EN IEC 63009:2019

SLOVENSKI STANDARD
01-januar-2020
Ultrazvok - Fizioterapevtski sistemi - Poljske specifikacije in merilne metode v
frekvenčnem območju od 20 kHz do 500 kHz (IEC 63009:2019)
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement
in the frequency range 20 kHz to 500 kHz (IEC 63009:2019)
Ultraschall - Physiotherapiesysteme - Feldspezifikationen und Messmethoden im
Frequenzbereich 20 kHz bis 500 kHz (IEC 63009:2019)
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)
Ta slovenski standard je istoveten z: EN IEC 63009:2019
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 63009

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2019
ICS 17.140.50; 11.040.60
English Version
Ultrasonics - Physiotherapy systems - Field specifications and
methods of measurement in the frequency range 20 kHz to 500
kHz
(IEC 63009:2019)
Ultrasons - Systèmes de physiothérapie - Spécifications Ultraschall - Physiotherapiesysteme - Feldspezifikationen
des champs et méthodes de mesure dans la plage de und Messmethoden im Frequenzbereich 20 kHz bis 0,5
fréquences de 20 kHz à 500 kHz MHz
(IEC 63009:2019) (IEC 63009:2019)
This European Standard was approved by CENELEC on 2019-08-15. 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63009:2019 E
European foreword
The text of document 87/705/CDV, future edition 1 of IEC 63009, prepared by IEC/TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-05-15
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-08-15
document have to be withdrawn
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.

Endorsement notice
The text of the International Standard IEC 63009:2019 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 61689:2013 NOTE Harmonized as EN 61689:2013 (not modified)
IEC 61161 NOTE Harmonized as EN 61161
IEC 62127-3 NOTE Harmonized as EN 62127-3
IEC 62555 NOTE Harmonized as EN 62555

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 60565 -  Underwater acoustics - Hydrophones - Calibration in EN 60565 -
the frequency range 0,01 Hz to 1 MHz
IEC 60601-2-5 -  Medical electrical equipment - Part 2-5: Particular EN 60601-2-5 -
requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
IEC 62127-1 -  Ultrasonics - Hydrophones - Part 1: Measurement EN 62127-1 -
and characterization of medical ultrasonic fields up to
40 MHz
IEC 62127-2 -  Ultrasonics - Hydrophones - Part 2: Calibration for EN 62127-2 -
ultrasonic fields up to 40 MHz

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

– 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
BN
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
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

– 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
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.
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:

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.
– 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.

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

– 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
Q
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
–1
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
m
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,)
N
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
N
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).

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
f
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]

– 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
tp
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.

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
A
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
R
BN
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
pA
max,RMS ER
R =
(2)
BN
pms A
t0
where
p is the maximum RMS acoustic pressure;
max,RMS
A is the effective radiating area;
ER
pms is the total mean square acoustic pressure;
t
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.]

– 12 – IEC 63009:2019  IEC 2019
3.16
beam type
descriptive classification for the ultrasonic beam in one of three types: collimated,
convergent or divergent
[SOURCE: IEC 61689:2013, 3.16]
3.17
continuous wave
wave in which the ratio p 2 p , at a distance on the beam alignment axis of either a /λ
tp RMS
is the
or 2a, whichever is the more appropriate, is less than or equal to 1,05, where p
tp
temporal-peak acoustic pressure and p is the RMS acoustic pressure
RMS
[SOURCE: IEC 61689:2013, 3.17, modified – Measurement distance is specified differently to
account for lower frequencies.]
3.18
collimated
beam for which the active area coefficient, Q, obeys the following inequality:
-1 -1
-0,05 cm ≤ Q ≤ 0,1 cm
[SOURCE: IEC 61689:2013, 3.18]
3.19
convergent
beam for which the active area coefficient, Q, obeys the following inequality:
-1
Q < -0,05 cm
[SOURCE: IEC 61689:2013, 3.19]
3.20
divergent
beam for which the active area coefficient, Q, obeys the following inequality:
-1
Q > 0,1 cm
[SOURCE: IEC 61689:2013, 3.20]
3.21
duty factor
ratio of the pulse duration to the pulse repetition period
[SOURCE: IEC 61689:2013, 3.21]
3.22
effective intensity
I
e
intensity given by I = P/A where P is the output power and A is the effective radiating
e ER ER
area
Note 1 to entry: Effective intensity is expressed in units of watt per metre squared (W/m ).
[SOURCE: IEC 61689:2013, 3.22]

IEC 63009:2019  IEC 2019 – 13 –
3.23
effective radiating area
A
ER
beam cross-sectional area determined at a distance of 0,3 cm from the front of the
treatment head, A (0,3), multiplied by a dimensionless factor, F , given by:
BCS ac
F = 1,333 (3)
ac
Note 1 to entry: The conversion factor F is used here in order to derive the area close to the treatment head
ac
which contains 100 % of the total mean square acoustic pressure. The origin of the value of F is described in
ac
IEC 61689 [2] and in references [3] and [4].
Note 2 to entry: Effective radiating area is expressed in units of metre squared (m ).
[SOURCE: IEC 61689:2013, 3.23]
3.24
end-of-cable loaded sensitivity
end-of-cable loaded sensitivity of a hydrophone
end-of-cable loaded sensitivity of a hydrophone-assembly
M (f)
L
ratio of the instantaneous voltage at the end of any integral cable or output connector of a
hydrophone or hydrophone-assembly, when connected to a specified electric load
impedance, to the instantaneous acoustic pressure in the undisturbed free field of a plane
wave in the position of the reference centre of the hydrophone if the hydrophone were
removed
Note 1 to entry: End-of-cable loaded sensitivity is expressed in units of volt per pascal (V/Pa).
[SOURCE: IEC 61689:2013, 3.24]
3.25
hydrophone
transducer that produces electrical signals in response to waterborne acoustic signals
[SOURCE: IEC 60050-801:1994, 801-32-26][5]
3.26
instantaneous acoustic pressure
p(t)
pressure minus the ambient pressure at a particular instant in time and at a particular point in
an acoustic field
Note 1 to entry: Instantaneous acoustic pressure is expressed in pascals (Pa).
[SOURCE: IEC 60050-802:2011, 802-01-03, modified – Note 1 to entry has been added.][6]
3.27
maximum RMS acoustic pressure
p
max,RMS
maximum value over the entire acoustic field of the RMS acoustic pressure
Note 1 to entry: Maximum RMS acoustic pressure is expressed in pascals (Pa).
[SOURCE: IEC 61689:2013, 3.28, modified – removed measurement criteria from definition
(“detected by a hydrophone”).]

– 14 – IEC 63009:2019  IEC 2019
3.28
mean square acoustic pressure
mean square of the instantaneous acoustic pressure at a particular point in the acoustic
field, taken over an integral number of acoustic repetition periods
Note 1 to entry: In practice, the mean value is often derived from RMS measurements.
Note 2 to entry: Mean square acoustic pressure is expressed in units of pascal squared (Pa ).
[SOURCE: IEC 61689:2013, 3.29, modified – The definition has been drafted as a single
phrase.]
3.29
modulation waveform
temporal envelope waveform of the amplitude modulated wave at the point of peak RMS
acoustic pressure on the beam alignment axis and displayed over a period sufficiently long
to include all significant acoustic information in the amplitude modulated wave
[SOURCE: IEC 61689:2013, 3.30]
3.30
output power
P
time-average ultrasonic power emitted by a treatment head of ultrasonic physiotherapy
equipment into an approximately free field under specified conditions in water
Note 1 to entry: Output power is expressed in watts (W).
[SOURCE: IEC 61161:2013, 3.3, modified – In the definition, "treatment head of ultrasonic
physiotherapy equipment" has replaced "ultrasonic transducer".][7]
3.31
peak RMS acoustic pressure
maximum value of the RMS acoustic pressure over a specified region, line or plane in an
acoustic field
Note 1 to entry: Peak RMS acoustic pressure is expressed in pascals (Pa).
[SOURCE: IEC 61689:2013, 3.32]
3.32
pulse duration
time interval beginning at the first time the modulation waveform exceeds a reference value
and ending at the last time the modulation waveform returns to that value
Note 1 to entry: The reference value is equal to the sum of the minimum value of the modulation waveform and
10 % of the difference between the maximum and minimum value of the modulation waveform.
Note 2 to entry: This definition differs from that in IEC 62127-1:2013, from which it is derived, to account for
incomplete modulation.
Note 3 to entry: Pulse duration is expressed in seconds (s).
[SOURCE: IEC 61689:2013, 3.33, modified – In the definition, "pressure amplitude" has
been replaced by "modulation waveform". The details of the reference value have been
moved to a note to entry.]
3.33
pulse repetition period
prp
time interval between equivalent points on successive pulses or tone-bursts

IEC 63009:2019  IEC 2019 – 15 –
Note 1 to entry: Pulse repetition period is expressed in seconds (s).
[SOURCE: IEC 61689:2013, 3.34]
3.34
pulse repetition rate
prr
reciprocal of the pulse repetition period
Note 1 to entry: The pulse repetition rate is equal to the repetition frequency of the modulated waveform.
Note 2 to entry: The pulse repetition rate is expressed in hertz (Hz).
[SOURCE: IEC 61689:2013, 3.35]
3.35
rated output power
temporal-maximum output power of the ultrasonic physiotherapy equipment at the rated
value of the mains voltage, with control settings configured to deliver maximum output power
Note 1 to entry: Rated output power is expressed in watts (W).
[SOURCE: IEC 61689:2013, 3.36, modified – In the definition, "maximum output power" has
been replaced by "temporal-maximum output power".]
3.36
reference centre
point on or near a transducer about which its acoustic receiving sensitivity and transmitting
responses are defined
Note 1 to entry: Generally, the reference centre is expected to be at or near the centre of the active portion of
the transducer. This often corresponds to the geometric centre of the transducer. For example, the reference
centre for a transducer utilizing a piezoelectric ceramic spherical shell should be located at the centre of the
sphere. The reference centre of a piezoelectric spherical cap should be located on the axis of symmetry between
the centre of curvature of the cap and the geometric centre of the cap. It should be located closer to the geometric
centre of the cap for smaller cap angles. In the limiting case of a piston transducer, the reference centre should
be located at the centre of the radiating piston face. This choice tends to minimize the measurement uncertainty
introduced by performing calibrations at separation distances less than that required to achieve far-field conditions.
3.37
RMS acoustic pressure
p
RMS
root-mean-square (RMS) of the instantaneous acoustic pressure at a particular point in an
acoustic field
Note 1 to entry: The mean should be taken over an integral number of acoustic repetition periods unless
otherwise specified.
Note 2 to entry: RMS acoustic pressure is expressed in pascals (Pa).
[SOURCE: IEC 62127-1:2007, 3.53]
3.38
spatial-peak temporal-peak acoustic pressure
p
sptp
spatial maximum of the temporal-peak acoustic pressure
Note 1 to entry: Spatial-peak temporal-peak acoustic pressure is expressed in pascals (Pa).
[SOURCE: IEC 61689:2013, 3.38, modified – The definition has been replaced.]

– 16 – IEC 63009:2019  IEC 2019
3.39
temporal-maximum output power
P
tm
actual output power of an amplitude modulated wave, scaled by half of the squared ratio of
the temporal-peak acoustic pressure and the RMS acoustic pressure
p

tp
PP= (4)

tm
2 p
RMS
where
P is the actual output power under amplitude modulated wave conditions;
p is the temporal-peak acoustic pressure;
tp
p is the true RMS acoustic pressure.

RMS
Note 1 to entry: p and p are measured under amplitude modulated wave conditions and at a specified point
p RMS
on the beam alignment axis.
Note 2 to entry: Temporal-maximum output power is expressed in watts (W).
[SOURCE: IEC 61689:2013, 3.39, modified – The definition has been drafted as a single
phrase. The letter symbol used for the temporal-peak acoustic pressure has been modified
(p replaced by p ).]
p tp
3.40
total mean square acoustic pressure
pms
t
sum of the mean square acoustic pressure values, each with a specified incremental area,
in a specified plane over specified limits of summation
Note 1 to entry: Total mean square acoustic pressure is expressed in units of pascal squared (Pa ).
[SOURCE: IEC 61689:2013, 3.40]
3.41
temporal-maximum intensity
I
tm
in the case of an amplitude modulated wave, the temporal-maximum intensity is given by
P
tm
(5)
I =
tm
A
ER
where
P is the temporal-maximum output power;
tm
A is the effective radiating area

ER
Note 1 to entry: Temporal-maximum intensity is expressed in units of watt per square metre (W/m ).
[SOURCE: IEC 61689:2013, 3.41, modified – The letter symbol used for the temporal
maximum intensity has been modified (I replaced by I ).]
m tm
3.42
temporal-peak acoustic pressure
p
tp
maximum value of the modulus of the instantaneous acoustic pressure at a particular point
in an acoustic field
Note 1 to entry: Temporal-peak acoustic pressure is expressed in pascals (Pa).

IEC 63009:2019  IEC 2019 – 17 –
[SOURCE: IEC 61689:2013, 3.42]
3.43
treatment head
assembly comprising one ultrasonic transducer and associated parts for local application of
ultrasound to the patient
[SOURCE: IEC 61689:2013, 3.43]
3.44
ultrasonic transducer
device capable of converting electrical energy to mechanical energy within the ultrasonic
frequency range and/or reciprocally of converting mechanical energy to electrical energy
[SOURCE: IEC 62127-1:2013, 3.73]
3.45
ultrasound
acoustic oscillation whose frequency is above the high-frequency limit of audible sound
(about 20 kHz)
[SOURCE: IEC 60050-802:2011, 802-01-01]
3.46
ultrasonic physiotherapy equipment
equipment
equipment for the generation and application of ultrasound to a patient for therapeutic
purposes
Note 1 to entry: 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).
[SOURCE: IEC 60601-2-5:2009, 201.3.216, modified – The note has been modified to give
some examples of excluded equipment.]
4 Symbols
a geometrical radius of the active element of a treatment head
A beam cross-sectional area
BCS
A (0,3) beam cross-sectional area evaluated at 0,3 cm from the front face of the
BCS
treatment head
A (z ) beam cross-sectional area evaluated at the position of the last maximum, z
BCS N N
A effective radiating area of a treatment head
ER
geometrical radius of the active element of a hydrophone
a
g
a maximum hydrophone effective radius
max
A unit area for a raster scan
arp acoustic repetition period

– 18 – IEC 63009:2019  IEC 2019
c speed of sound in water
f acoustic working frequency
awf
F conversion factor to convert A (0,3) to A
ac BCS ER
I effective intensity
e
I temporal maximum intensity
tm
k (= 2π/λ) circular wave number
m active area gradient
M (f) end-of-cable loaded sensitivity of a hydrophone
L
P output power of a treatment head
P temporal-maximum output power
tm
p(t) instantaneous acoustic pressure
prp pulse repetition period
temporal-peak acoustic pressure
p
tp
p spatial-peak temporal-peak acoustic pressure
sptp
p maximum RMS acoustic pressure
max,RMS
p RMS acoustic pressure
RMS
pms total mean square acoustic pressure
t
prr pulse repetition rate
Q active area coefficient
R beam non-uniformity ratio
BN
s step size for a line or raster scan
U end-of-cable voltage for a hydrophone
U hydrophone signal for the i-th scan point
i
z distance from the face of
...