This document specifies the requirements for adoption of new or changed products to a validated sterilization process for medical devices using ethylene oxide sterilization. It provides methods for evaluating the equivalence of sterilization processes when using different sterilization equipment. This document applies to medical devices sterilized with ethylene oxide using conventional release or parametric release. This document applies to ethylene oxide sterilization of medical devices including: a) adding new products to a confirmed ethylene oxide sterilization process; b) evaluating changes to confirmed products; c) transferring a confirmed process to a different site or equipment; d) evaluating the equivalence of sterilization processes.
Basic Data
Standard ID
YY/T 1268-2023 (YY/T1268-2023)
Description (Translated English)
Product adoption and process equivalence for ethylene oxide sterilization
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C47
Classification of International Standard
11.080.01
Word Count Estimation
15,116
Date of Issue
2023-03-14
Date of Implementation
2024-05-01
Older Standard (superseded by this standard)
YY/T 1268-2015
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the requirements for adding new or changed products to the confirmed sterilization process in 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 is applicable to medical devices sterilized by ethylene oxide, using traditional release or parametric release. The ethylene oxide sterilization conditions for medical devices to which this document applies include: a) adding new products to the validated ethylene oxide sterilization process; b) evaluating changes to the validated product; c) transferring the validated process to different sites or equipment; d) assess the equivalence of the sterilization process.
