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SSH EN ISO 10993-5:2000

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

Jan 1, 2000
95.99 Withdrawal of Standard   Dec 30, 2009

General information

95.99     Dec 30, 2009

DPS

DPS/KT 206

European Norm

11.100  

English  

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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 directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SSH EN ISO 10993-5:2000
95.99 Withdrawal of Standard
Dec 30, 2009

REVISED BY

PUBLISHED
SSH EN ISO 10993-5:2009

Related project

Adopted from EN ISO 10993-5:1999