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See Chinese contents: YY/T 1268-2015 YY/T 1268-2015: Product adoption and process equivalence for ethylene oxide sterilization
This standard specifies the equivalence of the sterilization process when using new equipment in the process of adopting new product or changed product into the originally validated ethylene oxide sterilization process. This standard applies to medical devices that have been treated by ethylene oxide (EO) sterilization and that use conventional release or parametric release.
