Active , Reaffirmed Report
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AAMI TIR14:2016/(R)2024

Contract sterilization using ethylene oxide

Summary

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.  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 20
Themes Sterilization—Industrial
EAN ---
ISBN ---
Weight (in grams) ---
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