本文件规定了适用于植入式心律转复除颤器和CRT-D的要求以及旨在治疗快速性心律失常的有源植入式医疗器械的功能。 ISO 14708中规定的试验是型式试验，将在器械样品上进行，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快速性心律失常脉冲发生器。在本版出版时，作者认识到不使用心内膜或心外膜电极导线的技术的出现，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）。植入式脉冲发生器或电极导线的特性应通过本文件中详述的适当方法或经证明准确度等于或优于规定方法的任何其他方法来确定。如有争议，应适用本文件中详述的方法。 ISO 14708-2涵盖了旨在治疗缓慢性心律失常或心脏再同步的有源植入式医疗器械的任何方面。 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要求部分或完全可植入，但需要指定非-可植入部件和附件，如果它们可能影响可植入器械的安全性或性能。 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 implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads 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 characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply. Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2. 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.