IEC_TR_80001-2-3-2012.pdf

IEC/TR 80001-2-3 Edition 1.0 2012-07 TECHNICAL REPORT Application of risk management for IT-networks incorporating medical devices Part 2-3:Guidance for wireless networks IEC/TR 80001-2-3:2012(E)colourinsideCopyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-28-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.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 either IEC or IECs 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.:+41 22 919 02 11 3,rue de Varemb Fax:+41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch 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 The advanced search enables you to find IEC publications by a variety of criteria(reference number,text,technical committee,).It also gives information on projects,replaced and withdrawn publications.IEC Just Published-webstore.iec.ch/justpublished Stay up to date on all new IEC publications.Just Published details all new publications released.Available on-line and also once a month by email.Electropedia-www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French,with equivalent terms in additional languages.Also known as the International Electrotechnical Vocabulary(IEV)on-line.Customer Service Centre-webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance,please contact the Customer Service Centre:csciec.ch.Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-28-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.IEC/TR 80001-2-3 Edition 1.0 2012-07 TECHNICAL REPORT Application of risk management for IT-networks incorporating medical devices Part 2-3:Guidance for wireless networks INTERNATIONAL ELECTROTECHNICAL COMMISSION X ICS 11.040.01;35.240.80 PRICE CODE ISBN 978-2-83220-203-6 Warning!Make sure that you obtained this publication from an authorized distributor.colourinsideCopyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-28-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.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 Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-28-2014 by James Madi