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  1. Home
  2. ISO 10993-16:1997

ISO 10993-16:1997 Historical

24797

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

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

This document has been replaced. View the most recent version.

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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.

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Document History

  1. ISO 10993-16:2017

    May 2017
    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    • Most Recent  Most Recent
  2. ISO 10993-16:2010

    February 2010
    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    • Historical Version
  3. ISO 10993-16:1997

    You are currently viewing this product 👀 currently
    viewing

    September 1997
    Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables

    • Historical Version

Browse related products from International Organization for Standardization

  • International Organization for Standardization > By ICS Code > 11: Health care technology > 11.100: Laboratory medicine
  • International Organization for Standardization > By ICS Code > 11: Health care technology > 11.100: Laboratory medicine > 11.100.20: Biological evaluation of medical devices
  • International Organization for Standardization > By Technical Committee > TC 194: Biological evaluation of medical devices > TC 194/WG 2: Degradation aspects related to biological testing

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Product Details

Published:

09/01/1997

Number of Pages:

9

File Size:

1 file

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This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus
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