1、BRITISH STANDARD BS EN 61157:2007Standard means for the reporting of the medical diagnostic ultrasonic equipmentICS 11.040.55; 17.140.50nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull nullnullnull nullnullnullnullnullnullnullnullnullnull nullnullnullnullnullnull nullnull nullnulln
2、ullnullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnullacoustic output of +A1:2013National forewordThis British Standard is the UK implementation of EN 61157:2007+A1:2013. It is identical to IEC 61157:2007 incorporating amendment 1:2013. It supersedes BS EN 61157:2007
3、which will be withdrawn on 4 March 2016.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .The UK participation in i
4、ts preparation was entrusted to Technical Committee EPL/87, Ultrasonics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct app
5、lication.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN 61157:2007+A1:2013This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 31 December 2007 The British Standards Institution 2013. Published by BSI Standards
6、Limited 2013Amendments/corrigenda issued since publicationDate Comments 30 June 2013 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2013: Annex ZA updatedISBN 978 0 580 71772 7EUROPEAN STANDARD EN 61157:2007+A1NORME EUROPENNE EUROPISCHE NORM CENELEC European Committee for Electro
7、technical StandardizationComit Europende NormalisationElectrotechnique EuropischesKomiteefr Elektrotechnische Normung Central Secretariat: rue de Stassart35,B - 1050 Brussels 2007 CENELEC - Allrightsof exploitation in anyformand byanymeans reserved worldwide for CENELEC members.Ref. No. EN 61157:200
8、7 EICS 11.040.50; 11.140.50 English versionStandard means for the reporting of the acoustic outputof medical diagnostic ultrasonic equipment(IEC 61157:2007)Moyens normalisspour la dclaration des missionsacoustiques des appareilsde diagnostic mdical ultrasons(CEI 61157:2007)Normverfahren frdie Angabe
9、 der akustischen Ausgangsgrenvon medizinischenUltraschalldiagnostikgerten(IEC 61157:2007)This European Standard was approved by CENELEC on 2007-10-01.CENELEC members are boundtocomplywith theCEN/CENELEC Internal Regulations which stipulate theconditions for giving thisEuropean Standardthe status of
10、a national standard without any alteration.Up-to-datelists and bibliographical references concerning such national standards may be obtained onapplication to the Central Secretariat or to any CENELEC member.This European Standard exists in three official versions (English, French, German). A version
11、 in any otherlanguage made by translation under the responsibility of a CENELEC member into its own languageand notified to the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzec
12、h Republic,Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy,Latvia, Lithuania,Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal,Romania,Slovakia, Slovenia, Spain,Sweden, Switzerland and the United Kingdom. March 2013ForewordThe text of document 87/356/CD
13、V, future edition 2 of IEC61157, prepared by IECTC87, Ultrasonics, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved byCENELEC as EN 61157 on2007-10-01. This European Standard supersedes EN 61157:1994. The changes with respect to EN 61157:1994 arelisted below:mai
14、ntenance onthis standard and thereferenced standardsEN 61161and EN62127-1; a clause on compliance hasbeen added. The following dateswere fixed: latestdate by whichthe EN hasto be implementedat nationallevel by publication of an identicalnational standard or by endorsement(dop) 2008-07-01latestdate b
15、y whichthe national standards conflictingwith the ENhaveto bewithdrawn (dow) 2010-10-01NOTE The followingprinttypes are used:Requirements: inroman type Test specifications:in italic type Notes: in small romantype Wordsin boldin the text are defined in Clause 3. Annex ZA has been addedby CENELEC._End
16、orsement noticeThe text of the International Standard IEC61157:2007 wasapproved by CENELEC as a EuropeanStandard without anymodification._ 2 EN 61157:2007+A1:2013BS EN 61157:2007+A1:2013Foreword to amendment A1 The text of document 87/517/FDIS, future amendment 1 to edition 2 of IEC 61157, prepared
17、by IEC/TC 87 “Ultrasonics“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61157:2007/A1:2013. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop
18、) 2013-12-04 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2016-03-04 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for iden
19、tifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 61157:2007/A1:2013 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 61157:2007, replace the existing text with the following: IEC 61689 NOTE Harmonis
20、ed as EN 61689. CONTENTS12344.14.24.2.14.2.24.2.34.2.44.2.555.15.25.367Figure C.1 Schematic diagram showing the relationship between the variousdefined surfaces and distances fora mechanical sector scannerwithwater stand-off Figure C.2 Schematic diagram showing the relationship between the variousde
21、fined parametersand distances for a mechanical sector scanner during the Figure C.3 Schematic diagram showing various defined parameters associated withthe distributionof the scan lines ina linear arrayscanner and mechanically-Figure C.4 Schematic diagram illustrating the peak-rarefactional acoustic
22、 pressureTable A.1 An example ofreporting of the acoustic outputof a 3,5 MHz scan-head for 3 INTRODUCTION.4 Scope.5Normative references.5Terms, definitionsand symbols 5Requirements.15General.15Requirements for the reportingof acoustic output information.16Technical data sheets information format16De
23、tailed operatingmode data sheets information format.17Background information.18Diagnostic fieldsin the absence of scan-frame synchronization.19Dataset for low acoustic output equipment.19Compliance statement20General.20Maximum probable values.20Sampling.20Test methods .21Presentation of results21 An
24、nex A(normative) Presentationof acoustic output information.22 AnnexB (informative)Reporting requirements for extensive systems24Annex C (informative)Rationale25 Indexof defined terms29Bibliography31distancewhen applied to a patient26measurement of acoustic output.26scanned sector scanner27during an
25、 acoustic pulse.28 Table 1 List of symbols14a phased-array sectorscanner inaccordance with thisstandard23Annex ZA (normative) Normative references to international publications with theircorresponding European publications.32BS EN 61157:2007+A1:201361157 Amend.1 IEC:2013INTRODUCTION This Internation
26、al Standard specifies a standard means and format forthe reporting of the acoustic output ofmedical diagnostic ultrasonic eq uipment.The numeric al valuesfor reporting purposes represent the average values for the maximum output conditions for a givendiscrete- orcombined-operating mode and are deriv
27、edfrommeasurements made in water.Intensityparameters are specified in this standard, but these are regarded as derivedquantities that are meaningful only under certain assumptions related to the ultrasonic fieldbeing measured. 4 BS EN 61157:2007+A1:201361157 Amend.1 IEC:2013STANDARD MEANS FOR THE RE
28、PORTING OF THEACOUSTIC OUTPU TOF MEDICAL DIAGNOSTICULTRASONIC EQUIPMENT 1 Scope This International Standard is applicable to medical diagnostic ultrasonic equipment.It provides aset of traceable acoustic parameters describing the acousticfields. It defines a standard means and format for the reporti
29、ng of the acoustic output information. It also describes a reduced dataset recommended for equipment generating low acousticoutput 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 epidem
30、iological studies conducted using exposure conditions similar to those reported in 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 referencesThe f
31、ollowing referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies. For undated r eferences, thelatesteditionof the referenced document (including anyamendments)applies.IEC 61161, Ultrasonics Power measurement Radiation force bal
32、ances and performancerequirements3 Terms, definitions and symbols Forthe purposes of this document, the terms and definitions given in IEC 62127-1, IEC 61161,the Index of defined terms at the end ofthisstandard and the following definitions apply.Figures C.1 to C.4 illustrate someof the defined para
33、meters given below. 3.1acoustic output freezecondition of a systemfor which the acoustic output is disabled when there is no activeupdating ofultrasonic echo information 5 IEC 60050-801, International Electrotechnical Vocabulary Chapter 801: Acoustics and electroacoustics IEC 62127-1:2007, Ultrasoni
34、cs Hydrophones Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz Amendment 1:2013ISO 16269-6, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals ISO/IEC Guide 98-3, Uncertainty of measurement Part 3: Guide to the expression of
35、 uncertainty in measurement (GUM:1995) BS EN 61157:2007+A1:201361157 Amend.1 IEC:2013IEC 60050-802, International Electrotechnical Vocabulary Chapter 802: Ultrasonics3.2acoustic pulse waveform temporal waveformofthe instantaneousacoustic pressure at a specified position in an acoustic field and disp
36、layed over a period sufficientlylongtoinclude all significant acousticinformation in a singlepulse or tone-burst,or in one ormore cycles in a continuous waveNOTE Temporal waveform is a representation (e.g. oscilloscope presentation or equation) of the instantaneousacoustic pressure. 3.3acoustic repe
37、tition periodarppulse repetition perio d for non-automatic scanning systems and the scan repetition periodforautomatic scanningsystems,equal to the time interval betweencorresponding points ofconsecutive cycles for continuouswave systemsNOTE 1 The acoustic repetition period is expressed in seconds (
38、s). IEC 62127-1, definition 3.23.4acoustic frequency acoustic-working frequencyfrequency of anacousticsignal basedon the observa tion ofthe output of a hydrophoneplaced in an acousticfield atthe position corresponding to the spatial-peak temporal-peakacoustic pressureNOTE 1 The signal is analysed us
39、ing either the zero-crossing acoustic-working frequency technique or aspectrum analysis method. Acoustic-working frequencies are defined in 3.4.1 and 3.4.2.NOTE 2 In a number of cases, the present definition is not very helpful or convenient, especially for broadbandtransducers. In that case, a full
40、 description of the frequency spectrum should be given in order to enable anyfrequency-dependent correction to the signal.NOTE 3 Acoustic frequency is expressed in hertz (Hz).3.4.1 zero-crossing acoustic-working frequencyf awf 6 SOURCE: IEC 62127-1:2007, definition 3.1 number, n, of consecutive half
41、-cycles (irrespective of polarity) divided by twice the time between the commencement of the first half-cycle and the end of the n-th half-cycle NOTE 1 None of the n consecutive half-cycles should show evidence of phase change. NOTE 2 The measurement should be performed at terminals in the receiver,
42、 that are as close as possible to the receiving transducer (hydrophone) and, in all cases, before rectification. NOTE 3 This frequency is determined according to the procedure specified in IEC/TR 60854. NOTE 4 This frequency is intended for continuous-wave systems only. SOURCE: IEC 62127-1:2007/Amen
43、dment 1:, definition 3.3.1 BS EN 61157:2007+A1:201361157 Amend.1 IEC:20133.4.2arithmetic-mean acoustic-workingfrequencyf awfarithmetic mean of the most widely separated frequencies f 1 and f 2 ,within the range of threetimes f1 ,at which the magnitude of the acousticpressure spectrumis 3 dB below th
44、e peakmagnitudeNOTE 1 This frequency is intended for pulse-wave systems only.NOTE 2 It is assumed that f 1 f 2 .3.5bandwidthBWdifference in the most widely separated frequencies f 1 and f 2 at whichthe magnitude of the acoustic pressure spectrum becomes 3 dB below the peak magnitude, at a specified
45、point inthe acousticfield NOTE Bandwidth is expressed in hertz (Hz).SOURCE: IEC 62127-1:2007, definition 3.6 NOTE 3 If f2is not found within the range 3f1, f2is to be understood as the lowest frequency above this range at which the spectrum magnitude is -3 dB from the peak magnitude. SOURCE: IEC 621
46、27-1, definition 3.3.2 3.6beam area area in aspecified plane perpendicularto the beam axis consisting ofall points at which the pulse-pressure-squared integral isgreater thana specified fractionofthe ma ximumvalueof the pulse-pressure-squared integral in that planeAb,6, Ab,20NOTE 1 If the position o
47、f the plane is not specified, it is the plane passing through the point corresponding to the maximum value of the pulse-pressure-squared integral in the whole acoustic field. NOTE 2 In a number of cases, the term pulse-pressure-squared integral is replaced everywhere in the abovedefinition by any li
48、nearly related quantity, for example:a) inthe case ofa 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-squared int
49、egral may be replaced by temporal average intensity.NOTE 3 Some specified fractions are 0,25 and 0,01 for the 6 dB and 20 dB beam areas, respectively.NOTE 4 Beam area is expressed in square metres (m2 ). 3.7beam axisstraight line that passes through the beam centrepoints of two planes perpendicular to theline which connects the point ofmaximal pulse-pressure-squared integral with the centre ofthe external transducerapertureNOTE 1 The location of the f
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