ISO-80001-2-6 Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements

ISO-80001-2-6 - 1ST EDITION - CURRENT


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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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11.040.01 (Medical equipment in general)

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Document Number

ISO/TR 80001-2-6:2014

Revision Level

1ST EDITION

Status

Current

Publication Date

Dec. 1, 2014

Committee Number

ISO/TC 215