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BSI BS ISO 5841-2:2014

Implants for surgery. Cardiac pacemakers -- Reporting of clinical performance of populations of pulse generators or leads
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BSI BS ISO 5841-2:2014

Implants for surgery. Cardiac pacemakers -- Reporting of clinical performance of populations of pulse generators or leads

PUBLISH DATE 2014
PAGES 38
BSI BS ISO 5841-2:2014

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.

SDO BSI: British Standards Institution
Document Number ISO 5841-2
Publication Date Aug. 31, 2014
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/150/2
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