Reference number
ISO 10993-3:2014
© ISO 2024
International Standard
ISO 10993-3:2014
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 3
2014-10
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Published (Edition 3, 2014)
This publication was last reviewed and confirmed in 2023. Therefore this version remains current.

ISO 10993-3:2014

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Format
CHF 151
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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.

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 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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