11.040.01 : Medical equipment in general

UNE-EN 13718-1:2015+A1:2020

UNE-EN 13718-1:2015+A1:2020

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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

€69.00

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UNE-EN 13718-2:2015+A1:2020

UNE-EN 13718-2:2015+A1:2020

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Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

€89.00

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UNE-EN ISO 14155:2021

UNE-EN ISO 14155:2021

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Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

€139.00

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UNE-EN ISO 15223-1:2022

UNE-EN ISO 15223-1:2022

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Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

€118.00

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UNE-EN ISO 10993-7:2009/A1:2022

UNE-EN ISO 10993-7:2009/A1:2022

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

€53.00

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24/30500890 DC:2024

24/30500890 DC:2024

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BS EN ISO 20417 Medical devices - Information to be supplied by the manufacturer

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24/30506269 DC:2024

24/30506269 DC:2024

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BS EN IEC 60601-1/FRAG1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - (Fragment 1)

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24/30506273 DC:2024

24/30506273 DC:2024

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BS EN IEC 60601-1/FRAG11 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Electromagnetic exposure hazards (Fragment 11)

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24/30506277 DC:2024

24/30506277 DC:2024

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BS EN IEC 60601-1/FRAG2 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Physical environment hazard (Fragment 2)

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24/30506281 DC:2024

24/30506281 DC:2024

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BS EN IEC 60601-1/FRAG3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - User interface hazards (Fragment 3)

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24/30506285 DC:2024

24/30506285 DC:2024

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BS EN IEC 60601-1/FRAG4 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Materials hazards (Fragment 4)

€24.00

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25/30502360 DC:2025

25/30502360 DC:2025

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BS EN IEC 62304 Health software – Software life cycle processes

€44.00

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25/30528405 DC:2025

25/30528405 DC:2025

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Draft BS EN IEC 60601-1/FRAG11 Medical electrical equipment Part 1. General requirements for basic safety and essential performance. Electromagnetic exposure hazards (Fragment 11)

€24.00

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25/30528984 DC:2025

25/30528984 DC:2025

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Draft BS EN 60601-1/FRAG10 ED4 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Ionizing radiation hazards (Fragment 10)

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25/30529542 DC:2025

25/30529542 DC:2025

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Draft BS EN IEC 60601-1/FRAG5 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - PEMS related hazards (Fragment 5)

€44.00

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