This National Standard of Canada is equivalent to International Standard ISO 5841-2:2000. 1 Scope 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.