11.040.01 : Medical equipment in general

NBN EN 13718-1:2014

NBN EN 13718-1:2014

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

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NBN EN 13718-2:2015

NBN EN 13718-2:2015

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

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ISO 14971:2019 (R2025)

ISO 14971:2019 (R2025)

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Medical devices — Application of risk management to medical devices

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ISO/TR 24971:2020

ISO/TR 24971:2020

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Medical devices — Guidance on the application of ISO 14971

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ISO 15223-1:2021

ISO 15223-1:2021

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Abstract General information

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ISO/DIS 11197:2025

ISO/DIS 11197:2025

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Medical supply units General information

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ISO 15223-1:2021/Amd 1:2025

ISO 15223-1:2021/Amd 1:2025

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Sign up for email updates General information

€21.00

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ISO 15378:2017/Amd 1:2024

ISO 15378:2017/Amd 1:2024

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Sign up for email updates General information

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CEN/TR 17223:2018

CEN/TR 17223:2018

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Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

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NBN EN ISO 14971:2019/A11:2021

NBN EN ISO 14971:2019/A11:2021

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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

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NBN EN ISO 14971:2020

NBN EN ISO 14971:2020

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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

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NBN EN ISO 13485:2016

NBN EN ISO 13485:2016

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

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NBN EN 13718-1:2014+A1:2020

NBN EN 13718-1:2014+A1:2020

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

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NBN ENV 13004:1999

NBN ENV 13004:1999

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Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system

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IEC 61847:2025

IEC 61847:2025

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IEC 61847:2025 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

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