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ANSI/AAMI/ISO 10993-16:2020 (R2022)

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. This third edition cancels and replaces the second edition (ISO 10993-16:2010), which has been technically revised.

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Association for the Advancement of Medical Instrumentation [aami]

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