SIST EN 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)

This International Standard 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. 211
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;
- acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment 224 based on routine testing methods.
Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard.

Ultraschall - Physiotherapiesysteme - Feldspezifikation und Messverfahren im Frequenzbereich von 0,5 MHz bis 5 MHz (IEC 61689:2022)

Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz (IEC 61689:2022)

IEC 61689:2022 est disponible sous forme de IEC 61689:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.

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.

Ultrazvok - Fizioterapevtski sistemi - Specifikacije polja in merilne metode v frekvenčnem območju od 0,5 MHz do 5 MHz (IEC 61689:2022)

Ta mednarodni standard se navezuje na ultrazvočno opremo, namenjeno fizioterapiji, ki vključuje ultrazvočni pretvornik, ki ustvarja neprekinjeno ali skoraj neprekinjeno (npr. tonski izbruh) ultrazvočno valovanje v frekvenčnem območju od 0,5 MHz do 5 MHz. 211
Ta standard se navezuje samo na ultrazvočno fizioterapevtsko opremo, ki uporablja enoravninski neosrediščeni krožni pretvornik na glavo za obdelavo, ki proizvaja statične snope, pravokotne na ploskev glave za obdelavo.
Ta standard določa:
– metode merjenja in karakterizacije izhoda ultrazvočne fizioterapevtske opreme na podlagi metod referenčnega preskušanja;
– lastnosti, ki jih morajo specificirati proizvajalci ultrazvočne fizioterapevtske opreme na podlagi metod referenčnega preskušanja;
– smernice za varnost ultrazvočnega polja, ki ga proizvaja oprema za ultrazvočno fizioterapijo;
– metode merjenja in karakterizacije izhoda ultrazvočne fizioterapevtske opreme na podlagi metod rutinskega preskušanja;
– kriterije sprejemljivosti za vidike izhoda ultrazvočne fizioterapevtske opreme 224 na podlagi metod rutinskega preskušanja.
Ta standard ne zajema terapevtske vrednosti in metod uporabe opreme za ultrazvočno fizioterapijo.

General Information

• Status: Published
• Publication Date: 09-May-2022
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: I11 - Imaginarni 11
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 03-May-2022
• Due Date: 08-Jul-2022
• Completion Date: 10-May-2022
• Ref Project: EN IEC 61689:2022 - Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz

Relations

• Revised: SIST EN 61689:2013 - Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
• Effective Date: 29-Dec-2020
• Replaces: SIST EN 61689:2013 - Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
• Effective Date: 26-Apr-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 61689:2022
01-junij-2022
Nadomešča:
SIST EN 61689:2013
Ultrazvok - Fizioterapevtski sistemi - Specifikacije polja in merilne metode v
frekvenčnem območju od 0,5 MHz do 5 MHz (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)
Ultraschall - Physiotherapiesysteme - Feldspezifikation und Messverfahren im
Frequenzbereich von 0,5 MHz bis 5 MHz (IEC 61689:2022)
Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de
mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz (IEC 61689:2022)
Ta slovenski standard je istoveten z: EN IEC 61689:2022
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 61689:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 61689:2022

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SIST EN IEC 61689:2022


EUROPEAN STANDARD EN IEC 61689

NORME EUROPÉENNE

EUROPÄISCHE NORM April 2022
ICS 11.040.60 Supersedes EN 61689:2013
English Version
Ultrasonics - Physiotherapy systems - Field specifications and
methods of measurement in the frequency range 0,5 MHz to 5
MHz
(IEC 61689:2022)
Ultrasons - Systèmes de physiothérapie - Spécifications Ultraschall - Physiotherapiesysteme - Feldspezifikation und
des champs et méthodes de mesure dans la plage de Messverfahren im Frequenzbereich von 0,5 MHz bis 5 MHz
fréquences de 0,5 MHz à 5 MHz (IEC 61689:2022)
(IEC 61689:2022)
This European Standard was approved by CENELEC on 2022-04-12. 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 national 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 61689:2022 E

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SIST EN IEC 61689:2022
EN IEC 61689:2022 (E)
European foreword
The text of document 87/784/FDIS, future edition 4 of IEC 61689, prepared by IEC/TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 61689:2022.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-01-12
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-04-12
document have to be withdrawn
This document supersedes EN 61689:2013 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61689:2022 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 NOTE Harmonized as EN IEC 61828
IEC 62127-2 NOTE Harmonized as EN 62127-2
IEC 62127-3 NOTE Harmonized as EN 62127-3
IEC 62555 NOTE Harmonized as EN 62555
IEC 63009 NOTE Harmonized as EN IEC 63009
2

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SIST EN IEC 61689:2022
EN IEC 61689:2022 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-1 - Medical electrical equipment - Part 1: General EN 60601-1 -
requirements for basic safety and essential
performance
IEC 60601-2-5 - Medical electrical equipment - Part 2-5: EN 60601-2-5 -
Particular requirements for the basic safety
and essential performance of ultrasonic
physiotherapy equipment
IEC 61161 - Ultrasonics - Power measurement - Radiation EN 61161 -
force balances and performance requirements
IEC 62127-1 - Ultrasonics - Hydrophones - Part 1: - -
Measurement and characterization of medical
ultrasonic fields

3

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SIST EN IEC 61689:2022



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




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN IEC 61689:2022
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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

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IEC 61689:2022 © IEC 2022 – 3 –
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 technique . 58
I.7 Relationship of results to reference testing method . 59
Annex J (informative) Guidance on uncertainty determination . 60
Annex K (informative) Examples of pulse duration and pulse repetition period of
amplitude modulated waves . 62
Bibliography . 64

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
2
piston source of ka = 30, plotted against the normalized distance s , where s = λz/a . 33
n n
Figure A.2 – Histogram of R values for 37 treatment heads of various diameters and
BN
frequencies . 34
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 . 50
Figure I.2 – Measured power as a function of aperture diameter for commercially
available 1 MHz physiotherapy treatment heads . 54

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Figure I.3 – Cumulative sum of annular power contributions, previously sorted in
descending order of intensity contributions, plotted against the cumulative sum of their
respective annular areas . 58
Figure K.1 – Example 1: Tone-burst (i.e. rectangular modulation waveform) . 62
Figure K.2 – Example 2: Half-wave modulation with no filtering of the AC mains voltage. 62
Figure K.3 – Example 3: Full-wave modulation with no filtering of the AC mains voltage . 62
Figure K.4 – Example 4: Half-wave modulation with filtering of the AC mains voltage;
filtering insufficient to define the wave as continuous wave (3.17) . 63
Figure K.5 – Example 5: Full-wave modulation with filtering of the AC mains voltage;
filtering insufficient to define the wave as continuous wave (3.17) . 63

Table C.1 – Constitution of the transformed array [B] used for the analysis of half-line
scans . 39
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 ,
1
and the target distance, z, calculated in accordance with A.5.3.1 of IEC 61161:2013
(see [8]) . 45
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

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SIST EN IEC 61689:2022
IEC 61689:2022 © IEC 2022 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ULTRASONICS – PHYSIOTHERAPY SYSTEMS –
FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT
IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
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preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 61689 has been prepared by IEC technical committee 87: Ultrasonics. It is an International
Standard.
This fourth edition 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.

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The text of this International Standard is based on the following documents:
Draft Report on voting
87/784/FDIS 87/789/RVD

Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
NOTE The following print types are used:
• Requirements: in Arial 10 point
• Notes: in Arial 8 point
• Words in bold in the text are defined in Clause 3
• Symbols and formulae: Times New Roman + Italic
• Compliance clauses: in Arial Italic
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN IEC 61689:2022
IEC 61689:2022 © IEC 2022 – 7 –
INTRODUCTION
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 contains a transducer, usually a disc of piezoelectric material, for converting the electrical
energy to ultrasound and is often designed for contact with the human body.

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ULTRASONICS – PHYSIOTHERAPY SYSTEMS –
FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT
IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz



1 Scope
This document 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 60601-1, Medical electrical equipment – Part 1: General requirements for basic 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, Ultrasonics – Power measurement – Radiation force balances and performance
requirements
IEC 62127-1, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of
medical ultrasonic fields

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3
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