ISO 11138-2:2017

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ISO 11138-2:2017 is a standard that specifies requirements for biological indicators used to assess the effectiveness of ethylene oxide (EO) sterilization processes. It outlines details for test organisms, suspensions, inoculated carriers, biological indicators, and test methods. This standard is used to ensure that EO sterilization processes meet the necessary quality standards for sterilizing medical devices and healthcare product