Standard ISO/TR 80001-2-6:2014 20.11.2014 preview

ISO/TR 80001-2-6:2014

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

Automatically translated name:

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements



STANDARD published on 20.11.2014


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The information about the standard:

Designation standards: ISO/TR 80001-2-6:2014
Publication date standards: 20.11.2014
SKU: NS-420959
The number of pages: 15
Approximate weight : 45 g (0.10 lbs)
Country: International technical standard
Category: Technical standards ISO

Annotation of standard text ISO/TR 80001-2-6:2014 :

Description / Abstract: 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.

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