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现行 AAMI 14117:2019
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Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices 有源植入式医疗设备.电磁兼容性.植入式心脏起搏器 植入式心脏复律除颤器和心脏再同步设备的EMC测试协议
发布日期: 2019-09-27
规定了评估有源植入式心血管设备电磁兼容性的综合测试方法。本标准涉及的设备包括为心动过缓、心动过速和心脏再同步提供一种或多种治疗的设备。本文件详细介绍了适用于相关干扰频率的测试方法。它规定了性能限制或要求披露EM发射器存在时的性能,如有指示。
Specifies a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable cardiovascular devices. The devices addressed by this standard include those that provide one or more therapies for bradycardia, tachycardia, and cardiac resynchronization. This document details test methods appropriate for the interference frequencies at issue. It specifies performance limits or requires disclosure of performance in the presence of EM emitters, where indicated.
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相似标准/计划/法规
现行
ISO 14117-2019
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
活动植入式医疗器械 - 电磁兼容性 - 可植入心脏起搏器的Emc测试方案 植入式心律转复除颤器和心脏再同步装置
2019-09-03
现行
BS ISO 14117-2019
Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
主动植入式医疗设备 电磁兼容性 用于植入式心脏起搏器、植入式心脏复律除颤器和心脏再同步装置的EMC测试协议
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YY/T 1874-2023
有源植入式医疗器械 电磁兼容 植入式心脏起搏器、植入式心律转复除颤器和心脏再同步器械的电磁兼容测试细则
Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers,implantable cardioverter defibrillators and cardiac resynchronization devices
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UNE-EN 50527-1-2011
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices -- Part 1: General
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BS EN 50527-2-2-2018
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices-Specific assessment for workers with cardioverter defibrillators (ICDs)
佩戴有源植入式医疗设备的工人暴露于电磁场的评估程序 对使用心脏复律除颤器(ICD)的工人的具体评估
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Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 1: General; German version EN 50527-1:2010
携带有源植入式医疗器械的工人暴露于电磁场的评估程序第1部分:总则;德文版EN 50527-1:2010
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ETSI TR 101 981
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电磁兼容性和无线电频谱管理(ERM);频率范围为30 MHz至37.5 MHz的无线电设备 用于超低功率有源医用薄膜植入物和附件;第1部分:技术特性和试验方法
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电磁兼容性和无线电频谱问题;短程设备;用于在403.5 MHz至403.8 MHz范围内工作、占空比小于或等于0.01%的超低功率有源医用植入物通话前收听的替代干扰缓解技术;系统参考文件
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2019-11-01