AAMI TIR14:2009

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This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical devicemanufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses howANSI/AAMI/ISO 11135-1:2007applies to contract ethylene oxide (EO) sterilization operations for devices marketed inthe 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.

Product Details

Published:

03/17/2009

ISBN(s):

1570203377

Number of Pages:

22

File Size:

1 file , 350 KB

Part of:

AAMI STBK10-3