Projects of DKE/K 804

DIN EN IEC 63686 2026-04-23 Management systems - Guidelines for incorporating ecodesign in the medical device sector More  Comment 
DIN EN IEC 63719-2 2026-02-11 Medical devices - In silico technologies - Part 2: Credibility assessment of first-principles based methods More  Comment 
IEC/DIS 80601-2-78 2024-09-26 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation More  Comment 
IEC/DIS 80601-2-77 2024-09-26 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment More  Comment 
IEC/AWI TS 80601-4-1 2024-09-26 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a level of autonomy More  Comment 
DIN IEC 80601-2-78 2024-08-27 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation More  Comment 
IEC 62D/1070/CDV 2013-04-05 ISO 80601-2-70: Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment More  Comment 
IEC 62A/850/CDV 2013-03-22 IEC 60601-1-12: Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment More  Comment 
IEC 62D/1020/CDV 2012-09-14 IEC 60601-2-36: Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy More  Comment 
IEC 62A/809/CD 2012-05-11 ISO/TR 24971: Guidance on the application of ISO 14971 More  Comment 

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