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AAMI TIR28:2016

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AAMI TIR28:2016

Product adoption and process equivalence for ethylene oxide sterilization

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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.

Author AAMI
Editor AAMI
Document type Standard
Format File
EAN ISBN 9781570206542
ICS 11 : Health care technology
Number of pages 22
Year 2016
Country USA