Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz

IEC 63009:2019 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz.
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;
• 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.
The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document.
Excluded equipment includes, but is not limited to:
• equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type;
• equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters);
• equipment in which ultrasound waves are intended to sensitize tissue to further therapies (for example radiation or chemotherapy);
• equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High Intensity Therapeutic Ultrasound (HITU).

Ultrasons – Systèmes de physiothérapie – Spécifications des champs et méthodes de mesure dans la plage de fréquences de 20 kHz à 500 kHz

L'IEC 63009:2019 est applicable aux appareils à ultrasons, conçus pour la physiothérapie, comprenant un transducteur ultrasonique fournissant des ultrasons dans la plage de fréquences de 20 kHz à 500 kHz.
Le présent document ne traite que des appareils à ultrasons pour physiothérapie employant un seul transducteur circulaire plan sans focalisation par transducteur, produisant des faisceaux statiques perpendiculaires à la face du transducteur.
Le présent document spécifie:
• les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, reposant sur des méthodes d’essai de référence;
• les caractéristiques à préciser par les fabricants des appareils à ultrasons pour physiothérapie;
• les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, reposant sur des méthodes d’essai de routine;
• les critères d’aptitude concernant les divers aspects de la sortie des appareils à ultrasons pour physiothérapie.
La valeur thérapeutique et les modes d’utilisation des appareils à ultrasons pour physiothérapie ne relèvent pas du domaine d’application du présent document.
Les appareils exclus comprennent entre autres:
• les appareils avec lesquels les ondes ultrasonores sont destinées à détruire des conglomérats (par exemple, des calculs rénaux ou biliaires) ou des tissus de tout type;
• les appareils avec lesquels un outil est entraîné par ultrasons (par exemple, scalpels chirurgicaux, phacoémulseurs, instruments à détartrer dentaires ou lithotriteurs intracorporels);
• les appareils avec lesquels les ondes ultrasonores sont destinées à sensibiliser les tissus à d’autres thérapies (par exemple, rayonnement ou chimiothérapie);
• les appareils avec lesquels les ondes ultrasonores sont destinées à traiter les tissus cancéreux (c’est-à-dire malins) ou précancéreux, voire les masses bénignes. Il s’agit par exemple des ultrasons focalisés de haute intensité (HIFU, high intensity focused ultrasound) ou des ultrasons thérapeutiques de haute intensité (HITU, high intensity therapeutic ultrasound).

General Information

Status
Published
Publication Date
10-Jul-2019
Technical Committee
Current Stage
PPUB - Publication issued
Completion Date
11-Jul-2019
Ref Project

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IEC 63009
Edition 1.0 2019-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 20 kHz to 500 kHz
Ultrasons – Systèmes de physiothérapie – Spécifications des champs et
méthodes de mesure dans la plage de fréquences de 20 kHz à 500 kHz
IEC 63009:2019-07(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 63009
Edition 1.0 2019-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 20 kHz to 500 kHz
Ultrasons – Systèmes de physiothérapie – Spécifications des champs et
méthodes de mesure dans la plage de fréquences de 20 kHz à 500 kHz
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50; 11.040.60 ISBN 978-2-8322-7153-7

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 63009:2019  IEC 2019
CONTENTS

FOREWORD ........................................................................................................................... 4

INTRODUCTION ..................................................................................................................... 6

1 Scope .............................................................................................................................. 7

2 Normative references ...................................................................................................... 7

3 Terms and definitions ...................................................................................................... 8

4 Symbols ........................................................................................................................ 17

5 Ultrasonic field specifications ......................................................................................... 18

6 Conditions of measurement and test equipment used for field measurements ................ 19

6.1 General ................................................................................................................. 19

6.2 Test vessel ........................................................................................................... 20

6.3 Hydrophone .......................................................................................................... 20

6.4 RMS or peak signal measurement ......................................................................... 20

7 Type testing reference procedures and measurements .................................................. 21

7.1 General ................................................................................................................. 21

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

A.1 General ................................................................................................................. 27

A.2 Rated output power ............................................................................................... 27

A.3 Effective intensity.................................................................................................. 27

A.4 Beam non-uniformity ratio ..................................................................................... 27

A.4.1 General ......................................................................................................... 27

A.4.2 Rationale behind using a limiting value for the beam non-uniformity

ratio, R ...................................................................................................... 27

Annex B (normative) Raster scan measurement and analysis procedures ............................ 30

B.1 General ................................................................................................................. 30

B.2 Requirements for raster scans .............................................................................. 30

B.3 Requirements for analysis of raster scan data ....................................................... 30

B.3.1 General ......................................................................................................... 30

B.3.2 Total mean square acoustic pressure ............................................................ 31

B.3.3 Calculation of the beam cross-sectional area, A ...................................... 31

BCS
---------------------- Page: 4 ----------------------
IEC 63009:2019  IEC 2019 – 3 –

Annex C (normative) Diametrical (line) scan measurement and analysis procedures............ 32

C.1 General ................................................................................................................. 32

C.2 Requirements for line scans .................................................................................. 32

C.3 Analysis of line scans ........................................................................................... 32

Bibliography .......................................................................................................................... 35

Table C.1 – Constitution of the transformed array [B] used for the analysis of half-line

scans .................................................................................................................................... 33

---------------------- Page: 5 ----------------------
– 4 – IEC 63009:2019  IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – PHYSIOTHERAPY SYSTEMS – FIELD SPECIFICATIONS
AND METHODS OF MEASUREMENT IN THE FREQUENCY
RANGE 20 kHz TO 500 kHz
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, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their 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

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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

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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

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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.

International Standard IEC 63009 has been prepared by technical committee 87: Ultrasonics.

The text of this International Standard is based on the following documents:
CDV Report on voting
87/705/CDV 87/714A/RVC

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:
---------------------- Page: 6 ----------------------
IEC 63009:2019  IEC 2019 – 5 –
• Terms defined in Clause 3: bold type
• Compliance clauses: Arial Italic
• Symbols of quantities: Times New Roman + Italic

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://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: 7 ----------------------
– 6 – IEC 63009:2019  IEC 2019
INTRODUCTION

Ultrasound is used in medicine for the purposes of physiotherapy. Such equipment consists

of a generator of electrical energy and usually a hand-held treatment head, often

referred to as an applicator. The treatment head contains a transducer for converting the

electrical energy to ultrasound and is often designed for contact with the human body.

---------------------- Page: 8 ----------------------
IEC 63009:2019  IEC 2019 – 7 –
ULTRASONICS – PHYSIOTHERAPY SYSTEMS – FIELD SPECIFICATIONS
AND METHODS OF MEASUREMENT IN THE FREQUENCY
RANGE 20 kHz TO 500 kHz
1 Scope

This International Standard is applicable to ultrasonic equipment designed for physiotherapy

containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to

500 kHz.

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;
• 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.

The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not

within the scope of this document.
Excluded equipment includes, but is not limited to:

• equipment in which ultrasound waves are intended to destroy conglomerates (for example

stones in the kidneys or the bladder) or tissue of any type;

• equipment in which a tool is driven by ultrasound (for example surgical scalpels,

phacoemulsifiers, dental scalers or intracorporeal lithotripters);

• equipment in which ultrasound waves are intended to sensitize tissue to further therapies

(for example radiation or chemotherapy);

• equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or

pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound

(HIFU) or High Intensity Therapeutic Ultrasound (HITU).
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 60565, Underwater acoustics – Hydrophones – Calibration in the frequency range

0,01 Hz to 1 MHz

IEC 60601-2-5, Medical electrical equipment – Part 2-5: Particular requirements for the basic

safety and essential performance of ultrasonic physiotherapy equipment
---------------------- Page: 9 ----------------------
– 8 – IEC 63009:2019  IEC 2019

IEC 62127-1, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of

medical ultrasonic fields up to 40 MHz

IEC 62127-2, Ultrasonics – Hydrophones – Part 2: Calibration for ultrasonic fields up to

40 MHz
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).
[SOURCE: IEC 61689:2013, 3.1]
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)
BCS

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

[SOURCE: IEC 61689:2013, 3.2]
3.3
active area gradient

ratio of the difference of the beam cross-sectional area at z , A (z ), and the beam

N BCS N

cross-sectional area at 0,3 cm from the face of the treatment head, A (0,3), divided by

BCS
the difference of the respective distances
[Az( )− A (03, )]
BCS N BCS
m= (1)
(z − 03,)
where
A is the beam cross-sectional area;
BCS

z is the distance of the last axial maximum of the RMS acoustic pressure from the face

of the treatment head;

Note 1 to entry: If z < 0,3 cm then A at a /λ or 2a, whichever is greater, should be used instead of A (z ),

N BCS BCS N
where a is the geometrical radius of the active element of the treatment head.
Note 2 to entry: Active area gradient is expressed in metres (m).
---------------------- Page: 10 ----------------------
IEC 63009:2019  IEC 2019 – 9 –

[SOURCE: IEC 61689:2013, 3.3, modified – by defining the term "gradient" within the

definition and adding the equation to calculate the gradient.]
3.4
absolute maximum beam non-uniformity ratio

beam non-uniformity ratio plus the 95 % confidence overall uncertainty in the beam non-

uniformity ratio
[SOURCE: IEC 61689:2013, 3.4]
3.5
absolute maximum effective intensity

value of the effective intensity corresponding to the absolute maximum rated output

power and the absolute minimum effective radiating area from the equipment
[SOURCE: IEC 61689:2013, 3.5]
3.6
absolute minimum effective radiating area

effective radiating area minus the 95 % confidence overall uncertainty in the effective

radiating area
[SOURCE: IEC 61689:2013, 3.6]
3.7
acoustic working frequency
awf

frequency of an acoustic signal based on the observation of the output of a hydrophone

placed in an acoustic field at the position corresponding to the spatial-peak temporal-peak

acoustic pressure or 0,3 cm, whichever is greater

Note 1 to entry: The signal is analysed using either the zero-crossing acoustic-working frequency technique or

a spectrum analysis method. Acoustic-working frequencies are defined in 3.7.1 and 3.7.2.

Note 2 to entry: In a number of cases the present definition is not very helpful or convenient, especially for

broadband transducers. In that case a full description of the frequency spectrum should be given in order to

enable any frequency-dependent correction to the signal.
Note 3 to entry: Acoustic-working frequency is expressed in hertz (Hz).

[SOURCE: IEC 61689:2013, 3.7, modified – by adding a minimum measurement distance for

low frequencies for which the distance to the spatial-peak temporal-peak acoustic pressure

may be too close to the transducer to allow for hydrophone measurements.]
3.7.1
arithmetic-mean acoustic-working frequency

arithmetic mean of the most widely separated frequencies f and f , within the range of three

1 2

times f , at which the magnitude of the acoustic pressure spectrum is 3 dB below the peak

magnitude
Note 1 to entry: This frequency is intended for pulse-wave systems only.
Note 2 to entry: It is assumed that f < f .
1 2

Note 3 to entry: If f is not found within the range < 3f , f is to be understood as the lowest frequency above this

2 1 2
range at which the spectrum magnitude is 3 dB below the peak magnitude.
[SOURCE: IEC 61689:2013, 3.7.1]
---------------------- Page: 11 ----------------------
– 10 – IEC 63009:2019  IEC 2019
3.7.2
zero-crossing acoustic-working frequency

number, n, of consecutive half-cycles (irrespective of polarity) divided by twice the time

between the commencement of the first half-cycle and the end of the n-th half-cycle

Note 1 to entry: None of the n consecutive half-cycles should show evidence of phase change.

Note 2 to entry: The measurement should be performed at terminals in the receiver that are as close as possible

to the receiving transducer (hydrophone) and, in all cases, before rectification.

Note 3 to entry: This frequency is determined according to the procedure specified in IEC TR 60854 [1] .

Note 4 to entry: This frequency is intended for continuous-wave systems only.
[SOURCE: IEC 61689:2013, 3.7.2]
3.8
acoustic pulse waveform

temporal waveform of the instantaneous acoustic pressure at a specified position in an

acoustic field and displayed over a period sufficiently long to include all significant acoustic

information in a single pulse or tone-burst, or one or more cycles in a continuous wave

Note 1 to entry: Temporal waveform is a representation (e.g. oscilloscope presentation or equation) of the

instantaneous acoustic pressure.
[SOURCE: IEC 61689:2013, 3.8]
3.9
acoustic repetition period
arp

pulse repetition period equal to the time interval between corresponding points of

consecutive cycles for continuous wave systems
Note 1 to entry: Acoustic repetition period is expressed in seconds (s).
[SOURCE: IEC 61689:2013, 3.9]
3.10
amplitude modulated wave

wave in which the ratio p 2 p at a distance on the beam alignment axis of either a /λ

tp RMS

or 2a, whichever is the more appropriate, is greater than 1,05, where p is the temporal-peak

acoustic pressure and p is the RMS acoustic pressure
RMS

[SOURCE: IEC 61689:2013, 3.10, modified – to allow for low frequencies for which the

distance a /λ may be too close to the transducer to allow hydrophone measurements.]

3.11
attachment head

accessory intended to be attached to the treatment head for the purpose of modifying the

ultrasonic beam characteristics
[SOURCE: IEC 60601-2-5:2009, 201-3-202]
—————————
Numbers in square brackets refer to the Bibliography.
---------------------- Page: 12 ----------------------
IEC 63009:2019  IEC 2019 – 11 –
3.12
beam alignment axis

straight line joining two points of maximum RMS acoustic pressure on two plane surfaces

parallel to the face of the treatment head at specific distances

Note 1 to entry: One plane is at a distance of approximately a /λ, where a is the geometrical radius of the active

2 2

element of the treatment head. The second plane surface is at a distance of either 2a /λ or a /(3λ), whichever is

the more appropriate. For the purposes of alignment, this line may be projected to the face of the treatment head.

Note 2 to entry: As the beam alignment axis is used purely for the purposes of alignment, the definitions of

specific distances may be relaxed slightly to reflect the constraints of the measurement system employed. For

example, some treatment heads will have a /λ considerably greater than 12 cm, in which case a maximum

distance of 12 cm may be used to define the first plane. General guidelines for determining the beam alignment

axis are given in 7.3.

[SOURCE: IEC 61689:2013, 3.12, modified – The details of the plane surfaces have been

moved to a note to entry.]
3.13
beam cross-sectional area
BCS

minimum area in a specified plane perpendicular to the beam alignment axis for which the

sum of the mean square acoustic pressure is 75 % of the total mean square acoustic

pressure

Note 1 to entry: Beam cross-sectional area is expressed in units of metre squared (m ).

[SOURCE: IEC 61689:2013, 3.13, modified – Note 2 to entry has been removed.]
3.14
beam maximum intensity
product of the beam non-uniformity ratio and effective intensity

Note 1 to entry: Beam maximum intensity is expressed in units of watt per metre squared (W/m ).

[SOURCE: IEC 61689:2013, 3.14]
3.15
beam non-uniformity ratio

ratio of the square of the maximum RMS acoustic pressure to the spatial average of the

square of the RMS acoustic pressure, where the spatial average is taken over the effective

radiating area
max,RMS ER
R =
(2)
pms A
where
p is the maximum RMS acoustic pressure;
max,RMS
A is the effective radiating area;
pms is the total mean square acoustic pressure;
A is the unit area for the raster scan.
[SOURCE: IEC 61689:2013, 3.15, modified – The symbol used for the maximum RMS
acoustic pressure has been modified.]
---------------------- Page: 13 ----------------------
– 12 – IEC 63009:2019  IEC 2019
3.16
beam type
des
...

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