在用医疗器械电磁兼容性评价研究-中国药事.PDFVIP

中国药事 2019年1月 第33卷 第1期 79 ·质量评价· 在用医疗器械电磁兼容性评价研究 杨凯 （四川省医疗器械检测中心有源医疗器械检测室，成都 611731） 摘要 目的： 通过开展在用医用电气设备电磁兼容性评价研究，提升质量监管手段，保障民众用械安 全，促进医疗器械产业健康发展。方法：梳理可操作的电磁兼容现场检测项目，提出根据使用范围、频 次、风险等因素选择检测品种，为保证全面、有效评价研究提出了需要采取的措施。结果与结论：充分 考虑在用医疗器械受到的电磁干扰的影响，尽可能防止出现医疗误诊、报警失灵、意外能量输出等危害 患者或医护人员的情况，探索在用医疗器械电磁兼容性评价研究机制。 关键词：在用医疗器械；电磁干扰；电磁兼容性；现场测试；评价；措施 R197.39 A 1002-7777(2019)01-0079-06 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2019.01.014 Electromagnetic Compatibility Evaluation of In-use Medical Devices Yang Kai (Active Medical Device Testing Office, Sichuan Testing Center of Medical Devices, Chengdu 611731, China) Abstract Objective: To carry out the study on the electromagnetic compatibility evaluation of in-use medical devices in order to improve the means of quality supervision, to ensure the safety of medical equipment and to promote the healthy development of medical device industry. Methods: The operational field test items of electromagnetic compatibility were analyzed, the suggestion that the selection of test varieties should be done according to the scope of use, frequency, risk and other factors was put forward, and the necessary measures to ensure comprehensive and effective evaluation were also proposed. Results and Conclusion: The effects of electromagnetic interference on in- use medical devices were fully analyzed so as to prevent medical misdiagnosis, alarm failure, unexpected energy output and other hazards to patients or medical staffs and to explore the mechanism of electromagnetic compatibility evaluation of in-use medical devices. Keywords: in-use medical devices; electromagnetic interference; electromagnetic compatibility; on-site testing; evaluation; measures 1 引言 患者和医护人员造成危害。因此，加强在用医疗器 [1] 电磁兼容性 （Electromagnetic Comp