Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)
Date: 2008-07-23
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device

23.7.2008

EN

Official Journal of the European Union

C 186/9

NOTICES FROM MEMBER STATES

Commission communication in the framework of the implementation of the Council Directive
93/42/EEC concerning medical devices

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

(2008/C 186/07)

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN 375:2001
Information supplied by the manufacturer with in vitro diagnostic
reagents for professional use

EN 376:2002
Information supplied by the manufacturer with in vitro diagnostic
reagents for self-testing

—

—

EN 455-1:2000
Medical gloves for single use — Part 1: Requirements and testing for
freedom from holes

EN 455-1:1993

EN 455-2:2000
Medical gloves for single use — Part 2: Requirements and testing for
physical properties (including Technical Corrigendum 1:1996)

EN 455-2:1995

EN 455-3:2006
Medical gloves for single use — Part 3: Requirements and testing for
biological evaluation

EN 455-3:1999

EN 556-1:2001
Sterilization of medical devices — Requirements for medical devices to
be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized
medical devices

EN 556:1994 + A1:1998

Date expired
(30.4.2001)

Date expired
(30.4.2001)

Date expired
(30.6.2007)

Date expired
(30.4.2002)

EN 556-1:2001/AC:2006

EN 556-2:2003
Sterilization of medical devices — Requirements for medical devices to
be designated ‘STERILE’ — Part 2: Requirements for aseptically processed
medical devices

EN 591:2001
Instructions for use for in vitro diagnostic instruments for professional
use

CEN

EN 592:2002
Instructions for use for in vitro diagnostic instruments for self-testing

—

—

—

ESO (1)

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C 186/10

EN

Official Journal of the European Union

23.7.2008

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

ESO (1)

CEN

CEN

CEN

EN 737-1:1998
Medical gas pipeline systems — Part 1: Terminal units for compressed
medical gases and vacuum

EN 737-4:1998
Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas
scavenging systems

EN 794-1:1997
Lung ventilators — Part 1: Particular requirements for critical care venti-
lators

EN 794-1:1997/A1:2000

CEN

EN 794-3:1998
Lung ventilators — Part 3: Particular requirements for emergency and
transport ventilators

EN 794-3:1998/A1:2005

—

—

—

Note 3

—

Note 3

Date expired
(31.5.2001)

Date expired
(31.12.2005)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN 980:2008
Symbols for use in the labelling of medical devices

EN 980:2003

31.5.2010

EN 1041:1998
Information supplied by the manufacturer with medical devices

EN 1060-1:1995
Non-invasive sphygmomanometers — Part 1: General requirements

EN 1060-1:1995/A1:2002

EN 1060-2:1995
Non-invasive sphygmomanometers — Part 2: Supplementary require-
ments for mechanical sphygmomanometers

EN 1060-3:1997
Non-invasive sphygmomanometers — Part 3: Supplementary require-
ments for electro-mechanical blood pressure measuring systems

EN 1060-3:1997/A1:2005

EN 1060-4:2004
Non-invasive sphygmomanometers — Part 4: Test procedures to deter-
mine the overall system accuracy of automated non-invasive sphygmo-
manometers

—

—

Note 3

—

—

Note 3

—

EN 1089-3:2004
Transportable gas cylinders — Gas cylinder identification (excluding LPG)
— Part 3: Colour coding

EN 1089-3:1997

EN 1282-2:2005
Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modi-
fied)

EN 1282-2:1997

EN 1422:1997
Sterilizers for medical purposes — Ethylene oxide sterilizers — Require-
ments and test methods

—

Date expired
(30.11.2002)

Date expired
(30.6.2006)

Date expired
(31.10.2004)

Date expired
(31.12.2005)

23.7.2008

EN

Official Journal of the European Union

C 186/11

ESO (1)

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Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN 1618:1997
Catheters other than intravascular catheters — Test methods for common
properties

—

EN 1639:2004
Dentistry — Medical devices for dentistry — Instruments

EN 1640:2004
Dentistry — Medical devices for dentistry — Equipment

EN 1641:2004
Dentistry — Medical devices for dentistry — Materials

EN 1642:2004
Dentistry — Medical devices for dentistry — Dental implants

EN 1707:1996
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain
other medical equipment — Lock fittings

EN 1782:1998
Tracheal tubes and connectors

EN 1639:1996

EN 1640:1996

EN 1641:1996

EN 1642:1996

—

—

Date expired
(31.12.2004)

Date expired
(31.12.2004)

Date expired
(31.12.2004)

Date expired
(31.12.2004)

EN 1789:2007
Medical vehicles and their equipment — Road ambulances

EN 1820:2005
Anaesthetic reservoir bags (ISO 5362:2000, modified)

EN 1789:1999

EN 1820:1997

Date expired
(30.11.2007)

Date expired
(31.12.2005)

EN 1865:1999
Specifications for stretchers and other patient handling equipment used
in road ambulances

CEN

EN 1970:2000
Adjustable beds for disabled persons — Requirements and test methods

EN 1970:2000/A1:2005

EN 1985:1998
Walking aids — General requirements and test methods

EN ISO 3826-3:2007
Plastics collapsible containers for human blood and blood components
— Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

—

—

Note 3

—

—

Date expired
(30.9.2005)

EN ISO 4074:2002
Natural
(ISO 4074:2002)

latex rubber condoms — Requirements and test methods

EN 600:1996

Date expired
(31.8.2005)

CEN

EN ISO 4135:2001
Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001)

EN ISO 4135:1996

Date expired
(28.2.2002)

C 186/12

EN

Official Journal of the European Union

23.7.2008

ESO (1)

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CEN

CEN

CEN

CEN

CEN

CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

EN ISO 5356-1:2004
Anaesthetic and respiratory equipment — Conical connectors — Part 1:
Cones and sockets (ISO 5356-1:2004)

EN 1281-1:1997

EN ISO 5356-2:2007
Anaesthetic and respiratory equipment — Conical connectors — Part 2:
Screw-threaded weight-bearing connectors (ISO 5356-2:2006)

EN 1281-2:1995

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

Date expired
(30.11.2004)

Date expired
(29.2.2008)

EN ISO 5359:2008
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)

EN 739:1998

30.6.2010

EN ISO 5360:2007
Anaesthetic vaporizers — Agent-specific filling systems (ISO 5360:2006)

EN 1280-1:1997

EN ISO 5366-1:2004
Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1:
Tubes and connectors for use in adults (ISO 5366-1:2000)

EN 1282-1:1996

Date expired
(30.6.2008)

Date expired
(31.1.2005)

EN ISO 5840:2005
Cardiovascular implants — Cardiac valve prostheses (ISO 5840:2005)

EN 12006-1:1999

Date expired
(30.6.2006)

EN ISO 7197:2006
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and
components (ISO 7197:2006)

—

EN ISO 7376:2003
Anaesthetic and respiratory equipment — Laryngoscopes for tracheal
intubation (ISO 7376:2003)

EN 1819:1997

Date expired
(30.6.2004)

EN ISO 7396-1:2007
Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum (ISO 7396-1:2007)

EN 737-3:1998

30.4.2009

EN ISO 7396-2:2007
Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging
disposal systems (ISO 7396-2:2007)

EN 737-2:1998

30.4.2009

EN ISO 7439:2002
Copper-bearing intra-uterine contraceptive devices — Requirements, tests
(ISO 7439:2002)

EN ISO 7886-3:2005
Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes
for fixed-dose immunization (ISO 7886-3:2005)

EN ISO 7886-4:2006
Sterile hypodermic syringes for single use — Part 4: Syringes with re-use
prevention feature (ISO 7886-4:2006)

—

—

—

EN ISO 8185:2007
Respiratory tract humidifiers for medical use — Particular requirements
for respiratory humidification systems (ISO 8185:2007)

EN ISO 8185:1997

Date expired
(31.1.2008)

23.7.2008

EN

Official Journal of the European Union

C 186/13

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN ISO 8359:1996
Oxygen concentrators
(ISO 8359:1996)

for medical use — Safety

requirements

EN ISO 8536-4:2007
Infusion equipment for medical use — Part 4: Infusion sets for single use,
gravity feed (ISO 8536-4:2007)

—

—

EN ISO 8835-2:2007
Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems
(ISO 8835-2:2007)

EN 740:1998

31.5.2009

EN ISO 8835-3:2007
Inhalational anaesthesia systems — Part 3: Transfer and receiving systems
of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

EN 740:1998

31.5.2009

EN ISO 8835-4:2004
Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery
devices (ISO 8835-4:2004)

EN ISO 8835-4:2004/AC:2006

CEN

EN ISO 8835-5:2004
Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators
(ISO 8835-5:2004)

EN ISO 8835-5:2004/AC:2006

EN ISO 9360-1:2000
Anaesthetic and respiratory equipment — Heat and moisture exchangers
(HMEs) for humidifying respired gases in humans — Part 1: HMEs for
use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

EN ISO 9360-2:2002
Anaesthetic and respiratory equipment — Heat and moisture exchangers
(HMEs) for humidifying respired gases in humans — Part 2: HMEs for
use with tracheostomized patients having minimum tidal volumes of
250 ml (ISO 9360-2:2001)

EN ISO 9713:2004
Neurosurgical
(ISO 9713:2002)

implants — Self-closing intracranial aneurysm clips

—

—

—

—

—

EN ISO 9919:2005
Medical electrical equipment — Particular requirements for the basic
safety and essential performance of pulse oximeter equipment for medical
use (ISO 9919:2005)

EN 865:1997

Date expired
(30.9.2005)

EN ISO 10079-1:1999
Medical suction equipment — Part 1: Electrically powered suction equip-
ment — Safety requirements (ISO 10079-1:1999)

EN ISO 10079-1:1996

EN ISO 10079-2:1999
Medical suction equipment — Part 2: Manually powered suction equip-
ment (ISO 10079-2:1999)

EN ISO 10079-2:1996

Date expired
(29.2.2000)

Date expired
(29.2.2000)

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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C 186/14

EN

Official Journal of the European Union

23.7.2008

ESO (1)

CEN

CEN

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CEN

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CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN ISO 10079-3:1999
Medical suction equipment — Part 3: Suction equipment powered from
vacuum or pressure source (ISO 10079-3:1999)

EN ISO 10079-3:1996

Date expired
(29.2.2000)

EN ISO 10328:2006
Prosthetics — Structural testing of
ments and test methods (ISO 10328:2006)

lower-limb prostheses — Require-

—

EN ISO 10524-1:2006
Pressure regulators for use with medical gases — Part 1: Pressure
regulators
devices
(ISO 10524-1:2006)

regulators with

flow-metering

pressure

and

EN 738-1:1997

31.10.2008

EN ISO 10524-2:2006
Pressure regulators for use with medical gases — Part 2: Manifold and
line pressure regulators (ISO 10524-2:2005)

EN 738-2:1998

31.10.2008

EN ISO 10524-3:2006
Pressure regulators for use with medical gases — Part 3: Pressure regula-
tors integrated with cylinder valves (ISO 10524-3:2005)

EN 738-3:1998

31.10.2008

EN ISO 10524-4:2008
Pressure regulators for use with medical gases — Part 4: Low-pressure
regulators (ISO 10524-4:2008)

EN 738-4:1998

30.6.2010

EN ISO 10535:2006
Hoists for the transfer of disabled persons — Requirements and test
methods (ISO 10535:2006)

EN ISO 10535:1998

Date expired
(30.6.2007)

EN ISO 10555-1:1996
Sterile, single-use intravascular catheters — Part 1: General requirements
(ISO 10555-1:1995)

EN ISO 10555-1:1996/A1:1999

EN ISO 10555-1:1996/A2:2004

—

Note 3

Note 3

EN ISO 10651-2:2004
Lung ventilators for medical use — Particular requirements for basic
safety and essential performance — Part 2: Home care ventilators for
ventilator-dependent patients (ISO 10651-2:2004)

EN 794-2:1997

EN ISO 10651-4:2002
Lung ventilators — Part 4: Particular requirements for operator-powered
resuscitators (ISO 10651-4:2002)

EN ISO 10651-6:2004
Lung ventilators for medical use — Particular requirements for basic
safety and essential performance — Part 6: Home-care ventilatory
support devices (ISO 10651-6:2004)

EN ISO 10993-1:2003
Biological evaluation of medical devices — Part 1: Evaluation and testing
(ISO 10993-1:2003)

—

—

—

Date expired
(31.1.2000)

Date expired
(30.11.2004)

Date expired
(31.1.2005)

23.7.2008

EN

Official Journal of the European Union

C 186/15

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

ESO (1)

CEN

Date expired
(30.4.2004)

Date expired
(30.4.2003)

Date expired
(31.1.2007)

Date expired
(30.11.1999)

Date expired
(31.10.2007)

Date expired
(31.3.2003)

Date expired
(31.1.2007)

Date expired
(28.2.2007)

Date expired
(31.5.2008)

EN ISO 10993-3:2003
Biological evaluation of medical devices — Part 3: Tests for genotoxicity,
carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

EN 30993-3:1993

CEN

EN ISO 10993-4:2002
Biological evaluation of medical devices — Part 4: Selection of tests for
interactions with blood (ISO 10993-4:2002)

EN 30993-4:1993

EN ISO 10993-4:2002/A1:2006

Note 3

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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CEN

EN ISO 10993-5:1999
Biological evaluation of medical devices — Part 5: Tests for in vitro cyto-
toxicity (ISO 10993-5:1999)

EN 30993-5:1994

EN ISO 10993-6:2007
Biological evaluation of medical devices — Part 6: Tests for local effects
after implantation (ISO 10993-6:2007)

EN 30993-6:1994

EN ISO 10993-9:1999
Biological evaluation of medical devices — Part 9: Framework for
identification and quantification of potential degradation products
(ISO 10993-9:1999)

—

EN ISO 10993-10:2002
Biological evaluation of medical devices — Part 10: Tests for irritation
and delayed-type hypersensitivity (ISO 10993-10:2002)

EN ISO 10993-10:1995

EN ISO 10993-10:2002/A1:2006

Note 3

EN ISO 10993-11:2006
Biological evaluation of medical devices — Part 11: Tests for systemic
toxicity (ISO 10993-11:2006)

EN ISO 10993-11:1995

EN ISO 10993-12:2007
Biological evaluation of medical devices — Part 12: Sample preparation
and reference materials (ISO 10993-12:2007)

EN ISO 10993-12:2004

EN ISO 10993-13:1998
Biological evaluation of medical devices — Part 13: Identification and
quantification of degradation products from polymeric medical devices
(ISO 10993-13:1998)

EN ISO 10993-14:2001
Biological evaluation of medical devices — Part 14:
and
quantification
(ISO 10993-14:2001)

degradation

products

of

Identification
from ceramics

EN ISO 10993-15:2000
Identification
Biological evaluation of medical devices — Part 15:
and quantification of degradation products from metals and alloys
(ISO 10993-15:2000)

EN ISO 10993-16:1997
Biological evaluation of medical devices — Part 16: Toxicokinetic study
design for degradation products and leachables (ISO 10993-16:1997)

—

—

—

—

ESO (1)

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C 186/16

EN

Official Journal of the European Union

23.7.2008

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN ISO 10993-17:2002
Biological evaluation of medical devices — Part 17: Establishment of
allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 10993-18:2005
Biological evaluation of medical devices — Part 18: Chemical characteri-
zation of materials (ISO 10993-18:2005)

—

—

EN ISO 11135-1:2007
Sterilization of health care products — Ethylene oxide — Part 1: Require-
ments for development, validation and routine control of a sterilization
process for medical devices (ISO 11135-1:2007)

EN 550:1994

31.5.2010

EN ISO 11137-1:2006
Sterilization of health care products — Radiation — Part 1: Requirements
for development, validation and routine control of a sterilization process
for medical devices (ISO 11137-1:2006)

EN 552:1994

30.4.2009

EN ISO 11137-2:2007
Sterilization of health care products — Radiation — Part 2: Establishing
the sterilization dose (ISO 11137-2:2006, corrected version 1.8.2006)

EN ISO 11138-2:2006
Sterilization of health care products — Biological indicators — Part 2:
Biological
processes
(ISO 11138-2:2006)

sterilization

indicators

ethylene

oxide

for

EN ISO 11138-3:2006
Sterilization of health care products — Biological indicators — Part 3:
Biological
processes
(ISO 11138-3:2006)

for moist

sterilization

indicators

heat

—

—

—

EN ISO 11140-1:2005
Sterilization of health care products — Chemical indicators — Part 1:
General requirements (ISO 11140-1:2005)

EN 867-2:1997

EN ISO 11140-3:2007
Sterilization of health care products — Chemical indicators — Part 3:
Class 2 indicator systems for use in the Bowie and Dick-type steam pene-
tration test (ISO 11140-3:2007)

EN 867-3:1997

CEN

EN ISO 11197:2004
Medical supply units (ISO 11197:2004)

CEN

CEN

EN ISO 11607-1:2006
Packaging for terminally sterilized medical devices — Part 1: Require-
ments for materials, sterile barrier systems and packaging systems
(ISO 11607-1:2006)

EN ISO 11607-2:2006
Packaging for
dation requirements
(ISO 11607-2:2006)

terminally sterilized medical devices — Part 2: Vali-
sealing and assembly processes

forming,

for

EN 793:1997

EN 868-1:1997

—

Date expired
(31.1.2006)

Date expired
(30.9.2007)

Date expired
(30.6.2005)

Date expired
(30.4.2007)

23.7.2008

EN

Official Journal of the European Union

C 186/17

ESO (1)

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Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

EN ISO 11737-1:2006
Sterilization of medical devices — Microbiological methods — Part 1:
Determination of
a population of microorganisms on products
(ISO 11737-1:2006)

EN 1174-1:1996
EN 1174-2:1996
EN 1174-3:1996

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

Date expired
(31.10.2006)

EN ISO 11810-2:2007
Lasers and laser-related equipment — Test method and classification for
the laser-resistance of surgical drapes and/or patient-protective covers —
Part 2: Secondary ignition (ISO 11810-2:2007)

—

EN ISO 11979-8:2006
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental
requirements (ISO 11979-8:2006)

EN 13503-8:2000

EN ISO 11990:2003
Optics and optical instruments — Lasers and laser-related equipment —
Determination
shafts
resistance
of
(ISO 11990:2003)

tracheal

laser

tube

of

EN ISO 11990:1999

Date expired
(31.1.2007)

Date expired
(31.10.2003)

EN 12006-2:1998
Non active surgical implants — Particular requirements for cardiac and
vascular implants — Part 2: Vascular prostheses including cardiac valve
conduits

EN 12006-3:1998
Non active surgical implants — Particular requirements for cardiac and
vascular implants — Part 3: Endovascular devices

EN 12011:1998
Instrumentation to be used in association with non-active surgical
implants — General requirements

EN 12182:1999
Technical aids for disabled persons — General requirements and test
methods

EN 12322:1999
In vitro diagnostic medical devices — Culture media for microbiology —
Performance criteria for culture media

—

—

—

—

—

EN 12322:1999/A1:2001

Note 3

Date expired
(30.4.2002)

EN 12342:1998
Breathing tubes intended for use with anaesthetic apparatus and ventila-
tors

EN 12470-1:2000
Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers
with maximum device

EN 12470-2:2000
Clinical thermometers — Part 2: Phase change type (dot matrix) thermo-
meters

—

—

—

C 186/18

EN

Official Journal of the European Union

23.7.2008

ESO (1)

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN 12470-3:2000
Clinical thermometers — Part 3: Performance of compact electrical ther-
mometers (non-predictive and predictive) with maximum device

EN 12470-4:2000
Clinical thermometers — Part 4: Performance of electrical thermometers
for continuous measurement

EN 12470-5:2003
Clinical thermometers — Part 5: Performance of infra-red ear thermo-
meters (with maximum device)

—

—

—

EN ISO 12870:2004
Ophthalmic optics — Spectacle frames — Requirements and test
methods (ISO 12870:2004)

EN ISO 12870:1997

Date expired
(28.2.2005)

EN ISO 12870:2004/AC:2005

EN 13014:2000
Connections for gas sampling tubes to anaesthetic and respiratory equip-
ment

EN 13060:2004
Small steam sterilizers

EN 13220:1998
Flow-metering devices for connection to terminal units of medical gas
pipeline systems

—

—

—

EN ISO 13485:2003
Medical devices — Quality management systems — Requirements for
regulatory purposes (ISO 13485:2003)

EN 46003:1999
EN ISO 13485:2000
EN ISO 13488:2000

31.7.2009

EN ISO 13485:2003/AC:2007

EN 13544-1:2007
Respiratory therapy equipment — Part 1: Nebulizing systems and their
components

EN 13544-1:2001

Date expired
(31.10.2007)

EN 13544-2:2002
Respiratory therapy equipment — Part 2: Tubing and connectors

EN 13544-3:2001
Respiratory therapy equipment — Part 3: Air entrainment devices

EN 13624:2003
Chemical disinfectants and antiseptics — Quantitative suspension test for
the evaluation of fungicidal activity of chemical disinfectants for instru-
ments used in the medical area — Test method and requirements
(phase 2, step 1)

EN 13718-1:2002
Air, water and difficult terrain ambulances — Part 1: Medical device inter-
face requirements for the continuity of patient care

EN 13726-1:2002
Test methods for primary wound dressings — Part 1: Aspects of absor-
bency

—

—

—

—

—

23.7.2008

EN

Official Journal of the European Union

C 186/19

ESO (1)

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CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN 13726-2:2002
Test methods for primary wound dressings — Part 2: Moisture vapour
transmission rate of permeable film dressings

EN 13727:2003
Chemical disinfectants and antiseptics — Quantitative suspension test for
the evaluation of bactericidal activity of chemical disinfectants for instru-
ments used in the medical area — Test method and requirements
(phase 2, step 1)

EN 13824:2004
Sterilization of medical devices — Aseptic processing of liquid medical
devices — Requirements

EN 13867:2002
Concentrates for haemodialysis and related therapies

EN 13976-1:2003
Rescue systems — Transportation of
conditions

incubators — Part 1:

Interface

EN 13976-2:2003
Rescue systems — Transportation of
requirements

incubators — Part 2: System

EN 14079:2003
Non-active medical devices — Performance requirements and test
methods for absorbent cotton gauze and absorbent cotton and viscose
gauze

—

—

—

—

—

—

—

EN ISO 14155-1:2003
Clinical investigation of medical devices for human subjects — Part 1:
General requirements (ISO 14155-1:2003)

EN 540:1993

Date expired
(31.8.2003)

EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2:
Clinical investigation plans (ISO 14155-2:2003)

EN ISO 14160:1998
Sterilization of single-use medical devices incorporating materials of
animal origin — Validation and routine control of sterilization by liquid
chemical sterilants (ISO 14160:1998)

EN 14180:2003
Sterilizers for medical purposes — Low temperature steam and formalde-
hyde sterilizers — Requirements and testing

EN 14299:2004
Non active surgical implants — Particular requirements for cardiac and
vascular implants — Specific requirements for arterial stents

EN 14348:2005
Chemical disinfectants and antiseptics — Quantitative suspension test for
the evaluation of mycobactericidal activity of chemical disinfectants in the
medical area including instrument disinfectants — Test methods and
requirements (phase 2, step 1)

—

—

—

—

—

C 186/20

EN

Official Journal of the European Union

23.7.2008

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN ISO 14408:2005
Tracheal tubes designed for laser surgery — Requirements for marking
and accompanying information (ISO 14408:2005)

—

EN ISO 14534:2002
Ophthalmic optics — Contact lenses and contact lens care products —
Fundamental requirements (ISO 14534:2002)

EN ISO 14534:1997

Date expired
(31.12.2002)

EN 14561:2006
Chemical disinfectants and antiseptics — Quantitative carrier test for the
evaluation of bactericidal activity for instruments used in the medical
area — Test method and requirements (phase 2, step 2)

EN 14562:2006
Chemical disinfectants and antiseptics — Quantitative carrier test for the
evaluation of fungicidal or yeasticidal activity for instruments used in the
medical area — Test method and requirements (phase 2, step 2)

EN ISO 14602:1998
Non-active surgical implants — Implants for Osteosynthesis — Particular
requirements (ISO 14602:1998)

EN ISO 14607:2007
Non-active surgical implants — Mammary implants — Particular require-
ments (ISO 14607:2007)

—

—

—

—

EN ISO 14630:2008
Non-active surgical implants — General requirements (ISO 14630:2008)

EN ISO 14630:2005

31.7.2008

EN 14683:2005
Surgical masks — Requirements and test methods

—

EN ISO 14889:2003
Ophthalmic optics — Spectacle lenses — Fundamental requirements for
uncut finished lenses (ISO 14889:2003)

EN ISO 14889:1997

Date expired
(30.11.2003)

EN 14931:2006
Pressure vessels for human occupancy (PVHO) — Multi-place pressure
chamber systems for hyperbaric therapy — Performance, safety require-
ments and testing

EN ISO 14937:2000
Sterilization of health care products — General
for
characterization of a sterilizing agent and the development, validation
and routine control of a sterilization process
for medical devices
(ISO 14937:2000)

requirements

—

—

EN ISO 14971:2007
Medical devices — Application of risk management to medical devices
(ISO 14971:2007)

EN ISO 14971:2000

31.3.2010

EN ISO 15001:2004
Anaesthetic and respiratory equipment — Compatibility with oxygen
(ISO 15001:2003)

—

23.7.2008

EN

Official Journal of the European Union

C 186/21

ESO (1)

CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN ISO 15004-1:2006
Ophthalmic instruments — Fundamental requirements and test methods
— Part 1: General requirements applicable to all ophthalmic instruments
(ISO 15004-1:2006)

EN ISO 15004:1997

Date expired
(31.12.2006)

CEN

EN ISO 15225:2000
Nomenclature — Specification for a nomenclature system for medical
devices for the purpose of regulatory data exchange (ISO 15225:2000)

EN ISO 15225:2000/A1:2004

EN 15424:2007
Sterilization of medical devices — Low temperature steam and formalde-
hyde — Requirements for development, validation and routine control of
a sterilization process for medical devices

EN 15546-1:2008
Small bore connectors for liquids and gases in healthcare applications —
Part 1 — General Requirements

EN ISO 15747:2005
Plastics containers for intravenous injection (ISO 15747:2003)

EN ISO 15883-1:2006
Washer-disinfectors — Part 1: General requirements, terms and defini-
tions and tests (ISO 15883-1:2006)

EN ISO 15883-2:2006
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfec-
tors employing thermal disinfection for surgical
instruments, anaes-
thetic equipment, bowls, dishes,
receivers, utensils, glassware, etc.
(ISO 15883-2:2006)

EN ISO 15883-3:2006
Washer-disinfectors — Part 3: Requirements and tests for washer-disinfec-
containers
tors
(ISO 15883-3:2006)

employing thermal disinfection for human waste

EN ISO 15883-4:2008
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfec-
tors
endoscopes
(ISO 15883-4:2008)

employing chemical disinfection for

thermolabile

EN ISO 16201:2006
Technical aids for disabled persons — Environmental control systems for
daily living (ISO 16201:2006)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

Date expired
(31.8.2004)

—

Note 3

—

—

—

—

—

—

—

—

EN ISO 17510-1:2007
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing
therapy equipment (ISO 17510-1:2007)

EN ISO 17510-1:2002

EN ISO 17510-2:2007
Sleep apnoea breathing therapy — Part 2: Masks and application acces-
sories (ISO 17510-2:2007)

EN ISO 17510-2:2003

Date expired
(30.4.2008)

Date expired
(30.4.2008)

C 186/22

EN

Official Journal of the European Union

23.7.2008

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN ISO 17664:2004
Sterilization of medical devices — Information to be provided by the
manufacturer
resterilizable medical devices
for
(ISO 17664:2004)

the processing of

—

EN ISO 17665-1:2006
Sterilization of health care products — Moist heat — Part 1: Require-
ments for the development, validation and routine control of a steriliza-
tion process for medical devices (ISO 17665-1:2006)

EN ISO 18777:2005
Transportable liquid oxygen systems for medical use — Particular require-
ments (ISO 18777:2005)

EN ISO 18778:2005
Respiratory equipment — Infant monitors — Particular requirements
(ISO 18778:2005)

EN ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures — Particular
requirements (ISO 18779:2005)

EN 554:1994

31.8.2009

—

—

—

EN ISO 19054:2006
Rail systems for supporting medical equipment (ISO 19054:2005)

EN 12218:1998

Date expired
(30.6.2008)

EN 20594-1:1993
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain
other medical
requirements
(ISO 594-1:1986)

equipment — Part

1: General

EN 20594-1:1993/A1:1997

EN ISO 21171:2006
Medical
(ISO 21171:2006)

gloves — Determination of

removable

surface powder

—

Note 3

—

EN ISO 21534:2007
Non-active surgical implants — Joint replacement implants — Particular
requirements (ISO 21534:2007)

EN 12010:1998

EN ISO 21535:2007
Non-active surgical implants — Joint replacement implants — Specific
requirements for hip-joint replacement implants (ISO 21535:2007)

EN 12563:1998

EN ISO 21536:2007
Non-active surgical implants — Joint replacement implants — Specific
requirements for knee-joint replacement implants (ISO 21536:2007)

EN 12564:1998

EN ISO 21647:2004
Medical electrical equipment — Particular requirements for the basic
safety
gas monitors
and
(ISO 21647:2004)

performance

respiratory

essential

of

EN 12598:1999
EN 864:1996
EN ISO 11196:1997

EN ISO 21647:2004/AC:2006

Date expired
(31.5.1998)

Date expired
(31.3.2008)

Date expired
(31.3.2008)

Date expired
(31.3.2008)

Date expired
(31.5.2005)

23.7.2008

EN

Official Journal of the European Union

C 186/23

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN ISO 21649:2006
Needle-free injectors for medical use — Requirements and test methods
(ISO 21649:2006)

—

EN ISO 21969:2006
High-pressure flexible connections for use with medical gas systems
(ISO 21969:2005)

EN 13221:2000

Date expired
(31.12.2007)

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

EN 12442-1:2000

EN ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives — Part 2:
Controls on sourcing, collection and handling (ISO 22442-2:2007)

EN 12442-2:2000

EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives — Part 3:
Validation of the elimination and/or inactivation of viruses and transmis-
sible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

EN 12442-3:2000

Date expired
(30.6.2008)

Date expired
(30.6.2008)

Date expired
(30.6.2008)

EN ISO 22523:2006
External limb prostheses and external orthoses — Requirements and test
methods (ISO 22523:2006)

EN 12523:1999

Date expired
(30.4.2007)

EN ISO 22610:2006
Surgical drapes, gowns and clean air suits, used as medical devices, for
patients, clinical staff and equipment — Test method to determine the
resistance to wet bacterial penetration (ISO 22610:2006)

EN ISO 22612:2005
Clothing for protection against infectious agents — Test method for resis-
tance to dry microbial penetration (ISO 22612:2005)

EN ISO 22675:2006
Prosthetics — Testing of ankle-foot devices and foot units — Require-
ments and test methods (ISO 22675:2006)

—

—

—

EN ISO 23328-1:2008
Breathing system filters for anaesthetic and respiratory use — Part 1: Salt
test method to assess filtration performance (ISO 23328-1:2003)

EN 13328-1:2001

30.9.2008

EN ISO 23328-2:2008
Breathing system filters for anaesthetic and respiratory use — Part 2:
Non-filtration aspects (ISO 23328-2:2002)

EN 13328-2:2002

30.9.2008

EN ISO 23747:2007
Anaesthetic and respiratory equipment — Peak expiratory flow meters
for the assessment of pulmonary function in spontaneously breathing
humans (ISO 23747:2007)

EN 13826:2003

Date expired
(31.1.2008)

C 186/24

EN

Official Journal of the European Union

23.7.2008

ESO (1)

CEN

Reference and title of the harmonised standard
(and reference document)

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

EN 27740:1992
Instruments for surgery, scalpels with detachable blades, fitting dimen-
sions (ISO 7740:1985)

EN 27740:1992/A1:1997

—

Note 3

Date expired
(31.5.1998)

(1) ESO: European Standardisation Organisation:

— CEN: rue de Stassart 36, B-1050 Brussels, Tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu)
— Cenelec: rue de Stassart 35, B-1050 Brussels, Tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org)
— ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org).

Note 1 Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’),
set by the European Standardisation Organisation, but attention of users of these standards is drawn
to the fact that in certain exceptional cases this can be otherwise.

Note 3 In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if
any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of
EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment.
On the date stated, the superseded standard ceases to give presumption of conformity with the
essential requirements of the directive.

Note:

— Any information concerning the availability of the standards can be obtained either from the European
Standardisation Organisations or from the national standardisation bodies of which the list is annexed to
the Directive 98/34/EC of the European Parliament and of the Council (1) amended by the Directive
98/48/EC (2).

— Publication of the references in the Official Journal of the European Union does not imply that the stan-

dards are available in all the Community languages.

— This list replaces all the previous lists published in the Official

Journal of

the European Union. The

Commission ensures the updating of this list.

More information about harmonised standards on the Internet at:

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/

(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ L 217, 5.8.1998, p. 18.