• 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 811.3

Document number Begin Title Comment
DIN EN IEC 81001-5-1 Beiblatt 1 2025-10-10 Interpretation Sheet 1 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle 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 
ISO/CD 81001-1 2025-02-26 Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts More  Comment 
DIN EN 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 
IEC 62A/839/CD 2012-10-26 IEC 82304-1: Health Software - Part 1: General requirements for product safety More  Comment 

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