Approved Work Item
ISO/AWI 10993-16
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Reference number
ISO/AWI 10993-16
Edition 4
© ISO 2024
Approved Work Item
Under development
A working group has prepared a draft.
Will replace ISO 10993-16:2017

Abstract

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

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • 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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