Norm

NPR-ISO/TR 80001-2-6:2015 en

Toepassing van risicomanagement voor IT-netwerken en medische hulpmiddelen - Deel 2-6: Toepassingsrichtlijn - Richtlijn voor overeenstemming over verantwoordelijkheden

79,70

Over deze norm

Status Definitief
Aantal pagina's 15
Commissie Informatievoorziening in de zorg
Gepubliceerd op 01-01-2015
Taal Engels
NPR-ISO/TR 80001-2-6 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.

Details

ICS-code 11.040.01
35.240.80
Nederlandse titel Toepassing van risicomanagement voor IT-netwerken en medische hulpmiddelen - Deel 2-6: Toepassingsrichtlijn - Richtlijn voor overeenstemming over verantwoordelijkheden
Engelse titel Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements

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