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AAMI TIR39:2009 (R2022)
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
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.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
