EN 61689-2013 en Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0 5 MHz to 5 MHz.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationUltrasonics Physiotherapy systems Field specificationsand methods of measurement in the frequency range 0,5 MHzto 5 MHzBS EN 61689:2013National forewordThis British Standard is t

2、he UK implementation of EN 61689:2013. It is identical to IEC 61689:2013. It supersedes BS EN 61689:2007,which will be withdrawn on 02 April 2016.The UK participation in its preparation was entrusted to Technical CommitteeEPL/87, Ultrasonics.A list of organizations represented on this committee can

3、be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. The British Standards Institution 2013Published by BSI Standards Limited 2013ISBN 978 0 580 72089 5ICS 11.040.60Compliance

4、 with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 May 2013.Amendments issued since publicationDate Text affectedBRITISH STANDARDBS EN 61689:2013EUROPEAN STANDARD EN 61689 N

5、ORME EUROPENNE EUROPISCHE NORM April 2013 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2013 CENELEC - All rights of exploitation

6、in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61689:2013 E ICS 11.040.60 Supersedes EN 61689:2007 English version Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz (IEC 61689:2013) Ultrason

7、s - Systmes de physiothrapie - Spcifications des champs et mthodes de mesure dans la gamme de frquences de 0,5 MHz 5 MHz (CEI 61689:2013) Ultraschall - Physiotherapiesysteme - Feldspezifikation und Messverfahren im Frequenzbereich von 0,5 MHz bis 5 MHz (IEC 61689:2013) This European Standard was app

8、roved by CENELEC on 2013-04-02. 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 any alteration. Up-to-date lists and bibliographical references concerning such nat

9、ional standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its

10、own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedon

11、ia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 61689:2013EN 61689:2013 - 2 - Foreword The text of document 87

12、/522/FDIS, future edition 3 of IEC 61689, prepared by IEC TC 87 “Ultrasonics“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61689:2013. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identic

13、al national standard or by endorsement (dop) 2014-01-02 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2016-04-02 This document supersedes EN 61689:2007. EN 61689:2013 includes the following significant technical changes with respect to EN 61689:

14、2007: restriction introduced of 0,2 W/cm2effective intensity during hydrophone measurements for treatment heads with ka 20, to limit the likelihood of cavitation; a change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333; change to SI units for terms and definitions;

15、 closer alignment and re-ordered, updated definitions in line with standards in EN 62127 series; minor arithmetical errors corrected in data analysis; inconsistencies and errors in symbol usage removed throughout; large number of editorial and formal corrections made; changes introduced to reference

16、s in the bibliography. This standard should be read in conjunction with EN 60601-2-5, which, as indicated in its preface, will itself be revised in order to be compatible with this standard. NOTE The following print types are used: Requirements: in Arial 10 point Notes: in Arial 8 point Words in bol

17、d in the text are defined in Clause 3 Symbols and formulae: Times New Roman + Italic Compliance clauses : in Arial Italic 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 identif

18、ying any or all such patent rights. Endorsement notice The text of the International Standard IEC 61689:2013 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 61828

19、 NOTE Harmonized as EN 61828. IEC 62127-2 NOTE Harmonized as EN 62127-2. IEC 62127-3 NOTE Harmonized as EN 62127-3. BS EN 61689:2013- 3 - EN 61689:2013 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in w

20、hole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publicati

21、on has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 - IEC 60601-2-5 - Medical electrical equipme

22、nt - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment EN 60601-2-5 - IEC 61161 2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements EN 61161 2013 IEC 62127-1 + corr. August + A1 2007 2008 20

23、13 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz EN 62127-1 + A1 2007 2013 BS EN 61689:2013 2 61689 IEC:2013 CONTENTS INTRODUCTION . 6 1 Scope . 7 2 Normative references . 7 3 Terms and definitions . 8 4 List of symbols . 16 5 Ultrason

24、ic field specifications . 18 6 Conditions of measurement and test equipment used . 19 6.1 General . 19 6.2 Test vessel 19 6.3 Hydrophone . 20 6.4 rms or peak signal measurement . 20 7 Type testing reference procedures and measurements . 20 7.1 General . 20 7.2 Rated output power . 21 7.3 Hydrophone

25、measurements . 21 7.4 Effective radiating area 22 7.5 Reference type testing parameters 23 7.6 Acceptance criteria for reference type testing 24 8 Routine measurement procedure 24 8.1 General . 24 8.2 Rated output power . 24 8.3 Effective radiating area 25 8.4 Beam non-uniformity ratio . 25 8.5 Effe

26、ctive intensity 25 8.6 Acceptance criteria for routine testing . 25 9 Sampling and uncertainty determination . 26 9.1 Reference type testing measurements . 26 9.2 Routine measurements 26 9.3 Uncertainty determination 26 Annex A (informative) Guidance for performance and safety 27 Annex B (normative)

27、 Raster scan measurement and analysis procedures 31 Annex C (normative) Diametrical or line scan measurement and analysis procedures 33 Annex D (informative) Rationale concerning the beam cross-sectional area definition 36 Annex E (informative) Factor used to convert the beam cross-sectional area (A

28、BCS) at the face of the treatment head to the effective radiating area (AER) 41 Annex F (informative) Determining acoustic power through radiation force measurements 43 Annex G (informative) Validity of low-power measurements of the beam cross-sectional area (ABCS) 45 Annex H (informative) Influence

29、 of hydrophone effective diameter . 46 Annex I (informative) Effective radiating area measurement using a radiation force balance and absorbing apertures 48 BS EN 61689:201361689 IEC:2013 3 Annex J (informative) Guidance on uncertainty determination 58 Bibliography 60 Figure A.1 Normalized, time-ave

30、raged values of 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, versus the normalized distance sn, where sn= z/a2. 30 Figure A.2 Histogram of RBNvalues for 37 treatment heads of various diamete

31、r and frequency 30 Figure D.1 Iso-pressure lines of a typical physiotherapy treatment head of small geometrical area (ka = 17) 38 Figure D.2 Plot of beam cross-sectional area against different limit values for a small range of values in distance along the beam alignment axis, z 38 Figure D.3 Normali

32、zed values of beam cross-sectional area for IEC and FDA limit values for five transducers of different ka values . 39 Figure D.4 Range of values of the beam cross-sectional area (ABCS) with distance from the face of the treatment head 40 Figure D.5 Range of values of the normalized beam cross-sectio

33、nal area (ABCS) with transducer ka 40 Figure E.1 Conversion factor Facas a function of the ka product for ka product between 40 and 160 . 42 Figure I.1 Schematic representation of aperture measurement set-up 49 Figure I.2 Measured power as a function of aperture diameter for commercially-available 1

34、 MHz physiotherapy treatment heads . 53 Figure I.3 Cumulative sum of annular power contributions, previously sorted in descending order of intensity contribution, plotted against the cumulative sum of their respective annular areas . 56 Table C.1 Constitution of the transformed array B used for the

35、analysis of half-line scans 34 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, and the target distance, z, calculated according to A.5.3 of IEC 61161: 2013 (see 6) 44 Table G.1 Va

36、riation of the beam cross-sectional area (ABCS(z) with the indicated output power from two transducers . 45 Table H.1 Comparison 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 2,0 mm . 47 Table I.1 Aperture meas

37、urement 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 Table I.5 Annular power contributions, sorted in descending order of intensity contribution . 55 Table I.6 Cumulati

38、ve sum of annular power contributions, previously sorted in descending order of intensity contribution, and the cumulative sum of their respective annular areas 56 BS EN 61689:2013 6 61689 IEC:2013 INTRODUCTION Ultrasound at low megahertz frequencies is widely used in medicine for the purposes of ph

39、ysiotherapy. 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 contains a transducer, usually a disk of piezoelectric material, for converting the electrical energy to ultrasound a

40、nd is often designed for contact with the human body. BS EN 61689:201361689 IEC:2013 7 ULTRASONICS PHYSIOTHERAPY SYSTEMS FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz 1 Scope This International Standard is applicable to ultrasonic equipment designed for phys

41、iotherapy containing an ultrasonic transducer generating continuous or quasi-continuous wave ultrasound in the frequency range 0,5 MHz to 5 MHz. This standard only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing st

42、atic 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 methods; characteristics to be specified by manufacturers of ultrasonic physiotherapy equipm

43、ent 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 physiotherapy equipment based on routine testing methods; acceptance criteria for aspects of

44、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 Normative references The following documents, in whole or in part, are normatively referenced

45、 in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1, Medical electrical equipment Part 1: General requirements for basi

46、c safety and essential performance IEC 60601-2-5, Medical electrical equipment Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment IEC 61161: 2013, Ultrasonics Power measurement Radiation force balances and performance requirements I

47、EC 62127-1: 2007, Ultrasonics Hydrophones Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz Amendment 1: 2013 BS EN 61689:2013 8 61689 IEC:2013 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. NOTE SI units (see IS

48、O/IEC Directives Part 2:2011, Annex I b) are used in the Notes to entry below certain parameter definitions for defining certain parameters, such as beam areas and intensities. It may be convenient to use decimal multiples or submultiples in practice but care should be taken in using decimal prefixe

49、s in combination with units when using and calculating numerical data. For example, beam area may be specified in cm2and intensities in W/cm2or mW/cm2. 3.1 absolute maximum rated output power sum of the rated output power, the 95 % confidence overall uncertainty in the rated output power, and the maximum increase in the rated output power for a 10 % variation in the rated value of the mains voltage Note 1 to entry: The p