AAMI-TIR24-1999.pdf
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1、Technical Information Report AAMI TIR No. 24:1999 AAMI Association for the Advancement of Medical Instrumentation Acquisition and use of physiologic waveform databases for testing of medical devices Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license wi
2、th AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:24 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI TIR No. 24:1999 Acquisition and use of physiologic waveform databases for testing of medical devices Approved 18 August 1999
3、 by Association for the Advancement of Medical Instrumentation Abstract:This report defines the nomenclature, ingredients, and principles needed to develop, annotate, evaluate, and use physiologic waveform databases in developing and testing medical devices. Keywords:waveform, physiologic, algorithm
4、s, arrhythmia Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:24 MDTNo reproduction or networking permitted without license from IHS -,-,- Published by A
5、ssociation for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2000 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise,
6、of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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
7、 externally) without the prior written permission 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, contact
8、 AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570201323 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111
9、111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:24 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Sta
10、ndards 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 TIR differs markedly from a standard
11、 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 supervised by the AAMI Standards Boa
12、rd and, in the case of American National Standards, the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a technical committee and the AAMI Standards Board do approve a TIR for distribution. Another difference is that although bo
13、th standards and TIRs are periodically reviewed, a standard must be acted uponeither reaffirmed, revised, or withdrawnand the action must be 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 publicat
14、ion 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 more responsive to underly
15、ing 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 technical information report may be revise
16、d 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. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under l
17、icense with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:24 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IH
18、S Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:24 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Committee representationvii Acknowledgmentsvii Foreword. viii Introduction.ix 1Scope1 2Normative reference .1 3Definitions.1 4Database
19、 requirements 2 4.1Intended use of database 2 4.2Clinical requirements .2 4.2.1Population2 4.2.2Study design2 4.3Engineering requirements2 4.4Annotation requirements3 4.5Archive requirements.3 5Waveform acquisition and synthesis 3 5.1Overview3 5.2Signal issues and requirements.3 5.2.1Distortion .3 5
20、.2.2Distortion classifications4 5.2.3Skew6 5.2.4Duration.6 5.2.5Frequency translation6 5.3System design issues and requirements.6 5.3.1Sampling theory considerations 7 5.3.2Architectural issues .21 5.3.3Channel acquisition guidelines22 5.4Storage 23 5.4.1Raw signalsanalog databases .24 5.4.2Waveform
21、sdigital databases24 5.5Archive.24 5.5.1Environmental considerations .24 5.5.2Format .25 5.5.3Data integrity25 5.5.4Applicable standards .25 5.6Database annotation25 5.6.1Annotation process25 5.6.2Annotation rules.26 5.6.3Data presentation specifications26 5.7Maintenance and distribution.27 6Applica
22、tion of waveform databases to testing 27 6.1Evaluation of performance.27 6.2Test objectives.27 6.3Algorithm versus device testing system.28 6.4Sufficiency and validity.28 6.4.1Sufficiency .28 6.4.2Validitycorrect conclusions from results.29 6.4.3Precautions, limitations, interpolations, and interpre
23、tations (limited scope of results) 29 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:24 MDTNo reproduction or networking permitted without license from
24、IHS -,-,- Annexes ACSE ECG Reference Library (Measurement Database).31 BCSE ECG Reference Library (Diagnostic Database)33 CMIT-BIH Arrhythmia Database36 DNoise Stress Database.38 EEuropean ST-T Database.39 FAmerican Heart Association Database for Evaluation of Automated Ventricular Arrhythmia Detect
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