Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Implants médicaux actifs de puissance ultra basse (ULP-AMI) et périphériques associés (ULP-AMI-P) fonctionnant dans la plage de fréquences de 402 MHz à 405 MHz - Norme harmonisée couvrant les exigences essentielles de l’article 3, paragraphe 2, de la Directive 2014/53/UE (V2.1.1)
€100.63
Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Systèmes de services de données médicales de très faible puissance (MEDS) fonctionnant dans la plage de fréquences 401 MHz à 402 MHz et 405 MHz à 406 MHz ; Norme harmonisée couvrant les exigences essentielles de l'article 3.2 de la Directive 2014/53/UE (V2.0.1)
€104.16
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements
€102.33
Medical device software - Software life-cycle processes
€153.00
Medical electrical equipment - Part 1-2 : general requirements for basic safety and essential performance - Collateral standard : electromagnetic disturbances - Requirements and tests - Appareils électromédicaux
€237.33
Biological evaluation of medical devices - Part 4 : Selection of tests for interactions with blood
€159.33
Medical electrical equipment - Part 1-8 : general requirements for basic safety and essential performance - Collateral Standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
€126.00
Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance
€43.67
Medical devices - Quality management systems - Requirements for regulatory purposes - Dispositifs médicaux
Medical electrical equipment - Part 1-12 : general requirements for basic safety and essential performance - Collateral standard : requirements for medical equipment and medical electrical systems intended for use the emergency medical services environment
€166.33
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements - Dispositifs médicaux
€89.33
Biological evaluation of medical devices - Part 12 : Sample preparation and reference materials - Évaluation biologique des dispositifs médicaux - Partie 12 : Préparation des échantillons et matériaux de référence
€93.67
Biological evaluation of medical devices - Part 10 : Tests for skin sensitization
€141.33
Medical devices - Information to be provided by the manufacturer
€167.33
Évaluation biologique des dispositifs médicaux - Partie 17 : évaluation des risques toxicologiques des constituants des dispositifs médicaux
