Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 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
Quality systems - Medical devices - Particular requirements for the application of ISO 9002
ISO 9000:2015, ISO 9001:2015, ISO 9004:2018 and ISO 19011:2018
Document History
Revised By:
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS