IEC 61689:2007
(Main)Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
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 employing 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 methods; - 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 physiotherapy 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. This second edition cancels and replaces the first edition published in 1996 and constitutes a technical revision. This second edition is a result of maintenance on this standard and the referenced standards IEC 61161 (2006) and IEC 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 small transducers. Be aware that this change may alter the value obtained for this and related parameters.
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IEC 61689
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 0,5 MHz to 5 MHz
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IEC 61689
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 0,5 MHz to 5 MHz
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XB
ICS 11.040.60 ISBN 2-8318-9256-2
– 2 – 61689 © IEC:2007(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms and definitions .8
4 List of symbols .15
5 Ultrasonic field specifications .16
6 Conditions of measurement and test equipment used .17
6.1 General .17
6.2 Test vessel.18
6.3 Hydrophone.18
6.4 RMS or peak signal measurement .18
7 Type testing reference procedures and measurements.19
7.1 General .19
7.2 Rated output power .19
7.3 Hydrophone measurements.19
7.4 Effective radiating area .20
7.5 Reference type testing parameters .22
7.6 Acceptance criteria for reference type testing.22
8 Routine measurement procedure.23
8.1 General .23
8.2 Rated output power .23
8.3 Effective radiating area .23
8.4 Beam non-uniformity ratio .24
8.5 Effective intensity.24
8.6 Acceptance criteria for routine testing .24
9 Sampling and uncertainty determination .24
9.1 Reference type testing measurements.24
9.2 Routine measurements.24
9.3 Uncertainty determination.25
Annex A (informative) Guidance for performance and safety.26
Annex B (normative) 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 ) at
BCS
the face of the treatment head to the effective radiating area (A ) .42
ER
Annex F (informative) Determining acoustic power through radiation force
measurements.44
Annex G (informative) The validity of low-power measurements of the beam cross-
sectional area (A ).46
BCS
Annex H (informative) Influence of hydrophone effective diameter .47
Annex I (informative) Effective radiating area measurement using a radiation force
balance and absorbing apertures.49
Annex J (informative) Guidance on uncertainty determination .59
61689 © IEC:2007(E) – 3 –
Bibliography.61
Figure 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, versus the normalized distance s, where s = λz/a .29
Figure A.2 – Histogram of R values for 37 treatment heads of various diameter and
BN
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 variation in distance along the beam alignment axis, z .39
Figure D.3 – Normalized values of beam cross-sectional area for IEC and FDA limit
values for five transducers of different ka values, z = 0,5 cm .40
Figure D.4 – Variation of the beam cross-sectional area (A ) with distance from the
BCS
face of the treatment head .41
Figure D.5 – Variation of the normalized beam cross-sectional area (A ) with
BCS
transducer ka .41
Figure E.1 – Conversion factor F as a function of the ka product for ka product
ac
between 40 and 160 .43
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 MHz physiotherapy treatment heads .54
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.57
Table C.1 – Constitution of the transformed array [B] used for the 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, a ,
and the target distance, z, calculated according to 5.3 of IEC 61161 (see [5]). .
Table G.1 – Variation of the beam cross-sectional area (A (z)) with the indicated
BCS
output power from two transducers .46
Table H.1 – Comparison of measurements of the beam cross-sectional area (A (z))
BCS
made using hydrophones of geometrical active element radii 0,3 mm, 0,5 mm and
2,0 mm .48
Table I.1 – Aperture measurement check sheet .53
Table I.2 – Annular power contributions .55
Table I.3 – Annular intensity contributions .55
Table I.4 – Annular intensity contributions, sorted in descending order .56
Table I.5 – Annular power contributions, sorted in descending order of intensity
contribution.56
Table I.6 – Cumulative sum of annular power contributions, previously sorted in
descending order of intensity contribution, and the cumulative sum of their respective
annular areas.57
– 4 – 61689 © IEC:2007(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS –
PHYSIOTHERAPY SYSTEMS –
FIELD SPECIFICATIONS AND METHODS OF
MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz
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