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Contract sterilization using ethylene oxide
standard by Association for the Advancement of Medical Instrumentation, 03/17/2009
Description
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
- Note:
- This product is unavailable in Russia, Ukraine, Belarus
