BS ISO 14117:2019-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-国家数字标准馆

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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

发布日期： 2019-09-04

本文件规定了电磁兼容性评估的试验方法
（EMC）为心动过缓提供一种或多种治疗的主动植入式心血管设备，
心动过速和心脏再同步与经静脉导联系统。
注:本文件设计用于心内膜导线或心外膜导线的脉冲发生器。在
在本版出版时，作者认识到出现了不使用心内膜导联或心外膜导联的技术，需要对这一部分进行调整。此类调整由采用这些技术的制造商自行决定。交叉引用:ISO 14708-1:2014BS EN ISO 14708-2:2019ISO 14708-6:2019ISO 14708-2:2019BS EN ISO 14708-6:2019EN 301489-35EN 50527-1ISO/IEC指南51IEEE C95。VDE 0848-3-1EN 301489-1ANSI/AAMI PC69:2000EN 301489中的1:2005EN 45502-2-2EN 50527-2-1ERC建议70-03IEEE标准802.15.6-2012-
27IEEE C95。6:2003EN 50061EN 45502-2-1ANSI/AAMI PC69:2007ANSI C63。5-1988prEN 50527-2-2EN 301489-29EN 301489-31ISO 11318:2002ISO 5841-3:2013ISO 27186:2010购买本文件时可获得的所有当前修订版均包含在购买本文件中。

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.Cross References:ISO 14708-1:2014BS EN ISO 14708-2:2019ISO 14708-6:2019ISO 14708-2:2019BS EN ISO 14708-6:2019EN 301489-35EN 50527-1ISO/IEC Guide 51IEEE C95.1:2005EN 45502-2-2EN 50527-2-1ERC Recommendation 70-03IEEE Std 802.15.6-2012DIN VDE 0848-3-1EN 301489-1ANSI/AAMI PC69:2000EN 301489-27IEEE C95.6:2003EN 50061EN 45502-2-1ANSI/AAMI PC69:2007ANSI C63.5-1988prEN 50527-2-2EN 301489-29EN 301489-31ISO 11318:2002ISO 5841-3:2013ISO 27186:2010All current amendments available at time of purchase are included with the purchase of this document.

分类信息

发布单位或类别：英国-英国标准学会

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相似标准/计划/法规

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

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

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

BS EN 50527-1-2016

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices-General
携带有源植入式医疗设备的工人暴露于电磁场的评估程序

BS EN 50527-2-3-2021

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices-Specific assessment for workers with implantable neurostimulators
携带有源植入式医疗设备的工人暴露于电磁场的评估程序

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
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

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
电磁兼容性和无线电频谱管理（ERM）；超低功耗有源医用植入物（ULP-AMI）；在30兆赫至37.5兆赫频段运行的“膜植入”装置；系统参考文件

BS EN 50527-2-1-2016

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices-Specific assessment for workers with cardiac pacemakers
携带有源植入式医疗设备的工人暴露于电磁场的评估程序

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

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

GOST R 52459.27-2009

Совместимость технических средств электромагнитная. Технические средства радиосвязи. Часть 27. Частные требования к активным медицинским имплантатам крайне малой мощности и связанным с ними периферийным устройствам
技术设备的电磁兼容性无线电通信设备第27部分超低功率有源医疗植入物和相关外围设备的具体要求

VDE 0848-527-1/DIN EN 50527-1

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

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

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

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

ETSI TR 102 343

Electromagnetic compatibility and Radio spectrum Matters (ERM); Ultra Low Power Active Medical Implants (ULP-AMI) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands; System Reference Document
电磁兼容性和无线电频谱管理（ERM）；在401 MHz至402 MHz和405 MHz至406 MHz频段工作的超低功率有源医用植入物（ULP-AMI）；系统参考文件

ETSI EN 302 510-1

Electromagnetic compatibility and Radio spectrum Matters (ERM); 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
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

GOST R 52459.31-2009

Совместимость технических средств электромагнитная. Технические средства радиосвязи. Часть 31. Частные требования к радиооборудованию для активных медицинских имплантатов крайне малой мощности и связанных с ними периферийных устройств, работающему в полосе частот от 9 до 315 кГц
技术设备的电磁兼容性无线电通信设备第31部分超低功率有源医疗植入物和相关外围设备的9 kHz至315 kHz频段设备的具体要求

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

DIN EN 50527-2-2

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs); German version EN 50527-2-2:2018
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2-2部分:使用心脏复律除颤器（ICD）的工人的特殊评估；德文版EN 50527-2-2:2018

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