Subscribe to updates

ISO 13485:1996

Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001

This standard has been revised by: ISO 13485:2003



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.


Preview and follow ISO 13485:1996 on our Online Browsing Platform


Contact customer services

Send your enquiry by email
or call us on +41 22 749 08 88
09:00 – 12:30, 14:00 – 17:00 (UTC+1).

Related standards

Standards in the same category (03.120.10)
Standards in the same category (11.040.01)
Standards from the same committee