Reference number
ISO 10993-16:2017
© ISO 2026
International Standard
ISO 10993-16:2017
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Edition 3
2017-05
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Published (Edition 3, 2017)
This publication was last reviewed and confirmed in 2022. Therefore this version remains current.

ISO 10993-16:2017

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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
     : Published
    Publication date
     : 2017-05
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 3
    Number of pages
     : 13
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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Next version under development

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 1
© ISO 2026
Draft International Standard

ISO/DIS 10993-16

Biological evaluation of medical devices

Part 16: Toxicokinetic evaluation for degradation products and leachables

ISO/DIS 10993-16

Language
Format
CHF 67
* Shipping costs not included
Convert Swiss francs (CHF) to your currency

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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