Historical
ANSI/AAMI/ISO 10993-3: 2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
Specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices.
Association for the Advancement of Medical Instrumentation [aami]