Abstract 

Specifies, in conjunction with the application of ISO 9001, the quality system requirements for the design/development and, when relevant, installation and servicing of medical devices.


General information

  • Status :  Withdrawn
    Publication date : 1996-12
  • Edition : 1
    Number of pages : 10
  • Technical Committee
    :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • ICS :
    03.100.70
    Management systems
    11.040.01
    Medical equipment in general

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)

Keep up to date with ISO

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

  2. Store
  3. Standards catalogue
  4. ICS
  5. 03
  6. 03.100
  7. 03.100.70
  8. ISO 13485:1996