11.040.01 : Medical equipment in general

NF EN 302195, Z84-195 (03/2024)

NF EN 302195, Z84-195 (03/2024)

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Dispositifs à courte portée (SRD) - Implants médicaux actifs de puissance ultra basse (ULP-AMI) et accessoires (ULP-AMI-P) fonctionnant dans la plage de fréquences de 9 kHz à 315 kHz - Norme harmonisée couvrant les exigences essentielles de l'article 3, paragraphe 2, de la Directive 2014/53/UE (V2.1.1)Automatic translation from French : Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz - Harmonized standard covering the essential requirements of the Article 3, paragraph 2, of Directive 2014/53/EU (V2.1.1)

€95.00

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ISO 15378:2017/Amd 1:2024

ISO 15378:2017/Amd 1:2024

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IEC 80601-2-26:2019/AMD1:2024

IEC 80601-2-26:2019/AMD1:2024

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IEC 80601-2-26:2019/AMD1:2024 Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

€23.00

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24/30450887 DC:2024

24/30450887 DC:2024

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BS 8684. Technology enabled care. Assessment of user needs and risks, system design, installation and maintenance. Code of practice

€24.00

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BS EN IEC 60601-2-35:2021+A1:2024

BS EN IEC 60601-2-35:2021+A1:2024

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Medical electrical equipment Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses intended in medical use

€421.00

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BS EN IEC 80601-2-77:2021+A1:2023

BS EN IEC 80601-2-77:2021+A1:2023

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Medical electrical equipment Particular requirements for the basic safety and essential performance of robotically assisted surgical

€390.00

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IEC 60601-2-35:2020/AMD1:2023

IEC 60601-2-35:2020/AMD1:2023

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IEC 60601-2-35:2020/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

€23.00

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NF EN ISO 17664-2, S98-116-2 (12/2023)

NF EN ISO 17664-2, S98-116-2 (12/2023)

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Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 2 : dispositifs médicaux non critiquesAutomatic translation from French : Processing of healthcare products - Information relating to the processing of medical devices to be provided by the device manufacturer - Part 2: non-critical medical devices

€105.00

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XP S99-223 (12/2023)

XP S99-223 (12/2023)

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Dispositifs médicaux - Gestion du rapport bénéfice/risqueAutomatic translation from French : Medical devices - Management of the benefit/risk ratio

€138.00

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IEC 80601-2-77:2019/AMD1:2023

IEC 80601-2-77:2019/AMD1:2023

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IEC 80601-2-77:2019/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

€23.00

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NF EN ISO 10993-17, S99-501-17 (11/2023)

NF EN ISO 10993-17, S99-501-17 (11/2023)

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Évaluation biologique des dispositifs médicaux - Partie 17 : évaluation des risques toxicologiques des constituants des dispositifs médicauxAutomatic translation from French : Biological evaluation of medical devices - Part 17: assessment of toxicological risks of constituents of medical devices

€159.33

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ASTM E3418-23e1

ASTM E3418-23e1

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Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices

€94.00

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ASTM F3604-23

ASTM F3604-23

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Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion

€72.00

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BS EN IEC 60601-2-76:2019+A1:2023

BS EN IEC 60601-2-76:2019+A1:2023

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Medical electrical equipment Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis

€281.00

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PR NF S97-414, S97-414PR (09/2023)

PR NF S97-414, S97-414PR (09/2023)

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Activité de remise en bon état d'usage de dispositifs médicaux à usage individuel - Exigences générales et de sécuritéAutomatic translation from French : Activity of restoring medical devices for individual use to good condition - General and safety requirements

€59.50

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