Status : Published (To be revised)

This standard was last reviewed and confirmed in 2023. Therefore this version remains current.
This standard will be replaced by ISO/AWI 10993-3 | ISO/CD 10993-3
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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.

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General information

  • Status
     : Published
    Publication date
     : 2014-10
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 3
    Number of pages
     : 34
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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