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.
Document identifier
AAMI TIR16:2009/(R)2013
Title
Microbiological aspects of ethylene oxide sterilization
AAMI Category
EO and Chemical Disinfection
Publication date
2010-03-03
International Relationship
History of version
AAMI TIR16:2017*AAMI TIR16:2009/(R)2013 * AAMI TIR16:2017 * AAMI TIR16:2009/(R)2013 * AAMI TIR16:2000
| Price |
148 vnd |
AAMI TIR16:2009/(R)2013
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