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
5、em, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission
6、of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or cont
7、act AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1570204535 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement o
8、f Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A
9、TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is
10、supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Bo
11、ard. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about fi
12、ve years after the publication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is
13、 more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be rev
14、ised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices, technical information reports, and other types of t
15、echnical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the ado
16、pting agency is responsible for enforcement of its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registe
17、red by the American National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registr
18、ation of Technical Reports with ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, A
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
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