IEC 61157 Edition 2.1-2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment《医用超声诊断设备的声学输出报告用标准平均值》.pdf

1、 IEC 61157 Edition 2.1 2013-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment Critres normaliss de dclaration des missions acoustiques des appareils de diagnostic mdical ultrasons IEC61157:2007+A1:2013 co

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16、ANDARD NORME INTERNATIONALE Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment Critres normaliss de dclaration des missions acoustiques des appareils de diagnostic mdical ultrasons INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE I

17、NTERNATIONALE ICS 11.040.50, 17.140.50 ISBN 978-2-8322-0634-8 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez

18、vous assurer que vous avez obtenu cette publication via un distributeur agr. colourinside 2 61157 IEC:2007+A1:2013 CONTENTS FOREWORD . 3 INTRODUCTION . 5 1 Scope . 6 2 Normative references . 6 3 Terms, definitions and symbols 6 4 Requirements . 17 4.1 General . 17 4.2 Requirements for the reporting

19、of acoustic output information . 19 4.2.1 Technical data sheets information format 19 4.2.2 Detailed operating mode data sheets information format . 19 4.2.3 Background information . 21 4.2.4 Diagnostic fields in the absence of scan-frame synchronization . 22 4.2.5 Dataset for low acoustic output eq

20、uipment . 22 5 Compliance statement 22 5.1 General . 22 5.2 Maximum probable values . 23 5.3 Sampling . 23 6 Test methods . 23 7 Presentation of results 23 Annex A (normative) Presentation of acoustic output information . 24 Annex B (informative) Reporting requirements for extensive systems 26 Annex

21、 C (informative) Rationale 27 Index of defined terms 31 Bibliography 33 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 patient 28 Figure C.2 Schematic diagram sho

22、wing the relationship between the various defined parameters and distances for a mechanical sector scanner during the measurement of acoustic output . 28 Figure C.3 Schematic diagram showing various defined parameters associated with the distribution of the scan lines in a linear array scanner and m

23、echanically-scanned sector scanner 29 Figure C.4 Schematic diagram illustrating the peak-rarefactional acoustic pressure during an acoustic pulse . 30 Table 1 List of symbols 16 Table A.1 An example of reporting of the acoustic output of a 3,5 MHz scan-head for a phased-array sector scanner in accor

24、dance with this standard 25 61157 IEC:2007+A1:2013 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 worldwide organization for standard

25、ization 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 activities, IEC publishes Intern

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34、wn to the Normative references cited in this publication. Use of the referenced 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

35、 be held responsible for identifying any or all such patent rights. This consolidated version of IEC 61157 consists of the second edition (2007) documents 87/356/CDV and 87/374/RVC, its amendment 1 (2013) documents 87/517/FDIS and 87/523/RVD and its corrigendum of August 2008. It bears the edition n

36、umber 2.1. The technical content is therefore identical to the base edition and its amendment and has been prepared for user convenience. A vertical line in the margin shows where the base publication has been modified by amendment 1. Additions and deletions are displayed in red, with deletions bein

37、g struck through. 4 61157 IEC:2007+A1:2013 International Standard IEC 61157 has been prepared by IEC technical committee 87: Ultrasonics. The changes with respect to the previous edition are listed below: maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1. a clause o

38、n compliance has been added. This bilingual version (2012-06) corresponds to the monolingual English version, published in 2007-08. The French version of this standard has not been voted upon. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. NOTE The following pri

39、nt types are used: Requirements: in roman type Test specifications: in italic type Notes: in small roman type Words in bold in the text are defined in Clause 3. The committee has decided that the contents of the base publication and its amendments will remain unchanged until the stability date indic

40、ated 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 reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The “colour inside” logo on the cover page of this publication indicates that it

41、contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this publication using a colour printer. 61157 IEC:2007+A1:2013 5 INTRODUCTION This International Standard specifies a standard means and format for the reporting of the aco

42、ustic output of medical diagnostic 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

43、this standard, but these are regarded as derived quantities that are meaningful only under certain assumptions related to the ultrasonic field being measured. 6 61157 IEC:2007+A1:2013 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT 1 Scope This Inte

44、rnational Standard is applicable to medical 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

45、 for equipment generating low acoustic output 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

46、this standard. In the absence of actual 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 docum

47、ent. For dated references, only the edition 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 60050-802, International

48、Electrotechnical Vocabulary Chapter 802: Ultrasonics IEC 61161, Ultrasonics Power measurement Radiation force balances and performance requirements IEC 62127-1:2007, Ultrasonics Hydrophones Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz Amendment 1:2013 ISO 16269-

49、6:2005, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals ISO/IEC Guide 98:1995, Guide to the expression of uncertainty in measurement (GUM) ISO/IEC Guide 98-3, Uncertainty of measurement Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) 3 Terms, definitions and symbols For the purposes of this document, the terms and definitions given in IEC