医用超声耦合剂质量管理探析  

Quality Control of Medical Ultrasonic Couplant

作　　者：李宝林 LI Bao-lin(Hebei Testing Institute for Drug and Medical Devices Control,Hebei Shijiazhuang 050200)

机构地区：[1]河北省药品医疗器械检验研究院,河北石家庄050200

出　　处：《中国医疗器械信息》2021年第7期6-7,38,共3页China Medical Device Information

摘　　要：目的:探讨医用超声耦合剂及其添加消毒剂的应用和质量控制现状。方法:比对医用超声耦合剂医药行业标准、医疗器械分类目录、豁免临床文件与消毒技术规范、消毒剂产品国家标准在消毒剂应用要求和质量控制方面的相关规定。结果:由于管理部门和技术要求不同,对消毒剂的应用部位、作用时间、有关物质限量和生物学评价要求存在一定差异。结论:已上市医用超声耦合剂多数添加不同的消毒剂,临床使用不应忽视所添加消毒剂的种类和应用要求,应加强超声耦合剂的质量控制,以确保其安全性。Objective:It was discussed status of application and quality control for medical ultrasonic couplant and its disinfectant.Methods:It was compared the pharmaceutical industry standard for medical ultrasonic couplant and text of split catalog for medical devices with the technical standard for disinfection and hygienic requirements for disinfectant.Results:It was differences not only site and time of operating but also related substance and biological evaluating.Conclusion:It was necessary to work out requirements both in clinical use and in quality control for disinfectant of medical ultrasonic couplant approved to insure its safety.

关 键 词：超声耦合剂 消毒剂 质量控制 生物学评价 

分 类 号：TH789[机械工程—仪器科学与技术]