1087282

AAMI/ISO 10993-16:1997 (R2009)

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 08/04/1997

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Full Description

This standard 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:
08/04/1997
ANSI:
ANSI Approved
Number of Pages:
19
File Size:
1 file , 260 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 10993-16:2020/(R)2022


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

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  2. AAMI/ISO 10993-16:2010/(R)2014


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

    • Historical Version

  3. AAMI/ISO 10993-16:1997 (R2009)

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

    • Historical Version