Status : Withdrawn

This standard has been revised by ISO 14971:2019

Abstract

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

General information

  • Status
     : Withdrawn
    Publication date
     : 2007-03
    Corrected version (en)
     : 2007-09
    Corrected version (fr)
     : 2007-09
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 2
    Number of pages
     : 82
  • Technical Committee :
    ISO/TC 210
    ICS :
    11.040.01 
  • RSS updates

Life cycle

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. TC
  5. ISO/TC 210
  6. ISO 14971:2007