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AAMI TIR16:2023

Microbiological aspects of ethylene oxide sterilization


Addresses various microbiological aspects of the development and validation of an ethylene oxide sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. Provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.


CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought
Compatibility of materials subject to sterilization
Physical aspects of ethylene oxide sterilization
Contract sterilization using ethylene oxide
Document History
Amendments & Corrections
We have no amendments or corrections for this standard.