EN
Diagnostic
X-ray
imaging
60627:2003
oprema Ope znaajke

uporabljivosti
i
svojstva
mamografskih reetki protiv
60627:2001
rasipanja
zraenja
(IEC
60627:2001;
EN
60627:2001+Corr.:2002)
equipment Characteristics of
general
purpose
and
mammographic
anti-scatter
grids (IEC 60627:2001; EN
60627:2001+Corr.:2002)
Electroacoustics
Elektroakustika Mjerila
Audiological equipment Part
HRN
EN sluha 1.dio: Mjerila sluha s EN
606451: Pure-tone audiometers (IEC
60645-1:2002 istim tonom (IEC 60645- 1:2001
60645-1:2001; EN 606451:2001; EN 60645-1:2001)
1:2001)
Audiometri 2. dio: Oprema
Audiometers Part 2:
HRN
EN za govornu audiometriju (IEC EN
60645- Equipment
for
speech
60645-2:1998 60645-2:1993; EN 60645- 2:1997
audiometry
(IEC
606452:1997)
2:1993; EN 60645-2:1997)
Audiometri
3.
dio:
Audiometers Part 3:
Kratkotrajni sluni ispitni
Auditory test signals of short
HRN
EN signali za audiometrijske i EN
60645- duration for audiometric and
60645-3:1998 neuro-otoloke namjene (IEC 3:1995
neuro-otological
purposes
60645-3:1994; EN 60645(IEC
60645-3:1994;
EN
3:1995)
60645-3:1995)
Elektroakustika
Electroacoustics
Audiometarska oprema 3.
Audiometric equipment Part
HRN
EN
EN
60645dio:
Kratkotrajni
ispitni
3: Test signals of short
60645-3:2008
3:2007
signali (IEC 60645-3:2007;
duration (IEC 60645-3:2007;
EN 60645-3:2007)
EN 60645-3:2007)
Audiometri 4. dio: Oprema
Audiometers Part 4:
za audiometriju u proirenom
Equipment for extended highHRN
EN
EN
60645visokofrekvencijskom
frequency audiometry (IEC
60645-4:1998
4:1995
podruju (IEC 60645-4:1994;
60645-4:1994; EN 60645EN 60645-4:1995)
4:1995)
Radioterapijski ureaji
HRN
EN Koordinate, pokretanja i skale EN
61217:2000
(IEC
61217:1996;
EN 61217:1996
61217:1996)
Radiotherapy equipment
Coordinates, movements and
scales (IEC 61217:1996; EN
61217:1996)
Radioterapijska oprema
HRN
EN Koordinate, pokretanja i skale EN
61217:2000/A1:
61217:1996/A1 scales
2003
(IEC 61217:1996/am1:2000; :2001
EN 61217:1996/A1:2001)
(IEC 61217:1996/am1:2000;
EN 61217:1996/A1:2001)
Radioterapijska oprema
HRN
EN
EN
Koordinate, pokretanja i skale
61217:2000/A2:
61217:1996/A2 scales
(IEC
(IEC 61217:1996/am2:2007;
2008
:2008
61217:1996/am2:2007;
EN
EN 61217:1996/A2:2008)
61217:1996/A2:2008)
Ureaji za neinvazivno
mjerenje zraenja rendgenske
cijevi
u
dijagnostikoj
HRN
EN
EN
radiologiji
61676:2003
61676:2002
(IEC
61676:2002;
61676:2002)
EN

Zahtjevi za sigurnost
radioterapijskih
(opreme)
HRN
EN sustava za planiranje terapije EN
62083:2003
62083:2001
(IEC
62083:2000;
EN
62083:2001)

Dosimetric instruments used
for non-invasive measurement
of X-ray tube voltage in
diagnostic radiology (IEC
61676:2002; EN 61676:2002)

Requirements for the safety of
radiotherapy
treatment
planning
systems
(IEC
62083:2000; EN 62083:2001)

Znaajke
digitaliziranih
Characteristics of digital X-ray
rendgenskih ureaja 1. dio:
imaging devices Part 1:
HRN
EN
EN
62220Odreivanje
osjetljivosti
Determination of the detective
62220-1:2008
1:2004
otkrivanja (detekcije) zraenja
quantum
efficiency
(IEC
(IEC
62220-1:2003;
EN
62220-1:2003; EN 6222062220-1:2004)
1:2004)
Znaajke
digitaliziranih
rendgenskih ureaja Dio 1imaging devices Part 1-2:
HRN
EN 2: Odreivanje osjetljivosti EN 62220-1- Determination of the detective
62220-1-2:2008 otkrivanja (detekcije) zraenja 2:2007
quantum
efficiency
Detektori za uporabu u
Detectors
used
in
mamografiji (IEC 62220-1mammography (IEC 62220-12:2007; EN 62220-1-2:2007)
2:2007; EN 62220-1-2:2007)
HRN
62220-1-3:2008 Znaajke
digitaliziranih 3:2008
rendgenskih ureaja Dio 1imaging devices Part 1-3:
3: Odreivanje osjetljivosti
Determination of the detective
otkrivanja (detekcije) zraenja
quantum
efficiency
Detektori za uporabu pri

Detectors used in dynamic
dobivanju dinamikih slika

(IEC 62220-1-3:2008; EN
62220-1-3:2008)
imaging (IEC 62220-1-3:2008;

EN 62220-1-3:2008)
Programske
podrke
medicinskih
ureaja
HRN
EN Odravanje
programske EN
62304:2008
podrke za vrijeme ivotnog 62304:2006
vijeka (IEC 62304:2006; EN
62304:2006)

Software life-cycle processes
(IEC
62304:2006;
EN
62304:2006)

Primjena
prikladnog
HRN
EN
EN
oblikovanja i konstrukcije
62366:2008
62366:2008
medicinskih ureaja (IEC
62366:2007; EN 62366:2008)
Medical devices Application

of usability engineering to
medical
devices
(IEC
62366:2007; EN 62366:2008)

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Na temelju lanka 8. stavka 2. Zakona o medicinskim proizvodima (Narodne novine, br.

67/08), te na temelju dostavljenog popisa hrvatskih norma na podruju medicinskih proizvoda

Aktivni medicinski proizvodi za ugradnju

Symbols for use in the

Information supplied by the

Sterilization of health care

Sterilization of health care

EN ISO 14155- Clinical investigation of

subjects Part 1: General

Sterilization of health care

Sterilization of health care

HRN EN 45502- Aktivni

45502- Active implantable medical

Medical electrical equipment

Medicinski elektrini ureaji

Medical electrical equipment

In vitro dijagnostiki medicinski proizvodi

Medical device software

Naslov hrvatske norme

Information supplied by the

Information supplied by the

Instructions for use for in

Instructions for use for in

Symbols for use in the

In vitro diagnostic medical

In vitro diagnostic medical

In vitro diagnostic medical

Performance criteria for

Medical devices Quality

Medical devices Quality

General requirements for in

Stability testing of in vitro

Sampling procedures used

Use of external quality

In vitro diagnostic medical

Single-use containers for

ISO Sterilizacija proizvoda za EN

ISO Sterilization of health care

In vitro diagnostic test

ISO In vitro diagnostic medical

Clinical laboratory testing

Medical device software

Medical gloves for single use

Medical gloves for single use

Medical gloves for single use

Naslov europske norme

designated STERILE Part

Symbols for use in the

Information supplied by the

the overall system accuracy of

Transportable gas cylinders

Tracheostomy tubes Part 2:

EN Trahealne cijevi i prikljuci

Zrani baloni za anesteziju

Specifikacije za nosila i drugu

Specifications for stretchers

Adjustable beds for disabled

Plastics collapsible containers

Plastics collapsible containers

Natural latex rubber condoms

Sterile hypodermic syringes

prevention feature (ISO 78864:2006; EN ISO 7886-4:2006)

Prosthetics Structural testing

Regulatori tlaka za uporabu s