ISO 5841-2:2014 PDF

Scope: This part of ISO 5841 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. Annex A 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 ISO 5841 is limited by the size of population under consideration. Annex B gives the rationale for this part of ISO 5841.

ISO 5841-2:2014 Referenced Document

ISO 14708-2:2012 Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

2014 ISO 5841-2:2014 Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
2000 ISO 5841-2:2000 Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
1986 ISO 5841-2:1986 Implants for surgery; Cardiac pacemakers; Part 2 : Reporting of the clinical performance of populations of pulse generators