ISO/AWI 10993-3
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Reference number
ISO/AWI 10993-3
Edition 4
Working draft
ISO/AWI 10993-3
A working group has prepared a draft.
Will replace ISO 10993-3:2014


ISO 10993-3:2014 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.

ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

General information

  •  : Under development
    : New project registered in TC/SC work programme [20.00]
  •  : 4
  • ISO/TC 194
  • RSS updates

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This standard contributes to the following Sustainable Development Goal

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