Projects of NA 176-08-08 AA

ISO/DIS 21474-4 2024-10-31 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 4: Detection of pathogens More  Comment 
ISO/DIS 25379-2 2024-10-31 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination More  Comment 
ISO/DIS 25379-1 2024-10-31 In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination More  Comment 
DIN EN ISO 23640 2024-03-15 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO/DIS 23640:2026); German and English version prEN ISO 23640:2026 More  Comment 
ISO/DIS 23640 2024-03-01 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents More  Comment 
ISO/DTS 24883 2024-02-20 In vitro diagnostic medical devices - General guidance for manufacturers of lateral flow immunoassay (LFIA) for rapid diagnostic testing (RDT) More  Comment 
ISO/DIS 24051-1 2024-01-08 Medical laboratories - Part 1: General principles for the application of artificial intelligence in medical laboratories More  Comment 
ISO/DIS 24051-2 2024-01-08 Medical laboratories - Part 2: Digital pathology and artificial intelligence (AI)-based image analysis More  Comment 
ISO/DTS 8219 2023-11-13 Requirements and recommendations for the identification and characterisation of microbes using next generation sequencing directly from clinical specimens in the management of infectious disease 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 15194:2026); German version EN ISO 15194:2026 More  Comment 

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