This standard specifies the equivalence of the sterilization process when new products or changed products are added to the original confirmed ethylene oxide sterilization process and different equipment is used. This standard applies to medical devices processed by ethylene oxide (EO) sterilization and using traditional release or parametric release. The ethylene oxide sterilization situations applicable to this standard include: a) adding new products to the confirmed ethylene oxide sterilization process; b) evaluating changes to confirmed products; c) transferring the confirmed process to a different Site or equipment; d) Evaluate the equivalence of the sterilization process. Although this standard is intended to apply to medical devices, its contents are also applicable to other related products or materials.
YY/T 1268-2015 history
2023YY/T 1268-2023 Product additions and process equivalence for ethylene oxide sterilization
2015YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization