AAMI TIR16:2000


Process development and performance qualification for ethylene oxide sterilization-Microbiological aspects
standard by Association for the Advancement of Medical Instrumentation, 03/13/2000

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This AAMI technical information report presents the various microbiological aspects of thedevelopment of an ethylene oxide sterilization process and the validation of this process. Thisdocument does not discuss the effect of the microbiological bioburden or the effect of theenvironment that the product is exposed to during the manufacturing process. TIR16:2000 is acompanion document to ANSI/AAMI/ISO 11135:1994.

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