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AAMI - TIR16

Microbiological aspects of ethylene oxide sterilization

inactive
Organization: AAMI
Publication Date: 1 January 2009
Status: inactive
Page Count: 33
scope:

This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.

Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.

Document History

January 1, 2017
Microbiological aspects of ethylene oxide sterilization
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various...
TIR16
January 1, 2009
Microbiological aspects of ethylene oxide sterilization
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various...
January 1, 2009
Microbiological aspects of ethylene oxide sterilization
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various...
January 1, 2000
PROCESS DEVELOPMENT AND PERFORMANCE QUALIFICATION FOR ETHYLENE OXIDE STERILIZATION - MICROBIOLOGICAL ASPECTS
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various...

References

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