| 医用超声耦合剂质量管理探析 |
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| 引用本文： | 李宝林. 医用超声耦合剂质量管理探析[J]. 中国医疗器械信息, 2021, 0(7): 6-7,38 |
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| 作者姓名： | 李宝林 |
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| 作者单位： | 河北省药品医疗器械检验研究院 |
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| 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...
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| 关 键 词： | 超声耦合剂 消毒剂 质量控制 生物学评价 |
Quality Control of Medical Ultrasonic Couplant |
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| LI Bao-lin. Quality Control of Medical Ultrasonic Couplant[J]. China Medical Devices Information, 2021, 0(7): 6-7,38 |
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| Authors: | LI Bao-lin |
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| Affiliation: | (Hebei Testing Institute for Drug and Medical Devices Control,Hebei Shijiazhuang 050200) |
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| Abstract: | 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. |
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| Keywords: | ultrasonic couplant disinfectant quality controlling biological evaluation |
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