11.040.01 : Medical equipment in general

25/30529546 DC:2025

25/30529546 DC:2025

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Draft BS EN IEC 60601-1/FRAG6 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Electrical hazards (Fragment 6)

€24.00

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25/30529550 DC:2025

25/30529550 DC:2025

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Draft BS EN IEC 60601-1/FRAG7 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Mechanical hazards (Fragment 7)

€24.00

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25/30529554 DC:2025

25/30529554 DC:2025

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Draft BS EN IEC 60601-1/FRAG8 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Thermal fire hazards (Fragment 8)

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25/30511190 DC:2025

25/30511190 DC:2025

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Draft BS EN 60601-2-36 Medical electrical equipment Part 2-36: Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy

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25/30502119 DC:2025

25/30502119 DC:2025

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BS EN ISO 11608-1:2022/Amd 1 Needle-based injection systems for medical use —Requirements and test methods Part 1: systems. Amendment

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25/30533722 DC:2025

25/30533722 DC:2025

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Draft BS EN IEC 60976 ED3 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics

€24.00

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25/30544826 DC:2025

25/30544826 DC:2025

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Draft BS EN IEC 60050-880/AMD1 ED1 International Electrotechnical Vocabulary (IEV) Part 880: Electrical equipment, electrical systems and software used in healthcare

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25/30510772 DC:2025

25/30510772 DC:2025

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Draft BS EN IEC 80601-2-77 ED2 Medical electrical equipment Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical

€24.00

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25/30510776 DC:2025

25/30510776 DC:2025

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Draft BS EN IEC 80601-2-78 ED2 Medical electrical equipment Part 2-78: Particular requirements for basic safety and essential performance of medical robots rehabilitation, assessment, compensation or alleviation

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UNE-EN ISO 10993-7:2009/AC:2010

UNE-EN ISO 10993-7:2009/AC:2010

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

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UNE-EN ISO 13485:2018/A11:2022

UNE-EN ISO 13485:2018/A11:2022

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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

€76.00

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NF EN ISO 10993-10/A1, S99-510/A1 (10/2006)

NF EN ISO 10993-10/A1, S99-510/A1 (10/2006)

Superseded Historical

Évaluation biologique des dispositifs médicaux - Partie 10 : essais d'irritation et d'hypersensibilité retardée

€26.67

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PD IEC TS 81001-2-2:2025

PD IEC TS 81001-2-2:2025

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Health software and health IT systems safety, effectiveness security Coordination. Guidance for the implementation, disclosure communication of needs, risks controls

€421.00

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NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)

NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)

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Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals - Amendment 1

€44.50

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NF EN 60601-1-10/A2, C74-020/A2 (07/2021)

NF EN 60601-1-10/A2, C74-020/A2 (07/2021)

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Appareils électromédicaux - Partie 1-10 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour le développement des régulateurs physiologiques en boucle fermée

€93.33

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