Buy this standard

Abstract Preview

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 :  Published
    Publication date : 2007-03
    Corrected version (en) : 2007-09
    Corrected version (fr) : 2007-09
  • Edition : 2
    Number of pages : 82
  • Technical Committee
    :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • ICS :
    11.040.01
    Medical equipment in general

Buy this standard

Format Language
PDF + ePub
Paper
PDF
  • CHF198

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

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