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: 2008-07-23
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health

C 186/28

EN

Official Journal of the European Union

23.7.2008

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)

(2008/C 186/09)

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

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 556-1:2001/AC:2006

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 980:2008
Symbols for use in the labelling of medical devices

EN 980:2003

31.5.2010

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 tests for
interactions 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 cyto-
toxicity (ISO 10993-5:1999)

EN 30993-5:1994

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

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)

—

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

Date expired
(30.4.2003)

Date expired
(31.1.2007)

Date expired
(30.11.1999)

Date expired
(31.10.2007)

Date expired
(31.3.2003)

Date expired
(31.1.2007)

ESO (1)

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

CEN

23.7.2008

EN

Official Journal of the European Union

C 186/29

ESO (1)

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

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

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

Date expired
(28.2.2007)

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
(31.5.2008)

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 11135-1:2007
Sterilization of health care products — Ethylene oxide — Part 1: Require-
ments 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 sterilization 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
processes
(ISO 11138-2:2006)

sterilization

indicators

ethylene

oxide

for

EN ISO 11138-3:2006
Sterilization of health care products — Biological indicators — Part 3:
processes
Biological
(ISO 11138-3:2006)

for moist

sterilization

indicators

heat

—

—

—

C 186/30

EN

Official Journal of the European Union

23.7.2008

ESO (1)

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

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

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

—

EN ISO 11607-1:2006
Packaging
sterilized medical devices — Part 1:
Requirements for materials, sterile barrier systems and packaging systems
(ISO 11607-1:2006)

terminally

for

EN 868-1:1997

Date expired
(30.4.2007)

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

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

EN 46003:1999
EN ISO 13485:2000
EN ISO 13488:2000

Date expired
(31.10.2006)

31.7.2009

EN ISO 13485:2003/AC:2007

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)

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

requirements

—

—

EN ISO 14971:2007
Medical devices — Application of risk management to medical devices
(ISO 14971:2007)

EN ISO 14971:2000

31.3.2010

EN ISO 17665-1:2006
Sterilization of health care products — Moist heat — Part 1: Require-
ments for the development, validation and routine control of a steriliza-
tion 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

—

23.7.2008

EN

Official Journal of the European Union

C 186/31

ESO (1)

CEN

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

Reference of superseded
standard

Date of cessation of presump-
tion of conformity of superseded
standard
(Note 1)

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.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.

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

Commission 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.