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ISO 10993-3:2003

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Oct 22, 2003
95.99   Withdrawal of Standard   Sep 24, 2014

General information

95.99     Sep 24, 2014

ISO

ISO/TC 194

International Standard

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-3:1992

NOW

WITHDRAWN
ISO 10993-3:2003
95.99 Withdrawal of Standard
Sep 24, 2014

REVISED BY

PUBLISHED
ISO 10993-3:2014

National adoptions

SRPS EN ISO 10993-3:2008  
ISS

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

95.99   Withdrawal of Standard

Z076 more

SRPS EN ISO 10993-3:2011  
ISS

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

95.99   Withdrawal of Standard

Z076 more