Abstract

 Preview

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
  • Edition
     : 3
    Number of pages
     : 26
  • Technical Committee
     : ISO/TC 150/SC 6 Active implants
  • ICS
     :
    11.040.40 Implants for surgery, prosthetics and orthotics

Buy this standard

Format Language
PDF + ePub
Paper
  • CHF124

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 FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO 5841-2:2014