Commission communication in the framework of the implementation of Council Directive 90/385/EEC of  20 June 1990  on the approximation of the laws of the Member States relating to active implantable medical devices   (Text with EEA relevance)
Date: 2006-06-02
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device

C 129/2

EN

Official Journal of the European Union

2.6.2006

Commission communication in the framework of the implementation of Council Directive
90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to
active implantable medical devices

(2006/C 129/02)

(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Reference of superseded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 presump-
tion of conformity of super-
seded standard
Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

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

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

—

—

—

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

EN 556:1994 + A1:1998

Date expired
(30.4.2002)

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

EN 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

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

the population of

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

the population of

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

EN ISO 10993-1:2003
Biological evaluation of medical devices — Part 1: Evaluation and testing
(ISO 10993-1:2003)

—

—

—

—

—

2.6.2006

EN

Official Journal of the European Union

C 129/3

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

EN ISO 10993-4:2002
Biological evaluation of medical devices — Part 4: Selection of tests for
interactions with blood (ISO 10993-4:2002)

EN 30993-4:1993

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

EN 30993-5:1994

EN ISO 10993-9:1999
Biological evaluation of medical devices — Part 9: Framework for identi-
fication and quantification of potential degradation products (ISO
10993-9:1999)

—

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

Date expired
(30.4.2003)

Date expired
(30.11.1999)

EN ISO 10993-10:2002
Biological evaluation of medical devices — Part 10: Tests for irritation
and delayed-type hypersensitivity (ISO 10993-10:2002)

EN ISO 10993-10:1995

Date expired
(31.3.2003)

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

—

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

EN ISO 10993-12:1996

Date expired
(31.5.2005)

EN ISO 10993-13:1998
Biological evaluation of medical devices — Part 13: Identification and
quantification of degradation products from polymeric medical devices
(ISO 10993-13:1998)

EN ISO 10993-16:1997
Biological evaluation of medical devices — Part 16: Toxicokinetic study
design for degradation products and leachables (ISO 10993-16:1997)

EN ISO 10993-17:2002
Biological evaluation of medical devices — Part 17: Establishment of
allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 10993-18:2005
Biological evaluation of medical devices — Part 18: Chemical characteri-
zation of materials (ISO 10993-18:2005)

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

—

—

—

—

—

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

EN ISO 13485:2000
EN ISO 13488:2000

31.7.2006

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

—

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)

C 129/4

EN

Official Journal of the European Union

2.6.2006

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

Date expired
(31.3.2004)

Date expired
(31.3.2004)

ESO (1)

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

Reference of superseded
standard

CEN

CEN

CEN

CEN

CEN

EN ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2:
Clinical investigation plans (ISO 14155-2:2003)

—

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

EN ISO 14971:2000/A1:2003

EN 1441:1997

Note 3

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

EN 45502-1:1997
Active implantable medical devices — Part 1: General requirements for
safety, marking and information to be provided by the manufacturer

EN 45502-2-1:2004
Active implantable medical devices — Part 2-1: Particular requirements
for active implantable medical devices intended to treat bradyarrhythmia
(cardiac pacemakers)

—

—

—

(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 standards
is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 3 In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if
any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of
EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment.
On the date stated, the superseded standard ceases to give presumption of conformity with the
essential requirements of the directive.

NOTE:

— Any information concerning the availability of the standards can be obtained either from the European
Standardisation Organisations or from the national standardisation bodies of which the list is annexed
to Directive 98/34/EC (1) of the European Parliament and of the Council amended by Directive
98/48/EC (2).

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

dards are available in all the Community languages.

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

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