AAMI-TIR18-1997.pdf
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1、Technical Information Report AAMI TIR18:1997 AAMI Association for the Advancement of Medical Instrumentation Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers Part 1: Radiated radio-frequency electromagnetic energy AAMI TIR No.181997 Guidance on Electroma
2、gnetic Compatibility of Medical Devices for Clinical/Biomedical EngineersPart 1: Radiated Radio-Frequency Electromagnetic Energy Approved 4 August 1997 Abstract: This AAMI Technical Information Report (TIR) provides information and guidance to clinical engineers and other biomedical personnel on ele
3、ctromagnetic compatibility (EMC) of medical devices. It is intended to help them evaluate the radiated radio-frequency (RF) electromagnetic environment in their individual health care facilities and implement actions needed to minimize electromagnetic interference (EMI) problems. The TIR covers gene
4、ral recommendations regarding EMC, with emphasis on radiated RF immunity. Principles of electromagnetic energy and interference mechanisms are discussed, as are: assessment of the radiated RF electromagnetic environment; site selection, design, and construction of new facilities; management of the r
5、adiated RF electromagnetic environment; management of medical devices for EMC; investigation and reporting of EMI problems; selected case studies in radiated EMI problems; and a model EMC/EMI policy and guidance for developing EMC/EMI policies. Definitions of terms and a bibliography are also provid
6、ed. Keywords: ad hoc testing, cellular telephones, conducted, EMC, EMI, ESD, PCS telephones, radiated, RF immunity, wireless LANs Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 1997 by the Association for the Advancement
7、 of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this d
8、raft 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 of the Association for the Advancement of Medical Instrumentation. Violators risk lega
9、l 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, contact Kurt C. Larrick, Director, Technical Publishing, at AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ex
10、t. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-092-0 AAMI TECHNICAL INFORMATION REPORT A Technical Information Report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect
11、of medical technology. Although the material presented in a TIR may need further evaluation by experts, there is value in releasing the information because of the immediate need for it by the industry and the professions. A TIR differs markedly from a standard or recommended practice, and readers sh
12、ould 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 supervised by the AAMI Standards Board and, in the case of American National
13、 Standards, 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 Board. Another difference is that although both standards and TIRs are periodical
14、ly reviewed, a standard must be acted uponeither reaffirmed, revised, or withdrawnand the action formally approved usually every 5 years but at least every 10 years. For a TIR, AAMI consults with a technical committee about every 5 years after the publication date (and periodically thereafter) for g
15、uidance 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 more responsive to underlying safety or performance issues than a stan
16、dard 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 technical Information report may be revised or withdrawn at any time. Because it addr
17、esses 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. CONTENTS Page Committee representation.vii Foreword.ix Acknowledgmentsx 1Introduction and scope.1 2Abbreviations and definitions.1 2.1
18、Abbreviations.1 2.2 Definitions3 3Recommendations4 4Principles of electromagnetic energy and interference mechanisms5 4.1Coupling of electromagnetic energy.5 4.1.1Radiation 5 4.1.2Conduction5 4.1.3Induction.6 4.2Mechanisms of electromagnetic interference 6 4.2.1Junction rectification .6 4.2.2Bit cor
19、ruption6 4.2.3Co-channel, adjacent channel, and intermodulation interference6 4.3Factors affecting the degree of electromagnetic interference7 4.3.1Frequency and wavelength.7 4.3.2Radiated power .7 4.3.3Field strength 9 4.3.4Absorption and reflection.10 4.3.5Modulation10 4.3.6Device design11 4.3.7De
20、vice maintenance.11 5Assessment of the radiated radio-frequency electromagnetic environment in existing facilities11 5.1Identification of RF sources.11 5.1.1Intentional sources.11 5.1.2Unintentional sources 12 5.2Identification of areas where critical medical devices are used12 5.3Ambient electromag
21、netic measurements.12 6Site selection, design, and construction of new facilities13 7Management of the radiated radio-frequency electromagnetic environment13 7.1On-site portable and mobile RF sources.13 7.1.1Categories of RF communications equipment users13 -,-,- 1997 Association for the Advancement
22、 of Medical Instrumentationvi 7.1.2Management strategies 14 7.2On-site fixed RF sources.15 7.2.1Pager transmitters15 7.2.2Commercial and safety service RF repeaters and cellular and PCS base stations16 7.2.3Outside RF sources .18 7.2.4Analysis18 7.3Other EMI Mitigation Measures18 7.3.1Floorplanning1
23、9 8Management of medical devices for electromagnetic compatibility19 8.1New medical devices.19 8.2Existing medical devices20 8.2.1User training .20 8.2.2Service/maintenance20 8.2.3Ad hoc RF immunity testing21 8.3Implantable medical devices22 9Investigation and reporting of EMI problems22 9.1Investig
24、ation .22 9.2Reporting23 10 Selected case studies in radiated EMI problems23 10.1Electroencephalography equipment24 10.1.1Interference from cellular telephones24 10.1.2Interference from an elevator relay switching system24 10.2Dialysis equipment24 10.3Ventilators24 10.3.1Interference from a two-way
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