Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads
NORM herausgegeben am 29.7.2014
Bezeichnung normen: ISO 5841-2:2014-ed.3.0
Ausgabedatum normen: 29.7.2014
Zahl der Seiten: 26
Gewicht ca.: 78 g (0.17 Pfund)
Land: Internationale technische Norm
Kategorie: Technische Normen ISO
Description / Abstract: 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.