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
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
ISO 14117:2019 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
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
ANSI/AAMI PC69-2007 有源可植入的医疗装置.电磁兼容性.可植入心脏起搏器和可植入心律转复除颤器用电磁兼容性(EMC)试验程序
This standard sets forth a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
ISO/IEC TR 20017:2011 信息技术.项目管理的射频识别.植入式起博器和植入式心律转复除颤器的ISO/IEC 18000询问发射器的电磁干扰影响
Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators
ISO 14117:2012 有源可植入医疗装置.电磁兼容性.可植入心脏起搏器,可植入心律转复除颤器和心脏再同步治疗设备用电磁兼容性(EMC)测试协议
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
YY/T 0946-2014 心脏除颤器 植入式心脏除颤器用DF‐1连接器组件 尺寸和试验要求
本标准适用于将植入式心脏除颤电极导线与最大输出不超过1 kV/50 A的植入式心脏除颤脉冲发生器进行连接时使用的DF-1单极连接器组件。本标准规定了组件间配合的基本尺寸、性能要求和相应的试验方法。本标准未规定连接器的其他特性,如紧固方式和材料。本标准适用于连接器组件的外形和适配。本标准不适用于不同的
Cardiac defibrillators.Connector assembly DF-1 for implantable defibrillators.Dimensions and test requirements
KS P ISO 11318-2012(2017 心脏除颤器植入式除颤器用连接器组件DF-1尺寸和试验要求
Cardiac defibrillators－Connector assembly DF-1 for implantable defibrillators－Dimensions and test requirements
BS ISO 14117:2013 有源可植入医疗装置.电磁兼容性.可植入心脏起搏器,可植入复律除颤器和心脏再同步治疗器械用EMC试验协议
Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 11318:2002 心脏除颤器.可植入心脏除颤器联结器系统DF-1.尺寸和试验要求
This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads
Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensional and test requirements
GOST R 57506-2017 医疗器械. 用于治疗快速心律失常的植入式除颤器和其他有源植入式医疗器械. 政府采购技术要求
Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
KS P ISO 11318:2012 心脏除颤器.可植入体内的心脏除颤器联结器系统DF.1.尺寸和试验要求
이 표준은 최대 출력 1 kV/50 A 이하의 이식용 제세동기 전원에 이식 가능한 제세동기
Cardiac defibrillators－Connector assembly DF-1 for implantable defibrillators－Dimensions and test requirements
YY 0989.6-2016 手术植入物 有源植入医疗器械 第6部分：治疗快速性心律失常的有源植入医疗器械（包括植入式除颤器）的专用要求
ISO 14708-6:2019 手术植入物 - 有源植入式医疗器械 - 第6部分:旨在治疗快速性心律失常的有源可植入医疗器械的特殊要求（包括可植入除颤器）
Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
JJF 1149-2006 心脏除颤器和心脏除颤监护仪校准规范
本规范适用于新制造、使用中及修理后的普通心脏除颤器（以下简称除颤器）和心脏除颤监护仪（以下简称除颤监护仪）除颤部分（含除颤过程中除颤部分对心电监护部分的影响）的校准；不适用于自动外部除颤器、体内植入式除颤器的校准，除颤监护仪心电的计量特性及其校准可参照JJG 760-2003 心电监护仪检定
Calibration Specification for Cardiac Defibrillators & Cardiac Defibrillator-monitors
IEC TR3 61288-2:1993 心脏除颤器 心脏除颤监护器 第2部分:维护
Contains guidelines regarding maintenance to be performed by clinical engineering personnel. Does not apply to automatic implantable defibrillators
Cardiac defibrillators; cardiac defibrillators-monitors; part 2: maintenance
IEC TR3 61288-1:1993 心脏除颤器 心脏除颤监护器 第1部分:操作
Contains guidelines regarding the safe and effective operation and maintenance to be performed by medical and nursing personnel. Does not apply
Cardiac defibrillators; cardiac defibrillators-monitors; part 1: operation
DB22/T 1962-2013 心脏除颤器和心脏除颤监护仪质量控制规范
WS/T 603-2018 心脏除颤器安全管理
JJF 1149-2014 心脏除颤器校准规范
本规范适用于手动心脏除颤器和自动体外除颤器(AED)与除颤功能直接相关的计量特性的校准;不适用于植入式除颤器、遥控除颤器的校准
Calibration Specification for Cardiac Defibrillators
EN ISO 14708-6:2022 外科植入物.有源可植入医疗装置.第6部分:用于治疗快速性心律失常(包括可植入去纤颤器)有源植入式医疗器件的特殊要求
This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
ISO 14708-6:2010 外科植入物.有源可植入医疗装置.第6部分:用于治疗快速性心律失常(包括可植入去纤颤器)有源植入式医疗器件的特殊要求
This part of ISO 14708 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 11318:1993 心脏去纤颤器. 可植入体内的心脏去纤颤器联结器系统和试验要求
Cardiac defibrillators; connector assembly for implantable defibrillators; dimensional and test requirements
GOST R ISO 11318-2010 植入式除纤颤器连接器总成 DF-1.技术要求和试验方法
Connector assembly DF-1 for implantable defibrillators. Technical requirements and test methods
BS ISO 11318:2002 心脏去纤颤器.可植入的心脏去纤颤器联结器组件DF-1.尺寸和试验要求
This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads
Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements
CSA CEI-1288-2-98-CAN/CSA-1998 心脏除颤器-心脏除颤器监视器-第2部分:维修.第1版.CEI/IEC 1288-2:1993
Defibrillateurs Cardiaques - Moniteurs-Defibrillateurs Cardiaques - Partie 2: Maintenance Premiere Edition; CEI/IEC 1288-2: 1993
Defibrillateurs Cardiaques - Moniteurs-Defibrillateurs Cardiaques - Partie 2: Maintenance Premiere Edition; CEI/IEC 1288-2: 1993
CSA IEC-1288-1-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第1部分:操作.第1版.CEI/IEC 1288-1:1993
Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993
Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993
CSA IEC-1288-2-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第2部分:维护.第1版.CEI/IEC 1288-2:1993
This International Standard specifies requirements for classification of wire electrodes in the as-welded condition and in the post weld heat-treated
Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 2: Maintenance First Edition; CEI/IEC 1288-2: 1993
ANSI/AAMI/ISO 14117:2012 主动可植入医疗器械.电磁兼容性.移植心脏起搏器,可植入心律转变器和心脏再同步治疗设备的EMC测试协议
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 11318:1993/Amd 1:1996 心脏去纤颤器. 可植入体内的心脏去纤颤器联结器系统和试验要求.修改件1
Cardiac defibrillators - Connector assembly for implantable defibrillators - Dimensional and test requirements; Amendment 1
NF C74-502-2-2*NF EN 45502-2-2:2008 可植入的有源医疗器件 第2-2部分：用于处理心律不齐的有源可植入医疗装置用特殊要求（包括可植入自动减颤器）
Active implantable medical devices - Part 2-2 : particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
编辑：北检院编辑部
