共找到 150 条与 pacemaker 相关的标准，共 10 页
本标准涵盖起搏器紧急干预系统（EIS）的标签和性能要求。EIS旨在用于医院和诊所的急诊室，允许将符合标准的植入式缓慢性心脏起搏器转换为标准高输出模式（例如VVI、VOO），当检查者认为起搏器以非标准方式运行或以检查者不理解的方式运行时。EIS由符合标准的缓慢性起搏器和环形磁铁组件组成，该组件能够启动起搏器内的电路，从而将功能更改为简单的标准运行模式。符合标准的起搏器是指设计用于满足本标准性能要求的起搏器，无论其具有其他任何功能或能力。由于EIS使用永久磁场作为致动介质，因此不需要外部电源或电池，因此是无源的。
Pacemaker emergency intervention system
Cardiac pacemakers; part 1: implantable pacemakers
This standard sets forth a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable cardiovascular devices (pacemakers and implantable cardioverter defibrillators, or ICDs). The standard details test methods appropriate for the interference frequencies at issue. It specifies performance limits or requires disclosure of performance in the presence of EM emitters, where indicated. In addition, it provides manufacturers of EM emitters with information about the level of immunity to be expected from active implantable cardiovascular devices. This standard addresses the interaction of pacemakers and ICDs with EM emitters operating across the EM spectrum. It divides the EM frequency spectrum into three discrete segments: 0 Hz ≤∫< 450 MHz; 450 MHz ≤ ∫ ≤ 3,000 MHz; and ∫> 3,000 MHz.
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
本标准建立了用于在指定运行条件下获取和/或显示心电图 (ECG) 信号的监护仪、心率计和报警器的最小安全和性能要求。本标准要求涵盖监护仪的所有必要部分，用于：a) 通过患者身体的无创 ECG 感应获取心率指示；b) 放大和传输该信号并显示心率及/或 ECG 波形；c) 基于可调报警标准，在发生以下与心率相关的现象（持续存在）时提供报警：心搏停止、心动过缓和/或心动过速。
本标准适用于心电图（ECG）监测美利体育官网首页网址的基本安全和基本性能。该标准适用于医院环境中的心电图监测美利体育官网首页网址，也适用于在医院环境之外使用的美利体育官网首页网址，例如救护车和航空运输中使用的美利体育官网首页网址。本标准也适用于医院环境中使用的心电遥测系统。 intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their INTENDED USE. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.
Medical electrical equipment - Part 2-27: Particular requirements for basic safety and essential performance of electrocardiogram monitoring equipment
This International Standard 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. It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges: 0 Hz ≤ ? < 450 MHz; 450 MHz ≤ ? ≤ 3000 MHz This International Standard also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
201.1???Scope, object and related standards Clause?1 of the general standard 1 applies, except as follows: 201.1.1???* Scope Replacement: This?part?of?IEC?60601 applies to the basic safety and essential performance of external pacemakers powered by an internal electrical power source , hereafter referred to as me equipment . This document applies to patient cables as defined in 201.3.209, but does not apply to leads as defined in 201.3.206. Hazards inherent in the intended physiological function of me equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document does not apply to the implantable parts of active implantable medical devices covered by ISO?14708?1. This document does not apply to
Medical electrical equipment - Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
该欧洲标准提供了在EN 50527-1:2016，附录A要求的具体评估过程，以确定安装了起搏器的员工可能产生的风险。本标准提供不同的方法来进行风险评估，选择最合适的进行操作。如果工作人员还植入了其他有源植入式医疗美利体育官网首页网址（AIMDs），则需要单独评估。 具体评估的目的是为了确定工人暴露于工作场所电磁场下引起的植入心脏起搏器的风险，包括可能产生临床上显著效应的概率，并考虑到短暂和长期暴露情况。
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers
本文档扩展了基础标准 ISO/IEEE 11073-10101:2004，旨在为心电图（ECG）注释术语提供支持。本词汇表涵盖的主要主题领域包括心电图搏动注释、波形成分注释、节律注释和噪声注释。它还定义了额外的“全局”和“按导联”数值观察标识符、心电图导联系统以及额外的心电图导联标识符。该词汇表扩展可与 IEEE 11073 标准的其他组件（例如 ISO/IEEE 11073-10201:2004）结合使用，也可独立与其他标准结合使用。
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG (ISO/IEEE 11073-10102:2014); English version EN ISO 11073-10102:2014
This standard specifies the particular basic safety requirements and essential performance for electrocardiographic (ECG) monitoring equipment used in a hospital environment.
Medical electrical equipment - Part 2-27: Particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment
本特定标准适用于心电图监测美利体育官网首页网址的基本安全和基本性能，如201.3.63所定义，以下也称为ME美利体育官网首页网址。本特定标准适用于医院环境内以及医院环境外（如救护车和航空运输）使用的ME美利体育官网首页网址。本特定标准也适用于医院环境中使用的心电图遥测系统。本特定标准不适用于家用心电图监测器。制造商应根据其预期用途适当考虑使用本标准的相关条款。动态（“Holter”）监测器、胎儿心率监测、脉搏血氧仪美利体育官网首页网址和其他心电图记录美利体育官网首页网址不在本特定标准的范围内。
Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
本标准提出的符号应能向特定心脏专业医疗保健群体传达预期信息，以便美利体育官网首页网址能够按照其预期用途使用。进行了验证测试，以确定当目标群体首次看到这些符号时，所提出的符号是否成功传达了预期信息。确定从主要心脏医疗保健用户群体收集反馈的最有效方法是通过在2009年5月13日至15日于波士顿举行的HRS（心律学会）大会上进行的调查。调查受访者是从大会与会者中随机选择的，并分为三类之一：医生、护士或行业代表。
Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Endorsed by Asociación Espa?ola de Normalización in May of 2020.)
本文件定义了低功率有源医疗植入物及其外围无线电控制系统对无线电频谱使用的新要求。本文件提出了一种概念，旨在为这些系统建立协调的监管框架，并为免许可安排提供基。詈檬窃诖渭斗峙涞幕∩。本文件包括支持欧洲电信标准化协会（ETSI）与欧洲邮政和电信行政会议（CEPT）电子通信委员会（ECC）之间合作所需的信息，包括：详细的市场信息、详细的技术信息、预期的共享和兼容性问题。
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
本标准扩展了基础标准ISO/IEEE 11073-10101:2004，以提供对ECG注释术语的支持。主要涵盖的主题包括ECG节拍注释、波形成分注释、节律注释和噪声注释。它还定义了额外的“全局”和“每导联”数值观察标识符、ECG导联系统以及额外的ECG导联标识符。这些命名扩展可以与其他IEEE 11073标准组件（如ISO/IEEE 11073-10201:2004）一起使用，或与其他标准独立使用。
Health informatics Point-of-care medical device communication Part 10102: Nomenclature Annotated ECG
