EN 62127-1-2007 en Ultrasonics - Hydrophones - Part 1 Measurement and characterization of medical ultrasonic fields up to 40 MHz (Incorporates Amendment A1 2013)《超声波 水听器 第1部分 医用超声波.pdf

1、BRITISH STANDARDBS EN 62127-1:2007Ultrasonics HydrophonesPart 1: Measurement and characterization of medical ultrasonic fields up to 40 MHzICS 17.140.50nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull nullnullnull nullnullnullnullnullnullnullnullnullnull nullnullnullnullnullnull nu

2、llnull nullnullnullnullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnull+A1:2013National forewordThis British Standard is the UK implementation of EN 62127-1:2007+A1:2013. It is identical to IEC 62127-1:2007, incorporating amendment 1:2013. It supersedes BS EN 62127-1:2

3、007, which will be withdrawn on 15 March 2016.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 participat

4、ion in its 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 cor

5、rect application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN 62127-1:2007+A1:2013This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 30 May 2008 The British StandardsInstitution 2013. Publishedby BSI Standar

6、ds Limited2013Amendments/corrigenda issued since publicationDate Comments 31 August 2013 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2013ISBN 978 0 580 71774 1EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMCENELEC European Committeefor ElectrotechnicalStandardization Comit E

7、uropen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CentralSecretariat: rue deStassart 35, B - 1050 Brussels 2007 CENELEC -All rights of exploitation in any formand by any means reserved worldwide for CENELEC members.Ref. No. EN 62127-1:2007 EICS 17.140.50 Engli

8、sh version Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz(IEC 62127-1:2007)Ultrasons - Hydrophones - Partie 1: Mesures et caractrisation des champs ultrasonores mdicauxjusqu 40 Mhz(CEI 62127-1:2007) Ultraschall - Hydrophone - Teil 1: Me

9、ssung und Charakterisierungvon medizinischen Ultraschallfeldern bis zu 40 MHz(IEC 62127-1:2007) This European Standard was approved by CENELEC on 2007-09-01. CE NELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard

10、the status of a national standard without any alteration.Up-to-date lists and bibliographicalreferences co ncerning such national standards maybe obtained on application to the Central Secretariat or to any CENELEC member.This European Standard exists inthree official versions (English,French, Germa

11、n). A version in any otherlanguage made by translation under the responsibility of a CENELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cy

12、prus, the Czech 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.EN 62127-1:2007+A1March 2013Fo

13、reword The text of document 87/352/CDV, future edition 1 of IEC 62127-1, prepared by IEC TC87, Ultrasonics,was submitted to the IEC-CENELEC parallelUnique Acceptance Procedure and was approved byCENELEC as EN 62127-1 on 2007-09-01.EN 62127-1, EN 62127-2 and EN 62127-3 are being published simu ltaneo

14、usly. Together these Europ ean Standards cancel and replace EN 61101:1993, EN61102:1993 + A1:1 994, EN61220:1995 andEN 62092:2001.The following dates were fixed: latest date by which the EN has to be implemented at nationallevel by publication of an identicalnational standard or byendorsement (dop)

15、2008-06-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-09-01 Annex ZA has been added by CENELEC._ Endorsement notice The text of the International Standard IEC 62127-1:2007 was approved byCENELEC as a EuropeanStandard without any modification.T

16、he text of document 87/518/FDIS, future amendment 1 to edition 1 of IEC 62127-1, prepared by IEC/TC 87 “Ultrasonics“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62127-1:2007/A1:2013. The following dates are fixed: latest date by which the document has to be implement

17、ed at national level by publication of an identical national standard or by endorsement (dop) 2013-12-15 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2016-03-15 Attention is drawn to the possibility that some of the elements of this document ma

18、y be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 62127-1:2007/A1:2013 was approved by CENELEC as a European Standard without any modification. Foreword to a

19、mendment A1BS EN 62127-1:2007+A1:2013 EN 62127-1:2007+A1:2013 (E) 2 CONTENTS123455.15.1.15.1.25.1.35.1.45.1.55.1.65.1.75.1.85.1.95.25.2.15.2.25.2.35.35.466.16.26.2.16.2.26.36.46.4.16.4.277.17.27.2.17.2.2Peak-compressional acoustic pressure and peak-rarefactional7.2.37.2.47.2.57.2.67.2.78INTRODUCTION

20、.6Scope and object7Normative references.7Terms, definitionsand symbols 8List of symbols.28Measurement requirements30Requirements for hydrophones andamplifiers.30Introduction.30General.30Sensitivity of a hydrophone30Directional response of a hydrophone30Effective hydrophone radius31Choice of the size

21、of a hydrophone active element31Bandwidth.32Linearity32Hydrophone signal amplifier335.1.10 Hydrophone cable length and amplifiers33Requirements for positioning and water baths.33General.33Positioning systems.34Water bath.35Requirements for data acquisition and analysis systems .36Recommendations for

22、 ultrasonic equipment being characterized.36Measurement procedure.36General.36Preparation andalignment.37Preparation37Aligning an ultrasonic transducer and a hydrophone37Measurement37Analysis37Corrections for restricted bandwidth and spatial resolution37Uncertainties.37Beam characterization38General

23、.38Primary pressure parameters39General.39acoustic pressure40Spatial-peak rms acoustic pressure.40Nonlinear propagationparameter.40Intensity parameters using instantaneous acousticpressure41Intensity parameters using pulse-pressure-squared integral41Derived ultrasonic power.43Requirements for specif

24、ic ultrasonic fields44 3 BS EN 62127-1:2007+A1:2013 IEC 62127-1:2007+A1:2013 (E)8.18.28.2.18.2.28.2.38.38.3.18.3.28.48.4.1Lithotripters and pressurepulse sources for other therapeutic8.4.28.599.19.29.3Annex F (informative) Acoustic output parameters for multi-mode medicalultrasonicAnnex I (informati

25、ve) Assessment of uncertainty in the acoustic quantities obtained byFigure 1 Schematic diagramof the different planes and lines in an ultrasonic fieldFigure J.1 Schematic diagram of theultrasonic transducerand hydrophone degreesGeneral.44Diagnostic fields44Simplified procedures and guidelines.44Puls

26、ed wave diagnostic equipment45Continuous wavediagnostic equipment.45Therapy fields .46Physiotherapy equipment 46Hyperthermia.46Surgical fields.46purposes.46Low frequencysurgical applications 47Fields from other medical applications.47Compliance statement47General.47Maximum probable value s.48Samplin

27、g.48AnnexA (informative) General rationale 49Annex B (informative) Hydrophones and positioningAnnex C (informative) Acoustic pressure and intensity.5Annex D (informative) Voltage to pressure conversion.5AnnexE (informative) Correction for spatial averaging.fields in the absence of scan-frame synchro

28、nizatio n.6AnnexG (informative) Propagation medium and degassing.Annex H (informative) Specific ultrasonic fieldshydrophone measurements.7Annex J (informative) Transducerand hydrophone positioning systems.7AnnexK (informative) Beamwidth midpoint methodBibliography(see alsoIEC 61828)10Figure 2 Schema

29、tic diagram ofthe method of determining pulse duration3Figure D.1 A flow diagram of the hydrophone deconvolutionprocess.Figure D.2 Example of waveformdeconvolution.of freedom7Annex ZA (normative) Normative references to international publications with theircorresponding European publications.8 4 Fig

30、ure 3 Several apertures and planes for a transducer of unknown geometry IEC 61828 Figure 4 Parameters for describing an example of a focusing transducer of a known geometry IEC 61828 modified !“.BS EN 62127-1:2007+A1:2013 IEC 62127-1:2007+A1:2013 (E)Table D.2 Methodof conversion from a single- to a

31、double-sided spectrum.Table F.1 Mainparame ters definedin IEC stan dards.TableF.2 List of parameters that are to be used or are to bedeleted. Table K.1 dB beamwidth levelsfor determining midpointsTable D.1 Methodof con version from a double- toa single-sided spectrum. 5 Table 1 Acoustic parameters a

32、ppropriate to various types of medical ultrasonic equipment.3Table B.1 Typical specification data for hydrophones, in thiscase givenat 1 MHz.5Table C.1 Properties of distilled or de-ionized water asa function of temperature5BS EN 62127-1:2007+A1:2013 IEC 62127-1:2007+A1:2013 (E)INTRODUCTION The main

33、 purpose of thispart of IEC 62127isto define various acoustic parameters thatcanbe used to specify and characterize ultrasonic f ieldspropagating in liquids, and, in particular, water, using hydrophones. Measurement procedures areoutlined that maybe used todetermine these parameters. Specific device

34、 related measurement standards, for example IEC61689, IEC 61157, IEC 61847or IEC 62359, can refer to this standard for appropriate acoustic parameters.The philosophybehind this standard is the specification of the acoustic field in terms ofacoustic pressure parameters, acousticpressure being the pri

35、mary measurement quantity when hydrophones are used to characterize the field.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. “! 6 BS EN 62127-1:2007+A1:2

36、013 IEC 62127-1:2007+A1:2013 (E)ULTRASONICS HYDROPHONES Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz 1 Scope and objectThis part of IEC 62127 specifies methods of useof calibrated hydrophones for themeasurement in liquids of acoustic fields generated byultrasoni

37、c medical equipment operatingin the frequency range up to 40MHz. The objectivesof thisstandard are: to define a group of acoustic parametersthat can be measured on a physically sound basis; to define a second group of parameters that can be derived under certain assumptionsfrom these measurements, a

38、nd called derivedintensityparameters; to define a measurement procedure that may be used for the determination of acousticpressure parameters; to define the conditions under which the measurements of acoustic parameters can bemade in the frequencyrangeup to 40 MHz using calibrated hydrophones;to def

39、ine procedures for correcting, for limitations caused bythe use ofhydrophones withfinite bandwidth and finite active element size. NOTE 1 Throughout this standard, SIunits are used. In the specification of certain parameters, such as beamareas and intensities, it may be convenient to use decimal mul

40、tiples or submultiples. For example beam area may be specified in cm2 and intensities in W/cm2 or mW/cm 2 . NOTE 2 The hydrophone as defined may be of a piezoelectric or an optic type. The introduction however impliesthat optical hydrophones are not covered.2 Normative referencesThe following refere

41、nced documents are indispensable for the application of this document.Fordated references,onlythe edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.IEC 60050-801:1994, InternationalElectrotechnical Vocabulary Chapter801: Ac

42、oustics andelectroacousticsIEC 60565, Underwater acoustics Hydrophones Calibration in the frequencyrange0,01Hzto 1 MHzIEC/TR 60854:1986, Methods of measuring the performance of ultrasonicpulse-echodiagnostic equipmentIEC 61689, Ultrasonics Physiotherapy systems Performance requirementsand methodsof

43、measurement inthe frequency range 0,5 MHz to 5 MHz IEC 61828, Ultrasonics Focusing transducers Definitions and measurement methods forthe transmittedfieldsIEC 61846, Ultrasonics Pressure pulselithotripters Characteristics of fields 7 !“BS EN 62127-1:2007+A1:2013 IEC 62127-1:2007+A1:2013 (E)IEC 61847

44、, Ultrasonics Surgical systems Measurement and declaration of t he basic outputcharacteristicsIEC 62127-2, Ultrasonics Hydrophones Part 2: Calibration for ultrasonic fields up to 40 MHz IEC 62127-3, Ultrasonics Hydrophones Part3:Properties of hydrophones for ultrasonicfields up to 40 MHz ISO 16269-6

45、:2005, Statistical interpretation of data Part6: Determination of statisticaltolerance intervalsNOTE The following standards relyon the proper use of this document.IEC 61157, Standard means for the reporting of the acousticoutput of medicaldiagnostic ultrasonic equipmentIEC 62359, Ultrasonics Field

46、characterization Testmethods for the determination of thermal and mechanicalindices related to medical diagnostic ultrasonic fieldsIEC 61847, Ultrasonics Surgical systems Measurement and declaration of the basic output characteristics. 3 Terms, definitions and symbols For the purposes of thisdocumen

47、t, the terms and definitions given in IEC 62127-2, IEC 62127-3 and the following apply. It also includes definitions related to s ubjects in this document to beused in particular medicalultrasound device standards.3.1acoustic pulse waveformtemporal waveform of the instantaneous acoustic pressure at

48、a specified position in anacoustic field and displayed over a period sufficiently long to include all significant acousticinformation in a single pulse or tone-burst,or one or m orecycles in a continuous waveNOTE 1Temporal waveform is a representation (e.g oscilloscope presentation or equation) of t

49、he instantaneousacoustic pressure. 3.2acoustic repetitionperiod arppulse repetition period for non-automatic scanning systems and the scan repetition periodfor automatic scanning systems, equal to thetimeinterval between corresponding pointsofconsecutive cycles for continuouswave systemsNOTE The acoustic repetition period is expressed in seconds (s).3.3acoustic frequency acoustic-working freq