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Full Description

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.

ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.

Guidance on selection of tests is provided in ISO 10993-1.


Document History

  1. ISO 10993-3:2003


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

    • Most Recent
  2. ISO 10993-3:1992

    Biological evaluation of medical devices; part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity

    • Historical Version