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ISO 11135

ISO 11135

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**ISO 11135**

What is ISO 11135?

ISO 11135 specifies requirements for the development, validation and routine control of ethylene oxide (EO) sterilization processes for medical devices. It includes requirements for EO sterilizers and specifies the necessary EO residuals levels following sterilization. It's commonly used by medical device manufacturers to ensure their products are sterile and safe for patient use.

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