certification

environmental technology

UNI CEI EN ISO 13485

The standard UNI CEI EN ISO 13485 or "The medical devices standard"

Sets forth the requirements for quality systems in relation to design and development, production, installation and assistance in the area of medical devices.
In particular it lays down all the good manufacturing principles for the following devices:

  • medical devices
  • active medical devices
  • active implantable medical devices
  • implantable medical devices
  • permanent medical devices
(June 2004)