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Copyright: © 2015 Shintani H. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. There are so many ISO documents to understand and utilize for validation study and routine control. Biological indicator (BI) is the essential items to conduct sterilization validation and routine control. ISO 11138-1 and ISO 14161 are the major ISO documents to read for both BI manufacturer and BI user, respectively. In ISO 11138-1, BI manufacturer must utilize BI with 106 CFU (colony forming unit)/ carrier as an initial population in validation study. In routine control, it is approved to use 105 CFU/carrier BI in ISO 11138-1.

Validation Study of Nitrogen Gas Plasma Exposure Based on ISO Documents (Mainly ISO TC 198 and 194 Documents)