ISO 14708-2:2005 外科移植物 有源可植入医疗装置 第2部分：心脏起搏器

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

ISO 14708-2:2005规定了适用于治疗缓慢性心律失常的主动植入式医疗设备（心脏起搏器）的要求。ISO 14708-2:2005中规定的试验为型式试验，应在装置样品上进行，以证明符合要求。ISO 14708-2:2005也适用于设备的一些非植入零件和附件。通常被称为有源植入式医疗设备的设备实际上可以是单个设备、设备的组合，或者一个或多个设备和一个或多个附件的组合。并非所有这些零件都要求部分或完全可植入，但如果非植入零件和附件可能影响可植入设备的安全或性能，则需要规定其某些要求。植入式脉冲发生器或导线的特性由ISO 14708中详述的适当方法确定-2:2005或任何其他方法证明其精度等于或优于规定的方法。如有争议，ISO 14708-2:2005中详述的方法适用。

ISO 14708-2:2005 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias (cardiac pacemakers).The tests that are specified in ISO 14708-2:2005 are type tests, and are to be carried out on samples of a device to show compliance.ISO 14708-2:2005 is also applicable to some non-implantable parts and accessories of the devices. 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.The characteristics of the implantable pulse generator or lead are to be determined by either the appropriate method detailed in ISO 14708-2:2005 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in ISO 14708-2:2005 is applicable.

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