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Full Description

This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.
 

Document History

  1. AAMI TIR28:2016

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    Product adoption and process equivalency for ethylene oxide sterilization

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


    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