本文件规定了评估与经静脉电极导线系统联合提供一种或多种心动过缓、心动过速和心脏再同步治疗的有源植入式心血管器械电磁兼容性（EMC）的测试方法。 注:本文件设计用于与心内膜电极导线或心外膜电极导线一起使用的脉冲发生器。在本版出版时，作者认识到不使用心内膜电极导线或心外膜电极导线的技术的出现需要对本部分进行调整。这种调整由结合这些技术的制造商自行决定。 它规定了这些器件的性能极限，这些器件与在以下两个范围内工作的EM光谱中的EM发射器相互作用:-0 Hz≤？<385MHz； -385z≤？≤3000 Z 本文件还规定了保护这些设备免受治疗环境中遇到的EM场影响的要求，并定义了其所需的随附文件，为EM发射器制造商提供了有关其预期抗扰度水平的信息。

This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems. NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges: — 0 Hz ≤ ? < 385 MHz; — 385 MHz ≤ ? ≤ 3 000 MHz This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.