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IEC TR 80001-2-1:2012

(Main)

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples

IEC/TR 80001-2-1:2012(E), which is a technical report, is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.

General Information

Status
Published
Publication Date
09-Jul-2012
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
WPUB - Publication withdrawn
Start Date
05-Apr-2024
Completion Date
05-Apr-2024
Ref Project

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IEC TR 80001-2-1:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examplesIEC TR 80001-2-1:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
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IEC TR 80001-2-1:2012 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
English language
66 pages
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IEC/TR 80001-2-1


Edition 1.0 2012-07




TECHNICAL



REPORT









colour

inside









Application of risk management for IT-networks incorporating medical devices –

Part 2-1: Step-by-step risk management of medical IT-networks – Practical

applications and examples




































IEC/TR 80001-2-1:2012(E)

---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2012 IEC, Geneva, Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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---------------------- Page: 2 ----------------------
IEC/TR 80001-2-1


Edition 1.0 2012-07




TECHNICAL



REPORT








colour

inside










Application of risk management for IT-networks incorporating medical devices –

Part 2-1: Step-by-step risk management of medical IT-networks – Practical

applications and examples


























INTERNATIONAL

ELECTROTECHNICAL

COMMISSION

PRICE CODE
XB


ICS 11.040.01; 35.240.80 ISBN 978-2-83220-201-2



  Warning! Make sure that you obtained this publication from an authorized distributor.

---------------------- Page: 3 ----------------------
– 2 – TR 80001-2-1  IEC:2012(E)
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Prerequisites . 14
5 Study of terms used in RISK MANAGEMENT . 14
5.1 Overview . 14
5.2 HAZARDS . 15
5.3 HAZARDOUS SITUATIONS . 15
5.4 Foreseeable sequences of events and causes . 16
5.5 UNINTENDED CONSEQUENCE . 16
5.6 RISK CONTROL measures (mitigations) .
...

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