医疗器械环氧乙烷灭菌实施参数放行的研究

Study on Parametric Release of Ethylene Oxide Sterilization of Medical Devices

摘要: 简单介绍灭菌的基础理论、医疗器械环氧乙烷灭菌的特点和影响灭菌效果的关键因素，并分析比较了医疗器械环氧乙烷灭菌的产品放行所使用的无菌检查法、传统放行和参数放行三种方法，着重研究了参数放行的理论基础、可行性、确认要求及优缺点。

Abstract: This study briefly introduces the basic theory of sterilization, the characteristics of ethylene oxide sterilization for medical devices and the key factors about sterilization effectiveness, analyzes and compares three methods used in the product release of medical devices sterilized by ethylene oxide: test for sterility, traditional release and parametric release, and focuses on the theoretical basis, feasibility, validation requirements, advantages and disadvantages of parametric release.