ISO 10993-16:2017

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

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

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Referenced standards

ISO 10993-12:2012ISO 10993-17:2002ISO 10993-18:2005ISO 10993-1:2009ISO 10993-2:2006ISO 14971:2007ISO/TR 10993-22
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ISO 10993-16:2017

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

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

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.

Edition2017
Standard Part No16
Published Date2017
Published ByInternational Standardization Organisation
Page Count13