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

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• Status: Withdrawn
• Publication Date: 09-Jul-2012
• Withdrawal Date: 04-Apr-2024
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 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• Current Stage: WPUB - Publication withdrawn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

Standards Content (Sample)

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)
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
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,

please contact the address below or your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]

CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
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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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XB
ICS 11.040.01; 35.240.80 ISBN 978-2-83220-201-2

– 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) . 17
5.7 Degrees of RISK . 17
5.8 Checking wording . 18
6 The steps . 18
6.1 Overview of the steps . 18
6.2 A basic example using the 10 steps . 19
6.2.1 General . 19
6.2.2 Initial RISK – Steps 1 – 5 (Figure 2) . 19
6.2.3 RISK CONTROL and final RISK – Steps 6 – 10 (Figure 3) . 20
7 IEC 80001-1:2010, Clause 4.4: Step by step . 23
7.1 General . 23
7.2 Application of Subclause 4.4.1: Document all RISK MANAGEMENT elements . 23
7.3 Note about RISK EVALUATION . 23
7.4 The 10-step PROCESS . 23
7.4.1 STEP 1: Identify HAZARDs and HAZARDOUS SITUATIONS . 23
7.4.2 STEP 2: Identify causes and resulting HAZARDOUS SITUATIONS . 24
7.4.3 STEP 3: Determine UNINTENDED CONSEQUENCES and estimate the
potential severities . 25
7.4.4 STEP 4: Estimate the probability of UNINTENDED CONSEQUENCE . 25

7.4.5 STEP 5: Evaluate RISK . 26
7.4.6 STEP 6: Identify and document proposed RISK CONTROL measures
and re-evaluate RISK (return to Step 3) . 27
7.4.7 STEP 7: Implement RISK CONTROL measures . 28
7.4.8 STEP 8: Verify RISK CONTROL measures . 29
7.4.9 STEP 9: Evaluate any new RISKS arising from RISK CONTROL . 30
7.5 The steps and their relationship to IEC 80001-1 and ISO 14971 . 30
8 Practical examples . 31
8.1 General . 31
8.2 Example 1: Wireless PATIENT monitoring during PATIENT transport . 32
8.2.1 Full description of context . 32
8.2.2 Description of network under analysis. 32
8.2.3 The 10 Steps . 32
8.3 Example 2: Remote ICU / Distance medicine . 35

TR 80001-2-1  IEC:2012(E) – 3 –

8.3.1 Full description of context . 35

8.3.2 Description of network under analysis. 35

8.3.3 The 10 Steps . 35

8.4 Example 3: Post Anaesthesia Care Unit (PACU) . 38

8.4.1 Full description of context . 38

8.4.2 Description of network under analysis. 38

8.4.3 The 10 Steps . 39

8.5 Example 4: Ultrasound –Operating system (OS) vulnerability . 44

8.5.1 Full description of context . 44

8.5.2 Description of network under analysis. 44

8.5.3 The 10 Steps . 44
Annex A (informative) Common HAZARDS, HAZARDOUS SITUATIONS, and causes to
consider in MEDICAL IT-NETWORKS . 48
Annex B (informative) List of questions to consider when identifying HAZARDs of the
MEDICAL IT-NETWORK . 52
Annex C (informative) Layers of MEDICAL IT-NETWORKS where errors can be found . 53
Annex D (informative) Probability, severity, and RISK acceptability scales used in the
examples in this technical report . 56
Annex E (informative) MONITORING RISK mitigation effectiveness . 59
Annex F (informative) RISK ANALYZING small changes in a MEDICAL IT-NETWORK . 62
Annex G (informative) Example of Change Window Form . 63
Annex H (informative) Template for examples . 64
Bibliography . 66

Figure 1 – Basic flow of concepts from HAZARD to HAZARDOUS SITUATION to UNINTENDED
CONSEQUENCE . 15
Figure 2 – Steps 1 – 5: HAZARD identification through RISK EVALUATION . 20
Figure 3 – Steps 6 – 10: RISK CONTROL measures through overall RESIDUAL RISK . 21
Figure 4 – Sample summary RISK ASSESSMENT register format . 22
Figure 5 – Relation of cause to HARM . 26
Figure 6 – Schematic of the post anaesthesia care unit (PACU). 39
Figure 7 – Example of the use of colour coding cables . 42
Figure 8 – Sample summary RISK ASSESSMENT register for the PACU example . 43

Figure D.1 – Application of STEPs 5 and 6 with 3 levels of RISK acceptability . 58
Figure F.1 – Overview of RISK ANALYZING small changes in a MEDICAL IT-NETWORK . 62

Table 1 – Relationship of KEY PROPERTIES, SAFETY, EFFECTIVENESS and DATA AND
SYSTEMS SECURITY with associated UNINTENDED CONSEQUENCE as used in this technical
report . 17
Table 2 – Methods for checking accurate and appropriate wording of causes,
HAZARDOUS SITUATIONS, and UNINTENDED CONSEQUENCES . 18
Table 3 – Relationship between this technical report, IEC 80001-1:2010 and
ISO 14971:2007 . 31
Table A.1 – HAZARDS related to potential required network characteristics . 50
Table A.2 – Relationship between HAZARDS, foreseeable sequences, and causes . 50
Table A.3 – Relationship between HAZARDS, causes, foreseeable sequences, and
HAZARDOUS SITUATIONS . 51

– 4 – TR 80001-2-1  IEC:2012(E)

Table C.1 – Layers of an MEDICAL IT-NETWORK . 53

Table C.2 – Example of the layers of an MEDICAL IT-NETWORK . 55

Table D.1 – Probability scales used in the examples in this technical report . 56

Table D.2 – Severity scales . 56

Table D.3 – RISK level matrix . 57

TR 80001-2-1  IEC:2012(E) – 5 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities,
...

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)
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
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: [e-mail].

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

– 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) . 17
5.7 Degrees of RISK . 17
5.8 Checking wording . 18
6 The steps . 18
6.1 Overview of the steps . 18
6.2 A basic example using the 10 steps . 19
6.2.1 General . 19
6.2.2 Initial RISK – Steps 1 – 5 (Figure 2) . 19
6.2.3 RISK CONTROL and final RISK – Steps 6 – 10 (Figure 3) . 20
7 IEC 80001-1:2010, Clause 4.4: Step by step . 23
7.1 General . 23
7.2 Application of Subclause 4.4.1: Document all RISK MANAGEMENT elements . 23
7.3 Note about RISK EVALUATION . 23
7.4 The 10-step PROCESS . 23
7.4.1 STEP 1: Identify HAZARDs and HAZARDOUS SITUATIONS . 23
7.4.2 STEP 2: Identify causes and resulting HAZARDOUS SITUATIONS . 24
7.4.3 STEP 3: Determine UNINTENDED CONSEQUENCES and estimate the
potential severities . 25
7.4.4 STEP 4: Estimate the probability of UNINTENDED CONSEQUENCE . 25
7.4.5 STEP 5: Evaluate RISK . 26
7.4.6 STEP 6: Identify and document proposed RISK CONTROL measures
and re-evaluate RISK (return to Step 3) . 27
7.4.7 STEP 7: Implement RISK CONTROL measures . 28
7.4.8 STEP 8: Verify RISK CONTROL measures . 29
7.4.9 STEP 9: Evaluate any new RISKS arising from RISK CONTROL . 30
7.5 The steps and their relationship to IEC 80001-1 and ISO 14971 . 30
8 Practical examples . 31
8.1 General . 31
8.2 Example 1: Wireless PATIENT monitoring during PATIENT transport . 32
8.2.1 Full description of context . 32
8.2.2 Description of network under analysis. 32
8.2.3 The 10 Steps . 32
8.3 Example 2: Remote ICU / Distance medicine . 35

TR 80001-2-1  IEC:2012(E) – 3 –
8.3.1 Full description of context . 35
8.3.2 Description of network under analysis. 35
8.3.3 The 10 Steps . 35
8.4 Example 3: Post Anaesthesia Care Unit (PACU) . 38
8.4.1 Full description of context . 38
8.4.2 Description of network under analysis. 38
8.4.3 The 10 Steps . 39
8.5 Example 4: Ultrasound –Operating system (OS) vulnerability . 44
8.5.1 Full description of context . 44
8.5.2 Description of network under analysis. 44
8.5.3 The 10 Steps . 44
Annex A (informative) Common HAZARDS, HAZARDOUS SITUATIONS, and causes to
consider in MEDICAL IT-NETWORKS . 48
Annex B (informative) List of questions to consider when identifying HAZARDs of the
MEDICAL IT-NETWORK . 52
Annex C (informative) Layers of MEDICAL IT-NETWORKS where errors can be found . 53
Annex D (informative) Probability, severity, and RISK acceptability scales used in the
examples in this technical report . 56
Annex E (informative) MONITORING RISK mitigation effectiveness . 59
Annex F (informative) RISK ANALYZING small changes in a MEDICAL IT-NETWORK . 62
Annex G (informative) Example of Change Window Form . 63
Annex H (informative) Template for examples . 64
Bibliography . 66

Figure 1 – Basic flow of concepts from HAZARD to HAZARDOUS SITUATION to UNINTENDED
CONSEQUENCE . 15
Figure 2 – Steps 1 – 5: HAZARD identification through RISK EVALUATION . 20
Figure 3 – Steps 6 – 10: RISK CONTROL measures through overall RESIDUAL RISK . 21
Figure 4 – Sample summary RISK ASSESSMENT register format . 22
Figure 5 – Relation of cause to HARM . 26
Figure 6 – Schematic of the post anaesthesia care unit (PACU). 39
Figure 7 – Example of the use of colour coding cables . 42
Figure 8 – Sample summary RISK ASSESSMENT register for the PACU example . 43
Figure D.1 – Application of STEPs 5 and 6 with 3 levels of RISK acceptability . 58
Figure F.1 – Overview of RISK ANALYZING small changes in a MEDICAL IT-NETWORK . 62

Table 1 – Relationship of KEY PROPERTIES, SAFETY, EFFECTIVENESS and DATA AND
SYSTEMS SECURITY with associated UNINTENDED CONSEQUENCE as used in this technical
report . 17
Table 2 – Methods for checking accurate and appropriate wording of causes,
HAZARDOUS SITUATIONS, and UNINTENDED CONSEQUENCES . 18
Table 3 – Relationship between this technical report, IEC 80001-1:2010 and
ISO 14971:2007 . 31
Table A.1 – HAZARDS related to potential required network characteristics . 50
Table A.2 – Relationship between HAZARDS, foreseeable sequences, and causes . 50
Table A.3 – Relationship between HAZARDS, causes, foreseeable sequences, and
HAZARDOUS SITUATIONS . 51

– 4 – TR 80001-2-1  IEC:2012(E)
Table C.1 – Layers of an MEDICAL IT-NETWORK . 53
Table C.2 – Example of the layers of an MEDICAL IT-NETWORK . 55
Table D.1 – Probability scales used in the examples in this technical report . 56
Table D.2 – Severity scales . 56
Table D.3 – RISK level matrix . 57

TR 80001-2-1  IEC:2012(E) – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “
...