标准编号：ISO 14708-6:2010
中文名称：外科植入物 有源植入性医疗器械 第6部分：治疗快速心律失常的有源植入性医疗器械的特殊要求（包括植入性心脏除颤器）
英文名称：Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
发布日期：2010-03
标准范围
This part of ISO 14708 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTERDEFIBRILLATORS 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 toshow compliance.This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (seeNote 1).The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriatemethod detailed in this part of ISO 14708 or by any other method demonstrated to have accuracy equal to, orbetter than, the method specified. In the case of dispute, the method detailed in this part of ISO 14708 shallapply.Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered byISO 14708-2.
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