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AAMI TIR39:2009/(R)2022

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
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AAMI TIR39:2009/(R)2022

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices

PUBLISH DATE 2022
AAMI TIR39:2009/(R)2022
This technical information report provides guidance on selecting the appropriate form of microbial challenge to use in a validation process and the appropriate inoculation sites for that microbial challenge. The objective of this TIR is to provide medical device manufacturers information on the appropriate microbial challenge to use in sterilization validation processes, the selection of appropriate inoculation sites for that challenge, and the means to qualify a method for liquid inoculation.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR39
Publication Date Jan. 1, 2022
Language en - English
Page Count 21
Revision Level
Supercedes
Committee
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