Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields

IEC 63045:2020 is applicable to
– therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses;
– therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy,
where the pressure pulses are released as single events of duration up to 25 µs.
This document does not apply to
– therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment;
– therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies
– measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field,
– methods of measurement and characterization of non-focused or weakly focused pressure pulse fields.
This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see IEC 60601 2-62 and IEC TR 62649).

Ultrasons - Sources d'impulsions de pression courtes non focalisées y compris les sources d'impulsions de pression balistiques - Caractéristiques des champs

L'IEC 63045:2020 s’applique
– à l’appareil de traitement utilisant des impulsions de pression faiblement ou non focalisées générées de manière extracorporelle;
– à l’appareil de traitement produisant une énergie mécanique faiblement ou non focalisée générée de manière extracorporelle;
lorsque les impulsions de pression sont délivrées de manière unitaire pendant une durée allant jusqu’à 25 µs.
Le présent document ne s’applique pas
– à l’appareil de traitement utilisant des sources d’impulsions de pression focalisées tel que l’appareil de lithotritie extracorporelle;
– à l’appareil de traitement utilisant d’autres formes d'ondes acoustiques comme l’appareil de physiothérapie, l’appareil à ultrasons de basse intensité et l’appareil à ultrasons focalisés de haute intensité (HIFU, high intensity focussed ultrasounds) ou l’appareil à ultrasons thérapeutiques de haute intensité (HITU, high intensity therapeutic ultrasound).
Le présent document spécifie
– les paramètres mesurables qui sont utilisés dans la déclaration de la production acoustique des appareils extracorporels qui produisent un champ d'impulsions de pression faiblement ou non focalisées ,
– les méthodes de mesure et de caractérisation du champ de pression généré par les champs d’impulsions de pression faiblement ou non focalisées.
Le présent document a été élaboré pour les appareils dont l’utilisation prévue est la thérapie par impulsions de pression, par exemple le traitement des douleurs orthopédiques telles que les douleurs de l’épaule, les douleurs d’épicondylite, les douleurs de l’épine calcanéenne, le traitement musculaire des points de fibromyalgie, les douleurs lombaires, etc. Il n’est pas destiné à être utilisé pour l’appareil de lithotritie extracorporelle (comme cela est décrit dans l’IEC 61846), l’appareil de physiothérapie utilisant d’autres formes d’ondes (comme cela est décrit dans l’IEC 61689) et l’appareil HIFU/HITU (voir l’IEC 60601 2-62 et l’IEC TR 62649).

General Information

Status
Published
Publication Date
24-May-2020
Technical Committee
Current Stage
PPUB - Publication issued
Completion Date
25-May-2020
Ref Project

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IEC 63045
Edition 1.0 2020-05
INTERNATIONAL
STANDARD
colour
inside
Ultrasonics – Non-focusing short pressure pulse sources including ballistic
pressure pulse sources – Characteristics of fields
IEC 63045:2020-05(en)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
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---------------------- Page: 2 ----------------------
IEC 63045
Edition 1.0 2020-05
INTERNATIONAL
STANDARD
colour
inside
Ultrasonics – Non-focusing short pressure pulse sources including ballistic
pressure pulse sources – Characteristics of fields
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.140.50 ISBN 978-2-8322-8340-0

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

® Registered trademark of the International Electrotechnical Commission
---------------------- Page: 3 ----------------------
– 2 – IEC 63045:2020 © IEC 2020
CONTENTS

FOREWORD ........................................................................................................................... 5

INTRODUCTION ..................................................................................................................... 7

1 Scope .............................................................................................................................. 8

2 Normative references ...................................................................................................... 8

3 Terms and definitions ...................................................................................................... 9

4 List of symbols .............................................................................................................. 20

5 Conditions of measurement ........................................................................................... 22

5.1 General ................................................................................................................. 22

5.2 Measurements in the water test chamber .............................................................. 22

5.3 Measurements in the dry test bench ...................................................................... 22

6 Test equipment .............................................................................................................. 22

6.1 Water test chamber ............................................................................................... 22

6.1.1 Coordinate system ......................................................................................... 23

6.1.2 Hydrophone for water test chamber measurements ....................................... 23

6.1.3 Hydrophone for pressure pulse measurements .............................................. 23

6.2 Dry test bench ...................................................................................................... 24

6.3 Voltage measurement ........................................................................................... 24

6.3.1 Oscilloscope or transient recorder ................................................................. 24

6.3.2 Pressure pulse waveform recording ............................................................... 25

7 Measurement procedure ................................................................................................ 25

7.1 Measurement procedure in the water test chamber ............................................... 26

7.1.1 General ......................................................................................................... 26

7.1.2 Spatial measurements ................................................................................... 26

7.1.3 Non-focusing source ...................................................................................... 28

7.1.4 Weakly focusing source ................................................................................. 29

7.1.5 Beam plots of peak-positive acoustic pressure .............................................. 29

7.1.6 Beam plots of peak-negative acoustic pressure ............................................. 29

7.1.7 Measurement centre point and beam axis ...................................................... 30

7.1.8 Beam width measurements ............................................................................ 30

7.1.9 Beam pressure maximum extent measurements ............................................ 31

7.1.10 Beam cross-sectional area and beam pressure maximum cross-

sectional area ................................................................................................ 31

7.1.11 Beam pressure maximum volume measurements ........................................... 31

7.1.12 Beam volume ................................................................................................. 31

7.2 Temporal measurements ....................................................................................... 31

7.3 Acoustic energy measurements ............................................................................ 32

7.3.1 General ......................................................................................................... 32

7.3.2 Pulse-pressure-squared integral .................................................................... 32

7.3.3 Derived pulse-intensity integral ...................................................................... 32

7.3.4 Derived beam −n dB pressure maximum acoustic pulse energy ..................... 32

7.3.5 Derived acoustic pulse energy ....................................................................... 33

7.4 Dry test bench measurements ............................................................................... 33

Annex A (informative) Acoustic pressure pulse therapy ....................................................... 34

A.1 Background........................................................................................................... 34

A.1.1 General ......................................................................................................... 34

A.1.2 Development of relevant measurement standard ........................................... 34

---------------------- Page: 4 ----------------------
IEC 63045:2020 © IEC 2020 – 3 –

A.1.3 Current knowledge on biomedical effects ....................................................... 34

A.1.4 Availability of clinical and technical data ........................................................ 34

A.2 Other treatment devices and methods not subject to this document ...................... 35

A.2.1 Percutaneous continuous and modulated wave systems ................................ 35

A.2.2 Extracorporeal shock wave lithotripsy ............................................................ 35

A.2.3 Further exclusions ......................................................................................... 35

Annex B (informative) Types of pressure pulse transducers ................................................. 36

B.1 Overview............................................................................................................... 36

B.1.1 General ......................................................................................................... 36

B.1.2 Principle of ballistic pressure pulse sources ................................................... 36

B.1.3 Rail gun principle ........................................................................................... 36

B.1.4 Further generation principles ......................................................................... 37

B.2 Non-focusing and focusing transducers ................................................................. 37

B.3 Examples of pressure pulse sources and their parameter sets .............................. 38

B.4 Positioning and targeting methods ........................................................................ 43

Annex C (informative) Field measurement ........................................................................... 44

C.1 Measurement probes and hydrophones ................................................................. 44

C.2 Water test chamber ............................................................................................... 46

C.2.1 General ......................................................................................................... 46

C.2.2 Degassing procedures ................................................................................... 46

C.3 Dry test bench ...................................................................................................... 46

C.3.1 General ......................................................................................................... 46

C.3.2 Selection and attachment of the hydrophone ................................................. 48

C.3.3 Attachment of the hand piece ........................................................................ 49

C.3.4 Proof of the similarity of measurements in water and the dry test bench ........ 49

C.3.5 Special measurements with the dry test bench .............................................. 49

C.4 Acoustic pulse energy ........................................................................................... 50

C.4.1 General ......................................................................................................... 50

C.4.2 Extrapolation of the applicator surface pressure value ................................... 51

Annex D (informative) Lists of parameters ........................................................................... 52

Bibliography .......................................................................................................................... 59

Figure 1 – Typical pressure pulse waveform at 2 mm distance from a ballistic pressure

pulse source ......................................................................................................................... 25

Figure 2 – Typical pressure distribution along the beam axis of an non-focusing

pressure pulse source ........................................................................................................... 27

Figure 3 – Typical pressure distribution along the beam axis of a weakly focusing

pressure pulse source ........................................................................................................... 28

Figure 4 – Typical lateral pressure distributions of p at the beam pressure maximum

of two ballistic pressure pulse sources .................................................................................. 30

Figure B.1 – Applicator directly coupled to the patient ........................................................... 39

Figure B.2 – Pressure pulse source, non-symmetric (linear), directly coupled to the

patient .................................................................................................................................. 39

Figure B.3 – Pressure pulse source, symmetric, distant from the patient ............................... 40

Figure B.4 – Applicator coupled to patient ............................................................................. 40

Figure B.5 – Non-focused pressure pulse field ...................................................................... 40

Figure B.6 – Non-focused pressure pulse field -n dB parameters (example: n = 6) ................ 41

Figure B.7 – Non-focused pressure pulse field isobars .......................................................... 41

---------------------- Page: 5 ----------------------
– 4 – IEC 63045:2020 © IEC 2020

Figure B.8 – Weakly-focused pressure pulse field −6 dB contour and parameters ................. 42

Figure B.9 – Weakly-focused pressure pulse field volume and isobar parameters ................. 42

Figure B.10 – Weakly-focused pressure pulse field parameters ............................................ 43

Figure C.1 – Design example of a dry test bench in two views .............................................. 47

Figure C.2 – Detail of the measurement chamber item of the dry test bench ......................... 48

Table C.1 – Hydrophone types for pressure pulse measurements ......................................... 45

Table C.2 – Measurement techniques and probes for quality assurance purposes ................ 46

Table D.1 – List of device parameters ................................................................................... 52

Table D.2 – Pressure pulse parameters ................................................................................ 53

Table D.3 – Additional parameters useful for the correlation with biological effects ............... 55

Table D.4 – Graphical representations of pressure pulse data .............................................. 56

Table D.5 – Data of hydrophones and measurement conditions ............................................ 57

---------------------- Page: 6 ----------------------
IEC 63045:2020 © IEC 2020 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – NON-FOCUSING SHORT PRESSURE
PULSE SOURCES INCLUDING BALLISTIC
PRESSURE PULSE SOURCES – CHARACTERISTICS OF FIELDS
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international

co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and

in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,

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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

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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

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6) All users should ensure that they have the latest edition of this publication.

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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 63045 has been prepared by IEC technical committee 87:

Ultrasonics.
The text of this International Standard is based on the following documents:
FDIS Report on voting
87/741/FDIS 87/743/RVD

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.

Words in bold in the text are defined in Clause 3.
---------------------- Page: 7 ----------------------
– 6 – IEC 63045:2020 © IEC 2020

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.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this document using a colour printer.

---------------------- Page: 8 ----------------------
IEC 63045:2020 © IEC 2020 – 7 –
INTRODUCTION

In this document, pressure pulses are single pulses of ultrasonic energy of up to 25 µs duration

which have only one significant positive and one negative peak carrying more than 95 % of the

energy (see definitions). Focused pressure pulses (sometimes called "strongly focused") are

characterized by a peak acoustic pressure in a point in the sound field distant from the source

aperture. Parameters and measurement methods for focusing pressure pulse sources are

described in IEC 61846. The parameters and measurement methods of any other types of

pressure pulses, i.e. weakly focused and non-focused pressure pulses, are described in this

document.

Devices with non-focusing/weakly focusing pressure pulse sources are used for the

extracorporeal treatment of soft tissue pain situations in, for example, the shoulder, the heel

spur or the tennis elbow and for trigger point therapy. Further, still under research are

applications in orthopaedics, pain therapy, treatment of angina pectoris, stem cell therapy of

infarcted cardiac areas, treatment of erectile dysfunction, of cellulitis, and wound repair.

The patients receive between 3 to 5 treatments of 10 min to 20 min duration with approximately

or on average 1 000 pulses. Each pressure pulse consists of one significant compressional

part and a trailing negative part and has an overall duration of less than 25 µs. In present

devices, 1 to 35 pulses per second are released to the target tissue. The pulses are usually

applied to the patient by a manually guided hand piece. Targeting is commonly done by asking

the patient to direct the pulses to the point of maximum pain.

The first use of non-focused/weakly focused pressure pulses to treat soft tissue pain situations

was described in 1999. The first devices used the ballistic principle for the generation of the

pressure pulses, which is based on an "air-gun" like acceleration of a projectile by pressurized

air. The projectile impinges on the rear side of a larger metal applicator, the front side of which

instantly releases one fast pressure pulse to the patient. Today, most of the devices on the

market use this design and often are called “radial shock wave devices” or “ballistic sources”

although a true shock wave is not created. Also, other pulse generating principles are being

applied including variations of common lithotripter sources (electromagnetic, piezoelectric,

electrohydraulic).

Before this first occurrence, focused pressure pulses were used clinically beginning in 1993

for the treatment of shoulder calcifications, tennis elbow pain and heel spur pain, initially using

lithotripter-like electrohydraulic, electromagnetic or piezoelectric sources. These focused

pressure pulses can be characterized by IEC 61846, but the parameters described therein are

not sufficiently applicable to characterize the parameters and fields of weakly focused and non-

focused pressure pulses and their propagation characteristics.

This document specifies methods of measuring and characterizing the acoustic pressure

pulses generated by non-focusing/weakly focusing pressure pulse equipment and their

propagation characteristics.
---------------------- Page: 9 ----------------------
– 8 – IEC 63045:2020 © IEC 2020
ULTRASONICS – NON-FOCUSING SHORT PRESSURE
PULSE SOURCES INCLUDING BALLISTIC
PRESSURE PULSE SOURCES – CHARACTERISTICS OF FIELDS
1 Scope
This document is applicable to

– therapy equipment using extracorporeally induced non-focused or weakly focused pressure

pulses;

– therapy equipment producing extracorporeally induced non-focused or weakly focused

mechanical energy,
where the pressure pulses are released as single events of duration up to 25 µs.
This document does not apply to
– therapy equipment using focusing pressure pulse sources such as extracorporeal
lithotripsy equipment;

– therapy equipment using other acoustic waveforms like physiotherapy equipment, low

intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies

– measurable parameters which are used in the declaration of the acoustic output of

extracorporeal equipment producing a non-focused or weakly focused pressure pulse

field,
– methods of measurement and characterization of non-focused or weakly focused
pressure pulse fields.

NOTE 1 The parameters defined in this document do not – at the time of publication – allow quantitative statements

to be made about clinical efficacy and possible hazard. In particular, it is not possible to make a statement about the

limits for these effects.

NOTE 2 Figure B.1 to Figure B.10 and Figure 2 to Figure 4 are useful to understand the geometry of the field

applied in this document.

This document has been developed for equipment intended for use in pressure pulse therapy,

for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain,

muscular trigger point therapy, lower back pain, etc. It is not intended to be used for

extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment

using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see
IEC 60601-2-62 and IEC TR 62649).
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 60565-1, Underwater acoustics – Hydrophones – Calibration of hydrophones – Part 1:

Procedures for free-field calibration of hydrophones

IEC 60565-2, Underwater acoustics – Hydrophones – Calibration of hydrophones – Part 2:

Procedures for low frequency pressure calibration
---------------------- Page: 10 ----------------------
IEC 63045:2020 © IEC 2020 – 9 –

IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of

medical ultrasonic fields up to 40 MHz
IEC 62127-1:2007/AMD1:2013

IEC 62127-2:2007, Ultrasonics – Hydrophones – Part 2: Calibration for ultrasonic fields up to

40 MHz

IEC 62127-3, Ultrasonics – Hydrophones – Part 3: Properties of hydrophones 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
applicator

part of the ballistic pressure pulse source which emits the pressure pulses to the patient

Note 1 to entry: In the case of a ballistic pressure pulse source, the front side of the applicator is often coupled

to the skin of the patient using an ultrasound coupling gel or other agent and releasing the pressure pulses to the

patient. In this case, the front of the applicator is equal to the source aperture.

Note 2 to entry: Depending on the design of the source, there may be a space between the source emitting the

pressure pulses (e.g. membrane, surface of piezoelectric crystals, spark gap etc.) and the source aperture. Usually,

this space is composed of an acoustically conducting pad coupling material or a fluid, which transmits the pressure

pulses from the source to the source aperture (see 3.48).
3.2
beam −n dB cross-sectional area
z,ndB

area enclosed by the peak-positive acoustic pressure contour in any plane perpendicular to

the beam axis, where all points on the contour have a pressure of −n dB relative to the value

at the beam axis in this plane

Note 1 to entry: The value of n and the axial distance z from the measurement centre point shall be stated as

subscript.

Note 2 to entry: Typical values of −n dB are: −3 dB, −6 dB, −10 dB, −12 dB, −20 dB. Reasonable values of n for

clinical approval and communication to the users can be identified by a risk analysis process, by applicable safety

standards, by consulting notified bodies, expert communities (e.g. ISMST – International Society for Medical

Shockwave Treatment) or through literature.

Note 3 to entry: The beam −n dB cross-sectional area is expressed in units of metre squared (m ).

3.3
beam −n dB extent
b,ndB

distance along the beam axis from the source aperture to the point where the peak-positive

acoustic pressure has dropped farthest by −n dB relative to the acoustic pressure at the

source aperture
Note 1 to entry: The value of n shall be stated as subscript.

Note 2 to entry: Typical values of −n dB are: −3 dB, −6 dB, −10 dB, −12 dB, −20 dB. Reasonable values of n for

clinical approval and communication to the users can be identified by a risk analysis process, by applicable safety

standards, by consulting notified bodies, expert communities (e.g. ISMST – International Society for Medical

Shockwave Treatment) or through literature.
Note 3 to entry: The beam −n dB extent is expressed in metres (m).
---------------------- Page: 11 ----------------------
– 10 – IEC 63045:2020 © IEC 2020
3.4
beam −n dB volume
b,ndB

volume in space defined by the −n dB (relative to the beam pressure maximum value) peak-

positive acoustic pressure contours measured around the beam axis

Note 1 to entry: It may be difficult to measure −n dB points throughout the volume around the beam. It is reasonable

in practice to approximate the beam -n dB volume from measurements taken in three orthogonal directions: the

beam axis (
...

IEC 63045
Edition 1.0 2020-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Ultrasonics – Non-focusing short pressure pulse sources including ballistic
pressure pulse sources – Characteristics of fields
Ultrasons – Sources d’impulsions de pression courtes non focalisées y compris
les sources d’impulsions de pression balistiques – Caractéristiques des champs
IEC 63045:2020-05(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 63045
Edition 1.0 2020-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Ultrasonics – Non-focusing short pressure pulse sources including ballistic
pressure pulse sources – Characteristics of fields
Ultrasons – Sources d’impulsions de pression courtes non focalisées y compris
les sources d’impulsions de pression balistiques – Caractéristiques des champs
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50 ISBN 978-2-8322-1007-2

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 63045:2020 © IEC 2020
CONTENTS

FOREWORD ........................................................................................................................... 5

INTRODUCTION ..................................................................................................................... 7

1 Scope .............................................................................................................................. 8

2 Normative references ...................................................................................................... 8

3 Terms and definitions ...................................................................................................... 9

4 List of symbols .............................................................................................................. 20

5 Conditions of measurement ........................................................................................... 22

5.1 General ................................................................................................................. 22

5.2 Measurements in the water test chamber .............................................................. 22

5.3 Measurements in the dry test bench ...................................................................... 22

6 Test equipment .............................................................................................................. 22

6.1 Water test chamber ............................................................................................... 22

6.1.1 Coordinate system ......................................................................................... 23

6.1.2 Hydrophone for water test chamber measurements ....................................... 23

6.1.3 Hydrophone for pressure pulse measurements .............................................. 23

6.2 Dry test bench ...................................................................................................... 24

6.3 Voltage measurement ........................................................................................... 24

6.3.1 Oscilloscope or transient recorder ................................................................. 24

6.3.2 Pressure pulse waveform recording ............................................................... 25

7 Measurement procedure ................................................................................................ 25

7.1 Measurement procedure in the water test chamber ............................................... 26

7.1.1 General ......................................................................................................... 26

7.1.2 Spatial measurements ................................................................................... 26

7.1.3 Non-focusing source ...................................................................................... 28

7.1.4 Weakly focusing source ................................................................................. 29

7.1.5 Beam plots of peak-positive acoustic pressure .............................................. 29

7.1.6 Beam plots of peak-negative acoustic pressure ............................................. 29

7.1.7 Measurement centre point and beam axis ...................................................... 30

7.1.8 Beam width measurements ............................................................................ 30

7.1.9 Beam pressure maximum extent measurements ............................................ 31

7.1.10 Beam cross-sectional area and beam pressure maximum cross-

sectional area ................................................................................................ 31

7.1.11 Beam pressure maximum volume measurements ........................................... 31

7.1.12 Beam volume ................................................................................................. 31

7.2 Temporal measurements ....................................................................................... 31

7.3 Acoustic energy measurements ............................................................................ 32

7.3.1 General ......................................................................................................... 32

7.3.2 Pulse-pressure-squared integral .................................................................... 32

7.3.3 Derived pulse-intensity integral ...................................................................... 32

7.3.4 Derived beam −n dB pressure maximum acoustic pulse energy ..................... 32

7.3.5 Derived acoustic pulse energy ....................................................................... 33

7.4 Dry test bench measurements ............................................................................... 33

Annex A (informative) Acoustic pressure pulse therapy ....................................................... 34

A.1 Background........................................................................................................... 34

A.1.1 General ......................................................................................................... 34

A.1.2 Development of relevant measurement standard ........................................... 34

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IEC 63045:2020 © IEC 2020 – 3 –

A.1.3 Current knowledge on biomedical effects ....................................................... 34

A.1.4 Availability of clinical and technical data ........................................................ 34

A.2 Other treatment devices and methods not subject to this document ...................... 35

A.2.1 Percutaneous continuous and modulated wave systems ................................ 35

A.2.2 Extracorporeal shock wave lithotripsy ............................................................ 35

A.2.3 Further exclusions ......................................................................................... 35

Annex B (informative) Types of pressure pulse transducers ................................................. 36

B.1 Overview............................................................................................................... 36

B.1.1 General ......................................................................................................... 36

B.1.2 Principle of ballistic pressure pulse sources ................................................... 36

B.1.3 Rail gun principle ........................................................................................... 36

B.1.4 Further generation principles ......................................................................... 37

B.2 Non-focusing and focusing transducers ................................................................. 37

B.3 Examples of pressure pulse sources and their parameter sets .............................. 38

B.4 Positioning and targeting methods ........................................................................ 43

Annex C (informative) Field measurement ........................................................................... 44

C.1 Measurement probes and hydrophones ................................................................. 44

C.2 Water test chamber ............................................................................................... 46

C.2.1 General ......................................................................................................... 46

C.2.2 Degassing procedures ................................................................................... 46

C.3 Dry test bench ...................................................................................................... 46

C.3.1 General ......................................................................................................... 46

C.3.2 Selection and attachment of the hydrophone ................................................. 48

C.3.3 Attachment of the hand piece ........................................................................ 49

C.3.4 Proof of the similarity of measurements in water and the dry test bench ........ 49

C.3.5 Special measurements with the dry test bench .............................................. 49

C.4 Acoustic pulse energy ........................................................................................... 50

C.4.1 General ......................................................................................................... 50

C.4.2 Extrapolation of the applicator surface pressure value ................................... 51

Annex D (informative) Lists of parameters ........................................................................... 52

Bibliography .......................................................................................................................... 59

Figure 1 – Typical pressure pulse waveform at 2 mm distance from a ballistic pressure

pulse source ......................................................................................................................... 25

Figure 2 – Typical pressure distribution along the beam axis of an non-focusing

pressure pulse source ........................................................................................................... 27

Figure 3 – Typical pressure distribution along the beam axis of a weakly focusing

pressure pulse source ........................................................................................................... 28

Figure 4 – Typical lateral pressure distributions of p at the beam pressure maximum

of two ballistic pressure pulse sources .................................................................................. 30

Figure B.1 – Applicator directly coupled to the patient ........................................................... 39

Figure B.2 – Pressure pulse source, non-symmetric (linear), directly coupled to the

patient .................................................................................................................................. 39

Figure B.3 – Pressure pulse source, symmetric, distant from the patient ............................... 40

Figure B.4 – Applicator coupled to patient ............................................................................. 40

Figure B.5 – Non-focused pressure pulse field ...................................................................... 40

Figure B.6 – Non-focused pressure pulse field -n dB parameters (example: n = 6) ................ 41

Figure B.7 – Non-focused pressure pulse field isobars .......................................................... 41

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– 4 – IEC 63045:2020 © IEC 2020

Figure B.8 – Weakly-focused pressure pulse field −6 dB contour and parameters ................. 42

Figure B.9 – Weakly-focused pressure pulse field volume and isobar parameters ................. 42

Figure B.10 – Weakly-focused pressure pulse field parameters ............................................ 43

Figure C.1 – Design example of a dry test bench in two views .............................................. 47

Figure C.2 – Detail of the measurement chamber item of the dry test bench ......................... 48

Table C.1 – Hydrophone types for pressure pulse measurements ......................................... 45

Table C.2 – Measurement techniques and probes for quality assurance purposes ................ 46

Table D.1 – List of device parameters ................................................................................... 52

Table D.2 – Pressure pulse parameters ................................................................................ 53

Table D.3 – Additional parameters useful for the correlation with biological effects ............... 55

Table D.4 – Graphical representations of pressure pulse data .............................................. 56

Table D.5 – Data of hydrophones and measurement conditions ............................................ 57

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IEC 63045:2020 © IEC 2020 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – NON-FOCUSING SHORT PRESSURE
PULSE SOURCES INCLUDING BALLISTIC
PRESSURE PULSE SOURCES – CHARACTERISTICS OF FIELDS
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

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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 63045 has been prepared by IEC technical committee 87:

Ultrasonics.
The text of this International Standard is based on the following documents:
FDIS Report on voting
87/741/FDIS 87/743/RVD

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.

Words in bold in the text are defined in Clause 3.
---------------------- Page: 7 ----------------------
– 6 – IEC 63045:2020 © IEC 2020

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.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this document using a colour printer.

---------------------- Page: 8 ----------------------
IEC 63045:2020 © IEC 2020 – 7 –
INTRODUCTION

In this document, pressure pulses are single pulses of ultrasonic energy of up to 25 µs duration

which have only one significant positive and one negative peak carrying more than 95 % of the

energy (see definitions). Focused pressure pulses (sometimes called "strongly focused") are

characterized by a peak acoustic pressure in a point in the sound field distant from the source

aperture. Parameters and measurement methods for focusing pressure pulse sources are

described in IEC 61846. The parameters and measurement methods of any other types of

pressure pulses, i.e. weakly focused and non-focused pressure pulses, are described in this

document.

Devices with non-focusing/weakly focusing pressure pulse sources are used for the

extracorporeal treatment of soft tissue pain situations in, for example, the shoulder, the heel

spur or the tennis elbow and for trigger point therapy. Further, still under research are

applications in orthopaedics, pain therapy, treatment of angina pectoris, stem cell therapy of

infarcted cardiac areas, treatment of erectile dysfunction, of cellulitis, and wound repair.

The patients receive between 3 to 5 treatments of 10 min to 20 min duration with approximately

or on average 1 000 pulses. Each pressure pulse consists of one significant compressional

part and a trailing negative part and has an overall duration of less than 25 µs. In present

devices, 1 to 35 pulses per second are released to the target tissue. The pulses are usually

applied to the patient by a manually guided hand piece. Targeting is commonly done by asking

the patient to direct the pulses to the point of maximum pain.

The first use of non-focused/weakly focused pressure pulses to treat soft tissue pain situations

was described in 1999. The first devices used the ballistic principle for the generation of the

pressure pulses, which is based on an "air-gun" like acceleration of a projectile by pressurized

air. The projectile impinges on the rear side of a larger metal applicator, the front side of which

instantly releases one fast pressure pulse to the patient. Today, most of the devices on the

market use this design and often are called “radial shock wave devices” or “ballistic sources”

although a true shock wave is not created. Also, other pulse generating principles are being

applied including variations of common lithotripter sources (electromagnetic, piezoelectric,

electrohydraulic).

Before this first occurrence, focused pressure pulses were used clinically beginning in 1993

for the treatment of shoulder calcifications, tennis elbow pain and heel spur pain, initially using

lithotripter-like electrohydraulic, electromagnetic or piezoelectric sources. These focused

pressure pulses can be characterized by IEC 61846, but the parameters described therein are

not sufficiently applicable to characterize the parameters and fields of weakly focused and non-

focused pressure pulses and their propagation characteristics.

This document specifies methods of measuring and characterizing the acoustic pressure

pulses generated by non-focusing/weakly focusing pressure pulse equipment and their

propagation characteristics.
---------------------- Page: 9 ----------------------
– 8 – IEC 63045:2020 © IEC 2020
ULTRASONICS – NON-FOCUSING SHORT PRESSURE
PULSE SOURCES INCLUDING BALLISTIC
PRESSURE PULSE SOURCES – CHARACTERISTICS OF FIELDS
1 Scope
This document is applicable to

– therapy equipment using extracorporeally induced non-focused or weakly focused pressure

pulses;

– therapy equipment producing extracorporeally induced non-focused or weakly focused

mechanical energy,
where the pressure pulses are released as single events of duration up to 25 µs.
This document does not apply to
– therapy equipment using focusing pressure pulse sources such as extracorporeal
lithotripsy equipment;

– therapy equipment using other acoustic waveforms like physiotherapy equipment, low

intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies

– measurable parameters which are used in the declaration of the acoustic output of

extracorporeal equipment producing a non-focused or weakly focused pressure pulse

field,
– methods of measurement and characterization of non-focused or weakly focused
pressure pulse fields.

NOTE 1 The parameters defined in this document do not – at the time of publication – allow quantitative statements

to be made about clinical efficacy and possible hazard. In particular, it is not possible to make a statement about the

limits for these effects.

NOTE 2 Figure B.1 to Figure B.10 and Figure 2 to Figure 4 are useful to understand the geometry of the field

applied in this document.

This document has been developed for equipment intended for use in pressure pulse therapy,

for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain,

muscular trigger point therapy, lower back pain, etc. It is not intended to be used for

extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment

using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see
IEC 60601-2-62 and IEC TR 62649).
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 60565-1, Underwater acoustics – Hydrophones – Calibration of hydrophones – Part 1:

Procedures for free-field calibration of hydrophones

IEC 60565-2, Underwater acoustics – Hydrophones – Calibration of hydrophones – Part 2:

Procedures for low frequency pressure calibration
---------------------- Page: 10 ----------------------
IEC 63045:2020 © IEC 2020 – 9 –

IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of

medical ultrasonic fields up to 40 MHz
IEC 62127-1:2007/AMD1:2013

IEC 62127-2:2007, Ultrasonics – Hydrophones – Part 2: Calibration for ultrasonic fields up to

40 MHz

IEC 62127-3, Ultrasonics – Hydrophones – Part 3: Properties of hydrophones 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
applicator

part of the ballistic pressure pulse source which emits the pressure pulses to the patient

Note 1 to entry: In the case of a ballistic pressure pulse source, the fron
...

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