标准编号：ISO 5841-2:2014
中文名称：外科植入物 心脏起搏器 第2部分：对脉搏发生器或导线的居民临床实践报告
英文名称：Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads
发布日期：2014-08
标准范围
This part of ISO 5841 specifies requirements for reports on the clinical performance in humans ofpopulation samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafterreferred to as devices. Devices to be reported has to be market approved in one or more geographies. Itincludes general requirements for all reports and supplementary requirements for reports on cumulativeexperience with devices and estimates of future clinical performance for devices, when appropriate.Annex A provides requirements for categorizing devices. It also provides normative requirementsfor statistical calculations, including a discussion of application of the results obtained. As with otherstatistical methods, the benefit of the analytical methods in this part of ISO 5841 is limited by the size ofpopulation under consideration. Annex B gives the rationale for this part of ISO 5841.
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