ISO 5841-2:2014-手术植入物 - 心脏起搏器 - 第2部分:报告脉冲发生器或引线人群的临床表现-国家数字标准馆

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Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads 手术植入物 - 心脏起搏器 - 第2部分:报告脉冲发生器或引线人群的临床表现

发布日期： 2014-07-29

ISO 5841-2:2014规定了用于长期植入的心脏脉冲发生器或导线（以下简称装置）人群样本的临床性能报告要求。它包括所有报告的一般要求和器械累积经验报告的补充要求，以及器械未来临床性能评估（如适用）。

ISO 5841-2:2014 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, 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.