BS ISO 5841-2-2001 外科植入物.心脏起搏器.对使用脉冲发生器或导线的人群的临床使用报告

标准号：BS ISO 5841-2-2001
中文标准名称：外科植入物.心脏起搏器.对使用脉冲发生器或导线的人群的临床使用报告
英文标准名称：Implants for surgery - Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads
标准类型：C45
发布日期：2001/2/15 12:00:00
实施日期：2001/2/15 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.40
适用范围：This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of pulse generators or leads, intended for long-term implantation as cardiac pacemakers, hereinafter referred to as devices. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate. Annex A provides requirements for categorizing devices. Annex B provides guidelines for statistics, including a discussion of application of the results obtained. As with other statistical methods, the benefit of the analytical methods in this part of ISO 5841 is limited by the size of population under consideration. Annex C gives the rationale for this part of ISO 5841.