标准编号：ISO 14708-2:2005
中文名称：外科移植物 有源可植入医疗装置 第2部分：心脏起搏器
英文名称：Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
发布日期：2005-10
标准范围
This Part 2 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treatbradyarrhythmias.The tests that are specified in ISO 14708 are type tests, and are to be carried out on samples of a device to showcompliance.This Part 2 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 appropriatemethod detailed in this Part 2 or by any other method demonstrated to have an accuracy equal to, or better than, themethod specified. In the case of dispute, the method detailed in this Part 2 shall apply.Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by another ISOdocument under development.
立即下载标准文件