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PD ISO/TR 80001-2-6:2014

Current
Current

The latest, up-to-date edition.

Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Key aspects for RESPONSIBILITY AGREEMENTS
5 Elements of a RESPONSIBILITY AGREEMENT
Annex A (informative) - RACI chart
Annex B (informative) - Typical documents

Gives 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.

1.1 Purpose This Technical Report provides guidance on implementing responsibility agreements, which are described in IEC80001-1 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 IEC80001-1. 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. 1.2 Prerequisites The responsible organization’s (ROs) top management has accepted responsibility for the successful implementation of IEC80001-1. As required by IEC80001-1, the RO has created and approved policies for the risk management process and risk acceptability criteria while balancing the three key properties with the mission of the RO. The RO has identified and provisioned adequate resources and assigned qualified personnel to perform tasks related to the standard. The RO has appointed a medical IT-network risk manager and is prepared to establish the responsibility agreement.

Committee
CH/62/1
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/TR 80001-2-6:2014 Identical

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

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$407.85
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