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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
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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

PUBLISH DATE 2017
AAMI/ISO TIR15499:2017
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR15499
Publication Date Nov. 1, 2017
Language en - English
Page Count 26
Revision Level
Supercedes
Committee
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