医疗器械环氧乙烷灭菌残留物的分析  

Analysis on sterilized residues of ethylene oxide for medical devices

作　　者：杨婷茹 史鑫宇 YANG Ting-ru;SHI Xin-yu(Lepu Medical Technology(Beijing)Co.,Ltd,Beijing 102200,China)

机构地区：[1]乐普(北京)医疗器械股份有限公司,北京102200

出　　处：《中国消毒学杂志》2024年第8期573-575,共3页Chinese Journal of Disinfection

摘　　要：目的研究医疗器械环氧乙烷灭菌后,环氧乙烷和2-氯乙醇的残留情况。方法对13种医疗器械常用高分子材料进行灭菌,不经解析,采用气相色谱法测试环氧乙烷和2-氯乙醇残留产生情况。解析3、5、7 d后,检测环氧乙烷残留情况和解析速率,以及浸提温度、时间、氯离子浓度3种因素对2-氯乙醇检出情况的影响。结果13种材料灭菌后均未检出2-氯乙醇。丙烯腈-苯乙烯-丁二烯共聚物(ABS)、聚氨酯和聚氯乙烯环氧乙烷残留量较多,分别为632.27、577.66和524.53μg/g,硅橡胶和氟塑料残留量较少,分别为5.34和72.73μg/g。不同材料解析速率相差较明显,其中氟塑料和聚醚酰胺嵌段共聚物解析速率最快,分别为100.00%和98.34%。氯离子浓度对2-氯乙醇检出结果产生影响。结论医疗器械企业在产品设计之初应对选择的材料进行具体分析,必要时通过控制灭菌和解析条件降低环氧乙烷残留,而对于2-氯乙醇残留的控制可能不是必要的。Objective To study the residual of ethylene oxide and 2-chloroethanol in medical devices.Methods Thirteen kinds of polymer materials commonly used in medical devices were sterilized,and ethylene oxide and 2-chloroethanol residues were tested by gas chromatography without analysis.After 3,5 and 7 days of analysis,the effects of ethylene oxide residue and resolution rate,as well as the effects of extraction temperature,time and chloride ion concentration on the detection of 2-chloroethanol were detected.Results No 2-chloroethanol was detected in any of the 13 materials after sterilization.Acrylonitrile-styrene-butadiene copolymer(ABS),polyurethane and polyvinyl chloride ethylene oxide residues were 632.27,577.66 and 524.53μg/g,respectively,while silicone rubber and fluoroplastics had fewer residues of 5.34 and 72.73μg/g,respectively.There was a significant difference in the resolution rate of different materials,and the resolution rate of fluoroplastics and polyetheramide block copolymers was the fastest,with 100.00%and 98.34%,respectively.The concentration of chloride ions had an effect on the detection of 2-chloroethanol.Conclusion Medical device companies should conduct specific analysis of the selected materials at the beginning of product design,and reduce ethylene oxide residues by controlling sterilization and analysis conditions if necessary,while the control of 2-chloroethanol residues may not be necessary.

关 键 词：环氧乙烷 2-氯乙醇 解析 氯离子浓度 

分 类 号：R187.2[医药卫生—流行病学]