DS/ISO 5841-2:2014

Kirurgiske implantater - Pacemakere - Del 2: Rapportering af klinisk ydeevne for grupper af pulsgeneratorer eller elektroder


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 507,00

Beskrivelse

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 pacemakers, hereinafter
referred to as devices. 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. Annex B provides guidelines for statistics, 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 C gives the
rationale for this part of ISO 5841.

Antal sider: 28

Udgivet: 2014-10-16

Godkendelsesdato: 2014-09-22

Internationale relationer : ISO 5841-2:2000 IDT

ICS: 11.040.40 - Implantater til kirurgi, protetik og ortoptik

Varenummer: M287739


Udvalg og komiteer

Komite

  • ISO/TC 150/SC 6

Dansk udvalg

DS/S-160