BS ISO 5841-2:2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Particular reporting requirements.
Annex A (normative) - Statistical method for survival
        analysis and discussion of application of results
        obtained
Annex B (informative) - Rationale
Bibliography

Defines requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices.

This part of ISO5841 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. Devices to be reported has to be market approved in one or more geographies. 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.

AnnexA provides requirements for categorizing devices. It also provides normative requirements for statistical calculations, including a discussion of application of the results obtained. As with other statistical methods, the benefit of the analytical methods in this part of ISO5841 is limited by the size of population under consideration. AnnexB gives the rationale for this part of ISO5841.