Historical

BS EN ISO 10993-3:2009

Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity (British Standard)


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.


CONTENT PROVIDER
British Standards Institution [bsi]

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Document History
Revises:
  • BS EN ISO 10993-3:2003
Revised By:
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