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About This Item

 

Full Description

This AAMI technical information report (TIR) provides guidance for the adoption of a new or modified product into an existing validated sterilization process and for the determination of equivalency of a sterilization process as conducted in different equipment. Its guidance is intended to augment ANSI/AAMI/ISO 11135:1994, Medical devices?Validation and routine control of ethylene oxide sterilization, and to expand on the areas of product adoption and process equivalency that are not addressed in ANSI/AAMI/ISO 11135:1994.
 

Document History

  1. AAMI TIR28:2016


    Product adoption and process equivalency for ethylene oxide sterilization

    • Most Recent
  2. AAMI TIR28:2009/(R)2013

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    viewing


    Product adoption and process equivalency for ethylene oxide sterilization

    • Historical Version
  3. AAMI TIR28:2001


    Product adoption and process equivalency for ethylene oxide sterilization

    • Historical Version