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AAMI TIR16:2009/(R)2013

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AAMI TIR16:2009/(R)2013 Microbiological aspects of ethylene oxide sterilization

standard by Association for the Advancement of Medical Instrumentation, 03/03/2010

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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: 03/03/2010 ISBN(s): 1570203741 Number of Pages: 33File Size: 1 file , 300 KB Part of: AAMI STBK10-3
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