• 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

DIN EN IEC 63450 2024-10-02 Testing of Artificial Intelligence / Machine Learning-enabled Medical Devices More  Comment 
IEC/CD TS 81001-2-2 2023-02-17 Health software and health IT systems safety, effectiveness and security - Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls More  Comment 
DIN EN 62304 2018-03-08 Health software - Software life cycle processes (IEC 62A/1235/CDV:2018); German and English version prEN 62304:2018 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 
IEC 62A/703/FDIS 2008-11-21 IEC 80001-1 Ed.1: Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities More  Comment 
IEC 62D/670/NP 2008-01-25 New Work Item Proposal on ISO 80369-2 ed1: Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for breathing systems and driving gases More  Comment 
IEC 62A/591/CD 2007-12-07 IEC 80001 Ed.1: Application of risk management for IT-networks incorporating medical devices More  Comment 
IEC 62A/536/NP 2006-07-07 Application of Risk Management for IT-Networks incorporating medical devices (German proposal) More  Comment 
IEC 62A/702A/RR Review report on IEC 62304: Medical device software - Software life cycle processes More  Comment 

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