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AAMI 5841-2
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AAMI 5841-2 2014 Edition, January 1, 2014 Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
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Description / Abstract:
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 have 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.
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.