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Projects of ISO/TC 212/WG 2

Document number Begin Title Comment
DIN EN ISO 15195/A1 2025-12-05 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 More  Comment 
ISO 15195 AMD 1 2025-11-28 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 More  Comment 
ISO/WD TS 25646 2025-04-22 In vitro diagnostic medical devices - Definition of analytical performance specifications for laboratory measurements based on medical requirements More  Comment 
ISO/CD 25459 2025-01-13 In vitro diagnostic medical devices - Requirements for determining commutability of certified reference materials used as secondary calibrators or trueness controls More  Comment 
DIN EN ISO 15194 2023-04-21 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023 More  Comment 
DIN EN ISO 15193 2021-03-29 In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023 More  Comment 
ISO/FDIS 15193 2021-02-26 In vitro diagnostic medical devices - Requirements for reference measurement procedures More  Comment 
ISO/FDIS 15194 2021-02-26 In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation More  Comment 

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