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About This Item

 

Full Description

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.

 

Document History

  1. ISO 10993-16:2017

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    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


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

    • Historical Version