IEC 61689:2022

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

IEC 61689:2022 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. This document 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 document 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 within the scope of this document.
Ultrasonic physiotherapy equipment using ultrasound in the frequency range from 20 kHz to 500 kHz is dealt with in IEC 63009.
IEC 61689:2022 cancels and replaces the third edition published in 2013. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition.
a) The requirement on water oxygen content is specified in 6.1.
b) Former recommendations in 6.2 have been changed to become requirements.
c) Several definitions in Clause 3 have been updated in line with other TC 87 documents.
d) The formerly informative Annex A has been changed to become normative, and now contains details on how conformance with IEC 60601-2-5 requirements is checked.
e) Annex D has been considerably shortened and reference to a now withdrawn regulatory document has been removed.

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

L'IEC 61689:2022 est applicable aux appareils à ultrasons, conçus pour la physiothérapie, qui comprennent un transducteur ultrasonique fournissant des ultrasons à onde entretenue ou quasi entretenue (par exemple, salve d’impulsions) dans la plage de fréquences de 0,5 MHz à 5 MHz. Le présent document ne traite que des appareils à ultrasons pour physiothérapie qui emploient un seul transducteur circulaire plan sans focalisation par transducteur, produisant des faisceaux statiques perpendiculaires à la face de ce même transducteur.
Le présent document spécifie:
- les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, qui reposent sur des méthodes d’essai de référence;
- les caractéristiques à spécifier par les fabricants des appareils à ultrasons pour physiothérapie qui reposent sur des méthodes d’essai de référence;
- les lignes directrices de sécurité du champ ultrasonique créé par les appareils à ultrasons pour physiothérapie;
- les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, qui reposent sur des méthodes d’essai individuel de série;
- les critères d’aptitude relatifs aux aspects de la sortie des appareils à ultrasons pour physiothérapie, qui reposent sur des méthodes d’essai individuel de série.
La valeur thérapeutique et les modes d’utilisation des appareils à ultrasons pour physiothérapie n’entrent pas dans le domaine d’application du présent document.
Les appareils à ultrasons pour physiothérapie qui utilisent des ultrasons dont la plage de fréquences est comprise entre 20 kHz et 500 kHz sont couverts par l’IEC 63009.
L'IEC 61689:2022 annule et remplace la troisième édition parue en 2013. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente.
a) L’exigence relative à la teneur en oxygène de l’eau est spécifiée en 6.1.
b) Les anciennes recommandations spécifiées en 6.2 ont été modifiées pour constituer des exigences.
c) Plusieurs définitions de l’Article 3 ont été actualisées conformément à d’autres documents qui relèvent du CE 87.
d) L’ancienne Annexe A informative a été modifiée en annexe normative, et contient désormais des informations détaillées sur la méthode selon laquelle la conformité aux exigences de l’IEC 60601-2-5 est vérifiée.
e) L’Annexe D a été raccourcie de manière importante et la référence à un document réglementaire désormais supprimé a été retirée.

General Information

• Status: Published
• Publication Date: 07-Mar-2022
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: TC 87 - Ultrasonics
• Drafting Committee: WG 8 - TC 87/WG 8
• Current Stage: PPUB - Publication issued
• Start Date: 18-Mar-2022
• Completion Date: 08-Mar-2022

Relations

• Revises: IEC 61689:2013 - 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 4.0 2022-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Ultrasonics – Physiotherapy systems – Field specifications and methods
of measurement in the frequency range 0,5 MHz to 5 MHz

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Secretariat Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always
committee, …). It also gives information on projects, replaced have access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and
and French, with equivalent terms in 19 additional languages.
once a month by email.
Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc

If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: [e-mail].
IEC 61689 ®
Edition 4.0 2022-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Ultrasonics – Physiotherapy systems – Field specifications and methods
of measurement in the frequency range 0,5 MHz to 5 MHz
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.60 ISBN 978-2-8322-5072-3

– 2 – IEC 61689:2022 RLV © IEC 2022
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Symbols . 19
5 Ultrasonic field specifications . 20
6 Conditions of measurement and test equipment used . 21
6.1 General . 21
6.2 Test vessel . 21
6.3 Hydrophone . 22
6.4 RMS or peak signal measurement . 23
7 Type testing reference procedures and measurements . 24
7.1 General . 24
7.2 Rated output power . 24
7.3 Hydrophone measurements . 24
7.4 Effective radiating area . 25
7.4.1 Effective radiating area measurements . 25
7.4.2 Hydrophone positioning . 26
7.4.3 Beam cross-sectional area determination . 26
7.4.4 Active area gradient determination . 26
7.4.5 Beam type determination . 26
7.4.6 Effective radiating area calculation . 26
7.4.7 Beam non-uniformity ratio calculation . 26
7.4.8 Testing requirements . 27
7.5 Reference type testing parameters. 27
7.6 Acceptance criteria for reference type testing . 28
8 Routine measurement procedure . 28
8.1 General . 28
8.2 Rated output power . 28
8.3 Effective radiating area . 28
8.4 Beam non-uniformity ratio . 29
8.5 Effective intensity. 29
8.6 Acceptance criteria for routine testing . 29
9 Sampling and uncertainty determination . 30
9.1 Reference type testing measurements . 30
9.2 Routine measurements . 30
9.3 Uncertainty determination . 30
Annex A (informative normative) Guidance for performance and safety . 31
A.1 General . 31
A.2 Rated output power . 31
A.3 Effective intensity. 31
A.4 Beam non-uniformity ratio . 31
A.4.1 General . 31

A.4.2 Rationale behind using a limiting value for the beam non-uniformity ratio
(R ) . 31
BN
Annex B (normative) Raster scan measurement and analysis procedures . 36
B.1 General . 36
B.2 Requirements for raster scans . 36
B.3 Requirements for analysis of raster scan data . 37
B.3.1 General . 37
B.3.2 Total mean square acoustic pressure . 37
B.3.3 Calculation of the beam cross-sectional area, A . 37
BCS
Annex C (normative) Diametrical or line scan measurement and analysis procedures . 39
C.1 General . 39
C.2 Requirements for line scans . 39
C.3 Analysis of line scans . 39
Annex D (informative) Rationale concerning the beam cross-sectional area definition . 43
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 ) . 48
ER
Annex F (informative) Determining acoustic power through radiation force
measurements . 50
Annex G (informative) Validity of low-power measurements of the beam cross-
sectional area (A ) . 52
BCS
Annex H (informative) Influence of hydrophone effective diameter . 53
Annex I (informative) Effective radiating area measurements using a radiation force
balance and absorbing apertures . 55
I.1 General . 55
I.2 Concept of aperture method . 55
I.3 Requirements for the aperture method . 56
I.3.1 Radiation force balance . 56
I.3.2 Apertures . 56
I.4 Measurement procedure for determining the effective radiating area . 57
I.5 Analysis of raw data to derive the effective radiating area . 58
I.6 Implementation of the aperture technique . 64
I.7 Relationship of results to reference testing method . 65
Annex J (informative) Guidance on uncertainty determination . 66
Annex K (informative) Examples of pulse duration and pulse repetition period of
amplitude modulated waves . 68
Bibliography . 70

Figure A.1 – Normalized, time-averaged values of acoustic intensity (solid line) and of
one of its plane-wave approximations (broken line), existing on the axis of a circular
piston source of ka = 30, plotted against the normalized distance s , where s = λz/a . 34
n n
Figure A.2 – Histogram of R values for 37 treatment heads of various diameters and
BN
frequencies . 35
Figure D.1 – Iso-pressure lines of a typical physiotherapy treatment head of small
geometrical area (ka = 17) .
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 .

– 4 – IEC 61689:2022 RLV © IEC 2022
Figure D.3 – Normalized values of beam cross-sectional area for IEC and FDA limit
values for five transducers of different ka values .
Figure D.4 – Range of values of the beam cross-sectional area (A ) with distance
BCS
from the face of the treatment head .
Figure D.5 – Range of values of the normalized beam cross-sectional area (A ) with
BCS
transducer ka .
Figure E.1 – Conversion factor F as a function of the ka product for ka product
ac
between 40 and 160 . 49
Figure I.1 – Schematic representation of aperture measurement set-up . 56
Figure I.2 – Measured power as a function of aperture diameter for commercially
available 1 MHz physiotherapy treatment heads . 60
Figure I.3 – Cumulative sum of annular power contributions, previously sorted in
...

IEC 61689 ®
Edition 4.0 2022-03
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 plage de fréquences de 0,5 MHz à 5 MHz

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et
les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Secretariat Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews. With a subscription you will always have
committee, …). It also gives information on projects, replaced access to up to date content tailored to your needs.
and withdrawn publications.
Electropedia - www.electropedia.org
IEC Just Published - webstore.iec.ch/justpublished
The world's leading online dictionary on electrotechnology,
Stay up to date on all new IEC publications. Just Published
containing more than 22 300 terminological entries in English
details all new publications released. Available online and once
and French, with equivalent terms in 19 additional languages.
a month by email.
Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
Centre: [e-mail].
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Recherche de publications IEC - Découvrez notre puissant moteur de recherche et consultez
webstore.iec.ch/advsearchform gratuitement tous les aperçus des publications. Avec un
La recherche avancée permet de trouver des publications IEC abonnement, vous aurez toujours accès à un contenu à jour
en utilisant différents critères (numéro de référence, texte, adapté à vos besoins.
comité d’études, …). Elle donne aussi des informations sur les
projets et les publications remplacées ou retirées. Electropedia - www.electropedia.org

Le premier dictionnaire d'électrotechnologie en ligne au monde,
IEC Just Published - webstore.iec.ch/justpublished
avec plus de 22 300 articles terminologiques en anglais et en
Restez informé sur les nouvelles publications IEC. Just
français, ainsi que les termes équivalents dans 19 langues
Published détaille les nouvelles publications parues.
additionnelles. Egalement appelé Vocabulaire
Disponible en ligne et une fois par mois par email.
Electrotechnique International (IEV) en ligne.

Service Clients - webstore.iec.ch/csc
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
[e-mail].
IEC Products & Services Portal - products.iec.ch

IEC 61689 ®
Edition 4.0 2022-03
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 plage de fréquences de 0,5 MHz à 5 MHz

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-1080-0

– 2 – IEC 61689:2022 © IEC 2022
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Symbols . 18
5 Ultrasonic field specifications . 19
6 Conditions of measurement and test equipment used . 20
6.1 General . 20
6.2 Test vessel . 20
6.3 Hydrophone . 21
6.4 RMS peak signal measurement . 22
7 Type testing reference procedures and measurements . 22
7.1 General . 22
7.2 Rated output power . 23
7.3 Hydrophone measurements . 23
7.4 Effective radiating area . 24
7.4.1 Effective radiating area measurements . 24
7.4.2 Hydrophone positioning . 24
7.4.3 Beam cross-sectional area determination . 24
7.4.4 Active area gradient determination . 24
7.4.5 Beam type determination . 25
7.4.6 Effective radiating area calculation . 25
7.4.7 Beam non-uniformity ratio calculation . 25
7.4.8 Testing requirements . 25
7.5 Reference type testing parameters. 26
7.6 Acceptance criteria for reference type testing . 26
8 Routine measurement procedure . 27
8.1 General . 27
8.2 Rated output power . 27
8.3 Effective radiating area . 27
8.4 Beam non-uniformity ratio . 27
8.5 Effective intensity. 28
8.6 Acceptance criteria for routine testing . 28
9 Sampling and uncertainty determination . 28
9.1 Reference type testing measurements . 28
9.2 Routine measurements . 28
9.3 Uncertainty determination . 29
Annex A (normative) Guidance for performance and safety . 30
A.1 General . 30
A.2 Rated output power . 30
A.3 Effective intensity. 30
A.4 Beam non-uniformity ratio . 30
A.4.1 General . 30

A.4.2 Rationale behind using a limiting value for the beam non-uniformity ratio
(R ) . 30
BN
Annex B (normative) Raster scan measurement and analysis procedures . 35
B.1 General . 35
B.2 Requirements for raster scans . 35
B.3 Requirements for analysis of raster scan data . 36
B.3.1 General . 36
B.3.2 Total mean square acoustic pressure . 36
B.3.3 Calculation of the beam cross-sectional area, A . 36
BCS
Annex C (normative) Diametrical or line scan measurement and analysis procedures . 37
C.1 General . 37
C.2 Requirements for line scans . 37
C.3 Analysis of scans . 37
Annex D (informative) Rationale concerning the beam cross-sectional area definition . 41
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) 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 measurements using a radiation force
balance and absorbing apertures . 49
I.1 General . 49
I.2 Concept of aperture method . 49
I.3 Requirements for the aperture method . 50
I.3.1 Radiation force balance . 50
I.3.2 Apertures . 50
I.4 Measurement procedure for determining the effective radiating area . 51
I.5 Analysis of raw data to derive the effective radiating area . 52
I.6 Implementation of the aperture
...