GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY.
€74.00
IEC 60601-1-9:2007 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
€244.00
IEC 60601-1-10:2007 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
€302.00
IEC 62366-1:2015/COR1:2016 Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices
€0.00
IEC 62304:2006 Medical device software - Software life cycle processes
€441.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
€20.00
Medical vehicles and their equipment - Air ambulances - Part 1 : requirements for medical devices used in air ambulances
€80.00
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1 : Application de la gestion des risques
€105.00
Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 2 : Contrôles de l'origine, de la collecte et du traitement
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 critiques
€91.33
IEC 60601-1-8:2006 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
Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
€83.00
