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DS/ISO 5841-2:2014
Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
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.*
Danish Standards [ds]