| 基于技术审评的3A类半导体激光治疗机研究 |
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| 引用本文： | 梁文,李竹,李非,杨牧,迟戈,马艳彬. 基于技术审评的3A类半导体激光治疗机研究[J]. 中国医疗器械信息, 2014, 0(6): 23-27 |
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| 作者姓名： | 梁文 李竹 李非 杨牧 迟戈 马艳彬 |
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| 作者单位： | 辽宁省食品药品监督管理局技术审评中心,沈阳110003 |
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| 摘 要： | 目的：从技术审评角度,研究3A类半导体激光治疗机产品的安全性和有效性。方法：基于各国行业标准和指南文件,对3A类半导体激光治疗机产品的结构和组成、工作原理、作用机理、预期用途、主要风险、适用标准、性能指标七个方面进行了分析研究。结论：从技术审评角度,为保证产品的安全性和有效性,应加强对3A类半导体激光治疗机的安全级别和生产工艺的控制。
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| 关 键 词： | 3A类半导体激光治疗机 技术审评 适用范围 安全级别 工艺 |
Research of 3A Diode Laser Treatment Apparatus Based on Medical Device Technical Evaluation |
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| LIANG Wen,LI Zhu,LI Fei,YANG Mu,CHI Ge,MAYan-bin. Research of 3A Diode Laser Treatment Apparatus Based on Medical Device Technical Evaluation[J]. China Medical Devices Information, 2014, 0(6): 23-27 |
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| Authors: | LIANG Wen LI Zhu LI Fei YANG Mu CHI Ge MAYan-bin |
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| Affiliation: | (Shenyang 110003) |
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| Abstract: | Objective：This article aim to study the safety and efficacy of Class 3A diode laser treatment apparatus. Methods： Based on standards and guidance from various countries and regions, a research is carried out focused on the structure, principle, mechanism, Intended use, principal risk, applicable standard and performance index. Conclusions： To assure the Safety and efficacy of Class 3A diode laser treatment apparatus, should be enhanced for Security level and Technology. |
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| Keywords: | class 3A diode laser treatment apparatus technical evaluation application security level technology |
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