DS/ISO 5841-2:2014

Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.18

Scope

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.

Number of pages: 28

Published: 2014-10-16

Date of approval: 2014-09-22

International relationships : ISO 5841-2:2000 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M287739


Committees

Committee

  • ISO/TC 150/SC 6

Danish committee

DS/S-160