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Product adoption and process equivalency for ethylene oxide sterilization
Published by | Publication Date | Number of Pages |
AAMI | 11/18/2016 | 22 |
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AAMI TIR28 – Product adoption and process equivalency for ethylene oxide sterilization
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.
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