Committee Draft
ISO/CD 10993-3
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Reference number
ISO/CD 10993-3
Edition 4
© ISO 2024
Committee Draft
Under development
A draft is being reviewed by the committee.
Will replace ISO 10993-3:2014

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
     : Under development
    Stage
    : CD consultation initiated [30.20]
  • Edition
     : 4
  • Technical Committee :
    ISO/TC 194
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

Got a question?

Check out our Help and Support

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Standards catalogue
  4. TC
  5. ISO/TC 194
  6. ISO/CD 10993-3