Standard

ISO TR 80001-2-6:2014 ED1

Nov 2014 Withdrawn

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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.

Document information

Standard from IEC
Published: 20 November 2014
Withdrawn: 15 August 2025
Edition: 1
Version: 1
Document type: TR
ISBN:

ICS 11.040.01
ICS 35.240.80
ISO TC TC 62/SC 62A

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Adopted by: NEK IEC PAS 61906:2005

ISO TR 80001-2-6:2014 ED1

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Abstract

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Abstract

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