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SRPS EN ISO 10993-3:2008

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

Feb 27, 2008
95.99   Withdrawal of Standard   Sep 30, 2011

General information

95.99     Sep 30, 2011

ISS

Z076

European Norm

11.100     11.100.20  

English  

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Scope

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.
ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
Guidance on selection of tests is provided in ISO 10993-1.

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.

93/42/EEC

Medical devices

Directive 93/42/EEC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 10993-3:2008
95.99 Withdrawal of Standard
Sep 30, 2011

REVISED BY

WITHDRAWN
SRPS EN ISO 10993-3:2011

Related project

Adopted from EN ISO 10993-3:2003

Adopted from ISO 10993-3:2003 IDENTICAL