本文件规定了适用于治疗缓慢性心律失常的有源植入式医疗器械和提供心脏再同步治疗的器械的要求。 本文件中规定的试验为型式试验，应在器械样品上进行，以显示符合性。 本文件设计用于与心内膜电极导线或心外膜电极导线一起使用的缓慢性心律失常脉冲发生器。在本版出版时，作者认识到无引线技术的出现，需要对这一部分进行调整。这种调整由结合这些技术的制造商自行决定。 本文件也适用于器械的某些非植入部件和附件（参见注释1）。 可植入脉冲发生器或电极导线的电特性可以通过本特定标准中详述的适当方法或通过任何其他被证明具有准确度等于或优于指定方法。如有争议，适用本特定标准中详述的方法。 ISO 14708-6涵盖了旨在治疗快速性心律失常的有源植入式医疗器械的任何特征。 注1:通常称为有源植入式医疗器械的器械实际上可以是单个器械、器械的组合、或者一个或多个器械与一个或多个附件的组合。并非所有这些部件都需要部分或完全可植入，但如果非可植入部件和附件可能影响可植入器械的安全性或性能，则需要规定非可植入部件和附件的一些要求。 注2在本文件中，斜体印刷的术语按照第3条中的定义使用。当一个定义的术语在另一个术语中用作限定词时，它不以斜体打印，除非这样限定的概念也被定义。

This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance. This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies. Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6. NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.