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AAMI/ISO TIR15499:2017

Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process

Summary

This technical information report provides guidance applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1 and is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2017
Page Count 26
Themes Biological Evaluation
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