ANSI TIR80001-2-3-2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3 Guidance for Wireless Networks.pdf

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1、ANSI/AAMI/IEC TIR80001-2-3:2012Technical Information ReportApplication of risk management for IT-networks incorporating medical devices Part 2-3: Guidance for wireless networksAn ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR80001-2-3:2012 Application of risk management for IT-networks inc

2、orporating medical devices Part 2-3: Guidance for wireless networks Approved 20 July 2012 by Association for the Advancement of Medical Instrumentation Approved 2 September 2012 by American National Standards Institute, Inc. Abstract: Supports the Healthcare Delivery Organizations (HDO) in the risk

3、management of medical IT-networks that incorporate one or more wireless links. Keywords: medical device, risk management, information technology, interoperability, wireless networks Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA

4、 22203-1633 www.aami.org 2012 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval syst

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19、rlington, VA 22203-1633. Contents Page Glossary of equivalent standards . vii Committee representation . x FOREWORD . xii INTRODUCTION xiv 1 Scope and object 1 1.1 Scope 1 1.2 Objective . 1 1.3 HDO scalability 2 2 Normative references 2 3 Terms and definitions 3 4 Wireless MEDICAL IT-NETWORK: An int

20、roduction 13 4.1 Basics 13 4.2 Enterprise MEDICAL IT-NETWORK 14 4.3 Use of VLANs and SSIDs . 14 4.4 Wide area MEDICAL IT-NETWORK 15 4.5 Smart phone applications . 16 4.5.1 General 16 4.5.2 Application clinical functionality 16 4.5.3 Cellular networks . 16 4.5.4 Smart phone coexistence . 17 4.5.5 Wir

21、eless data security 17 4.6 DISTRIBUTED ANTENNA SYSTEMS . 17 5 Wireless MEDICAL IT-NETWORKS: Planning and design 18 5.1 Clinical systems and their impact on the wireless network 18 5.1.1 Defining the clinical SLA 18 5.1.2 Creating partnerships . 18 5.1.3 Geographical location 18 5.1.4 Clinical use ca

22、se 19 5.2 MEDICAL DEVICE wireless capabilities 19 5.3 MEDICAL DEVICE capabilities and networking traffic profile . 19 5.4 Network performance requirements 19 5.5 QoS mechanisms . 20 5.6 Receiver capabilities 20 5.7 Received signal strength and SNR versus data rates . 21 5.8 Capacity versus coverage

23、versus AP density . 22 5.9 Deterministic versus non-deterministic wireless access protocol 23 5.10 Planning and design summary . 23 6 Wireless MEDICAL IT-NETWORKS: Deployment and configuration . 23 6.1 RISKS versus benefit of a wireless communications system 23 6.2 Licensed versus unlicensed spectru

24、m 24 Background of AAMI adoption of IEC/TR 80001-2-3:2012 . xi 6.3 Interference sources 24 6.4 Spectrum usage and allocation 24 6.4.1 Device coexistence 24 6.4.2 Spectrum management 24 6.4.3 Capacity management 25 6.5 Wireless network configuration (802.11 specific) 25 6.5.1 General 25 6.5.2 VLAN an

25、d SSID 25 6.5.3 Authentication and encryption 26 6.5.4 Vendor proprietary extensions 26 6.5.5 Cellular and proprietary networks . 26 6.5.6 Network availability 27 6.6 VERIFICATION testing . 27 6.6.1 General 27 6.6.2 Pre GO-LIVE VERIFICATION testing 27 6.6.3 GO-LIVE VERIFICATION testing 27 7 Wireless

26、 MEDICAL IT-NETWORKS: Management and support 28 7.1 General 28 7.2 Network and application management 28 7.3 Policies and procedures . 28 7.4 Change control 29 8 General RISK CONTROL measures . 29 8.1 General 29 8.2 Determining baseline networking performance . 29 8.3 Designing for coverage signal s

27、trength 30 8.4 Segregating traffic and data types 30 8.5 Environmental and physical changes . 30 8.6 Maintaining a clean RF environment 30 8.7 Capacity planning 31 8.7.1 General 31 8.7.2 5 GHz and DYNAMIC FREQUENCY SELECTION (DFS) . 31 8.7.3 Security measures and planning . 31 8.8 RF spectrum use 32

28、 8.9 Device and application classification 32 8.10 Guest or smart phone access . 33 8.11 WLAN infrastructure configuration 33 8.12 External partnering with both MEDICAL DEVICE and networking manufacturer . 33 8.13 Redundancy . 33 Annex A (informative) Clinical use cases and network traffic profiles

29、35 Annex B (informative) Questions to consider 37 Bibliography 42 Figure 2 HDO MEDICAL IT-NETWORK . 15 Figure 3 Wireless WAN connectivity . 16 Figure 4 SIGNAL TO NOISE RATIO . 21 Table A.1 Example clinical use cases and network traffic profiles . 36 Table A.2 Network profile parameters . 36 Figure 1

30、 Focus of technical report . xvi 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR80001-2-3:2012 vii Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each Inter

31、national Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document w

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33、his list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005/(R)2012 Major technical variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES60601

34、-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrigendum 1 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 collab

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43、 technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC 80001-2-3, which is a technical report, has been prepared by a Joint Working G

44、roup of subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice and ISO technical committee 215: Health informatics. 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR800

45、01-2-3:2012 xiii The text of this technical report is based on the following documents: Enquiry draft Report on voting 62A/784/DTR 62A/804/RVC Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. This publication

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48、go on the cover page of this publication indicates that it contains colors which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a color printer. xiv 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/

49、IEC TIR80001-2-3:2012 INTRODUCTION 0.1 Background Wireless communications has been a key technology enabling the connectivity of MEDICAL DEVICES for decades. Early examples of the use of wireless technologies and MEDICAL DEVICES include ambulatory cardiac monitoring systems in hospitals and telemetry systems used by paramedics over wide area wireless networks. While these solutions were based on proprietary technology, the advent of off-the-shelf standards-based approaches has resulted in increasingly ubiquitous wireless communications systems bot