Commission communication in the framework of the implementation of Council Directive 90/385/EEC
Date: 2004-07-08
Institutions: European Commission
Subjects: Cenelec, medical device

8.7.2004

EN

Official Journal of the European Union

C 176/3

Commission communication in the framework of the implementation of Council Directive
90/385/EEC

(Text with EEA relevance)

Publication of titles and references of harmonized standards under the directive

European Standardisation
Organisation (1)

Reference and title of the standard

Reference document

Reference of the superseded standard

Date of cessation
of presumption of
conformity of the
superseded
standard
Note 1

CEN/CENELEC

EN 45502-1:1997

NONE

Active implantable medical devices –
for
Part 1: General
safety, marking and information to be
provided by the manufacturer

requirements

CEN/CENELEC

EN 45502-2-1:2003

NONE

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

CEN/CENELEC

EN 46003:1999

NONE

Quality systems - Medical devices -
Particular requirements for the appli-
cation of EN ISO 9003

CENELEC

EN 60601-1:1990

IEC 60601-1:1988

NONE

Medical electrical equipment – Part 1:
General requirements for safety

Amendment A1:1993 to EN 60601-
1:1990

IEC 60601-1:1988

Note 3

/A1:1991

Amendment A2:1995 to EN 60601-
1:1990

IEC 60601-1:1988

Note 3

/A2:1995

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Amendment A13:1996 to EN 60601-
1:1990

Note 3

Date expired
(1.7.1996)

(1) CEN: rue de Stassart/De Stassartstraat 36, B—1050 Brussels, tel.: (32-2) 550 08 11, fax: (32-2) 550 08 19;

CENELEC: rue de Stassart/De Stassartstraat 35, B—1050 Brussels, tel.: (32-2) 519 68 71, fax: (32-2) 519 69 19;
ETSI: BP 152, F—06561 Valbonne Cedex, tel.: (33) 492 94 42 12, fax: (33) 493 65 47 16.

Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal
these
(‘dow’), set by the European Standardisation Organisation, but attention of users of
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 The superseded standard (column 4) therefore consists of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On the date stated, the superseded standard ceases to give presumption of conformity with the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 176/4

EN

Official Journal of the European Union

8.7.2004

Example: For EN 60601-1:1990, the following applies:

CENELEC

EN 60601-1:1990
Medical electrical equipment – Part 1: General
requirements for safety
[The
1:1990]

referenced standard is EN 60601-

Amendment A1:1993 to EN 60601-1:1990
[The referenced standard is EN 60601-1:1990
+A1:1993 to EN 60601-1:1990]

Amendment A2:1995 to EN 60601-1:1990
[The referenced standard is EN 60601-1:1990
+A1:1993 to EN 60601-1:1990
+A2:1995 to EN60601-1:1990]

Amendment A13:1996 to EN 60601-1:1990
[The referenced standard is EN 60601-1:1990
+ A1:1993 to EN 60601-1:1990
+ A2:1995 to EN 60601-1:1990
+ A13:1996 to EN 60601-1:1990]

IEC 60601-1:1988

NONE
[There is no superseded standard]

IEC 60601-1:1988
/A1:1991

IEC 60601-1:1988
/A2:1995

Note 3
superseded
[The
EN 60601-1:1990]

Note 3
[The
superseded
EN 60601-1:1990
+ A1:1993]

Note 3
[The
superseded
EN 60601-1:1990
+ A1:1993
+ A2:1995]

standard

is

standard

is

standard

is

Date expired
(1.7.1996)

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