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