| 医用电气设备电磁兼容说明的编写 |
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| 引用本文： | 苏宗文,李佳戈,张超,王权,侯晓旭. 医用电气设备电磁兼容说明的编写[J]. 中国医疗设备, 2013, 0(11): 88-90 |
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| 作者姓名： | 苏宗文 李佳戈 张超 王权 侯晓旭 |
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| 作者单位： | 中国食品药品检定研究院医疗器械检定所,北京100050 |
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| 基金项目： | 国家科技支撑计划课题（2012BA122B04）. |
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| 摘 要： | YY0505—2012对随机文件中有关电磁兼容（EMC）的说明有严谨、明确的求。本文通过分析这些求，梳理出说明书编写的思路，对厂家在随机文件编写上起到一定的指导作用，也利于医院了解所购置的设备需满足的标准条款，以保证医疗电气设备的使用安全。
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| 关 键 词： | 医用电气设备 电磁兼容标准 电磁辐射 电磁干扰 医疗设备安全 |
EMC Document Requirement for Medical Electrical Equipment |
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| SU Zong-wen,LI Jia-ge,ZHANG Chao,WANG Quan,HOU Xiao-xu. EMC Document Requirement for Medical Electrical Equipment[J]. Chinese medical equipment, 2013, 0(11): 88-90 |
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| Authors: | SU Zong-wen LI Jia-ge ZHANG Chao WANG Quan HOU Xiao-xu |
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| Affiliation: | Institute for Medical Devices Control, National Institutes for Food and Drug Control, Beijing 100050, China |
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| Abstract: | According to the rigorous and explicit EMC （Electro Magnetic Compatibility） requirements from YY 0505-2012 standard random document, this paper gives out the manual writing ideas, offers some instructions about Writing random document for manufacturers, and helps hospitals to learn about related standard clauses, so as to keep the use safe of medical electrical equipment. |
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| Keywords: | medical electrical equipment electromagnetic compatibility standard electromagnetic radiation electromagnetic interference medical equipment safety |
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