标准摘要
[中文适用范围]： 本文件规定了评估有源植入式心血管设备电磁兼容性 (EMC) 的测试方法，这些设备与经静脉导线系统结合提供一种或多种治疗心动过缓、心动过速和心脏再同步的方法。 注：本文件专为与心内膜导联或心外膜导联一起使用的脉冲发生器而设计。 在出版此版本时，作者认识到不使用心内膜导联或心外膜导联的技术的出现，需要对此部分进行调整。 此类调整由采用这些技术的制造商自行决定。 它规定了这些设备的性能限制，这些设备会受到与在以下两个范围内的电磁频谱上运行的电磁发射器的相互作用的影响： ——0 Hz ≤ f < 385 MHz； ——385 MHz ≤ f ≤ 3000 MHz 本文件还规定了保护这些设备免受治疗环境中遇到的电磁场影响的要求，并定义了其所需的随附文档，为电磁发射器制造商提供有关其预期抗扰度水平的信息。 [外文原描述]： 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.
英文名称Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices