NF EN IEC 80001-1

Application of risk management for IT-networks incorporating medical devices - Part 1 : safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

Le présent document spécifie des exigences générales au profit des ORGANISATIONS pour l'application de la GESTION DES RISQUES avant, pendant et après la connexion d'un SYSTEME TI DE SANTE au sein d'une INFRASTRUCTURE TI DE SANTE. Il traite des PROPRIETES CLES de SECURITE, d'EFFICACITE et de SURETE tout en impliquant les intervenants concernés. Thésaurus International Technique : industrie pharmaceutique, produit pharmaceutique, dispositif médical, traitement de l'information, échange d'information, technique numérique, application de l'informatique, architecture de réseau, interconnexion de réseaux, organisation, protection de l'information, gestion, sécurité, efficacité, gestion de projet, processus, gestion de processus, conception, planification, personnel, qualification, analyse informatique, analyse numérique, corps de métier, détermination, estimation, défaillance, spécification, cycle de vie.

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