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AAMI TIR14:2009

Contract sterilization using ethylene oxide

standard by Association for the Advancement of Medical Instrumentation , 03/17/2009

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Full Description

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.
 

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
 

Document History

  1. AAMI TIR14:2016 (R2020)


    Contract sterilization using ethylene oxide

    • Most Recent

  2. AAMI TIR14:2009

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    Contract sterilization using ethylene oxide

    • Historical Version

  3. AAMI TIR14:1997/A1:2004


    Contract Sterilization for Ethylene Oxide, Includes Amendment 1

    • Historical Version

  4. AAMI TIR14:1997


    Guidance for the Validation and Routine Control of Industrial Ethylene Oxide Sterilization - Contract Sterilization

    • Historical Version