ANSI/AAMI/ISO 10993-16:2017

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

This document 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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Association for the Advancement of Medical Instrumentation [aami]

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

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ANSI/AAMI/ISO 10993-16:2017

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

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