24797

ISO 10993-16:1997

Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables

standard by International Organization for Standardization , 09/01/1997

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Full Description

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

 

Product Details

Published:
09/01/1997
Number of Pages:
9
File Size:
1 file , 1.3 MB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 10993-16:2017


    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    • Most Recent

  2. ISO 10993-16:2010


    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    • Historical Version

  3. ISO 10993-16:1997

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    Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables

    • Historical Version