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手术植入物 有源植入式医疗器械 第1部分：安全、标记和制造商提供的信息的通用要求

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

耳蜗植入系统：安全性、功能验证、标识及可靠性报告要求

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

手术植入物 有源植入式医疗器械 第3部分：植入式神经刺激器

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

有源植入式医疗器械 制造商提供的安全、标记和信息的一般要求

General requirements for safety, labeling and information provided by manufacturers of active implantable medical devices

给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Implants for surgery - Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer

用于手术的植入物 有源植入式医疗美利体育官网首页网址 安全、标记和制造商提供的信息的一般要求

Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer

有源可植入医疗器械.耳蜗和听觉脑干植入系统的详细要求

Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems

EN ISO 9002 在医疗器械制造中的应用规范

Specification for Application of EN ISO 9002 to the manufacture of medical devices

活性可植入医疗装置.第1部分:安全性、标识和由制造商提供的信息的一般要求

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer; German version EN 45502-1:1997

活性可植入的医疗装置.第2-1部分:用于治疗缓慢性心率失常的活性可植入医疗装置(心脏起搏器)的特殊要求

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers); German version EN 45502-2-1:2003

医用电气美利体育官网首页网址.第1部分:基本安全和基本性能的一般要求 包含修改件A12,2014

Medical Electrical Equipment Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment

外科植入物. 有源可植入医疗器械. 第1部分. 安全, 标记和制造商信息的通用要求

Implants for surgery. Active implantable medical devices. Part 1. General requirements for safety, marking and information to be provided by the manufacturer

医用电气美利体育官网首页网址第2-31部分:带内部电源的体外心脏起搏器基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

铁路环境中电子和电气美利体育官网首页网址产生的与人体暴露有关的磁场水平.测量程序

Magnetic field levels generated by electronic and electrical apparatus in the railway environment with respect to human exposure - Measurement procedures

外科植入物.有源可植入医疗装置.第2部分:心脏起搏器

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

外科植入物.有源可植入医疗装置.第5部分:循环支撑装置

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices

患者带有有源植入性医疗器械用核磁共振成像的安全性评定

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

Chirurginiai implantai. Aktyvieji implantuojamieji medicinos ?taisai. 1 dalis. Bendrieji reikalavimai, keliami saugai, ?enklinimui ir gamintojo pateikiamai informacijai

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

有源植入式医疗器械 第2-1部分：用于治疗心动过缓的有源植入式医疗器械的特殊要求（心脏起搏器）

Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

有源植入性医疗器械 第2-2部分：用于心动过速治疗的有源植入性医疗器械（包括植入式除颤器）的特定要求

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2-3部分 耳蜗和脑干听觉植入系统所适用特殊要求

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

由唯一美利体育官网首页网址标识（UDI）实现的医疗美利体育官网首页网址可追溯性

Medical device traceability enabled by unique device identification (UDI)

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers); German version EN 45502-2-1:2003

Aktive implantierbare medizinische Geraete - Teil 2-1: Besondere Festlegungen fuer aktive implantierbare medizinische Geraete zur Behandlung von Bradyarrhythmie (Herzschrittmacher); Deutsche Fassung EN 45502-2-1:2003

外科植入物 有源植入式医疗器械 第1部分：安全标记和制造商提供的信息的一般要求

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

有源植入式医疗器械 第2-3部分：人工耳蜗和听觉脑干植入系统的特殊要求

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems; German version EN 45502-2-3:2010

手术植入物 有源植入式医疗器械 第3部分：植入式神经刺激器

Implants for surgery —— Active implantable medical devices —— Part 3: lmplantable neurostimulators