ISO 10993-16:2017

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

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

PUBLISH DATE 2017

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.

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