AAMI ANSI/AAMI/ISO 10993-16:2020/(R)2022

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

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AAMI ANSI/AAMI/ISO 10993-16:2020/(R)2022

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

PUBLISH DATE 2022
AAMI ANSI/AAMI/ISO 10993-16:2020/(R)2022
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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