Medical devices. Quality management systems. Requirements for regulatory purposes
€404.00
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
€107.33
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
€93.67
Biological evaluation of medical devices - Part 9 : Framework for identification and quantification of potential degradation products
€82.00
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : General requirements
€156.67
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: requirements, tests guidance alarm systems in medical
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements medical systems used in the home healthcare environment
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements the development of physiologic closed-loop controllers
€374.00
Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard: Usability
€269.00
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
€93.50
Medical devices — Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements
€225.00
Appareils électromédicaux - Partie 1-11 : exigences générales pour la sécurité de base et les performances essentielles - Norme Collatérale : exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile
€77.67
Amendment 2 - 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
€184.00
Appareils électromédicaux - Partie 1-10 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour le développement des régulateurs physiologiques en boucle fermée
€65.33
Amendment 2 - Medical electrical equipment - Part 1-6 : General requirements for basic safety and essential performance - Collateral standard : Usability - Amendement 2 - Appareils électromédicaux - Partie 1-6 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : aptitude à l'utilisation
