医疗设备静放电测试整改案例研究

Research on the Rectification Case of Electrostatic Discharge Testing of Medical Equipment

近年来,为了响应国家在医疗设备上自主创新的大力号召,涌现了一大批国产自主研发的医疗设备。然而,医疗设备的电磁兼容(EMC)设计、测试环境变得越来越复杂,医疗设备在研发过程中不可避免地产生了一系列问题。在我国医疗设备生产后要进行认证批准,才能允许销售使用。在进行认证时,根据标准YY 9706.102—2021的要求需要进行抗扰度项目测试,而静电放电(ESD)测试是其中一项重要的测试项目,其会对医疗设备的正常使用产生最直接的影响。故针对医疗设备在ESD测试时出现的故障进行了理论分析和相应的整改,整改后设备顺利通过了ESD测试,从而验证了所提供对策的可行性和实用性。

In recent years,in response to the country’s strong call for independent innovation in medical equipment,a large number of domestic independently developed medical equipment have emerged.However,the electromagnetic compatibility(EMC)design and testing environment of medical devices have become increasingly complex,and a series of problems inevitably arise during the development process of medical devices.After the production of medical equipment in China,certification and approval are required before it can be allowed for sale and use.When conducting certification,according to the requirement of YY 9706.102—2021,immunity testing is required,and electrostatic discharge(ESD)testing is one of the important testing items,it will have the most direct impact on the normal use of medical equipment.Therefore,the theoretical analysis and corresponding rectification are carried out for the faults of medical equipment in ESD test.After rectification,the equipment successfully passed ESD testing,thereby verifying the feasibility and practicality of the provided countermeasures.