AAMI TIR16:2000

Process development and performance qualification for ethylene oxide sterilization-Microbiological aspects

Association for the Advancement of Medical Instrumentation , 03/13/2000

Publisher: AAMI

File Format: PDF

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Description

Standard By:Association for the Advancement of Medical Instrumentation , 03/13/2000

Published:03/13/2000

Pages:28

File Size:1 file , 130 KB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.