ANSI/AAMI/ISO 10993-16:2020/(R)2022
Active , Reaffirmed Standard
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ANSI/AAMI/ISO 10993-16:2020/(R)2022

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

Summary

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. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2020
Confirmation Date 01/01/2022
Page Count 20
Themes Biological Evaluation
EAN ---
ISBN ---
Weight (in grams) ---
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