ANSI/AAMI/ISO 10993-3:2014(R2023)
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Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
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English
10-09-2023
This part of ISO 10993 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: — genotoxicity; — carcinogenicity; — reproductive and developmental toxicity.
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