Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-89079 or installed equipment to measure

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Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-89079 or installed equipment to measure1 Scope This part of ISO 5841 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. Devices to be reported has to be market approved in one or more geographies. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and