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

This standard has been revised by: ISO 10993-3:2014

This standard is also included in the online collection: Biological evaluation of medical devices .

Abstract

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.

 

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