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ISO TR 80001-2-6:2014

(Main)

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

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

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.

General Information

Status
Published
Publication Date
19-Nov-2014
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Technical Committee
SC 62A - Common aspects of medical equipment, software, and systems
Drafting Committee
JWG 7 - TC 62/SC 62A/JWG 7
Current Stage
PPUB - Publication issued
Start Date
28-Feb-2014
Completion Date
05-Dec-2014
Ref Project

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ISO TR 80001-2-6:2014 - Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreementsISO TR 80001-2-6:2014 - Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
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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
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Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 80001-2-6
First edition
2014-12-01

Application of risk management for
IT-networks incorporating medical
device —
Part 2-6:
Application guidance — Guidance for
responsibility agreements
Application de la gestion des risques pour les réseaux intégrant
appareils médicaux —
Partie 2-6: Application guidage — Orientation des accords de
responsabilité




Reference number
ISO/TR 80001-2-6:2014(E)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO/TR 80001-2-6:2014(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission.
Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO TR 80001-2-6:2014(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
1.1 Purpose . 1
1.2 Prerequisites . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Key aspects for RESPONSIBILITY AGREEMENTS . 5
4.1 Reasons and rationale . 5
4.2 Participants . 5
4.3 Proposed types of RESPONSIBILITY AGREEMENTS . 5
4.4 Communication control . 5
4.4.1 Bilateral versus multilateral RESPONSIBILITY AGREEMENTS . 5
4.4.2 Non-disclosure agreements . 5
4.4.3 Update of information and documentation . 6
4.5 Responsibility for establishing . 6
4.6 Methods for determination and of responsibilities . 6
4.7 Life cycle considerations. 6
5 Elements of a RESPONSIBILITY AGREEMENT . 7
Annex A (informative) RACI chart . 11
Annex B (informative) Typical documents . 12
© ISO 2014 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO TR 80001-2-6:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO,
...

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