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ISO 10993-3:2014

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

Standard Details

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
Standard Type: Main
Document No: ISO 10993-3:2014
Document Year: 2014
Pages: 34
Edition: 3
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

Life Cycle

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ISO 10993-3:2014
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