• 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 DKE/UK 804.3

Document number Begin Title Comment
DIN EN 62304 Berichtigung 1 2026-02-17 Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015; Corrigendum 1 More  Comment 
ISO/CD 81001-4-1 2026-02-04 Health software and health IT systems safety, effectiveness and security - Part 4-1: Application of risk management in the implementation and clinical use phases More  Comment 
DIN EN IEC 81001-5-1 Beiblatt 1 2025-10-10 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle; Supplement 1: Interpretation sheet 1 (IEC 81001-5-1:2021/ISH1:2025) More  Comment 
DIN EN IEC 81001-5-1 2025-10-08 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle More  Comment 
DIN IEC/IEEE 63685 2025-10-02 Post-market surveillance of machine learning-enabled medical device More  Comment 
DIN EN IEC 62304 2025-08-13 Health software - Software life cycle processes More  Comment 
DIN EN IEC 60601-1-105 2025-07-23 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - PEMS related hazards (Fragment 5) More  Comment 
DIN EN IEC 63521 2025-05-27 Machine learning-enabled medical device - Performance evaluation process More  Comment 
DIN IEC 63450 2024-10-02 Testing of Artificial Intelligence / Machine Learning-enabled Medical Devices More  Comment 
IEC 62A/838/CD 2012-10-26 IEC 62304: Medical device software - Software life cycle processes More  Comment 

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