ISO 11135:2014/Amd 1:2018

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ISO 11135:2014/Amd 1:2018 specifies requirements for developing, validating, and controlling ethylene oxide (EO) sterilization processes for medical devices. This standard, including its 2018 amendment, focuses on ensuring the effectiveness and safety of EO sterilization, particularly regarding the residual levels of EO and its by-products. It covers aspects like product testing, validation, and routine control to maintain product sterility and safety.