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
Working draft
ISO/AWI 10993-16
A working group has prepared a draft.
Will replace ISO 10993-16:2017


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

  •  : Under development
    : New project registered in TC/SC work programme [20.00]
  •  : 4
  • ISO/TC 194
  • RSS updates

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This standard contributes to the following Sustainable Development Goal

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