Standard: AAMI 5841-2

IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS

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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 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.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 5841-2
Publish Date: 2014-01-01
Page Count: 36
Change Type: NEW ADDITION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

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