AAMI TIR14:2009 PDF

This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.

EO contract sterilization guidance for health care providers is not specifically covered in this TIR.

Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.

File Size :	1 file , 350 KB
ISBN(s) :	1570203377
Note :	This product is unavailable in Belarus, Russia, Ukraine
Number of Pages :	22
Part of :	AAMI STBK10-3
Published :	03/17/2009