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作 者:朱明健 杨姝 张敏 王美 刘萌 李庆雨 ZHU Ming-jian;YANG Shu;ZHANG Min;WANG Mei;LIU Meng;LI Qing-yu(Department of Electromagnetic Compatibility,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Ji'nan 250101,China)
机构地区:[1]山东省医疗器械和药品包装检验研究院电磁兼容室,济南250101
出 处:《医疗卫生装备》2022年第12期85-87,共3页Chinese Medical Equipment Journal
基 金:山东省医疗器械和药品包装检验研究院内部科研项目(ZX202102)。
摘 要:介绍了红外额温计风险监测时电磁兼容试验的检验依据、试验项目和试验结果,分析了红外额温计电磁兼容不符合项产生的原因,结合日常注册检验对不符合项提出了相应的整改建议,为额温计制造商提供了技术参考,并为该类医疗器械的监管提供了依据。The test basis, items and results of electromagnetic compatibility(EMC) test in the infrared forehead thermometer risk monitoring were introduced. The causes for unqualified items during EMC test of the infrared forehead thermometer were analyzed. Some corrective measures for unqualified items were put forward combined with daily registration inspection.References were provided for infrared forehead thermometer manufacturers and the supervision of this kind of medical devices.
分 类 号:R318.6[医药卫生—生物医学工程] R443.8[医药卫生—基础医学]
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