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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
    Edition: 2014
    $442.60
    / user per year

Description of BS ISO 5841-2:2014 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.



Standard NumberBS ISO 5841-2:2014
TitleImplants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads
StatusConfirmed
Publication Date2014-08-31
ReplacesBS ISO 5841-2:2000
Identical National Standard OfISO 5841-2:2014
DescriptorsReliability, Clinical testing, Statistical data, Performance, Pacemakers, Statistical methods of analysis, Prosthetic devices, Reports, Life (durability), Classification systems, Implants (surgical), Artificial organs, Electrical medical equipment, Pulse generators, Cardiology, Prosthesis, Heart
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 580 81385 6
PublisherBSI
Pages38

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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