Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)
Date: 2009-02-19
Institutions: European Commission
Subjects: European standard, approximation of laws, harmonisation of standards, medical device, medical diagnosis

19.2.2009

EN

Official Journal of the European Union

C 41/13

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)

(2009/C 41/06)

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Reference of superseded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of superseded standard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)

EN 285:2006 + A1:2008
Sterilization — Steam sterilizers — Large sterilizers

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

EN 285:2006

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 desig-
nated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices
EN 556-1:2001/AC:2006

EN 556:1994 + A1:1998

CEN

CEN

CEN

CEN

CEN

CEN

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

CEN

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

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
(30.11.2008)

Date expired
(30.4.2001)

Date expired
(30.4.2001)

Date expired
(30.6.2007)

Date expired
(30.4.2002)

Date expired
(31.5.2001)

Date expired
(31.12.2005)

CEN

CEN

CEN

CEN

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

EN 980:2003

31.5.2010

EN 1041:2008
Information supplied by the manufacturer of medical devices

EN 1041:1998

31.8.2011

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

—

Note 3

—

Date expired
(30.11.2002)

C 41/14

EN

Official Journal of the European Union

19.2.2009

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
(30.6.2006)

Date expired
(31.10.2004)

Date expired
(31.12.2005)

Date expired
(31.12.2004)

Date expired
(31.12.2004)

Date expired
(31.12.2004)

Date expired
(31.12.2004)

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

—

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, modified)

EN 1282-2:1997

—

—

EN 1639:1996

EN 1640:1996

EN 1641:1996

EN 1642:1996

—

—

EN 1422:1997
Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements
and test methods

EN 1618:1997
Catheters other than intravascular catheters — Test methods for common proper-
ties

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 1789:2007
Medical vehicles and their equipment — Road ambulances

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

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 1789:1999

EN 1820:1997

Date expired
(30.11.2007)

Date expired
(31.12.2005)

—

—

Note 3

Date expired
(30.9.2005)

19.2.2009

EN

Official Journal of the European Union

C 41/15

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

CEN

CEN

CEN

CEN

CEN

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

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

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)

—

—

—

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

latex

rubber

condoms — Requirements

and

test methods

EN 600:1996

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

EN ISO 4135:1996

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 expired
(31.8.2005)

Date expired
(28.2.2002)

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

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

EN 12006-1:1999

Date expired
(30.6.2008)

Date expired
(31.1.2005)

Date expired
(30.6.2006)

EN ISO 7197:2006
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and compo-
nents (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
(ISO 7439:2002)

contraceptive devices — Requirements,

tests

—

C 41/16

EN

Official Journal of the European Union

19.2.2009

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 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 preven-
tion 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)

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

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

EN ISO 8835-5:2004
Inhalational
(ISO 8835-5:2004)
EN ISO 8835-5:2004/AC:2006

anaesthesia

systems — Part

5: Anaesthesia

ventilators

—

—

EN ISO 9170-1:2008
Terminal units for medical gas pipeline systems — Part 1: Terminal units for use
with compressed medical gases and vacuum (ISO 9170-1:2008)

EN 737-1:1998

31.7.2010

EN ISO 9170-2:2008
Terminal units for medical gas pipeline systems — Part 2: Terminal units for
anaesthetic gas scavenging systems (ISO 9170-2:2008)

EN 737-4:1998

31.7.2010

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

—

—

—

19.2.2009

EN

Official Journal of the European Union

C 41/17

ESO (1)

CEN

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
presumption of conformity
of superseded standard
(Note 1)

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

for medical

equipment

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

EN ISO 10328:2006
Prosthetics — Structural testing of lower-limb prostheses — Requirements and
test methods (ISO 10328:2006)

—

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

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

EN 738-2:1998

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

EN 738-3:1998

Date expired
(29.2.2000)

Date expired
(29.2.2000)

Date expired
(29.2.2000)

Date expired
(31.10.2008)

Date expired
(31.10.2008)

Date expired
(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,
(ISO 10555-1:1995)

single-use intravascular catheters — Part 1: General

requirements

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 resusci-
tators (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)

—

—

Date expired
(31.1.2000)

Date expired
(30.11.2004)

Date expired
(31.1.2005)

C 41/18

EN

Official Journal of the European Union

19.2.2009

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
presumption of conformity
of superseded standard
(Note 1)

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, carcino-
genicity 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 interac-
tions with blood (ISO 10993-4:2002)

EN 30993-4:1993

EN ISO 10993-4:2002/A1:2006

Note 3

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

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 10993-7:2008
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization
residuals (ISO 10993-7:2008)

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

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 10993-13:1998
Biological evaluation of medical devices — Part 13: Identification and quantifica-
tion
devices
(ISO 10993-13:1998)

from polymeric medical

degradation

products

of

EN ISO 10993-14:2001
Biological evaluation of medical devices — Part 14: Identification and quantifica-
tion of degradation products from ceramics (ISO 10993-14:2001)

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

—

—

—

19.2.2009

EN

Official Journal of the European Union

C 41/19

ESO (1)

CEN

CEN

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CEN

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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
presumption of conformity
of superseded standard
(Note 1)

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 11135-1:2007
Sterilization of health care products — Ethylene oxide — Part 1: Requirements
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 steri-
lization 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
indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

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

—

—

—

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 penetration test
(ISO 11140-3:2007)

EN 867-3:1997

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

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

EN 793:1997

EN 868-1:1997

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

—

Date expired
(31.1.2006)

Date expired
(30.9.2007)

Date expired
(30.6.2005)

Date expired
(30.4.2007)

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

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

Date expired
(31.10.2006)

ESO (1)

CEN

CEN

CEN

CEN

CEN

C 41/20

EN

Official Journal of the European Union

19.2.2009

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)

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
Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)

instruments — Lasers and laser-related equipment —

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

CEN

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

—

—

—

EN 12322:1999/A1:2001

Note 3

Date expired
(30.4.2002)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

EN 12342:1998
Breathing tubes intended for use with anaesthetic apparatus and ventilators

EN 12470-1:2000
Clinical
maximum device

thermometers — Part 1: Metallic liquid-in-glass thermometers with

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 ISO 12870:2004
Ophthalmic optics — Spectacle frames — Requirements and test methods
(ISO 12870:2004)
EN ISO 12870:2004/AC:2005

EN ISO 12870:1997

Date expired
(28.2.2005)

EN 13014:2000
Connections for gas sampling tubes to anaesthetic and respiratory equipment

EN 13060:2004
Small steam sterilizers

—

—

19.2.2009

EN

Official Journal of the European Union

C 41/21

ESO (1)

CEN

CEN

CEN

CEN

CEN

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CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

Reference of superseded
standard

EN ISO 13485:2003
Medical devices — Quality management systems — Requirements for regulatory
purposes (ISO 13485:2003)
EN ISO 13485:2003/AC:2007

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

Date of cessation of
presumption of conformity
of superseded standard
(Note 1)

31.7.2009

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

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

—

—

—

EN 13718-1:2008
Medical vehicles and their equipment — Air ambulances — Part 1: Requirements
for medical devices used in air ambulances

EN 13718-1:2002

28.2.2009

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 transmis-
sion 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)

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 perfor-
mance levels

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 incubators — Part 1: Interface conditions

—

—

—

—

—

—

—

—

—

C 41/22

EN

Official Journal of the European Union

19.2.2009

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

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

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 — Funda-
mental 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 evalua-
tion 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 evalua-
tion of fungicidal or yeasticidal activity for instruments used in the medical area
— Test method and requirements (phase 2, step 2)

EN 14563:2008
Chemical disinfectants and antiseptics — Quantitative carrier test for the evalua-
tion of mycobactericidal or tuberculocidal activity of chemical disinfectants used
for instruments in the medical area — Test method and requirements (phase 2,
step 2)

EN ISO 14602:1998
Non-active surgical implants — Implants for osteosynthesis — Particular require-
ments (ISO 14602:1998)

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

—

—

—

—

—

19.2.2009

EN

Official Journal of the European Union

C 41/23

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

CEN

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

EN ISO 14630:2005

Date expired
(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 requirements and testing

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

—

—

EN ISO 14971:2007
Medical devices — Application of
(ISO 14971:2007)

risk management

to medical devices

EN ISO 14971:2000

31.3.2010

EN ISO 15001:2004
Anaesthetic
and
(ISO 15001:2003)

respiratory

equipment — Compatibility with oxygen

—

EN ISO 15002:2008
Flow-metering devices for connection to terminal units of medical gas pipeline
systems (ISO 15002:2008)

EN 13220:1998

31.7.2010

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

to all ophthalmic

requirements

EN ISO 15004:1997

Date expired
(31.12.2006)

Date expired
(31.8.2004)

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 formaldehyde —
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 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)

—

Note 3

—

—

—

—

—

C 41/24

EN

Official Journal of the European Union

19.2.2009

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

CEN

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

thermolabile

disinfection

chemical

for

—

—

EN ISO 16061:2008
Instrumentation for use in association with non-active surgical
General requirements (ISO 16061:2008)

implants —

EN 12011:1998

30.6.2009

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

—

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

EN ISO 17510-1:2002

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

EN ISO 17510-2:2003

Date expired
(30.4.2008)

Date expired
(30.4.2008)

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

—

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

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

EN ISO 18778:2005
Respiratory
(ISO 18778:2005)

equipment — Infant monitors — Particular

requirements

EN ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures — Particular require-
ments (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 equipment — Part 1: General requirements (ISO 594-1:1986)

EN 20594-1:1993/A1:1997

EN ISO 21171:2006
Medical gloves — Determination of removable surface powder (ISO 21171:2006)

—

Note 3

—

Date expired
(31.5.1998)

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

EN 12010:1998

Date expired
(31.3.2008)

19.2.2009

EN

Official Journal of the European Union

C 41/25

ESO (1)

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

Reference of superseded
standard

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

EN 12563:1998

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

EN 12564:1998

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 21647:2004/AC:2006

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

EN ISO 21649:2006
Needle-free injectors
(ISO 21649:2006)

for medical use — Requirements and test methods

—

Date of cessation of
presumption of conformity
of superseded standard
(Note 1)

Date expired
(31.3.2008)

Date expired
(31.3.2008)

Date expired
(31.5.2005)

EN ISO 21969:2006
High-pressure
(ISO 21969:2005)

flexible

connections

for use with medical

gas

systems

EN 13221:2000

Date expired
(31.12.2007)

EN ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives — Part 1: Applica-
tion 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 transmissible 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
methods (ISO 22523:2006)

limb prostheses and external orthoses — Requirements and test

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 resistance to
dry microbial penetration (ISO 22612:2005)

EN ISO 22675:2006
Prosthetics — Testing of ankle-foot devices and foot units — Requirements 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

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

EN 13328-2:2002

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
(30.9.2008)

Date expired
(30.9.2008)

Date expired
(31.1.2008)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

C 41/26

EN

Official Journal of the European Union

19.2.2009

ESO (1)

CEN

CEN

CEN

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)

EN ISO 25539-1:2008
Cardiovascular implants — Endovascular devices — Part 1: Endovascular pros-
theses (ISO 25539-1:2003 including Amd 1:2005)

EN ISO 25539-2:2008
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
(ISO 25539-2:2008)

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

fitting dimensions

EN 27740:1992/A1:1997

EN 14299:2004

30.9.2011

EN 14299:2004

30.9.2011

—

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 Commis-

sion 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.