International Standard
ISO 5841-2:2014
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads
Reference number
ISO 5841-2:2014
Edition 3
2014-08
© ISO 2024
International Standard
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Published (Edition 3, 2014)
This standard was last reviewed and confirmed in 2019. Therefore this version remains current.

ISO 5841-2:2014

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Abstract

ISO 5841-2:2014 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. 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.

General information

  • Status
     : Published
    Publication date
     : 2014-08
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 3
    Number of pages
     : 26
  • Technical Committee :
    ISO/TC 150/SC 6
    ICS :
    11.040.40 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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