红外额温计电磁兼容试验方法分析及整改措施探讨

Analysis and corrective measures of electromagnetic compatibility test method for infrared forehead thermometer

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.