Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-86103 The types of digital printing

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Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-86103 The types of digital printingPart two 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.