AAMI TIR28:2016 (R2020)
Product adoption and process equivalency for ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 11/18/2016
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About This Item
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
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AAMI TIR28:2016 (R2020)
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Product adoption and process equivalency for ethylene oxide sterilization- Most Recent
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AAMI TIR28:2009/(R)2013
Product adoption and process equivalency for ethylene oxide sterilization- Historical Version
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AAMI TIR28:2001
Product adoption and process equivalency for ethylene oxide sterilization- Historical Version
