Commission communication in the framework of the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Text with EEA relevance)
Date: 2003-01-23
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, public health

C 16/6

EN

Official Journal of the European Communities

23.1.2003

Non-opposition to a notified concentration

(Case COMP/M.2964 — Global Crossing/Hutchison/ST Telemedia)

(2003/C 16/03)

(Text with EEA relevance)

On 16 January 2003, the Commission decided not to oppose the above notified concentration and to
declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council
Regulation (EEC) No 4064/89. The full text of the decision is only available in English and will be
made public after it is cleared of any business secrets it may contain. It will be available:

— as a paper version through the sales offices of the Office for Official Publications of the European

Communities (see list on the last page),

— in electronic form in the ‘CEN’ version of the CELEX database, under document No 303M2964. CELEX

is the computerised documentation system of European Community law.

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Commission communication in the framework of the implementation of Council Directive
90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to
active implantable medical devices (1)

(2003/C 16/04)

(Text with EEA relevance)

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

ESO (1)

Reference

Title of the Harmonised Standard

CEN

EN ISO 10993-10:2002

Biological evaluation of medical devices — Part 10: Tests for irritation and
delayed-type hypersensitivity (ISO 10993-10:2002)

CEN

EN ISO 10993-4:2002

Biological evaluation of medical devices — Part 4: Selection of tests for inter-
actions with blood (ISO 10993-4:2002)

(1) ESO (European standardisation organisations):

— CEN:

rue

de

Stassart/Stassartstraat 36, B-1050 Brussels. Tel.

(32-2) 550 08 11,

fax

(32-2) 550 08 19, website:

http://www.cenorm.be,

— CENELEC:

rue de Stassart/Stassartstraat 35, B-1050 Brussels. Tel.

(32-2) 519 68 71,

fax (32-2) 519 69 19, website:

http://www.cenelec.org,

— ETS:

route des Lucioles, F-06561 Sophia Antipolis Cedex. Tel.

(33-4) 92 94 42 00,

fax (33-4) 93 65 47 16, website:

http://www.etsi.org.

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 Directive 98/34/EC of the European Parliament and of the Council (2).

— 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.

— The Commission ensures the updating of this list.

(1) OJ L 189, 20.7.1990, p. 17.
(2) OJ L 204, 21.7.1998, p. 37.