EN 61689-2007 en Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0 5 MHz to 5 MHz (Remains Current)《超声波 物理治疗系统 频率范围在0 5.pdf

1、BRITISH STANDARDBS EN 61689:2007Ultrasonics Physiotherapy systems Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHzThe European Standard EN 61689:2007 has the status of a British StandardICS 11.040.60g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g4

2、4g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 61689:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2007 BSI 2007ISBN 978 0 580

3、54471 2National forewordThis British Standard is the UK implementation of EN 61689:2007. It is identical to IEC 61689:2007. It supersedes BS EN 61689:1997 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee EPL/87, Ultrasonics.A list of organizations repr

4、esented 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 application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments

5、 issued since publicationAmd. No. Date CommentsEUROPEAN STANDARD EN 61689 NORME EUROPENNE EUROPISCHE NORM November 2007 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat

6、 rue de Stassart 35, B - 1050 Brussels 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61689:2007 E ICS 11.040.60 Supersedes EN 61689:1996English version Ultrasonics - Physiotherapy systems - Field specifications and methods

7、 of measurement in the frequency range 0,5 MHz to 5 MHz (IEC 61689:2007) Ultrasons - Systmes de physiothrapie - Spcifications des champs et mthodes de mesure dans la gamme de frquences de 0,5 MHz 5 MHz (CEI 61689:2007) Ultraschall - Physiotherapiesysteme - Feldspezifikationen und Messverfahren im Fr

8、equenzbereich von 0,5 MHz bis 5 MHz (IEC 61689:2007) This European Standard was approved by CENELEC on 2007-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without

9、any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language m

10、ade by translation under the responsibility of a CENELEC member into its own language and 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, the Czech Republic, Denmark,

11、 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. Foreword The text of document 87/351/CDV, future edition 2 of

12、 IEC 61689, prepared by IEC TC 87, Ultrasonics, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by CENELEC as EN 61689 on 2007-10-01. This European Standard supersedes EN 61689:1996. EN 61689:2007 is a result of maintenance on this standard and the referenced s

13、tandards EN 61161:2007 and EN 62127-1. A relatively large technical change is the determination of the effective radiating area. This is now no longer based on the measurement of four areas but only on one. This change was needed to improve the accuracy of the determination of this parameter for sma

14、ll transducers. Be aware that this change may alter the value obtained for this and related parameters. This standard is to be used in conjunction with EN 60601-2-5. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical nat

15、ional standard or by endorsement (dop) 2008-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-10-01 NOTE The following print types are used: Requirements: in roman type Test specifications: in italic type Notes: in small roman type Words in bol

16、d in the text are defined in Clause 3. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 61689:2007 was approved by CENELEC as a European Standard without any modification. _ 2 EN 61689:2007CONTENTS 1 2 3 4 5 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7

17、6 8 8.1 8.2 8.3 8.4 8.5 8.6 9 9.1 9.2 9.3 Annex E (informative) Factor used to convert the beam cross-sectional area (ABCS) at the face of the treatment head to the effective radiating area (AERAnnex F (informative) Determining acoustic power through radiation force Annex G (informative) The validi

18、ty of low-power measurements of the beam cross-sectional area (ABCSAnnex I (informative) Effective radiating area measurement using a radiation force 3 EN 61689:2007INTRODUCTION.5 Scope.6 Normative references .6 Terms and definitions .7 List of symbols .14 Ultrasonic field specifications .15 Conditi

19、ons of measurement and test equipment used .16 General .16 Test vessel17 Hydrophone.17 RMS or peak signal measurement .17 Type testing reference procedures and measurements.18 General .18 Rated output power .18 Hydrophone measurements.18 Effective radiating area .19 Reference type testing parameters

20、 21 Acceptance criteria for reference type testing21 Routine measurement procedure22 General .22 Rated output power .22 Effective radiating area .22 Beam non-uniformity ratio .23 Effective intensity23 Acceptance criteria for routine testing .23 Sampling and uncertainty determination .23 Reference ty

21、pe testing measurements.23 Routine measurements23 Uncertainty determination24 Annex A (informative) Guidance for performance and safety25 Annex B (normative) Raster scan measurement and analysis procedures30 Annex C (normative) Diametrical or line scan measurement and analysis procedures32 Annex D (

22、informative) Rationale concerning the beam cross-sectional area definition35 ) 41 measurements43 )45 Annex H (informative) Influence of hydrophone effective diameter .46 balance and absorbing apertures48 Annex J (informative) Guidance on uncertainty determination 58 Annex ZA (normative) Normative re

23、ferences to international publications with theircorresponding European publications 61Figure A.1 The normalized, time-averaged values of the acoustic intensity (unbroken line) and of one of its plane-wave approximations (broken line), existing on the axis of a circular piston source of ka = 30, ver

24、sus the normalized distance s, where s = z/a2Figure A.2 Histogram of RBNvalues for 37 treatment heads of various diameter and Figure D.1 Iso-pressure lines of a typical physiotherapy treatment head of small Figure D.2 Plot of beam cross-sectional area against different limit values for a Figure D.3

25、Normalized values of beam cross-sectional area for IEC and FDA limit Figure D.4 Variation of the beam cross-sectional area (ABCS) with distance from the Figure D.5 Variation of the normalized beam cross-sectional area (ABCS) with Figure E.1 Conversion factor Facas a function of the ka product for ka

26、 product Figure I.2 Measured power as a function of aperture diameter for commercially-Figure I.3 Cumulative sum of annular power contributions, previously sorted in descending order of intensity contribution, plotted against the cumulative sum of their Table C.1 Constitution of the transformed arra

27、y B used for the analysis of half-line Table F.1 Necessary target size, expressed as the minimum target radius b, as a function of the ultrasonic frequency, f, the effective radius of the treatment head, a1, Table G.1 Variation of the beam cross-sectional area (ABCS(z) with the indicated Table H.1 C

28、omparison of measurements of the beam cross-sectional area (ABCS(z) made using hydrophones of geometrical active element radii 0,3 mm, 0,5 mm and Table I.5 Annular power contributions, sorted in descending order of intensity Table I.6 Cumulative sum of annular power contributions, previously sorted

29、in descending order of intensity contribution, and the cumulative sum of their respective 4 EN 61689:2007Bibliography60 .28 frequency29 geometrical area (ka = 17) 37 small variation in distance along the beam alignment axis, z .38 values for five transducers of different ka values, z = 0,5 cm .39 fa

30、ce of the treatment head 40 transducer ka 40 between 40 and 160 .42 Figure I.1 Schematic representation of aperture measurement set-up 48 available 1 MHz physiotherapy treatment heads .53 respective annular areas.56 scans33 and the target distance, z, calculated according to 5.3 of IEC 61161 (see 5)

31、 44 output power from two transducers .45 2,0 mm .47 Table I.1 Aperture measurement check sheet 52 Table I.2 Annular power contributions 54 Table I.3 Annular intensity contributions 54 Table I.4 Annular intensity contributions, sorted in descending order .55 contribution.55 annular areas56 INTRODUC

32、TION Ultrasound at low megahertz frequencies is widely used in medicine for the purposes of physiotherapy. Such equipment consists of a generator of high-frequency electrical energy and usually a hand-held treatment head, often referred to as an applicator. The treatment head consists of a transduce

33、r, usually a disk of piezoelectric material, for converting the electrical energy to ultrasound and is often designed for contact with the human body. 5 EN 61689:2007ULTRASONICS PHYSIOTHERAPY SYSTEMS FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz 1 Scope This

34、 International Standard is applicable to ultrasonic equipment designed for physiotherapy consisting of an ultrasonic transducer generating continuous or quasi-continuous wave ultrasonic energy in the frequency range 0,5 MHz to 5 MHz. This standard only relates to ultrasonic physiotherapy equipment e

35、mploying a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard specifies: methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on reference testing method

36、s; characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment based on reference testing methods; guidelines for safety of the ultrasonic field generated by ultrasonic physiotherapy equipment; methods of measurement and characterization of the output of ultrasonic physiot

37、herapy equipment based on routine testing methods; acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard. 2 Normati

38、ve references The following referenced documents are indispensable for the application of this document. 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 E

39、lectrotechnical Vocabulary (IEV) Chapter 801: Acoustics and electroacoustics IEC 60469-1:1987, Pulse techniques and apparatus Part 1: Pulse terms and definitions IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-2-5:2000, Medi

40、cal electrical equipment Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment IEC 61161:2006, Ultrasonics Power measurement Radiation force balances and performance requirements 6 EN 61689:2007IEC 62127-1:2007, Ultrasonics Hydrophones Part 1: Measurement and charact

41、erization of medical ultrasonic fields up to 40 MHz using hydrophones IEC 62127-3:2007, Ultrasonics Hydrophones Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 acoustic puls

42、e waveform temporal waveform of the instantaneous acoustic pressure at a specified 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 one or more cycles in a continuous wave NOTE 1 Temporal w

43、aveform is a representation (e.g. oscilloscope presentation or equation) of the instantaneous acoustic pressure. NOTE 2 Definition adopted from IEC 60469-1. 3.2 acoustic repetition period arp pulse repetition period for non-automatic scanning systems and the scan repetition period for automatic scan

44、ning systems, equal to the time interval between corresponding points of consecutive cycles for continuous wave systems NOTE 1 Acoustic repetition period is expressed in seconds (s). NOTE 2 Definition adopted from IEC 62127-1. 3.3 acoustic frequency acoustic-working frequency frequency of an acousti

45、c signal based on the observation of the output of a hydrophone placed in an acoustic 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 metho

46、d. Acoustic-working frequencies are defined in 3.3.1 and 3.3.2. NOTE 2 In a number of 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-depen

47、dent correction to the signal. NOTE 3 Acoustic frequency is expressed in hertz (Hz). NOTE 4 Definition adopted from IEC 62127-1. 3.3.1 zero-crossing acoustic-working frequency fawfthis is determined according to the procedure specified in IEC/TR 60854. NOTE This frequency is intended for continuous

48、wave systems only. 7 EN 61689:20073.3.2 arithmetic-mean acoustic-working frequency fawfarithmetic mean of the most widely separated frequencies 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 frequenc

49、y is intended for pulse-wave systems only. NOTE 2 It is assumed that f1 0,1 cm13.15 continuous wave wave in which the ratio pp / 2prms, at any point in the far field on the beam alignment axis, is less than or equal to 1,05, where ppis the temporal-peak acoustic pressure and prmsis the r.m.s. acoustic pressure 3.16 duty factor ratio of the pulse duration to the pulse repetition period NOTE Definition adopted from IEC 60469-1, 5.3.2.4.