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: 2005-09-30
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device

C 240/2

EN

Official Journal of the European Union

30.9.2005

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

(2005/C 240/02)

(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superseded standard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 super-
seded standard
Note 1

CEN

EN 285:1996
Sterilization — Steam sterilizers — Large sterilizers

CEN

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

CEN

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

—

—

—

CEN

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

EN 455-1:1993

Date expired
(30.4.2001)

CEN

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)

CEN

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 steriliza-
tion

EN 552:1994
Sterilization of medical devices — Validation and routine control of sterilization by irradia-
tion

EN 552:1994/A1:1999

EN 552:1994/A2:2000

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

CEN

CEN

CEN

CEN

—

—

—

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

Date expired
(30.4.2002)

30.9.2005

EN

Official Journal of the European Union

C 240/3

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

ESO (1)

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

CEN

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

CEN

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

CEN

CEN

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

Note 3

Date expired
(30.6.2000)

CEN

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

—

EN 737-3:1998/A1:1999

Note 3

Date expired
(30.6.2000)

CEN

CEN

CEN

CEN

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

EN 738-1:1997
Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure
regulators with flow metering devices

—

—

EN 738-1:1997/A1:2002

Note 3

Date expired
(31.10.2002)

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

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

—

—

EN 738-3:1998/A1:2002

Note 3

Date expired
(31.10.2002)

C 240/4

EN

Official Journal of the European Union

30.9.2005

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

ESO (1)

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

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 ventilators

EN 794-1:1997/A1:2000

—

Note 3

—

Note 3

—

Note 3

—

Note 3

Date expired
(31.10.2002)

Date expired
(31.10.2002)

Date expired
(31.7.2004)

Date expired
(31.5.2001)

CEN

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

—

EN 794-3:1998/A1:2005

Note 3

31.12.2005

CEN

CEN

CEN

CEN

CEN

CEN

EN 864:1996
Medical electrical equipment — Capnometers for use with humans — Particular require-
ments

EN 867-2:1997
Non-biological systems for use in sterilizers — Part 2: Process indicators (Class A)

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

—

—

—

—

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

—

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

Date expired
(30.11.2002)

—

Note 3

—

—

—

30.9.2005

EN

Official Journal of the European Union

C 240/5

ESO (1)

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

Reference of
superseded standard

CEN

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

EN 1060-1:1995/A1:2002

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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 1060-4:2004
Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall
system accuracy of automated non-invasive sphygmomanometers

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 the population of micro-organisms on
product — Part 1: Requirements

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

EN 1174-3:1996
Sterilization of medical devices — Estimation of the population of micro-organisms on
product — Part 3: Guide to the methods for validation 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)

Date expired
(24.11.2000)

Note 3

—

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

EN 1282-2:1997

31.12.2005

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

—

C 240/6

EN

Official Journal of the European Union

30.9.2005

ESO (1)

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

—

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

EN 1639:1996

Date expired
(31.12.2004)

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

EN 1640:1996

Date expired
(31.12.2004)

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

EN 1641:1996

Date expired
(31.12.2004)

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

EN 1642:1996

Date expired
(31.12.2004)

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)

—

—

—

Note 3

Date expired
(30.9.2003)

EN 1820:1997

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

—

—

EN 1970:2000/A1:2005

Note 3

30.9.2005

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

—

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

EN 600:1996

31.8.2005

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

EN ISO
4135:1996

Date expired
(28.2.2002)

30.9.2005

EN

Official Journal of the European Union

C 240/7

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 super-
seded standard
Note 1

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 7376:2003
Anaesthetic and respiratory equipment — Laryngoscopes for tracheal
7376:2003)

intubation (ISO

EN 1819:1997

Date expired
(30.6.2004)

CEN

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

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

CEN

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

CEN

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

CEN

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

EN ISO 8835-5:2004/AC:2004

CEN

CEN

EN ISO 9360-1:2000
Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humi-
difying 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 humi-
difying respired gases in humans — Part 2: HMEs for use with tracheostomized patients
having minimum tidal volumes of 250 ml (ISO 9360-2:2001)

CEN

EN ISO 9713:2004
Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002)

—

—

—

—

—

—

—

—

—

C 240/8

EN

Official Journal of the European Union

30.9.2005

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
presumption of
conformity of super-
seded standard
Note 1

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

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

Date expired
(29.2.2000)

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

EN ISO 10079-
2:1996

Date expired
(29.2.2000)

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

EN ISO 10079-
3:1996

Date expired
(29.2.2000)

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

Date expired
(31.1.2000)

Date expired
(30.11.2004)

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

Date expired
(31.1.2005)

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)

—

—

—

30.9.2005

EN

Official Journal of the European Union

C 240/9

ESO (1)

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

Date expired
(30.4.2004)

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

Date expired
(30.4.2003)

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
(30.11.1999)

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

EN ISO 10993-9:1999
Biological evaluation of medical devices — Part 9: Framework for identification and quanti-
fication 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 mate-
rials (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 degrada-
tion 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)

—

—

—

—

—

C 240/10

EN

Official Journal of the European Union

30.9.2005

ESO (1)

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

CEN

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

EN 793:1997

Date expired
(30.6.2005)

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

EN ISO
11990:1999

Date expired
(31.10.2003)

CEN

CEN

CEN

CEN

EN 12006-1:1999
Non active surgical implants — Particular requirements for cardiac and vascular implants
— Part 1: Heart valve substitutes

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

CEN

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

implants — General

CEN

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

CEN

EN 12183:1999
Manually propelled wheelchairs — Requirements and test methods

CEN

EN 12184:1999
Electrically powered wheelchairs, scooters and their charges — Requirements and test
methods

CEN

EN 12218:1998
Rail systems for supporting medical equipment

—

—

—

—

—

—

—

—

—

EN 12218:1998/A1:2002

Note 3

Date expired
(31.10.2002)

CEN

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)

30.9.2005

EN

Official Journal of the European Union

C 240/11

ESO (1)

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

CEN

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

CEN

CEN

CEN

CEN

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

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

CEN

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

CEN

CEN

CEN

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

thermometers — Part 5: Performance of

infra-red ear

thermometers (with

CEN

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

CEN

CEN

CEN

—

—

—

—

—

—

—

—

—

—

—

—

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

(ISO

EN ISO
12870:1997

Date expired
(28.2.2005)

C 240/12

EN

Official Journal of the European Union

30.9.2005

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

ESO (1)

CEN

CEN

CEN

CEN

CEN

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

EN 13060:2004
Small steam sterilizers

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

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

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

CEN

CEN

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

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

CEN

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

—

—

—

—

—

—

Note 3

Date expired
(30.6.2004)

31.7.2006

EN ISO
13488:2000
EN ISO
13485:2000

—

—

EN 13544-1:2001/A1:2004

Note 3

Date expired
(31.12.2004)

CEN

CEN

CEN

CEN

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

—

—

—

—

30.9.2005

EN

Official Journal of the European Union

C 240/13

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

ESO (1)

CEN

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

CEN

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

CEN

CEN

CEN

CEN

CEN

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)

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 — Require-
ments

CEN

EN 13826:2003
Peak expiratory flow meters

CEN

EN 13867:2002
Concentrates for haemodialysis and related therapies

CEN

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

CEN

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

CEN

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

—

—

—

—

—

—

—

—

—

—

—

—

C 240/14

EN

Official Journal of the European Union

30.9.2005

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
presumption of
conformity of super-
seded standard
Note 1

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 — Vali-
dation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)

EN 14180:2003
Sterilizers for medical purposes — Low temperature steam and formaldehyde 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
(ISO 14602:1998)

implants — Implants for Osteosynthesis — Particular requirements

—

CEN

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

EN ISO
14630:1997

30.11.2005

CEN

CEN

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 characterization of a steri-
lizing agent and the development, validation and routine control of a sterilization process
for medical devices (ISO 14937:2000)

—

30.9.2005

EN

Official Journal of the European Union

C 240/15

ESO (1)

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

Reference of
superseded standard

Date of cessation of
presumption of
conformity of super-
seded standard
Note 1

CEN

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

EN 1441:1997

Date expired
(31.3.2004)

EN ISO 14971:2000/A1:2003

Note 3

Date expired
(31.3.2004)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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)

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 accessories (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 — Particular 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

Date expired
(31.5.1998)

C 240/16

EN

Official Journal of the European Union

30.9.2005

ESO (1)

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 super-
seded standard
Note 1

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

Date expired
(31.5.2005)

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
7740:1985)

surgery,

scalpels with detachable blades,

fitting dimensions

(ISO

—

—

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 requirements for the application of EN
ISO 9003

—

—

(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)

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 stan-
dards 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 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 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.