IEC TS 60601-4-2:2024解析及相关标准的差异性分析  

Analysis of IEC TS 60601-4-2:2024 and Comparative Study with Relevant Standards

作　　者：蒋文硕 孙美秋 崔强[1] Jiang Wenshuo;Sun Meiqiu;Cui Qiang

机构地区：[1]中国电子技术标准化研究院

出　　处：《安全与电磁兼容》2025年第2期86-93,共8页Safety & EMC

摘　　要：随着医疗技术的不断发展,医用电气设备在医疗实践中的应用越来越广泛。电磁兼容性成为保证医用电气设备安全可靠运行的重要因素,国内外制定了一系列标准,对医用电气设备的设计、制造和试验提出了要求。文章主要对IEC TS 60601-4-2:2024进行解析,并与YY 9706.102-2021和IEC 60601-1-2:2020进行了比较分析,探讨其异同点和适用范围,为医用电气设备和系统的研发、试验和监管提供参考。With the continuous advancement of medical technology,medical electrical equipment is being increasingly utilized in clinical practice.Electromagnetic compatibility(EMC)has become a critical factor in ensuring the safe and reliable operation of such equipment,prompting the establishment of a series of standards that impose requirements on the design,manufacturing,and testing of medical electrical devices.This article provides an in-depth analysis of IEC TS 60601-4-2:2024 and conducts a comparative study with YY 9706.102-2021 and IEC 60601-1-2:2020,exploring their similarities,differences,and applicable scopes.The findings aim to offer valuable insights for the development,testing,and regulatory oversight of medical electrical equipment and systems.

关 键 词：电磁兼容 医用电气设备 医用电气系统 差异性分析 

分 类 号：TM7[电气工程—电力系统及自动化]