ISO 10993-3:2014 Preview

Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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

  • Status :  Published
    Publication date : 2014-10
  • Edition : 3
    Number of pages : 34
  • :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • 11.100.20
    Biological evaluation of medical devices

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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