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

ISO 5841-2:2014

Language
Format
CHF 129
Convert Swiss francs (CHF) to your currency

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 under systematic review [90.20]
  • Edition
     : 3
    Number of pages
     : 26
  • Technical Committee :
    ISO/TC 150/SC 6
    ICS :
    11.040.40 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

Got a question?

Check out our Help and Support

  2. Store
  3. Standards catalogue
  4. TC
  5. ISO/TC 150/SC 6
  6. ISO 5841-2:2014