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About This Item

 

Full Description

Provides additional guidance to augment ANSI/AAMI ISO 11135, Medical devices - Validation & routine control of ethylene oxide sterilization, for both medical device manufacturers that use contract sterilization facilities and contract sterilization.
 

Document History

  1. AAMI TIR14:2016 (R2020)


    Contract sterilization using ethylene oxide

    • Most Recent
  2. AAMI TIR14:2009


    Contract sterilization using ethylene oxide

    • Historical Version
  3. AAMI TIR14:1997/A1:2004

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    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