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| 医用激光设备安全分类的探讨 | |
| 引用本文： | 申高,;刘艳珍,;贺伟罡,;任海萍. 医用激光设备安全分类的探讨[J]. 中国医疗设备, 2014, 0(8): 82-84 |
| 作者姓名： | 申高, 刘艳珍, 贺伟罡, 任海萍 |
| 作者单位： | [1]国家食品药品监督管理总局医疗器械技术审评中心,北京100044; [2]中国食品药品检定研究院医疗器械检定所,北京100050 |
| 摘 要： | GB7247.1-2012《激光产品的安全第1部分：设备分类、要求》已发布实施，该标准规定了激光产品安全类别的分类方法。几乎所有医用激光设备均需引用该标准，且产品管理类别的划分也依据此标准。本文以1470 nm激光系统为例，通过计算与可达发射极限匹配的脉冲持续时间，来确定产品的类别，希望借此为检测机构及生产企业预判断产品类别提供一种新的思考角度。 |
| 关 键 词： | 激光设备 设备分类 可达发射极限 脉冲持续时间 激光辐射 |
Discussion on Safety Classiifcation of Medical Laser Equipment |
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| Affiliation: | SHEN Gao, LIU Yan-zhen, HE Wei-gang, REN Hai-ping (1 .Center for Medical Device Evaluation, CFDA, Beijing 100044, China; 2.Institute for Medical Devices Control, National Institutes for Food and Drug Control, Beijing 100050, China) |
| Abstract: | The standard GB7247.1-2012Safety of laser products-Part 1： Equipment classification and requirements, which specifies the methods to classify laser products has been promulgated and implemented. Almost all the medical laser equipment need to reference the standard and the classiifcation of product management categories is also based on this standard. Taking 1470 nm laser system as an example, the categories of products can be determined by calculating pulse duration which can match accessible emission limit （AEL）. It provides a new thinking angle for testing institutions and production enterprises to preliminary judge the categories of products. |
| Keywords: | laser equipment equipment classiifcation accessible emission limit pulse duration laser radiation |
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