Commission communication in the framework of the implementation of the 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: 2006-09-07
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health

7.9.2006

EN

Official Journal of the European Union

C 216/17

Commission communication in the framework of the implementation of the 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 216/02)

(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Reference of superseded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
superseded standard

Note 1

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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 sterilization
by moist heat

—

—

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

Date expired
(30.4.2002)

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

—

—

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
(30.4.2003)

Date expired
(30.11.1999)

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)

—

C 216/18

EN

Official Journal of the European Union

7.9.2006

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

Date expired
(31.3.2003)

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 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 10993-11:1995
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 characterisation of
materials (ISO 10993-18:2005)

EN ISO 11137-1:2006
Sterilization of healthcare 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 healthcare products — Radiation — Part 2: Establishing the
sterilization dose (ISO 11137-2:2006)

EN 552:1994

30.4.2009

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

—

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 868-1:1997

EN ISO 11737-1:2006
Sterilization 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

Date expired
(30.4.2006)

31.10.2006

7.9.2006

EN

Official Journal of the European Union

C 216/19

Date of cessation of
presumption of
conformity of
superseded standard

Note 1

31.7.2006

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded
standard

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

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

systems — Requirements

for

EN ISO 13485:2000
EN ISO 13488:2000

EN 13824:2004
Sterilisation 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)

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 1441:1997

EN ISO 14971:2000/A1:2003

Note 3

Date expired
(31.3.2004)

Date expired
(31.3.2004)

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

Note 3

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.

C 216/20

EN

Official Journal of the European Union

7.9.2006

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.