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Full Description

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.
 

Document History

  1. AAMI TIR14:2016

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    Contract sterilization using ethylene oxide

    • Most Recent
  2. AAMI TIR14:2009


    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