标准编号：ISO 14708-2:2012
中文名称：外科植入物 有源植入性医疗器械 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：2012-08
标准范围
This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias.The tests that are specified in this part of ISO 14708 are type tests, and are to be carried out on samples of a device to show compliance.This part of ISO 14708 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 may 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 part of ISO 14708, terms printed in SMALL CAPITAL LETTERS are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
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