医用防护服环氧乙烷快速灭菌方法研究与应用  

Research and application on rapid sterilization with ethylene oxide for medical protective clothing

作　　者：何乐春 谢朝珊 杨利 程琼莹 张和华 HE Yuechun;XIE Chao-shan;YANG Li(Chongqing Medical Equipment Quality Control Institute,Chongqing 401147,China;不详)

机构地区：[1]重庆医疗器械质量检验中心,重庆401147 [2]陆军军医大学大坪医院医学工程科,重庆400042

出　　处：《中国医学装备》2020年第9期189-192,共4页China Medical Equipment

摘　　要：目的:采用环氧乙烷快速灭菌法对医用一次性防护服进行无菌试验,探索防护服的最佳灭菌条件。方法:选用20批次医用一次性防护服作为供试品,采用薄膜过滤法进行无菌试验,每批次为1组,共计进行20组无菌试验。分析产品的包装、灭菌柜体积、环氧乙烷加入量、保温时长、灭菌温度、灭菌湿度以及灭菌时长对环氧乙烷灭菌效果的影响。结果:在20组无菌试验中,3组供试品有菌生长,17组供试品无菌生长,合格率为85%。当环氧乙烷的灭菌浓度与灭菌温湿度为恒量时,影响灭菌效果的主要因素为保温时长和灭菌时长。结论:在满足无菌的条件下,防护服的最佳灭菌条件是将保温时长和灭菌时长的较短值作为优选的灭菌参数,为保障供应的防护用品节约宝贵时间。Objective: To explore the optimum condition of sterilization for protective clothing by adopting rapid sterilization with ethylene oxide for implementing sterility test for medically disposable protective clothing. Methods: Twenty batches of medical disposable protective clothing were selected as test samples, and the sterility test was performed by membrane-filter procedure. Each batch was one group, and a total of 20 groups were tested for sterility test. And then the series of effects included product packaging, the volume of sterilization cabinet, the addition amount of ethylene oxide, heat preservation time, sterilization temperature, sterilization humidity, and the impact of sterilization duration on ethylene oxide were analyzed. Results: Among the 20 groups of sterility tests, 3 groups of the test products occurred bacterial growth, and 17 groups of the test products grew without bacterial, with a pass rate by 85%. When the sterilization concentration, temperature and humidity of ethylene oxide in environment were constant, the main factors that affected the sterilization effect were the heat preservation duration and the sterilization duration. Conclusion: The optimum sterilization condition of protective clothing is to use the shorter value of heat preservation duration and sterilization duration as the optimal sterilization parameters under the condition that can meet aseptic requirements. It can save precious time for the protective articles of supplies.

关 键 词：环氧乙烷灭菌 无菌试验 医用一次性防护服 

分 类 号：R197.323.4[医药卫生—卫生事业管理]