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ISO/TR 80001-2-7:2015

(Main)

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 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
ICS
11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Technical Committee
ISO/TC 215 - Health informatics
Drafting Committee
ISO/TC 215/JWG 7 - Joint ISO/TC 215 - IEC/SC 62A WG: Safe, effective and secure health software and health IT systems, including those incorporating medical devices
Current Stage
9060 - Close of review
Start Date
03-Jun-2024
Completion Date
04-Jun-2024
Ref Project

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ISO/TR 80001-2-7:2015 - Application of risk management for IT-networks incorporating medical devices -- Application guidanceISO/TR 80001-2-7:2015 - Application of risk management for IT-networks incorporating medical devices -- Application guidance
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Technical report
ISO/TR 80001-2-7:2015 - Application of risk management for IT-networks incorporating medical devices -- Application guidance
English language
102 pages
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Standards Content (Sample)

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

---------------------- Page: 1 ----------------------
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
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 2015 – All rights reserved

---------------------- Page: 2 ----------------------
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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