Active implantable medical devices-Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
主动植入式医疗设备

2010-01-31

Active implantable medical devices-Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
主动植入式医疗设备

2004-01-20

Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
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）

2019-09-03

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
Implants for surgery—Active implantable medical devices—Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

2016-01-26

Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
有源植入式医疗器械第2-2部分:用于治疗快速心律失常的有源植入式医疗器械（包括植入式除颤器）的特殊要求

2008-11-05

Active implantable medical devices-Particular requirements for cochlear and auditory brainstem implant systems
主动植入式医疗设备

2010-03-31

Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
有源植入式医疗器械第2-1部分:用于治疗缓慢性心律失常的有源植入式医疗器械（心脏起搏器）的特殊要求

2005-07-20

手术植入物　有源植入式医疗器械　第7部分：人工耳蜗植入系统的专用要求
Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems

2017-07-17

Имплантаты для хирургии. Активные имплантируемые медицинские изделия. Часть 7. Частные требования к системам кохлеарной имплантации
手术植入物 主动植入医疗器械 第7部分人工耳蜗系统的特殊要求

BS ISO 14708-6. Implants for surgery. Active implantable medical devices. Part 6. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BS ISO 14708-6 外科植入物 主动植入式医疗设备 第六部分 用于治疗快速心律失常的有源植入式医疗设备（包括植入式除颤器）的详细要求

2008-12-02

Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
外科植入物.有源植入医疗器械.第7部分:耳蜗和听觉脑干植入系统的特殊要求

2019-12-20

Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
有源植入式医疗器械第2-3部分:耳蜗和听觉脑干植入系统的特殊要求

2010-07-21

Draft Document - Implants for surgery - Active implantable medical devices - Part 5: Particular requirements for circulatory support systems (ISO/CDV2 14708-5:2006)
文件草稿外科植入物主动植入医疗器械第5部分:循环支持系统的特殊要求

2007-09-01

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer; German version EN 45502-1:2015
外科植入物.主动植入式医疗器械.第1部分:制造商提供的安全、标记和信息的一般要求；德文版EN 45502-1:2015

2016-02-01

Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
关于理事会指令90/385/EEC和93/42/EEC中规定的有关主动植入式医疗器械和使用动物源性组织制造的医疗器械的特殊要求的2012年8月8日第722/2012号委员会法规（EU）

2012-08-08

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

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 2 : Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive (Endorsement of the English version EN 302510-2 V1.1.1 (2007-07) as German standard)
电磁兼容性和无线电频谱管理（ERM）.短程设备（SRD）.超低功率有源医用薄膜植入物和附件用30MHz至37.5MHz频率范围内的无线电设备.第2部分:包括R

2007-11-01

Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (Endorsement of the English version EN 302 195 V2.1.1 (2016-06) as German standard)
短程设备（SRD）.在9 kHz至315 kHz频率范围内工作的超低功率有源医用植入物（ULP-AMI）和附件（ULP-AMI-P）.包括指令2014/53/EU第3.2条基本要求的协调标准（英文版EN 302的认可

2016-11-01

Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483.5 MHz to 2 500 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (Endorsement of the English version EN 301 559 V2.1.1 (2016-10) as German standard)
短程设备（SRD）.在2 483.5 MHz至2 500 MHz频率范围内运行的低功率有源医用植入物（LP-AMI）和相关外围设备（LP-AMI-P）.包括指令2014/53/EU第3.2条基本要求的协调标准（英文版本的认可）

2017-01-01

Short Range Devices (SRD) - Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37.5 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (Endorsement of the English version EN 302 510 V2.1.1 (2017-01) as German standard)
短程设备（SRD）.在30 MHz至37.5 MHz频率范围内运行的超低功率有源医用薄膜植入物（ULP-AMI-M）和外围设备（ULP-AMI-M-P）.包括指令2014/53/EU第3.2条基本要求的协调标准

2017-05-01