IEC TS 60601-4-2:2024 医用电气设备.第4-2部分:指南和解释.电磁抗扰度:医用电气设备和医用电气系统的性能

标准编号:IEC TS 60601-4-2:2024

中文名称:医用电气设备.第4-2部分:指南和解释.电磁抗扰度:医用电气设备和医用电气系统的性能

英文名称:Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

发布日期:2024-03-20

标准范围

IEC TS 60601-4-2:20 24适用于存在EM干扰的医疗电气设备或医疗电气系统的性能。以下,将医用电气设备或医用电气系统分别称为ME设备或ME系统。本文件的目的是为在存在电磁干扰的情况下评估ME设备或ME系统的性能提供指导。IEC TS 60601-4-2:20 24取消并取代2016年发布的第一版IEC TR 60601-4-2。本版构成技术修订版。本版本包括以下与IEC TR 60601-4-2:20 16相关的重大技术变更:a)符合IEC 60601-1-2:20 14和IEC 60601-1-2:20 4/AMD1:2020,b)更新的参考文献,c)将传导干扰电缆长度排除(表6)从3 m更改为1 m,并增加了IEC 61000-4-6:20 13附录B的引用。

IEC TS 60601-4-2:2024 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of EM DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM, respectively.
The object of this document is to provide guidance on the assessment of the performance of ME EQUIPMENT or an ME SYSTEM in the presence of EM DISTURBANCES.
IEC TS 60601-4-2:2024 cancels and replaces the first edition of IEC TR 60601-4-2 published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC TR 60601-4-2:2016:
a) aligned with IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020,
b) updated references,
c) changed conducted disturbance cable length exclusion (Table 6) from 3 m to 1 m and added a citation of IEC 61000-4-6:2013, Annex B.

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