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Projects of CEN/TC 140

DIN EN ISO 23640 rev 2024-03-15 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents More  Comment 
DIN EN ISO 15189+A11 2023-12-04 Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022+A11:2023 More  Comment 
DIN EN ISO 22367 rev 2023-10-11 Medical laboratories - Application of risk management to medical laboratories More  Comment 
DIN EN ISO 5649 2023-03-17 Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023 More  Comment 
DIN EN ISO 20776-3 2021-03-03 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 More  Comment 
DIN EN ISO 20916 2019-12-20 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024 More  Comment 
DIN EN ISO 18113-1 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/FDIS 18113-1:2022); German version FprEN ISO 18113-1:2022 More  Comment 
DIN EN ISO 18113-2 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022); German version FprEN ISO 18113-2:2022 More  Comment 
DIN EN ISO 18113-3 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022); German version FprEN ISO 18113-3:2022 More  Comment 
DIN EN ISO 18113-4 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022); German version FprEN ISO 18113-4:2022 More  Comment 

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