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Full Description

This AAMI technical information report presents the various microbiological aspects of the development of an ethylene oxide sterilization process and the validation of this process. This document does not discuss the effect of the microbiological bioburden or the effect of the environment that the product is exposed to during the manufacturing process. TIR16:2000 is a companion document to ANSI/AAMI/ISO 11135:1994.
 

Document History

  1. AAMI TIR16:2023


    Microbiological aspects of ethylene oxide sterilization

    • Most Recent
  2. AAMI TIR16:2017 (R2020)


    Microbiological aspects of ethylene oxide sterilization [HISTORICAL]

    • Historical Version
  3. AAMI TIR16:2009/(R)2013


    Microbiological aspects of ethylene oxide sterilization

    • Historical Version
  4. AAMI TIR16:2000

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    Process development and performance qualification for ethylene oxide sterilization-Microbiological aspects

    • Historical Version