Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

ISO/TR 80001-2-7:2015 is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001‑1.

Application du management du risque aux réseaux des technologies de l'information contenant les dispositifs médicaux — Conseils pour les applications — Partie 2-7: Directives de prestation de soins de santé organisations sur la façon de s'auto-évaluer leur conformité avec la norme IEC 80001-1

General Information

Status
Published
Publication Date
16-Mar-2015
Current Stage
9060 - Close of review
Start Date
03-Jun-2024
Completion Date
04-Jun-2024
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ISO/TR 80001-2-7:2015 - Application of risk management for IT-networks incorporating medical devices -- Application guidance
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TECHNICAL ISO/TR
REPORT 80001-2-7
First edition
2015-04-01
Application of risk management for
IT-networks incorporating medical
devices — Application guidance —
Part 2-7:
Guidance for Healthcare Delivery
Organizations (HDOs) on how to self-
assess their conformance with IEC
80001-1
Application du management du risque aux réseaux des technologies
de l’information contenant les dispositifs médicaux — Conseils pour
les applications —
Partie 2-7: Directives de prestation de soins de santé organisations sur
la façon de s’auto-évaluer leur conformité avec la norme IEC 80001-1
Reference number
ISO/TR 80001-2-7:2015(E)
©
ISO 2015

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ISO/TR 80001-2-7:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015
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
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2015 – All rights reserved

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ISO/TR 80001-2-7:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Assessment Method . 2
4.1 Prerequisites . 2
4.2 Assessment Method Overview . 2
4.3 Assessment Stages . 3
4.3.1 Stage 1 — Defining Assessment Scope . 3
4.3.2 Stage 2 — Stakeholder Involvement . 3
4.3.3 Stage 3 — Information Collection and Evaluation . 3
4.3.4 Stage 4 — Findings Report. 3
4.3.5 Stage 5 — Presentation of Findings . 4
4.3.6 Stage 6 — Improvement Plan (optional) . 4
4.3.7 Stage 7 — Follow-up Assessment (optional) . 4
4.4 Process attribute rating scale . 4
4.4.1 Rating of process attributes . 4
4.4.2 Process attribute rating values . 4
4.5 Capability Levels .
...

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