Historical
ANSI/AAMI/ISO 10993-3:2003 (R2013)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
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.
Association for the Advancement of Medical Instrumentation [aami]