AAMI TIR28:2016/(R)2024
Active , Reaffirmed Report
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AAMI TIR28:2016/(R)2024

Product adoption and process equivalence for ethylene oxide sterilization

Summary

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.   No annex

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2016
Confirmation Date 01/01/2024
Page Count 22
Themes Sterilization—Industrial
EAN ---
ISBN ---
Weight (in grams) ---
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