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ANSI/AAMI/ISO 10993-13-2010/(R)2019:2023

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

Summary

This standard describes general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2023
Confirmation Date 01/01/2019
Page Count 28
Themes Biological Evaluation
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