IEC TR 80001-2-3:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

IEC/TR 80001-2-3:2012(E), which is a technical report, supports the Healthcare Delivery Organizations (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a medical IT-network and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure and effective manner. The targeted audience for this technical report is the HDO IT department, biomedical and clinical engineering departments, risk managers, and the people responsible for design and operation of the wireless IT network.

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• Status: Withdrawn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• Current Stage: WPUB - Publication withdrawn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 80001-2-3
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –

Part 2-3: Guidance for wireless networks

IEC/TR 80001-2-3:2012(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.

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It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

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IEC/TR 80001-2-3
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –

Part 2-3: Guidance for wireless networks

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
X
ICS 11.040.01; 35.240.80 ISBN 978-2-83220-203-6

– 2 – TR 80001-2-3 © IEC:2012(E)

CONTENTS
FOREWORD . 4

INTRODUCTION . 6

1 Scope and object . 9

1.1 Scope . 9

1.2 Objective . 9

1.3 HDO scalability . 10

2 Normative references . 10
3 Terms and definitions . 11
4 Wireless MEDICAL IT-NETWORK: An introduction . 21
4.1 Basics . 21
4.2 Enterprise MEDICAL IT-NETWORK . 22
4.3 Use of VLANs and SSIDs . 22
4.4 Wide area MEDICAL IT-NETWORK . 23
4.5 Smart phone applications . 24
4.5.1 General . 24
4.5.2 Application clinical functionality . 24
4.5.3 Cellular networks . 24
4.5.4 Smart phone coexistence . 25
4.5.5 Wireless data security . 25
4.6 DISTRIBUTED ANTENNA SYSTEMS . 25
5 Wireless MEDICAL IT-NETWORKS: Planning and design. 26
5.1 Clinical systems and their impact on the wireless network . 26
5.1.1 Defining the clinical SLA . 26
5.1.2 Creating partnerships . 26
5.1.3 Geographical location . 26
5.1.4 Clinical use case . 27
5.2 MEDICAL DEVICE wireless capabilities . 27
5.3 MEDICAL DEVICE capabilities and networking traffic profile . 27
5.4 Network performance requirements . 27
5.5 QoS mechanisms . 28
5.6 Receiver capabilities . 28

5.7 Received signal strength and SNR versus data rates . 29
5.8 Capacity versus coverage versus AP density. 30
5.9 Deterministic versus non-deterministic wireless access protocol. 31
5.10 Planning and design summary . 31
6 Wireless MEDICAL IT-NETWORKS: Deployment and configuration . 31
6.1 RISKS versus benefit of a wireless communications system . 31
6.2 Licensed versus unlicensed spectrum . 31
6.3 Interference sources . 32
6.4 Spectrum usage and allocation . 32
6.4.1 Device coexistence . 32
6.4.2 Spectrum management . 32
6.4.3 Capacity management . 33
6.5 Wireless network configuration (802.11 specific) . 33
6.5.1 General . 33

TR 80001-2-3 © IEC:2012(E) – 3 –

6.5.2 VLAN and SSID . 33

6.5.3 Authentication and encryption . 33

6.5.4 Vendor proprietary extensions . 34

6.5.5 Cellular and proprietary networks . 34

6.5.6 Network availability. 34

6.6 VERIFICATION testing . 35

6.6.1 General . 35

6.6.2 Pre GO-LIVE VERIFICATION testing . 35

6.6.3 GO-LIVE VERIFICATION testing . 35

7 Wireless MEDICAL IT-NETWORKS: Management and support . 36

7.1 General . 36
7.2 Network and application management . 36
7.3 Policies and procedures . 36
7.4 Change control . 36
8 General RISK CONTROL measures . 37
8.1 General . 37
8.2 Determining baseline networking performance . 37
8.3 Designing for coverage signal strength . 37
8.4 Segregating traffic and data types . 38
8.5 Environmental and physical changes . 38
8.6 Maintaining a clean RF environment . 38
8.7 Capacity planning . 38
8.7.1 General . 38
8.7.2 5 GHz and DYNAMIC FREQUENCY SELECTION (DFS) . 39
8.7.3 Security measures and planning . 39
8.8 RF spectrum use . 40
8.9 Device and application classification . 40
8.10 Guest or smart phone access . 40
8.11 WLAN infrastructure configuration . 41
8.12 External partnering with both MEDICAL DEVICE and networking manufacturer. 41
8.13 Redundancy . 41
Annex A (informative) Clinical use cases and network traffic profiles . 42
Annex B (informative) Questions to consider . 44
Bibliography . 48

Figure 1 – Focus of technical report . 8
Figure 2 – HDO MEDICAL IT-NETWORK . 23
Figure 3 – Wireless WAN connectivity . 24
Figure 4 – SIGNAL TO NOISE RATIO . 29

Table A.1 – Example clinical use cases and network traffic profiles . 43
Table A.2 – Network profile parameters . 43

– 4 – TR 80001-2-3 © IEC:2012(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
APPLICATION OF RISK MANAGEMENT FOR

IT-NETWORKS INCORPORATING MEDICAL DEVICES –

Part 2-3: Guidance for wireless networks

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 “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interest
...

IEC/TR 80001-2-3
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –

Part 2-3: Guidance for wireless networks

IEC/TR 80001-2-3:2012(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 80001-2-3
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –

Part 2-3: Guidance for wireless networks

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
X
ICS 11.040.01; 35.240.80 ISBN 978-2-83220-203-6

– 2 – TR 80001-2-3 © IEC:2012(E)
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 9
1.1 Scope . 9
1.2 Objective . 9
1.3 HDO scalability . 10
2 Normative references . 10
3 Terms and definitions . 11
4 Wireless MEDICAL IT-NETWORK: An introduction . 21
4.1 Basics . 21
4.2 Enterprise MEDICAL IT-NETWORK . 22
4.3 Use of VLANs and SSIDs . 22
4.4 Wide area MEDICAL IT-NETWORK . 23
4.5 Smart phone applications . 24
4.5.1 General . 24
4.5.2 Application clinical functionality . 24
4.5.3 Cellular networks . 24
4.5.4 Smart phone coexistence . 25
4.5.5 Wireless data security . 25
4.6 DISTRIBUTED ANTENNA SYSTEMS . 25
5 Wireless MEDICAL IT-NETWORKS: Planning and design. 26
5.1 Clinical systems and their impact on the wireless network . 26
5.1.1 Defining the clinical SLA . 26
5.1.2 Creating partnerships . 26
5.1.3 Geographical location . 26
5.1.4 Clinical use case . 27
5.2 MEDICAL DEVICE wireless capabilities . 27
5.3 MEDICAL DEVICE capabilities and networking traffic profile . 27
5.4 Network performance requirements . 27
5.5 QoS mechanisms . 28
5.6 Receiver capabilities . 28
5.7 Received signal strength and SNR versus data rates . 29
5.8 Capacity versus coverage versus AP density. 30
5.9 Deterministic versus non-deterministic wireless access protocol. 31
5.10 Planning and design summary . 31
6 Wireless MEDICAL IT-NETWORKS: Deployment and configuration . 31
6.1 RISKS versus benefit of a wireless communications system . 31
6.2 Licensed versus unlicensed spectrum . 31
6.3 Interference sources . 32
6.4 Spectrum usage and allocation . 32
6.4.1 Device coexistence . 32
6.4.2 Spectrum management . 32
6.4.3 Capacity management . 33
6.5 Wireless network configuration (802.11 specific) . 33
6.5.1 General . 33

TR 80001-2-3 © IEC:2012(E) – 3 –
6.5.2 VLAN and SSID . 33
6.5.3 Authentication and encryption . 33
6.5.4 Vendor proprietary extensions . 34
6.5.5 Cellular and proprietary networks . 34
6.5.6 Network availability. 34
6.6 VERIFICATION testing . 35
6.6.1 General . 35
6.6.2 Pre GO-LIVE VERIFICATION testing . 35
6.6.3 GO-LIVE VERIFICATION testing . 35
7 Wireless MEDICAL IT-NETWORKS: Management and support . 36
7.1 General . 36
7.2 Network and application management . 36
7.3 Policies and procedures . 36
7.4 Change control . 36
8 General RISK CONTROL measures . 37
8.1 General . 37
8.2 Determining baseline networking performance . 37
8.3 Designing for coverage signal strength . 37
8.4 Segregating traffic and data types . 38
8.5 Environmental and physical changes . 38
8.6 Maintaining a clean RF environment . 38
8.7 Capacity planning . 38
8.7.1 General . 38
8.7.2 5 GHz and DYNAMIC FREQUENCY SELECTION (DFS) . 39
8.7.3 Security measures and planning . 39
8.8 RF spectrum use . 40
8.9 Device and application classification . 40
8.10 Guest or smart phone access . 40
8.11 WLAN infrastructure configuration . 41
8.12 External partnering with both MEDICAL DEVICE and networking manufacturer. 41
8.13 Redundancy . 41
Annex A (informative) Clinical use cases and network traffic profiles . 42
Annex B (informative) Questions to consider . 44
Bibliography . 48

Figure 1 – Focus of technical report . 8
Figure 2 – HDO MEDICAL IT-NETWORK . 23
Figure 3 – Wireless WAN connectivity . 24
Figure 4 – SIGNAL TO NOISE RATIO . 29

Table A.1 – Example clinical use cases and network traffic profiles . 43
Table A.2 – Network profile parameters . 43

– 4 – TR 80001-2-3 © IEC:2012(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –

Part 2-3: Guidance for wireless networks

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 “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees
...