标准号：ISO 5841-2-2000
实施状态：作废
中文名称：外科植入物.心脏起搏器.第2部分:脉冲发生器或导线的临床性能报告
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：2000-10-01
被替代标准：ISO 5841-2-2014
代替标准：ISO 5841-2-1986;ISO/FDIS 5841-2-2000
采用标准：BS ISO 5841-2-2001,IDT;CAN/CSA-ISO 5841-2-2001,IDT
起草单位：ISO/TC 150
标准简介：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.
文件格式：PDF
文件大小：423.37KB
文件页数：26
（以上信息更新时间为：2019-11-23）
ISO 5841-2-2000 外科植入物.心脏起搏器.第2部分_脉冲发生器或导线的临床性能报告.pdf
(423.37 KB)
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