M00000241
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ISO 5841-2 3rd Edition, August 1, 2014 Implants for Surgery - Cardiac Pacemakers - Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads
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Availability date: 07/13/2021
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 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.