Under publication
ISO 15194
In vitro diagnostic medical devices — Requirements for certified reference materials and the content of supporting documentation
Reference number
ISO 15194
Edition 3
2026-06
© ISO 2026
Under publication
Under publication (Edition 3, 2026)
Final production steps (up to seven weeks).
Will replace ISO 15194:2009

General information

  • Status
     : Under development
    Publication date
     : 2026-06
    Stage
    : International Standard under publication [60.00]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
  • RSS updates

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