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ISO 5841-2

Implants for Surgery - Cardiac Pacemakers - Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads

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Organization: ISO
Publication Date: 1 August 2014
Status: active
Page Count: 34
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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.

Document History

ISO 5841-2
August 1, 2014
Implants for Surgery - Cardiac Pacemakers - Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads
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,...
October 15, 2000
Implants for Surgery - Cardiac Pacemakers - Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads
This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of pulse generators or leads, intended for long-term implantation as cardiac...
January 1, 1986
Implants for Surgery - Cardiac Pacemakers - Part 2: Reporting of the Clinical Performance of Populations of Pulse Generators
A description is not available for this item.

References

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