PDF Standards AAMI TIR16:2017 (R2020)

PDF Standards AAMI TIR16:2017 (R2020)

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  • March 11, 2023
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Addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. 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.

Product Details

Published:
11/17/2017
ISBN(s):
1570206917
Number of Pages:
33
File Size:
1 file , 810 KB
Note:
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