Draft
International Standard
ISO/DIS 10993-16
Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables
Reference number
ISO/DIS 10993-16
Edition 4
© ISO 2026
Draft International Standard
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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 10993-16:2017

ISO/DIS 10993-16

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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
    : Close of voting [40.60]
  • Edition
     : 4
    Number of pages
     : 21
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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