IEC 61157-2007 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment《医疗诊断超声波设备声输出的报告用标准方法》.pdf

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1、 IEC 61157Edition 2.0 2007-08INTERNATIONAL STANDARD Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment IEC61157:2007(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no

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8、ustserv If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 61157Edition 2.0 2007-08INTERNATIONAL STANDARD Standard means for the reporting o

9、f the acoustic output of medical diagnostic ultrasonic equipment INTERNATIONAL ELECTROTECHNICAL COMMISSION VICS 11.040.50; 11.140.50 PRICE CODEISBN 2-8318-9257-0 2 61157 IEC:2007(E) CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope.6 2 Normative references .6 3 Terms, definitions and symbols 6 4 Requiremen

10、ts .16 4.1 General .16 4.2 Requirements for the reporting of acoustic output information .17 4.2.1 Technical data sheets information format 17 4.2.2 Detailed operating mode data sheets information format .18 4.2.3 Background information.19 4.2.4 Diagnostic fields in the absence of scan-frame synchro

11、nization.20 4.2.5 Dataset for low acoustic output equipment.20 5 Compliance statement 21 5.1 General .21 5.2 Maximum probable values .21 5.3 Sampling .21 6 Test methods .22 7 Presentation of results22 Annex A (normative) Presentation of acoustic output information.23 Annex B (informative) Reporting

12、requirements for extensive systems 25 Annex C (informative) Rationale 26 Index of defined terms 30 Bibliography32 Figure C.1 Schematic diagram showing the relationship between the various defined surfaces and distances for a mechanical sector scanner with water stand-off distance when applied to a p

13、atient27 Figure C.2 Schematic diagram showing the relationship between the various defined parameters and distances for a mechanical sector scanner during the measurement of acoustic output .27 Figure C.3 Schematic diagram showing various defined parameters associated with the distribution of the sc

14、an lines in a linear array scanner and mechanically-scanned sector scanner28 Figure C.4 Schematic diagram illustrating the peak-rarefactional acoustic pressure during an acoustic pulse.29 Table 1 List of symbols 15 Table A.1 An example of reporting of the acoustic output of a 3,5 MHz scan-head for a

15、 phased-array sector scanner in accordance with this standard24 61157 IEC:2007(E) 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT FOREWORD 1) The International Electrotechnical Commission (IEC) is a worl

16、dwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of 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 a

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18、ect dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions det

19、ermined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Comm

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21、h they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publicat

22、ion and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure tha

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25、d publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. Internatio

26、nal Standard IEC 61157 has been prepared by IEC technical committee 87: Ultrasonics. This second edition cancels and replaces the first edition published in 1992. This edition constitutes a minor revision. The changes with respect to the previous edition are listed below: maintenance on this standar

27、d and the referenced standards IEC 61161 and IEC 62127-1. a clause on compliance has been added. The text of this standard is based on the following documents: Enquiry draft Report on voting 87/356/CDV 87/374/RVC 4 61157 IEC:2007(E) Full information on the voting for the approval of this standard ca

28、n be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. NOTE The following print types are used: Requirements: in roman type Test specifications: in italic type Notes: in small roman type Words in bold in t

29、he text are defined in Clause 3. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be

30、reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. 61157 IEC:2007(E) 5 INTRODUCTION This International Standard specifies a standard means and format for the reporting of the acoustic output of medical diagnostic

31、ultrasonic equipment. The numerical values for reporting purposes represent the average values for the maximum output conditions for a given discrete- or combined-operating mode and are derived from measurements made in water. Intensity parameters are specified in this standard, but these are regard

32、ed as derived quantities that are meaningful only under certain assumptions related to the ultrasonic field being measured. 6 61157 IEC:2007(E) STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT 1 Scope This International Standard is applicable to medi

33、cal diagnostic ultrasonic equipment. It provides a set of traceable acoustic parameters describing the acoustic fields. It defines a standard means and format for the reporting of the acoustic output information. It also describes a reduced dataset recommended for equipment generating low acoustic o

34、utput levels. NOTE The information tabulated in this standard format can be used for a) exposure planning for biological effects studies; b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to those reported in this standard. In the absence of actual

35、exposure data for retrospective epidemiological studies, the information tabulated in this standard format might also be used with cautionary comment. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edit

36、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60050-801:1994 International Electrotechnical Vocabulary Chapter 801: Acoustics and electroacoustics IEC 61161, Ultrasonics Power measurement Radiation force balances and

37、performance requirements IEC 62127-1, Ultrasonics Hydrophones Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz ISO 16269-6:2005, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals ISO/IEC Guide 98:1995, Guide to the expressio

38、n of uncertainty in measurement (GUM) 3 Terms, definitions and symbols For the purposes of this document, the terms and definitions given in IEC 62127-1, IEC 61161, the Index of defined terms at the end of this standard and the following definitions apply. Figures C.1 to C.4 illustrate some of the d

39、efined parameters given below. 3.1 acoustic output freeze condition of a system for which the acoustic output is disabled when there is no active updating of ultrasonic echo information 61157 IEC:2007(E) 7 3.2 acoustic pulse waveform temporal waveform of the instantaneous acoustic pressure at a spec

40、ified position in an acoustic field and displayed over a period sufficiently long to include all significant acoustic information in a single pulse or tone-burst, or in one or more cycles in a continuous wave NOTE 1 Temporal waveform is a representation (e.g. oscilloscope presentation or equation) o

41、f the instantaneous acoustic pressure. NOTE 2 Definition adapted from IEC 60469-1. 3.3 acoustic repetition period arp pulse repetition period for non-automatic scanning systems and the scan repetition period for automatic scanning systems, equal to the time interval between corresponding points of c

42、onsecutive cycles for continuous wave systems NOTE 1 The acoustic repetition period is expressed in seconds (s). IEC 62127-1, definition 3.2 3.4 acoustic frequency acoustic-working frequency frequency of an acoustic signal based on the observation of the output of a hydrophone placed in an acoustic

43、field at the position corresponding to the spatial-peak temporal-peak acoustic pressure NOTE 1 The signal is analysed using either the zero-crossing acoustic-working frequency technique or a spectrum analysis method. Acoustic-working frequencies are defined in 3.4.1 and 3.4.2. NOTE 2 In a number of

44、cases, the present definition is not very helpful or convenient, especially for broadband transducers. In that case, a full description of the frequency spectrum should be given in order to enable any frequency-dependent correction to the signal. NOTE 3 Acoustic frequency is expressed in hertz (Hz).

45、 3.4.1 zero-crossing acoustic-working frequency fawfthis is determined according to the procedure specified in IEC/TR 60854 NOTE This frequency is intended for continuous wave systems only. 3.4.2 arithmetic-mean acoustic-working frequency fawfarithmetic mean of the most widely separated frequencies

46、f1and f2, within the range of three times f1, at which the magnitude of the acoustic pressure spectrum is 3 dB below the peak magnitude NOTE 1 This frequency is intended for pulse-wave systems only. NOTE 2 It is assumed that f1 f2.3.5 bandwidth BW difference in the most widely separated frequencies

47、f1and f2at which the magnitude of the acoustic pressure spectrum becomes 3 dB below the peak magnitude, at a specified point in the acoustic field NOTE Bandwidth is expressed in hertz (Hz). 8 61157 IEC:2007(E) 3.6 beam area Abarea in a specified plane perpendicular to the beam axis consisting of all

48、 points at which the pulse-pressure-squared integral is greater than a specified fraction of the maximum value of the pulse-pressure-squared integral in that plane NOTE 1 If the position of the plane is not specified, it is the plane passing through the point corresponding to the spatial-peak tempor

49、al-peak acoustic pressure in the whole acoustic field. NOTE 2 In a number of cases, the term pulse-pressure-squared integral is replaced everywhere in the above definition by any linearly related quantity, for example: a) in the case of a continuous wave signal the term pulse-pressure-squared integral is replaced by mean square acoustic pressure as defined in IEC 61689; b) in cases where signal synchronisation with the scanframe is not available the term pulse-pressure-