Commission communication in the framework of the implementation of Council Directive 93/42/EEC of  14 June 1993  concerning medical devices   (Text with EEA relevance)
Date: 2006-06-02
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device

C 129/8

EN

Official Journal of the European Union

2.6.2006

Commission communication in the framework of the implementation of Council Directive
93/42/EEC of 14 June 1993 concerning medical devices

(2006/C 129/04)

(Text with EEA relevance)

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

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Reference of superseded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 super-
seded standard
Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN 285:1996
Sterilization — Steam sterilizers — Large sterilizers

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

Date expired
(30.4.2001)

Date expired
(30.4.2001)

EN 455-3:1999
Medical gloves for single use — Part 3: Requirements and testing for
biological evaluation

EN 550:1994
Sterilization of medical devices — Validation and routine control of
ethylene oxide sterilization

EN 552:1994
Sterilization of medical devices — Validation and routine control of ster-
ilization by irradiation

EN 552:1994/A1:1999

EN 552:1994/A2:2000

EN 554:1994
Sterilization of medical devices — Validation and routine control of ster-
ilization by moist heat

—

—

—

Note 3

Note 3

—

Date expired
(30.11.1999)

Date expired
(31.5.2001)

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
(30.4.2002)

2.6.2006

EN

Official Journal of the European Union

C 129/9

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

ESO (1)

CEN

CEN

CEN

CEN

CEN

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

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

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

EN 737-2:1998
Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging
disposal systems — Basic requirements

EN 737-2:1998/A1:1999

CEN

EN 737-3:1998
Medical gas pipeline systems — Part 3: Pipelines for compressed medical
gases and vacuum

EN 737-3:1998/A1:1999

CEN

CEN

CEN

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

EN 738-2:1998
Pressure regulators for use with medical gases — Part 2: Manifold and
line pressure regulators

EN 738-3:1998
Pressure regulators for use with medical gases — Part 3: Pressure regula-
tors integrated with cylinder valves

EN 738-3:1998/A1:2002

CEN

EN 738-4:1998
Pressure regulators for use with medical gases — Part 4: Low-pressure
regulators intended for incorporation into medical equipment

EN 738-4:1998/A1:2002

CEN

EN 739:1998
Low-pressure hose assemblies for use with medical gases

EN 739:1998/A1:2002

—

—

—

—

—

Note 3

—

Note 3

—

—

—

Note 3

—

Note 3

—

Note 3

Date expired
(30.6.2000)

Date expired
(30.6.2000)

Date expired
(31.10.2002)

Date expired
(31.10.2002)

Date expired
(31.10.2002)

C 129/10

EN

Official Journal of the European Union

2.6.2006

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 super-
seded standard
Note 1

CEN

EN 740:1998
Anaesthetic workstations and their modules — Particular requirements

EN 740:1998/A1:2004

EN 740:1998/AC:1998

CEN

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

EN 867-3:1997
Non-biological systems for use in sterilizers — Part 3: Specification for
Class B indicators for use in the Bowie and Dick test

EN 868-1:1997
Packaging materials and systems for medical devices which are to be
sterilized — Part 1: General requirements and test methods

Date expired
(31.7.2004)

Date expired
(31.5.2001)

Date expired
(31.12.2005)

—

Note 3

—

Note 3

—

Note 3

—

—

EN 980:2003
Graphical symbols for use in the labelling of medical devices

EN 980:1996

Date expired
(31.10.2003)

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

—

Date expired
(30.11.2002)

30.6.2006

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

2.6.2006

EN

Official Journal of the European Union

C 129/11

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 super-
seded standard
Note 1

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

EN 1089-3:1997

Date expired
(31.10.2004)

EN 1174-1:1996
Sterilization of medical devices — Estimation of
micro-organisms on product — Part 1: Requirements

the population of

EN 1174-2:1996
Sterilization of medical devices — Estimation of
micro-organisms on product — Part 2: Guidance

the population of

EN 1174-3:1996
Sterilization of medical devices — Estimation of
the population of
micro-organisms on product — Part 3: Guide to the methods for valida-
tion of microbiological techniques

EN 1280-1:1997
Agent specific filling systems for anaesthetic vaporizers — Part 1:
Rectangular keyed filling systems

EN 1280-1:1997/A1:2000

EN 1281-2:1995
Anaesthetic and respiratory equipment — Conical connectors — Part 2:
Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified)

—

—

—

—

Note 3

—

Date expired
(24.11.2000)

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

EN 1282-2:1997

Date expired
(31.12.2005)

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

EN 1618:1997
Catheters other
common properties

than intravascular catheters — Test methods

for

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 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)

C 129/12

EN

Official Journal of the European Union

2.6.2006

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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 1789:1999
Medical vehicles and their equipment — Road ambulances

—

—

—

EN 1789:1999/A1:2003

Note 3

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

EN 1820:1997

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

—

—

Note 3

—

Date expired
(30.9.2003)

Date expired
(31.12.2005)

Date expired
(30.9.2005)

EN ISO 4074:2002
Natural latex rubber condoms — Requirements and test methods (ISO
4074:2002)

EN 600:1996

Date expired
(31.8.2005)

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

EN ISO 4135:1996

Date expired
(28.2.2002)

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

EN 1281-1:1997

Date expired
(30.11.2004)

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
(31.1.2005)

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

EN 12006-1:1999

30.6.2006

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

EN 1819:1997

Date expired
(30.6.2004)

2.6.2006

EN

Official Journal of the European Union

C 129/13

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

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 8185:1997
Humidifiers for medical use — General requirements for humidification
systems (ISO 8185:1997)

EN ISO 8359:1996
Oxygen concentrators for medical use — Safety requirements (ISO
8359:1996)

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 implants — Self-closing intracranial aneurysm clips (ISO
9713:2002)

—

—

—

—

—

—

—

—

—

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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)

C 129/14

EN

Official Journal of the European Union

2.6.2006

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded 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 738-1:1997

31.8.2006

EN ISO 10524-1:2006
Pressure regulators for use with medical gases — Part 1: Pressure regula-
tors and pressure regulators with flow-metering devices (ISO 10524-
1:2006)

EN ISO 10535:1998
Hoists for the transfer of disabled persons — Requirements and test
methods (ISO 10535:1998)

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)

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

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

EN 30993-5:1994

Date expired
(30.4.2004)

Date expired
(30.4.2003)

Date expired
(30.11.1999)

EN ISO 10993-7:1995
Biological evaluation of medical devices — Part 7: Ethylene oxide sterili-
zation residuals (ISO 10993-7:1995)

—

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

2.6.2006

EN

Official Journal of the European Union

C 129/15

ESO (1)

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 super-
seded standard
Note 1

EN ISO 10993-9:1999
Biological evaluation of medical devices — Part 9: Framework for identi-
fication 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

Date expired
(31.3.2003)

EN ISO 10993-11:1995
Biological evaluation of medical devices — Part 11: Tests for systemic
toxicity (ISO 10993-11:1993)

—

EN ISO 10993-12:2004
Biological evaluation of medical devices — Part 12: Sample preparation
and reference materials (ISO 10993-12:2002)

EN ISO 10993-12:1996

Date expired
(31.5.2005)

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: Identification and
quantification of degradation products from ceramics (ISO 10993-
14:2001)

EN ISO 10993-15:2000
Biological evaluation of medical devices — Part 15: Identification 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)

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

EN 867-2:1997

Date expired
(31.1.2006)

CEN

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

EN 793:1997

Date expired
(30.6.2005)

C 129/16

EN

Official Journal of the European Union

2.6.2006

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

resistance of

tracheal

shafts

laser

tube

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 12010:1998
Non-active surgical implants — Joint replacement implants — Particular
requirements

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 12183:1999
Manually propelled wheelchairs — Requirements and test methods

EN 12184:1999
Electrically powered wheelchairs, scooters and their charges — Require-
ments and test methods

CEN

EN 12218:1998
Rail systems for supporting medical equipment

EN 12218:1998/A1:2002

CEN

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

EN 12322:1999/A1:2001

CEN

CEN

CEN

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

EN 12442-1:2000
Animal
medical devices — Part 1: Analysis and management of risk

tissues and their derivatives utilized in the manufacture of

EN 12442-2:2000
Animal
tissues and their derivatives utilized in the manufacture of
medical devices — Part 2: Controls on sourcing, collection and handling

EN ISO 11990:1999

Date expired
(31.10.2003)

—

—

—

—

—

—

—

—

Note 3

—

Note 3

—

—

—

Date expired
(31.10.2002)

Date expired
(30.4.2002)

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

2.6.2006

EN

Official Journal of the European Union

C 129/17

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

EN 12442-3:2000
Animal
tissues and their derivatives utilized in the manufacture of
medical devices — Part 3: Validation of the elimination and/or inactiva-
tion of viruses and transmissible agents

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

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 12523:1999
External limb prostheses and external orthoses — Requirements and test
methods

EN 12563:1998
Non-active surgical implants — Joint replacement implants — Specific
requirements for hip joint replacement implants

EN 12564:1998
Non-active surgical implants — Joint replacement implants — Specific
requirements for knee joint replacement implants

—

—

—

—

—

—

—

—

—

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

CEN

EN 13221:2000
High-pressure flexible connections for use with medical gases

—

—

—

—

C 129/18

EN

Official Journal of the European Union

2.6.2006

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

ESO (1)

CEN

EN 13328-1:2001
Breathing system filters for anaesthetic and respiratory use — Part 1:
Salt test method to assess filtration performance

CEN

EN 13328-2:2002
Breathing system filters for anaesthetic and respiratory use — Part 2:
Non-filtration aspects

—

—

EN 13328-2:2002/A1:2003

Note 3

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

EN ISO 13485:2000
EN ISO 13488:2000

EN 13503-8:2000
Ophthalmic implants — Intraocular lenses — Part 8: Fundamental
requirements (ISO 11979-8:1999, modified)

EN 13544-1:2001
Respiratory therapy equipment — Part 1: Nebulizing systems and their
components

—

—

Date expired
(30.6.2004)

31.7.2006

EN 13544-1:2001/A1:2004

Note 3

Date expired
(31.12.2004)

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
instruments 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
interface requirements for the continuity of patient care

EN 13718-2:2002
Air, water and difficult terrain ambulances — Part 2: Operational and
technical requirements for the continuity of patient care

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

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

—

—

—

—

—

—

—

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

2.6.2006

EN

Official Journal of the European Union

C 129/19

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

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

EN 13795-1:2002
Surgical drapes, gowns and clean air suits, used as medical devices, for
patients, clinical staff and equipment — Part 1: General requirements for
manufacturers, processors and products

EN 13795-2:2004
Surgical drapes, gowns and clean air suits, used as medical devices for
patients, clinical staff and equipment — Part 2: Test methods

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

CEN

EN 13826:2003
Peak expiratory flow meters

CEN

EN 13867:2002
Concentrates for haemodialysis and related therapies

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

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

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—

—

—

—

—

—

—

—

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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)

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—

C 129/20

EN

Official Journal of the European Union

2.6.2006

ESO (1)

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 super-
seded standard
Note 1

EN 14180:2003
Sterilizers for medical purposes — Low temperature steam and formal-
dehyde 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)

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

—

EN ISO 14630:2005
Non-active surgical implants — General requirements (ISO 14630:2005)

EN ISO 14630:1997

Date expired
(30.11.2005)

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

—

CEN

EN ISO 14971:2000
Medical devices — Application of risk management to medical devices
(ISO 14971:2000)

EN 1441:1997

EN ISO 14971:2000/A1:2003

CEN

CEN

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

EN ISO 15004:1997
Ophthalmic instruments — Fundamental requirements and test methods
(ISO 15004:1997)

Note 3

—

—

Date expired
(31.3.2004)

Date expired
(31.3.2004)

2.6.2006

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Official Journal of the European Union

C 129/21

ESO (1)

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 super-
seded standard
Note 1

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

—

Note 3

Date expired
(31.8.2004)

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

EN ISO 17510-1:2002
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing
therapy devices (ISO 17510-1:2002)

EN ISO 17510-2:2003
Sleep apnoea breathing therapy — Part 2: Masks and application acces-
sories (ISO 17510-2:2003)

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

EN ISO 18777:2005
Transportable liquid oxygen systems for medical use — Particular
requirements (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 — Particu-
lar requirements (ISO 18779:2005)

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

—

—

—

—

—

—

—

—

EN 20594-1:1993/A1:1997

Note 3

CEN

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

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

EN ISO 21647:2004/AC:2006

CEN

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

—

Date expired
(31.5.1998)

Date expired
(31.5.2005)

C 129/22

EN

Official Journal of the European Union

2.6.2006

ESO (1)

CEN

CEN

CEN

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

Reference of superseded
standard

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

EN 27740:1992/A1:1997

EN 30993-6:1994
Biological evaluation of medical devices — Part 6: Tests for local effects
after implantation (ISO 10993-6:1994)

EN 46003:1999
Quality systems — Medical devices — Particular requirements for the
application of EN ISO 9003

—

Note 3

—

—

(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.cenorm.be)
— 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)

Date of cessation of presump-
tion of conformity of super-
seded standard
Note 1

Date expired
(31.5.1998)

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 Directive 98/34/EC (1) of the European Parliament and of the Council amended by 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.

More information about harmonised standards on the Internet at
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/

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