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SRPS EN ISO 10993-5:2008

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

Feb 27, 2008
95.99   Withdrawal of Standard   Aug 29, 2011

General information

95.99     Aug 29, 2011

ISS

Z076

European Norm

11.100     11.100.20  

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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 10993-5:2008
95.99 Withdrawal of Standard
Aug 29, 2011

REVISED BY

PUBLISHED
SRPS EN ISO 10993-5:2011

Related project

Adopted from EN ISO 10993-5:1999

Adopted from ISO 10993-5:1999 IDENTICAL