11.040.01 : Medical equipment in general

NF EN 13718-2+A1, S95-202-2 (03/2020)

NF EN 13718-2+A1, S95-202-2 (03/2020)

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

€105.00

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NF EN ISO 10993-23, S99-501-23 (03/2021)

NF EN ISO 10993-23, S99-501-23 (03/2021)

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Biological evaluation of medical devices - Part 23 : tests for irritation - Évaluation biologique des dispositifs médicaux - Partie 23 : Essais d'irritation

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NF EN 60601-1-9/A2, C74-019/A2 (09/2020)

NF EN 60601-1-9/A2, C74-019/A2 (09/2020)

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Medical electrical equipment - Part 1-9 : General requirements for basic safety and essential performance - Collateral Standard : requirements for environmentally conscious design

€58.00

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NF EN 60601-1-12/A1, C74-022/A1 (09/2020)

NF EN 60601-1-12/A1, C74-022/A1 (09/2020)

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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 - Appareils électromédicaux - Partie 1-12 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux

€58.00

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NF EN ISO 13485/A11, S99-101/A11 (09/2021)

NF EN ISO 13485/A11, S99-101/A11 (09/2021)

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

€91.33

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NF EN ISO 10993-2, S99-502 (11/2022)

NF EN ISO 10993-2, S99-502 (11/2022)

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Biological evaluation of medical devices - Part 2 : Animal welfare requirements

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FD CEN ISO/TR 24971, S99-124 (09/2020)

FD CEN ISO/TR 24971, S99-124 (09/2020)

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Medical devices - Guidance on the application of ISO 14971

€172.33

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FD CEN ISO/TR 20416, S99-125 (09/2020)

FD CEN ISO/TR 20416, S99-125 (09/2020)

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Medical devices - Post-market surveillance for manufacturers

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NF EN ISO 17664-1, S98-116-1 (09/2021)

NF EN ISO 17664-1, S98-116-1 (09/2021)

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Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1 : Critical and semi-critical medical devices

€105.00

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NF ISO 19461-2, M60-573 (08/2022)

NF ISO 19461-2, M60-573 (08/2022)

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Radioprotection - Mesurage pour la libération des déchets contaminés par des radioisotopes lors des applications médicales - Partie 2 : Gestion des déchets radioactifs solides dans les installations de médecine nucléaire

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NF EN ISO 10993-18/A1, S99-501-18/A1 (07/2023)

NF EN ISO 10993-18/A1, S99-501-18/A1 (07/2023)

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Évaluation biologique des dispositifs médicaux - Partie 18 : caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risque - Amendement 1 : détermination du coefficient d'incertitudeAutomatic translation from French : Biological evaluation of medical devices - Part 18: chemical characterization of medical device materials within a risk management process - Amendment 1: determination of the uncertainty coefficient

€46.00

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PD CEN/TR 17223:2018

PD 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

€421.00

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BS ISO/CIE 17166:2019

BS ISO/CIE 17166:2019

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Erythema reference action spectrum and standard erythema dose

€172.00

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PD CEN ISO/TR 24971:2020

PD CEN ISO/TR 24971:2020

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Medical devices. Guidance on the application of ISO 14971

€421.00

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BS EN 13718-1:2014+A1:2020

BS EN 13718-1:2014+A1:2020

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Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air

€201.00

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