Numéro de référence
ISO/TR 80001-2-6:2014
© ISO 2025
Rapport technique
ISO/TR 80001-2-6:2014
Application de la gestion des risques pour les réseaux intégrant appareils médicaux — Partie 2-6: Application guidage — Orientation des accords de responsabilité
Edition 1
2014-12
Annulée
Annulée (Edition 1, 2014)

Résumé

ISO/TR 80001-2-6:2014 provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1. Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK.

Informations générales

  • État actuel
     : Annulée
    Date de publication
     : 2014-12
    Stade
    : Annulation de la Norme internationale [95.99]
  • Edition
     : 1
  • Comité technique :
    ISO/TC 215
  • RSS mises à jour

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