• Hydrogen Technologies Standards form the basic framework for market ramp-up

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  • Climate change Standards and specifications support climate targets

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  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

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Projects of NA 176-08-08 AA

Document number Begin Title Comment
ISO/DIS 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/CD 24051-2 2024-01-08 Medical laboratories - Part 2: Digital pathology and artificial intelligence (AI)-based image analysis 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 TS 8219 2023-11-13 Sequencing and clinical application to infectious diseases More  Comment 
DIN EN ISO 23640/A11 2023-11-10 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents More  Comment 
DIN EN ISO 22367 2023-10-11 Medical laboratories - Application of risk management to medical laboratories (ISO/FDIS 22367:2026); German version FprEN ISO 22367:2026 More  Comment 
ISO 22367 2023-09-12 Medical laboratories - Application of risk management to medical laboratories 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/DIS 15194:2023); German and English version prEN ISO 15194:2023 More  Comment 
DIN CEN ISO/TS 18701 2023-02-06 Molecular in vitro diagnostic examinations - Specificationsfor pre-examination processes for human specimens - Isolated microbiome DNA More  Comment 

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