ISO 5841-2:2014 Preview

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

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
  • :
    ISO/TC 150/SC 6
    Active implants
  • 11.040.40
    Implants for surgery, prosthetics and orthotics

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

Buy this standard

Format Language
PDF + ePub
Paper
  • CHF118

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)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information

 Subscribe