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

IEC 61689:2022 is available as IEC 61689:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
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e) Annex D has been considerably shortened and reference to a now withdrawn regulatory document has been removed.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

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.

General Information

Status
Published
Publication Date
07-Mar-2022
Technical Committee
Current Stage
PPUB - Publication issued
Completion Date
08-Mar-2022
Ref Project

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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
IEC 61689:2022-03(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
IEC 61689:2022 © IEC 2022 – 3 –
A.4.2 Rationale behind using a limiting value for the beam non-uniformity ratio

(R ) ............................................................................................................ 30

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

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

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

frequencies ........................................................................................................................... 34

Figure E.1 – Conversion factor F as a function of the ka product for ka product

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

---------------------- Page: 5 ----------------------
– 4 – IEC 61689:2022 © IEC 2022
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 ,

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

---------------------- Page: 6 ----------------------
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

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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.
---------------------- Page: 7 ----------------------
– 6 – IEC 61689:2022 © IEC 2022
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.
---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
– 8 – IEC 61689:2022 © IEC 2022
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
---------------------- Page: 10 ----------------------
IEC 61689:2022 © IEC 2022 – 9 –
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
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 possibility of variation in the rated output power resulting from ±10 % variation in the rated

value of the mains voltage should be checked by using a variable output transformer between the mains voltage

supply and the ultrasonic physiotherapy equipment. See Clause A.2 for further guidance.

Note 2 to entry: Absolute maximum rated output power is expressed in watts (W).
3.2
active area coefficient

quotient of the active area gradient, m, and the beam cross-sectional area at 0,3 cm from

the face of the treatment head, A (0,3 cm)
BCS

Note 1 to entry: Active area coefficient is expressed in units of one per metre (m ).

3.3
active area gradient
ratio of the difference of the beam cross-section
...

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