Final Draft
International Standard
ISO/FDIS 15194
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
Reference number
ISO/FDIS 15194
Edition 3
© ISO 2024
Final Draft International Standard
Under development
This draft is in the approval phase.
Will replace ISO 15194:2009

General information

  • Status
     : Under development
    Stage
    : Final text received or FDIS registered for formal approval [50.00]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
  • RSS updates

Life cycle

Got a question?

Check out our Help and Support

  2. Store
  3. Standards catalogue
  4. TC
  5. ISO/TC 212
  6. ISO/FDIS 15194