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| 浅析医用电气设备外部标识的要求 | |
| 引用本文： | 李佳戈,苏宗文,张艳丽. 浅析医用电气设备外部标识的要求[J]. 中国医疗设备, 2014, 0(7): 70-72 |
| 作者姓名： | 李佳戈 苏宗文 张艳丽 |
| 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 |
| 基金项目： | 国家科技支撑计划课题（2012BAI22B04）。 |
| 摘 要： | 医用电气设备的通用安全标准为GB 9706.1-2007，该标准中的6.1设备以及其部件的外部标记是日常检验不合格比较集中的项目之一。文章针对此问题进行分析，提出整改建议，以期避免此类问题的发生。 |
| 关 键 词： | 医用电气设备 外部标识 安全标准 |
Analysis on Requirements of External Identiifers of Medical Electrical Equipment |
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| LI Jia-ge,Su Zong-wen,Zhang Yan-li. Analysis on Requirements of External Identiifers of Medical Electrical Equipment[J]. Chinese medical equipment, 2014, 0(7): 70-72 | |
| Authors: | LI Jia-ge Su Zong-wen Zhang Yan-li |
| Affiliation: | (Institute for Medical Devices Testing, National Institutes for Food and Drug Control, Beijing 100050, China) |
| Abstract: | GB 9706.1-2007 is the general safety standards of medical electrical equipment. The equipments with the external identiifers in section 6.1 of the standards are the most common unqualiifed items in daily inspection. This paper analyses the above problems and puts forward rectification suggestions to avoid the happen of such problems. |
| Keywords: | medical electrical equipment external identiifers safety standards |
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