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
€162.33
Maintenance of medical devices - Quality management system for the maintenance of medical devices and the management of risks associated with their use - Maintenance des dispositifs médicaux
€102.33
Medical devices - Application of risk management to medical devices - Dispositifs médicaux
€172.33
Medical electrical equipment - Part 1-6 : general requirements for basic safety and essential performance - Collateral standard : usability
€76.00
Information supplied by the manufacturer of medical devices
€24.50
Medical electrical equipment - Part 1-10 : general requirements for basic safety and essential performance - Collateral standard : requirements for the development of physiologic closed-loop controllers
€58.00
Medical devices - Application of usability engineering to medical devices - Dispositifs médicaux
€56.33
Medical electrical equipment - Part 1-9 : general requirements for basic safety and essential performance - Collateral Standard : requirements for environmentally conscious design
Medical electrical equipment - Part 1-2 : general requirements for basic safety and essential performance - Collateral standard : electromagnetic disturbances - Requirements and tests - Appareils électromédicaux
€231.33
€89.33
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) - Articles de conditionnement primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
€149.00
Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization - Évaluation biologique des dispositifs médicaux
Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
€80.00
Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance
€93.33
Short Range Devices (SRD) - Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (V2.1.1) - Dispositifs à courte portée (SRD) ; implants médicaux actifs de faible puissance (LP-AMI) et périphériques associés (LP-AMI-P) fonctionnant dans la plage de fréquences de 2 483,5 MHz à 2 500 MHz; Norme harmonisée couvrant les exigences essentielles de l'article 3.2 de la Directive 2014/53/UE
€100.63
