Committee Draft
ISO/CD 10993-16
Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables
Reference number
ISO/CD 10993-16
Edition 4
© ISO 2025
Committee Draft
Under development
A draft is being reviewed by the committee.
Will replace ISO 10993-16:2017

Abstract

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.

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

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