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

Publication date: Nov 20, 2014

General information

Current stage: 60.60 Effective date: Nov 20, 2014

Originator: ISO

Owner: ISO/TC 215

Type: Technical Report

ICS: 35.240.80 11.040.01

Languages: English

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Status: Published

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Scope

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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PUBLISHED
ISO/TR 80001-2-6:2014
60.60 Standard published
Nov 20, 2014

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