Abstract：Objective To analyze the clinical risks of cochlear implant systems, and study the corresponding safety and effectiveness
evaluation methods of electromagnetic compatibility immunity. Methods Combined with the operating principle of cochlear implant
system, the risk analysis was conducted around the operating mode, testing arrangement, testing procedure and judgment criteria,
and the key points of electromagnetic compatibility immunity evaluation for cochlear implant systems were summarized, as well
as the difficult points of the experiment were evaluated. Results General standards YY 0505-2012 and YY 9706.102-2021 set out
requirements and methods for electrostatic discharge and radiation immunity test of non-implantable parts of cochlear implant systems,
while YY 0989.7-2017 set higher requirements for electromagnetic compatibility of implant systems. On the basis of electrostatic
discharge and non-ionizing electromagnetic radiation tests on the implant system, it was suggested to add static magnetic field tests to
the implant to further ensure the safety and effectiveness of the cochlear implant system in the complex electromagnetic environment.
Conclusion This paper focuses on the electromagnetic compatibility immunity test method of cochlear implant system based on
risk analysis, and analyzes the increasingly complex electromagnetic environment, which can provide suggestions for supervision.
刘美丽，张淑溢，朱成科，刘萌，杨姝，李庆雨. 人工耳蜗植入系统的电磁兼容试验方法研究[J]. 中国医疗设备, 2023, 38(11): 27-32.
LIU Meili, ZHANG Shuyi, ZHU Chengke, LIU Meng, YANG Shu, LI Qingyu. Research on Electromagnetic Compatibility Test Method of Cochlear Implant System. China Medical Devices, 2023, 38(11): 27-32.
