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

作　　者：黄鸿新[1] 胡昌明[1] 刘文一 崔文波 徐海英 祝沛平 HUANG Hongxin;HU Changming;LIU Wenyi;CUI Wenbo;XU Haiying;ZHU Peiping(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou,510663;Suzhou GOLAS Medical Technology Co.Ltd.,Suzhou,215000;Xinxiang Huaxi Sanitary Materials Co.Ltd.,Xinxiang,453412;Suzhou Prosteri Medical Technology Co.Ltd.,Suzhou,215000)

机构地区：[1]广东省医疗器械质量监督检验所,广州市510663 [2]苏州高是医疗科技有限公司,苏州市215000 [3]新乡市华西卫材有限公司,新乡市453412 [4]苏州诺洁医疗技术有限公司,苏州市215000

出　　处：《中国医疗器械杂志》2022年第5期574-577,共4页Chinese Journal of Medical Instrumentation

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。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.

关 键 词：无菌保证水平 灭菌过程参数 参数放行 

分 类 号：R187[医药卫生—流行病学]