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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
发布日期: 2023-03-14
实施日期: 2024-05-01
本文件规定了用于评价可与经静脉电极导线系统一起提供一种或多种心动过缓、心动过速和心脏再同步等治疗的有源植入式心血管器械的电磁兼容(EMC)试验方法。本文件规定了此类器械与可运行于下列两个EM频谱范围内的EM发射器发生相互作用时的性能界限:0 Hz ≤ f < 385 MHz;385 MHz ≤ f ≤ 3000 MHz。本文件还规定了保护此类器械免受医疗环境EM场影响的要求,定义了所需的随附文件,并提供了关于EM发射器制造商与预期的抗扰度等级信息。本文件适用于可与经静脉电极导线系统一起提供一种或多种心动过缓、心动过速和心脏再同步等治疗的有源植入式心血管器械
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相似标准/计划/法规
现行
AAMI/ISO 14117-2019
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
2019-09-27
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
2019-09-04
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
AAMI 14117-2019
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
2019-09-27
现行
ETSI TR 102 309
Electromagnetic compatibility and Radio spectrum Matters (ERM); Ultra Low Power Active Medical Implants (ULP-AMI); "Membrane Implant" devices operating in the 30 MHz to 37,5 MHz band; System Reference Document
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2004-05-01
现行
ETSI EN 301 489-27
ElectroMagnetic Compatibility (EMC) standard for radio equipment & services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) & related peripheral devices (ULP-AMI-P); Covering the essential requirements of article 3.1(b) Directive 2014/53/EU
无线电设备和服务的电磁兼容性(EMC)标准;第27部分:超低功率有源医用植入物(ULP-AMI)及相关外围设备(ULP-AMI-P)的特定条件;涵盖2014/53/EU指令第3.1(b)条的基本要求
2019-04-01
现行
ETSI TR 102 655
Electromagnetic compatibility and Radio spectrum Matters (ERM); System reference document; Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in a 20 MHz band within 2 360 MHz to 3 400 MHz
电磁兼容性和无线电频谱管理(ERM);系统参考文件;短程设备(SRD);低功率有源医用植入物(LP-AMI) 在2 360 MHz至3 400 MHz的20 MHz频段内工作
2008-11-01
现行
ETSI TR 101 981
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); System Reference Document for inductive Loop - Ultra Low Power Active Medical Implants (ULP- AMI) - systems operating in the frequency bands 9 kHz to 315 kHz
电磁兼容性和无线电频谱管理(ERM);短程设备(SRD);感应回路系统参考文件.超低功率有源医用植入物(ULP-AMI).在9 kHz至315 kHz频带内运行的系统
2002-04-01
现行
ETSI EN 301 559-1
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 1: Technical characteristics and test methods
电磁兼容性和无线电频谱管理(ERM);短程设备(SRD);低功率有源医用植入物(LP-AMI) 工作频率范围为2483.5MHz至2500 MHz;第1部分:技术特性和试验方法
2012-06-01
现行
ETSI TR 102 434
Electromagnetic compatibility & Radio spectrum Matters; Short Range Devices; Alternative Interference Mitigation Technologies to Listen Before Talk for Ultra Low Power Active Medical Implants operating from 403,5 MHz to 403,8 MHz with a duty cycle of less than or equal to 0,01%; System Reference Doc
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
2005-06-01
现行
ETSI EN 301 559-2
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
电磁兼容性和无线电频谱管理(ERM);短程设备(SRD);低功率有源医用植入物(LP-AMI) 工作频率范围为2483.5MHz至2500 MHz;第2部分:涵盖R&TTE指令第3.2条基本要求的协调欧洲标准
2012-06-01
现行
DIN EN 302510-1
Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Radio equipment in the frequency range 30 MHz to 37.5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories - Part 1: Technical characteristics and test methods (Endorsement of the English version EN 302510-1 V1.1.1 (2007-07) as German standard)
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2007-11-01
现行
DIN EN 302510-2
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