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.
BS ISO 5841-2:2000 history
2014BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads
2001BS ISO 5841-2:2000 Implants for surgery - Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads
1987BS 6902-2:1987 Cardiac pacemakers. Method for reporting the clinical performance of populations of pulse generators
BS ISO 5841-2:2000 Implants for surgery - Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads has been changed from BS 6902-2:1987 Cardiac pacemakers. Method for reporting the clinical performance of populations of pulse generators.