Std

NS-EN ISO 10993-3:2009

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

standard by Standards Norway NS-EN ISO , 08/01/2009

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ADOPTED_FROM:EN ISO 10993-3:2009

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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Published:: 08/01/2009
Number of Pages:: 32

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