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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

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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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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