Historical

ISO 13485:1996

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

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.

CONTENT PROVIDER
International Organization for Standardization [iso]

Others Also Bought
Quality systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488
ISO 9000:2026, ISO 9001:2015, ISO 9004:2018 and ISO 19011:2026
Included in Packages
This standard is not included in any packages.
Document History
Revised By:
Amendments & Corrections
We have no amendments or corrections for this standard.