YY/T 1268-2023
Product additions and process equivalence for ethylene oxide sterilization (English Version)
- Standard No.
- YY/T 1268-2023
- Language
- Chinese, Available in English version
- Release Date
- 2023
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1268-2023
- Replace
- YY/T 1268-2015
- Scope
- This document specifies the requirements for adding new or changed products to the confirmed sterilization process during the ethylene oxide sterilization process of medical devices, and provides a method for evaluating the equivalence of the sterilization process when using different sterilization equipment. This document applies to medical devices that have been sterilized by ethylene oxide and adopt traditional release or parametric release. This document is applicable to the ethylene oxide sterilization of medical devices including: a) adding new products to the confirmed ethylene oxide sterilization process; b) evaluating changes to confirmed products; c) transferring the confirmed process to Different sites or equipment; d) Evaluate the equivalence of sterilization processes.
YY/T 1268-2023 history
- 2023 YY/T 1268-2023 Product additions and process equivalence for ethylene oxide sterilization
- 2015 YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization
