Standard

ISO 10993-3:2014

Historical draft

Note: This standard has a draft: ISO/DIS 10993-3

Corrigendums and amendments are bought separately.

Language
Services

Abstract

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.

Document information

  • Standard from ISO
  • Published:
  • Edition: 3
  • Version: 1
  • Document type: IS
  • Pages
  • ICS 11.100.20
  • ISO TC ISO/TC 194

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