EN ISO 10993-5:1999

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

Publication date:   Oct 23, 2003

General information

99.60 Withdrawal effective   Jun 3, 2009

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100   Laboratory medicine

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Scope

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or trough diffusion a) with extracts of a device , and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 30993-5:1994

NOW

WITHDRAWN
EN ISO 10993-5:1999
99.60 Withdrawal effective
Jun 3, 2009

REVISED BY

PUBLISHED
EN ISO 10993-5:2009