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AAMI TIR16:2017

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AAMI TIR16:2017 Microbiological aspects of ethylene oxide sterilization

standard by Association for the Advancement of Medical Instrumentation, 11/17/2017

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Addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) 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 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.

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Published: 11/17/2017 ISBN(s): 1570206917 Number of Pages: 33File Size: 1 file , 620 KB
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