YY/T 1302.1-2015 in English

This document specifies the physical performance requirements for ethylene oxide sterilization processes. It covers aspects such as the conditions and parameters necessary to ensure the effectiveness and safety of the sterilization process. The standard provides guidelines for monitoring and controlling key factors involved in the sterilization cycle, including temperature, pressure, and gas concentration. It also outlines the procedures for validating and maintaining the performance of the sterilization equipment. The document is applicable to medical devices and related products that require ethylene oxide sterilization. It serves as a reference for manufacturers, users, and regulatory authorities involved in the production and quality control of sterilized medical products. The content includes definitions, test methods, and criteria for evaluating the physical performance of the sterilization process.