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 and Council Directive 93/42/EEC of 14 June 1993 in relation to medical devices (Text with EEA relevance)
Date: 2000-10-14
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health

C 293/10

EN

Official Journal of the European Communities

14.10.2000

ESO (1)

Reference

Title of the harmonised standards

Year of ratification

CEN

EN 12470-3

Clinical thermometers (cid:151) Part 3: performance of compact
electrical thermometers (non-predictive and predictive) with
maximum device

CEN

EN 13220

Flow-metering devices for connection to terminal units of
medical gas pipeline systems

2000

1998

(1) ESO: (European standardisation organisation):

(cid:151) CEN: rue de Stassart/Stassartstraat 36, B-1050 Brussels; tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (www.cenorm.be);
(cid:151) Cenelec: rue de Stassart/Stassartstraat 35, B-1050 Brussels; tel. (32-2) 519 68 71, fax (32-2) 519 69 19 (www.cenelec.be);
(cid:151) ETSI: BP 152, F-06561 Valbonne Cedex, tel. (33-4) 92 94 42 12, fax (33-4) 93 65 47 16 (www.etsi.org).

NOTE:

(cid:151) 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 (1) of the European Parliament and of the Council of 22 June 1998.

(cid:151) publication of the references in the Official Journal of the European Communities does not imply that the

standards are available in all the Community languages.

(cid:151) The Commission ensures the updating of this list (2).

(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ C 181, 26.6.1999, p. 4, OJ C 227, 10.8.1999, p. 15, OJ C 288, 9.10.1999, p. 43.

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 (1) and Council
Directive 93/42/EEC of 14 June 1993 in relation to medical devices (2)

(2000/C 293/07)

(Text with EEA relevance)

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

ESO (1)

Reference

Title of the harmonised standards

Year of ratification

CEN

EN 980/A1

Graphical symbols for use in the labelling of medical devices

CEN

EN 30993-7

Biological evaluation of medical devices (cid:151) Part 7: ethylene
oxide sterilisation residuals (ISO 10993-7:1995)

CEN
Cenelec

EN 46003

Quality
requirements for the application of EN ISO 9003

systems (cid:151) medical

devices (cid:151) particular

1996
1999

1995

1999

(1) ESO: (European standardisation organisation):

(cid:151) CEN: rue de Stassart/Stassartstraat 36, B-1050 Brussels; tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (www.cenorm.be);
(cid:151) Cenelec: rue de Stassart/Stassartstraat 35, B-1050 Brussels; tel. (32-2) 519 68 71, fax (32-2) 519 69 19 (www.cenelec.be);
(cid:151) ETSI: BP 152, F-06561 Valbonne Cedex, tel. (33-4) 92 94 42 12, fax (33-4) 93 65 47 16 (www.etsi.org).

NOTE:
(cid:151) 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 (3) of the European Parliament and of the Council of 22 June 1998.

(cid:151) publication of the references in the Official Journal of the European Communities does not imply that the

standards are available in all the Community languages.

(cid:151) the Commission ensures the updating of this list (4).

(1) OJ L 189, 20.7.1990, p. 17.
(2) OJ L 169, 12.7.1993, p. 1.
(3) OJ L 204, 21.7.1998, p. 37.
(4) OJ C 181, 26.6.1999, p. 2, OJ C 227, 10.8.1999, p. 15, OJ C 288, 9.10.1999, p. 42.