CAN/CSA-ISO 5841.2-98

This National Standard of Canada is equivalent to International Standard ISo 5841/2-1986. 1 Scope and field of application This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of pulse generators. It includes general requirements for all reports and supplementary requirements for reports on recent experience and cumulative experience, including specific statistical expressions based on an adaptation of actuarial analysis. Annex A provides requirements for categorizing pulse generators. Annex b provides guidelines for statistics, including a discussion on 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.