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DIN EN ISO 5649
Medical laboratories – Concepts and specifications for the design, development, implementation and use of laboratory-developed tests (ISO/FDIS 5649:2024); German version FprEN ISO 5649:2024
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 20776-3
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 3: Discdiffusion agar reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
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
FprEN ISO 5649
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/FDIS 5649:2024)
ISO 5649
Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
ISO/CD 23640
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents