IEC TR 80001-2-1:2012

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)
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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 publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “
...