He Weigang, Gao Zhong, Zhang Weiqiang
Center for Medical Device Evaluation, CFDA, Beijing, 100081.
Shanghai Testing and Inspection Institute for Medical Devices, Shanghai, 201318.
Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Sep 30;42(5):372-374. doi: 10.3969/j.issn.1671-7104.2018.05.017.
In this paper,standards for active implantable cardiac medical devices are discussed.Potential EMC risks and its correspondent tests settings as well as the design principle of the tests have been analyzed.The problems arises from the difference between domestic and international standards on the limitation of exposure of the general public to electromagnetic fields and the lack of assessment of EMC risk which generated by the the 5th generation mobile communication for the impact on the active implantable devices devices.
本文讨论了有源植入式心脏医疗器械的标准。分析了潜在的电磁兼容性（EMC）风险及其相应的测试设置以及测试的设计原则。由于国内和国际关于公众暴露于电磁场限值的标准存在差异，以及缺乏对第五代移动通信对有源植入式设备产生的电磁兼容性风险影响的评估，从而产生了一些问题。
