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DIN EN ISO 15193
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023
DIN EN ISO 15194
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
DIN EN ISO 23640 rev
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
DIN EN ISO 23640/A11
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 23640/prA11
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
ISO/CD 21474-4
In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 4: Detection of pathogens
ISO/CD 23640
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
ISO/CD 25459
In vitro diagnostic medical devices - Requirements for determining commutability of certified reference materials used as secondary calibrators or trueness controls
ISO/DIS 24884
Electronic instructions for use for in vitro diagnostic medical devices - Minimum required information and means of delivery
ISO/FDIS 15193
In vitro diagnostic medical devices - Requirements for reference measurement procedures