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C 268/4 EN Official Journal of the European Communities 27.8.


Commission communication in the framework of the implementation of Council Directive

90/385/EEC of 20 June 1990 in relation to active implantable medical devices (Î)

(98/C 268/04)

(Text with EEA relevance)

(Publication of titles and references of European harmonised standards under the Directive)

Year of
OENØ(Î) Reference Title of harmonised standards

CEN EN 45502-1 Active implantable medical devices — Part 1: 1997

General requirements for safety, marking and
information to be provided by the manufacturer

(Î)ÙOEN (European standardisation organisation).

CEN: Rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550Ø08Ø11, fax (32-2) 550Ø08Ø19.
Cenelec: Rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519Ø68Ø71, fax (32-2) 519Ø69Ø19.
ETSI: BP 152, F-06561 Valbonne Cedex, tel. (33-4) 92Ø94Ø42Ø12, fax (33-4) 93Ø65Ø47Ø16.


—ÙAny 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 Council Directive 83/189/EECØ(Ï), amended by Directive

—ÙPublication of the references in the Official Journal of the European Communities does not
imply that the standards are available in all the Community languages.

—ÙThe Commission ensures the updating of this listØ(Ñ).

(Î)ÙOJ L 189, 20.7.1990, p. 17.

(Ï)ÙOJ L 109, 26.4.1983, p. 8.
(Ð)ÙOJ L 100, 19.4.1994, p. 30.
(Ñ)ÙOJ C 245, 23.8.1996, p. 2.
OJ C 149, 17.5.1997, p. 5.
OJ C 338, 8.11.1997, p. 10.
OJ C 144, 9.5.1998, p. 2.