Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices   (Text with EEA relevance)
Date: 2006-09-07
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device

7.9.2006

EN

Official Journal of the European Union

C 216/1

I

(Information)

COMMISSION

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

(2006/C 216/01)

(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Reference of superseded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
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN 285:2006
Sterilisation — Steam sterilisers — Large sterilisers

EN 285:1996

30.11.2008

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

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

EN 550:1994
Sterilisation of medical devices — Validation and routine control of ethylene
oxide sterilisation

EN 554:1994
Sterilisation of medical devices — Validation and routine control of sterilisation
by moist heat

EN 455-1:1993

EN 455-2:1995

Date expired
(30.4.2001)

Date expired
(30.4.2001)

—

—

—

C 216/2

EN

Official Journal of the European Union

7.9.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

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

EN 556:1994 + A1:1998

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN 556-2:2003
Sterilisation 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

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

EN 737-3:1998/A1:1999

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

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

CEN

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

EN 740:1998/A1:2004

—

—

—

—

—

Note 3

—

Note 3

—

—

Note 3

—

Note 3

—

Note 3

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

Date expired
(30.4.2002)

Date expired
(30.6.2000)

Date expired
(30.6.2000)

Date expired
(31.10.2002)

Date expired
(31.10.2002)

Date expired
(31.7.2004)

7.9.2006

EN

Official Journal of the European Union

C 216/3

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

EN 740:1998/AC:1998

CEN

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

EN 794-1:1997/A1:2000

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 sterilisers — Part 3: Specification for Class B
indicators for use in the Bowie and Dick test

—

Note 3

—

Note 3

—

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

Date expired
(31.5.2001)

Date expired
(31.12.2005)

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 requirements for
mechanical sphygmomanometers

EN 1060-3:1997
Non-invasive sphygmomanometers — Part 3: Supplementary requirements 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 determine the
overall system accuracy of automated non-invasive sphygmomanometers

—

—

Note 3

—

—

Note 3

—

Date expired
(30.11.2002)

Date expired
(30.6.2006)

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

EN 1280-1:1997/A1:2000

—

Note 3

Date expired
(24.11.2000)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

C 216/4

EN

Official Journal of the European Union

7.9.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

—

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

EN 1282-2:1997

Date expired
(31.12.2005)

EN 1422:1997
Sterilisers for medical purposes — Ethylene oxide sterilisers — Requirements
and test methods

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 1789:1999
Medical vehicles and their equipment — Road ambulances

EN 1789:1999/A1:2003

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

—

—

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)

Note 3

EN 1820:1997

Date expired
(30.9.2003)

Date expired
(31.12.2005)

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

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

—

—

7.9.2006

EN

Official Journal of the European Union

C 216/5

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

Date expired
(30.9.2005)

Date expired
(31.8.2005)

Date expired
(28.2.2002)

Date expired
(30.11.2004)

Date expired
(31.1.2005)

Date expired
(30.6.2006)

EN 1970:2000/A1:2005

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

EN ISO 4074:2002
Natural
4074:2002)

latex rubber condoms — Requirements and test methods (ISO

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

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

Note 3

—

EN 600:1996

EN ISO 4135:1996

EN 1281-1:1997

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

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

EN 12006-1:1999

EN ISO 7197:2006
Neurosurgical
components (ISO 7197:2006)

implants — Sterile,

single-use hydrocephalus

shunts and

—

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

for

tracheal

EN 1819:1997

Date expired
(30.6.2004)

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

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

—

—

—

—

—

—

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

C 216/6

EN

Official Journal of the European Union

7.9.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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
9713:2002)

implants — Self-closing intracranial aneurysm clips

(ISO

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 equipment
— Safety requirements (ISO 10079-1:1999)

EN ISO 10079-1:1996

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

EN ISO 10079-2:1996

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)

Date expired
(29.2.2000)

Date expired
(29.2.2000)

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

EN 738-1:1997

31.8.2006

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

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

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 738-2:1998

31.10.2006

EN 738-3:1998

31.10.2006

—

—

Note 3

Date expired
(31.1.2000)

7.9.2006

EN

Official Journal of the European Union

C 216/7

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

Date expired
(30.11.2004)

Date expired
(31.1.2005)

EN ISO 10555-1:1996/A2:2004

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)

—

—

—

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
interactions with blood (ISO 10993-4:2002)

tests for

EN 30993-4:1993

EN ISO 10993-5:1999
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
(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 sterilisation
residuals (ISO 10993-7:1995)

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

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)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

C 216/8

EN

Official Journal of the European Union

7.9.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

Identification and

EN ISO 10993-15:2000
Identification and
Biological evaluation of medical devices — Part 15:
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 characterization
of materials (ISO 10993-18:2005)

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

—

—

—

—

—

—

EN 552:1994

30.4.2009

EN ISO 11137-2:2006
Sterilisation of health care products — Radiation — Part 2: Establishing the
sterilisation dose (ISO 11137-2:2006)

EN 552:1994

30.4.2009

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

EN 867-2:1997

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

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

EN 793:1997

EN 868-1:1997

Date expired
(31.1.2006)

Date expired
(30.6.2005)

Date expired
(30.4.2006)

EN ISO 11607-2:2006
Packaging for terminally sterilised medical devices — Part 2: Validation
requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

—

7.9.2006

EN

Official Journal of the European Union

C 216/9

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

31.10.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN ISO 11737-1:2006
Sterilisation 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

EN ISO 11990:2003
Optics and optical
Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)

instruments — Lasers and laser-related equipment —

EN ISO 11990:1999

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 12010:1998
Non-active surgical
requirements

implants — Joint replacement

implants — Particular

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 — 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 ventilators

EN 12442-1:2000
Animal tissues and their derivatives utilized in the manufacture of medical
devices — Part 1: Analysis and management of risk

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

—

—

—

C 216/10

EN

Official Journal of the European Union

7.9.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN 12442-3:2000
Animal tissues and their derivatives utilized in the manufacture of medical
devices — Part 3: Validation of the elimination and/or inactivation 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) thermometers

EN 12470-3:2000
Clinical thermometers — Part 3: Performance of compact electrical thermo-
meters (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 thermometers
(with maximum device)

EN 12523:1999
External
methods

limb prostheses and external orthoses — Requirements and test

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

implants — Joint

replacement

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

implants — Joint

replacement

implants — Specific

implants — Specific

—

—

—

—

—

—

—

—

—

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 equipment

EN 13060:2004
Small steam sterilisers

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

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

—

—

—

—

7.9.2006

EN

Official Journal of the European Union

C 216/11

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

Date expired
(30.6.2004)

31.7.2006

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

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
regulatory purposes (ISO 13485:2003)

systems — Requirements

for

EN ISO 13488:2000
EN ISO 13485:2000

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

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

—

—

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 absorbency

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 instruments used
in the medical area — Test method and requirements (phase 2, step 1)

—

—

—

—

—

—

—

—

C 216/12

EN

Official Journal of the European Union

7.9.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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 13795-3:2006
Surgical drapes, gowns and clean air suits, used as medical devices for patients,
clinical staff and equipment — Part 3: Performance requirements and
performance levels

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

EN 13826:2003
Peak expiratory flow meters

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 incubators — Part 2: System requirements

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

EN 14180:2003
Sterilisers for medical purposes — Low temperature steam and formaldehyde
sterilisers — Requirements and testing

—

—

—

7.9.2006

EN

Official Journal of the European Union

C 216/13

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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
Fundamental requirements (ISO 14534:2002)

lenses and contact

lens care products —

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
requirements (ISO 14602:1998)

implants — Implants for Osteosynthesis — Particular

—

—

—

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

EN ISO 14937:2000
Sterilisation of health care products — General requirements for characteriza-
tion of a sterilising agent and the development, validation and routine control of
a sterilisation process for medical devices (ISO 14937:2000)

—

—

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

EN 1441:1997

Date expired
(31.3.2004)

C 216/14

EN

Official Journal of the European Union

7.9.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN ISO 14971:2000/A1:2003

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

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

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

EN ISO 15883-2:2006
Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors
employing thermal disinfection for surgical instruments, anaesthetic 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-disinfectors
employing thermal disinfection for human waste containers (ISO 15883-
3:2006)

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 accessories
(ISO 17510-2:2003)

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

resterilisable medical devices

the processing of

for

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)

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

Date expired
(31.3.2004)

Note 3

—

EN ISO 15004:1997

31.12.2006

—

Note 3

Date expired
(31.8.2004)

—

—

—

—

—

—

—

—

—

7.9.2006

EN

Official Journal of the European Union

C 216/15

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

—

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

EN 12218:1998

30.6.2008

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

EN ISO 21171:2006
Medical gloves — Determination of
21171:2006)

removable

surface powder

(ISO

—

Note 3

—

Date expired
(31.5.1998)

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

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

Date expired
(31.5.2005)

EN ISO 21647:2004/AC:2006

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

31.12.2006

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

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

—

—

EN 27740:1992/A1:1997

Note 3

Date expired
(31.5.1998)

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
application of EN ISO 9003

requirements for

the

—

—

(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)

C 216/16

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Official Journal of the European Union

7.9.2006

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.

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 1

Note 3

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 European Parliament and Council (1) amended by the Directive
the Directive 98/34/EC of
98/48/EC (2).

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

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://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.