YY/T 1268-2023 Product adoption and process equivalence for ethylene oxide sterilization
1 Scope
This document specifies the requirements for adopting new or changed products into the validated sterilization process during the ethylene oxide sterilization of medical devices, and provides methods for evaluating the sterilization process equivalence when using different sterilization equipment.
This document is applicable to medical devices that have undergone ethylene oxide sterilization processing and are subject to traditional release or parametric release.
The ethylene oxide sterilization situations of medical devices which this document is applicable to include:
a) adoption of new products into the validated ethylene oxide sterilization process;
b) evaluation of the changes in validated products;
c) transfer of validated process to different sites or equipment;
d) evaluation of the equivalence of sterilization process.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 18279.1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 18279.1 and the following apply.
3.1
candidate equipment
new or changed equipment intended to implement the existing validated sterilization process
3.2
candidate product
new or changed products (including packaging systems) proposed to be adopted into the existing validated sterilization process
3.3
EO processing category
combination of different products or product families that can be sterilized in the same ethylene oxide sterilization process
Note: The challenge to the sterilization process presented by all products within the processing category shall be no greater than that of the challenge devices in the processing category.
3.4
EO product family
product combinations that are allowed to be sterilized under the same technological conditions and have similar or the same validated purposes
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Product adoption
5 Process equivalence
Annex A (Informative) Guideline for evaluation of product adoption to EO product family or EO processing category
Annex B (Informative) Guideline for evaluation of process equivalence
Bibliography
