IEC 61689:2013

Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz

IEC 61689:2013 is applicable to ultrasonic equipment designed for physiotherapy 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 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;
- and 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 third edition cancels and replaces the second edition published in 2007. It constitutes a technical revision which includes the following significant technical changes with respect to the previous edition:
- restriction introduced of 0,2 W/cm2 effective intensity during hydrophone measurements for treatment heads with ka≤20, to limit the likelihood of cavitation;
- change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333;
- and change to SI units for terms and definitions.
This publication is to be read in conjunction with IEC 60601-2-5:2009.

Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz

La CEI 61689:2013 est applicable aux appareils à ultrasons, conçus pour la physiothérapie, comprenant un transducteur ultrasonique fournissant des ultrasons à onde entretenue ou quasi-entretenue dans la gamme de fréquences de 0,5 MHz à 5 MHz. La présente norme ne traite que des appareils de physiothérapie à ultrasons employant un seul transducteur circulaire plan sans focalisation par projecteur ultrasonore, produisant des faisceaux statiques perpendiculaires à la face du projecteur ultrasonore. La présente norme spécifie:
- les méthodes de mesure et la caractérisation de la sortie des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de référence;
- les caractéristiques à déclarer par les fabricants des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de référence;
- les lignes directrices de sécurité du champ ultrasonore créé par les appareils de physiothérapie à ultrasons;
- les méthodes de mesure et la caractérisation de la sortie des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de routine;
- et les critères d'aptitude concernant les divers aspects de la sortie des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de routine. La valeur thérapeutique et les modes d'utilisation des appareils de physiothérapie à ultrasons n'entrent pas dans le domaine d'application de la présente norme. Cette troisième édition annule et remplace la deuxième édition publiée en 2007, dont elle constitue une révision technique qui comprend les modifications techniques importantes suivantes par rapport à l'édition précédente:
- introduction d'une limitation de l'intensité moyenne de 0,2 W/cm2 au cours des mesures de l'hydrophone pour les projecteurs ultrasonores avec ka≤20, pour limiter la probabilité de cavitation;
- modification du facteur Fac, afin de déterminer la surface émettrice efficace entre 1,354 et 1,333;
- et modification des unités SI dans les termes et définitions.
Cette publication doit être lue conjointement avec la CEI 60601-2-5:2009.

General Information

• Status: Published
• Publication Date: 25-Feb-2013
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.60 - Therapy equipment
• ICS: 31.040.10 - Fixed resistors
• Technical Committee: TC 87 - Ultrasonics
• Drafting Committee: WG 8 - TC 87/WG 8
• Current Stage: DELPUB - Deleted Publication
• Start Date: 31-Aug-2020
• Completion Date: 08-Mar-2022

Relations

• Revised: IEC 61689:2022 - Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
• Effective Date: 05-Sep-2023
• Revises: IEC 61689:2007 - Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 61689 ®
Edition 3.0 2013-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 0,5 MHz to 5 MHz

Ultrasons – Systèmes de physiothérapie – Spécifications des champs et
méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz

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IEC 61689 ®
Edition 3.0 2013-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Physiotherapy systems – Field specifications and methods of

measurement in the frequency range 0,5 MHz to 5 MHz

Ultrasons – Systèmes de physiothérapie – Spécifications des champs et

méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.60 ISBN 978-2-83220-657-7

– 2 – 61689 © IEC:2013
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 List of symbols . 16
5 Ultrasonic 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 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 Effective 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) 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 ) . 41
ER
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 (A ) . 45
BCS
Annex H (informative) Influence of hydrophone effective diameter . 46
Annex I (informative) Effective radiating area measurement using a radiation force
balance and absorbing apertures . 48

61689 © IEC:2013 – 3 –
Annex J (informative) Guidance on uncertainty determination . 58
Bibliography . 60

Figure A.1 – Normalized, time-averaged 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 s , where s = λz/a . 30
n n
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 range of values in distance along the beam alignment axis, z . 38
Figure D.3 – Normalized 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 (A ) with distance
BCS
from the face of the treatment head . 40
Figure D.5 – Range of values of the normalized beam cross-sectional area (A ) with
BCS
transducer ka . 40
Figure E.1 – Conversion factor F as a function of the ka product for ka product
ac
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 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 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 A.5.3 of IEC 61161: 2013 (see [6]) . 44
Table G.1 – Variation of the beam cross-sectional area (A (z)) with the indicated
BCS
output power from two transducers . 45
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 . 47
Table I.1 – Aperture measurement check sheet . 52
Table I.2 – Annular power contributions . 54
Table I.3 – Annular intensity contributions.
...