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1、TECHNICAL SPECIFICATION IEC TS 61895 First edition 1999-10 Ultrasonics Pulsed Doppler diagnostic systems Test procedures to determine performance Ultrasons Systmes de diagnostic effet Doppler pulss Procdures dessai pour dterminer la performance Reference number IEC/TS 61895:1999(E) Copyright Interna
2、tional Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without license from IHS -,-,- Numbering As from 1 January 1997 all IEC publications are issued
3、 with a designation in the 60000 series. Consolidated publications Consolidated versions of some IEC publications including amendments are available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the base publication incorporating amendment 1 and the bas
4、e publication incorporating amendments 1 and 2. Validity of this publication The technical content of IEC publications is kept under constant review by the IEC, thus ensuring that the content reflects current technology. Information relating to the date of the reconfirmation of the publication is av
5、ailable in the IEC catalogue. Information on the subjects under consideration and work in progress undertaken by the technical committee which has prepared this publication, as well as the list of publications issued, is to be found at the following IEC sources: IEC web site* Catalogue of IEC public
6、ations Published yearly with regular updates (On-line catalogue)* IEC Bulletin Available both at the IEC web site* and as a printed periodical Terminology, graphical and letter symbols For general terminology, readers are referred to IEC 60050: International Electrotechnical Vocabulary (IEV). For gr
7、aphical symbols, and letter symbols and signs approved by the IEC for general use, readers are referred to publications IEC 60027: Letter symbols to be used in electrical technology, IEC 60417: Graphical symbols for use on equipment. Index, survey and compilation of the single sheets and IEC 60617:
8、Graphical symbols for diagrams. * See web site address on title page. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without
9、license from IHS -,-,- TECHNICAL SPECIFICATION IEC TS 61895 First edition 1999-10 Ultrasonics Pulsed Doppler diagnostic systems Test procedures to determine performance Ultrasons Systmes de diagnostic effet Doppler pulss Procdures dessai pour dterminer la performance PRICE CODE IEC 1999 Copyright -
10、all rights reserved 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 the publisher. International Electrotechnical Commission3, rue de Varemb Geneva, Switzerland T
11、elefax: +41 22 919 0300e-mail: inmailiec.ch IEC web site http:/www.iec.ch P For price, see current catalogue Commission Electrotechnique Internationale International Electrotechnical Commission Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Emp
12、loyees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without license from IHS -,-,- 2 TS 61895 IEC:1999(E) CONTENTS Page FOREWORD 4 INTRODUCTION 6 Clause 1Scope 7 2Normative references. 7 3Definitions 7 4Symbols. 12 5Overall tests of com
13、plete systems 12 5.1General considerations . 12 5.1.1Types of pulsed Doppler ultrasound systems 12 5.1.2Worst-case conditions. 13 5.1.3Doppler beam axes . 14 5.1.4Probe/target distance variation and measurement 14 5.2Initial conditions 15 5.2.1Power supply. 15 5.2.2Target movement direction 15 5.2.3
14、Propagation medium . 15 5.2.4Penetration depth 16 5.2.5Working depth. 16 5.2.6Focusing . 16 5.2.7Working Doppler angle 16 5.2.8Wall-thump filter cut-off frequency. 17 5.2.9Transmitter output power. 17 5.2.10 Working pulse repetition frequency (PRF) 17 5.2.11 Doppler (receiver) gain 17 5.2.12 Test fr
15、equency 17 5.2.13 Working sample volume length 17 5.2.14 Doppler signal power measurement. 17 5.3Zero signal noise level 17 5.4Doppler frequency response 18 5.4.1Frequency response range 18 5.4.2Deviation from flat response 18 5.4.3Large signal performance 18 5.5Spatial response . 19 5.5.1Sample vol
16、ume response. 19 5.6Sample volume position registration error 20 5.7Beam position and orientation . 21 5.8Intrinsic broadening. 22 5.9Dead zone 22 5.10Acoustic working frequency. 22 5.11Flow direction separation. 22 5.12Velocity estimation accuracy . 22 Copyright International Electrotechnical Commi
17、ssion Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without license from IHS -,-,- TS 61895 IEC:1999(E) 3 5.13Volume flow estimation accuracy. 22 5.14Maximum, mean, mode and me
18、dian frequency estimation accuracy. 23 5.15Velocity waveform indices estimation accuracy 25 6Doppler test objects. 26 6.1Test objects. 26 6.2Electronic test object . 26 Annex A (normative) Description of pulsed Doppler ultrasound systems 28 A.1 Single-channel system . 28 A.2 Multi-channel system 29
19、A.3 Aliasing 29 A.4 Duplex and triplex scanners . 29 Bibliography . 32 Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without
20、 license from IHS -,-,- 4 TS 61895 IEC:1999(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION ULTRASONICS PULSED DOPPLER DIAGNOSTIC SYSTEMS TEST PROCEDURES TO DETERMINE PERFORMANCE FOREWORD 1)The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising al
21、l national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Stand
22、ards. Their preparation is entrusted to technical committees; 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. The IEC c
23、ollaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2)The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus of op
24、inion on the relevant subjects since each technical committee has representation from all interested National Committees. 3)The documents produced have the form of recommendations for international use and are published in the form of standards, technical specifications, technical reports or guides
25、and they are accepted by the National Committees in that sense. 4)In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IE
26、C Standard and the corresponding national or regional standard shall be clearly indicated in the latter. 5)The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. 6) Attention is drawn
27、 to the possibility that some of the elements of this technical specification may be the subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. In exceptional circ
28、umstances, a technical committee may propose the publication of a technical specification when the required support cannot be obtained for the publication of an International Standard, despite repeated efforts, or the subject is still under technical development or where, for any other reason, there
29、 is the future but no immediate possibility of an agreement on an International Standard. Technical specifications are subject to review within three years of publication to decide whether they can be transformed into International Standards. IEC 61895, which is a technical specification, has been p
30、repared by IEC technical committee 87: Ultrasonics. The text of this technical specification is based on the following documents: Enquiry draftReport on voting 87/151/CDV87/168/RVC Full information on the voting for the approval of this technical specification can be found in the report on voting in
31、dicated in the above table. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without license from IHS -,-,- TS 61895 IEC:1999(E
32、) 5 This publication has been drafted in accordance with the ISO/IEC Directives, Part 3. Annex A forms an integral part of this technical specification. The committee has decided that this publication remains valid until 2005. At this date, in accordance with the committees decision, the publication
33、 will be reconfirmed; withdrawn; replaced by a revised edition,or amended. A bilingual version of this publication may be issued at a later date. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Res
34、ale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without license from IHS -,-,- 6 TS 61895 IEC:1999(E) INTRODUCTION Pulsed ultrasonic Doppler flowmeters and velocimeters are widely used in clinical practice, usually in combination with real-time B-mode imaging and colour-flow imag
35、ing instruments. The device periodically transmits pulses of ultrasound from an ultrasound transducer and measures the Doppler shift in the frequency of ultrasound reflected and scattered from moving tissues. This Doppler shift is proportional to the component of reflector or scatterer velocity alon
36、g the ultrasound beam. By looking for Doppler shifts in the received signal at specific times after transmission (range-gating), the device can be used to determine the variation of tissue velocity with distance along the ultrasound beam. The device is sensitive to movement only within a region of t
37、he beam called the sample volume. The position of the sample volume along the beam may be adjusted by altering the delay between transmission and range-gating. Multi- channel devices have a number of sample volumes operating simultaneously. The pulsed ultrasonic device is most commonly used to inves
38、tigate blood flow when the ultrasound is scattered from red blood cells. This technical specification describes a range of tests which may be used to measure performance and the test objects required. In many cases, the test method and test object have been described in IEC 61206 and in these cases
39、reference is simply made to this document. Other tests and test objects are described in 1 and 2. The test methods may be considered as falling into one of the following three categories. The first is routine quality control tests that can be carried out by a clinician or technologist to ensure that
40、 the system is working adequately or has adequate sensitivity. The second is more elaborate test methods, conducted less frequently, when, for example, the system is suspected of malfunctioning. The third represents tests that would be carried out by a manufacturer on complete systems in order to gu
41、arantee compliance with specification. Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/10/2007 02:55:25 MSTNo reproduction or networking permitted without license from IHS -,-,- TS 61895
42、 IEC:1999(E) 7 ULTRASONICS PULSED DOPPLER DIAGNOSTIC SYSTEMS TEST PROCEDURES TO DETERMINE PERFORMANCE 1 Scope This technical specification describes test methods for measuring the performance of pulsed Doppler ultrasound systems; Doppler test objects for carrying out these tests; and applies to test
43、s made on an overall pulsed Doppler ultrasound system, a system which is not disassembled or disconnected; tests made on pulsed Doppler ultrasound systems whether they are stand-alone or as part of another ultrasound instrument. Electrical safety, acoustic output and electromagnetic compatibility (E
44、MC) are not covered in this technical specification. The workload to perform all described tests is, in general, prohibitive. It is intended that a subset of the described tests is adopted for regular use. However, experience to give guidance for selection has still to be gathered and will be the su
45、bject of ongoing work. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this technical specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. Ho
46、wever, parties to agreements based on this technical specification are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IEC a
47、nd ISO maintain registers of currently valid International Standards. IEC 61102:1991, Measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0,5 MHz to 15 MHz IEC 61206:1993, Ultrasonics Continuous-wave Doppler systems Test procedures IEC 61390:1996, Ultrasoni
48、cs Real-time pulse-echo systems Test procedures to determine performance specifications 3 Definitions For the purposes of this technical report, the following definitions apply. 3.1 6 dB spectral width width of a frequency spectrum between the frequencies at which the spectral power is 6 dB less than the maximum power Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=IHS Employees/1111111001,