AAMI TIR16:2009/(R)2013 PDF

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.

File Size :	1 file , 300 KB
ISBN(s) :	1570203741
Note :	This product is unavailable in Belarus, Russia, Ukraine
Number of Pages :	33
Part of :	AAMI STBK10-3
Published :	03/03/2010