Draft
International Standard
ISO/DIS 10993-3
Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity
Reference number
ISO/DIS 10993-3
Edition 4
© ISO 2025
Draft International Standard
Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 10993-3:2014

Abstract

ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, 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
    : DIS registered [40.00]
  • Edition
     : 4
  • 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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