Commission Communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 in relation to medical devices and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices (Text with EEA relevance)
Date: 2002-07-31
Institutions: European Commission
Subjects: artificial reproduction, harmonisation of standards, medical device, medical diagnosis, public health, radiobiology

31.7.2002

EN

Official Journal of the European Communities

C 182/9

Commission Communication in the framework of the implementation of Council Directive
93/42/EEC of 14 June 1993 in relation to medical devices (1) and Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical
devices (2)

(2002/C 182/06)

(Text with EEA relevance)

(Publication of titles and references of European harmonised standards under the Directive)

OEN (1)

Reference

Title of the harmonised standards

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 455-2:2000

Medical gloves for single use — Part 2: Requirements and testing for physical
properties (including Corrigendum 1996)

CEN

EN 552:1994/
A2:2000

Sterilisation of medical devices — Validation and routine control of sterilisation
by irradiation

CEN

EN 556-1:2001

Sterilisation of medical devices — Requirements for medical devices to be
designated ‘Sterile’ — Part 1: Requirements for terminally sterilised 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

CEN

EN 794-1:1997/
A1:2000

EN 980:1996/
A2:2001

Lung ventilators — Part 1: Particular requirements for critical care ventilators

Graphical symbols for use in the labelling of medical devices

EN 1280-1:1997/
A1:2000

Agent specific filling systems for anaesthetic vaporisers — Part 1: Rectangular
keyed filling systems

CEN

EN ISO 4074:2002

Natural
(ISO 4074:2002)

latex

rubber

condoms — Requirements

and

test methods

CEN

EN ISO 4135:2001

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

CEN

CEN

CEN

EN ISO 10993-
8:2001

Biological evaluation of medical devices — Part 8: Selection and qualification of
reference materials for biological tests (ISO 10993-8:2000)

EN ISO 10993-
14:2001

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

EN 12322:1999/
A1:2001

In-vitro diagnostic medical devices — Culture media for microbiology —
Performance criteria for culture media

CEN

EN 12718:2001

Medical compression hosiery

CEN

ENV 12719:2001

Medical thrombosis prophylaxis hosiery

(1) OJ L 169, 12.7.1993, p. 1.
(2) OJ L 331, 7.12.1998, p. 1.

C 182/10

EN

Official Journal of the European Communities

31.7.2002

OEN (1)

Reference

Title of the harmonised standards

CEN

EN 12180:2000

Non-active
requirements for mammary implants

surgical

implants — Body contouring implants — Spedific

CEN

EN 13328-1:2001

Breathing system filters for anaesthetic and respiratory use — Part 1: Test
method to assess filtration performance

CEN

EN 13544-1:2001

Respiratory therapy equipment — Part 1: Nebulising systems and their
components

CEN

EN 13544-3:2001

Respiratory therapy equipment — Part 3: Air entrainment devices

CEN

CEN

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

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

(1) OEN: European standardisation body:

— 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

— 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 (1) of the European Parliament and of the Council of 22 June 1998.

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

standards are available in all the Community languages.

— The Commission ensures the updating of this list.

(1) OJ L 204, 21.7.1998, p. 37.