Commission communication in the framework of the implementation of the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable 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 41/9

NOTICES FROM MEMBER STATES

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

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

(2009/C 41/05)

ESO (1)

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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Reference of superseded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of superseded standard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 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 556:1994 + A1:1998

Date expired
(30.4.2002)

EN 556-1:2001/AC:2006

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

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

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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

Date expired
(30.4.2003)

Date expired
(31.1.2007)

Date expired
(30.11.1999)

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

Date expired
(31.10.2007)

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)

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C 41/10

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Official Journal of the European Union

19.2.2009

ESO (1)

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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 10993-10:2002
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
(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 10993-16:1997
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)

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—

—

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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)

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—

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19.2.2009

EN

Official Journal of the European Union

C 41/11

ESO (1)

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

Reference of superseded
standard

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 868-1:1997

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

Date expired
(30.4.2007)

Date expired
(31.10.2006)

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

EN ISO 13485:2000
EN ISO 13488:2000

31.7.2009

EN ISO 13485:2003/AC:2007

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

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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 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 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 554:1994

31.8.2009

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
(cardiac
pacemakers)

intended to treat bradyarrhythmia

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(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.

C 41/12

EN

Official Journal of the European Union

19.2.2009

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.