Projects of NA 176-08-08 AA

ISO/CD 21474-4 2024-10-31 In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 4: Detection of pathogens More  Comment 
ISO/CD 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/FDIS 24884 2024-02-20 Electronic instructions for use for in vitro diagnostic medical devices - Minimum required information and means of delivery More  Comment 
ISO/CD TS 24883 2024-02-20 In Vitro Diagnostic Medical Devices: Lateral Flow Immunoassay for Rapid Diagnostic Testing- General Guidance for Manufacturers 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/CD 24051-2 2024-01-08 Medical laboratories - Part 2: Digital pathology and artificial intelligence (AI)-based image analysis More  Comment 
ISO/CD TS 8219 2023-11-13 Requirements for the identification and characterisation of microbes using sequencing direct from clinical specimens in the management of infectious disease More  Comment 
DIN EN ISO 22367 2023-10-11 Medical laboratories – Application of risk management to medical laboratories (ISO 22367:2026); German version EN ISO 22367:2026 More  Comment 

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