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prEN ISO 15194 Edition 07/2025
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)
  •   
  •  
  • 49.3 / copy
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Status

Draft - Active

Origin

Technical Committee :
CEN/TC 140 : In vitro diagnostic medical devices

Implementation

start of the vote on the project    21/12/2023   date of ratification (dor)    22/05/2025
end of the vote on the project    19/03/2024   date of anouncement (doa)    22/10/2025
start of the vote on the final project    25/02/2025   date of publication (dop)    22/01/2026
end of the vote on the final project    22/04/2025   date of withdrawal (dow)    22/01/2026


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ILNAS-EN ISO 15194:2009

Relations to international standards
ISO 15194 

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