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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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
BS 8684. Technology enabled care. Assessment of user needs and risks, system design, installation and maintenance. Code of practice
€24.00
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
Medical electrical equipment Particular requirements for the basic safety and essential performance of robotically assisted surgical
€390.00
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
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
Dispositifs médicaux - Gestion du rapport bénéfice/risqueAutomatic translation from French : Medical devices - Management of the benefit/risk ratio
€138.00
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
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
Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
€94.00
Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion
€72.00
Medical electrical equipment Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis
€281.00
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