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: 2008-11-27
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health

27.11.2008

EN

Official Journal of the European Union

C 304/5

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 harmonized standards under the directive)

(2008/C 304/04)

Reference and title of the standard
(and reference document)

Reference of the
superseded standard

Date of cessation of
presumption of confor-
mity of the superseded
standard
(Note 1)

ESO (1)

Cenelec

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

Cenelec

EN 45502-2-1:2003
Active implantable medical devices — Part 2-1: Particular requirements for active
implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Cenelec

EN 45502-2-2:2008
Active implantable medical devices — Part 2-2: Particular requirements for active
implantable medical devices intended to treat tachyarrhythmia (includes implantable defi-
brillators)

Cenelec

EN 60601-1:1990
Medical electrical equipment — Part 1: General requirements for safety
(IEC 60601-1:1988)

Amendment A1:1993 to EN 60601-1:1990
(IEC 60601-1:1988/A1:1991)

Amendment A2:1995 to EN 60601-1:1990
(IEC 60601-1:1988/A2:1995)

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Note 3

Note 3

Cenelec

EN 60601-1:2006
Medical electrical equipment — Part 1: General requirements for basic safety and essen-
tial performance
(IEC 60601-1:2005)

EN 60601-1:1990
and its amendments
Note 2.1

Cenelec

EN 62304:2006
Medical device software — Software life-cycle processes
(IEC 62304:2006)

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(1) ESO: European Standarisation Organisation:

— CEN: rue de Stassart/De Stassartstraat 36, B-1050 Brussels, tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be),
— Cenelec: rue de Stassart/De Stassartstraat 35, B-1050 Brussels, tel. (32-2) 519 68 71, fax (32-2) 519 69 19 (http://www.cenelec.eu),
— ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 12, fax (33) 493 65 47 16 (http://www.etsi.org).

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C 304/6

EN

Official Journal of the European Union

27.11.2008

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 stan-
dards is drawn to the fact that in certain exceptional cases this can be otherwise.

Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date
stated, the superseded standard ceases to give presumption of conformity with the essential
requirements of the directive.

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.