SIST EN IEC 63045:2020
(Main)Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields (IEC 63045:2020)
Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields (IEC 63045:2020)
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).
Ultraschall - Quellen für nicht fokussierte kurze Druckimpulse einschließlich pneumatischen und ballistischen Druckpulsquellen - Feldcharakterisierung (IEC 63045:2020)
Ultrasons - Sources d'impulsions de pression courtes sans focalisation, y compris les sources d'impulsions de pression balistiques - Caractéristiques des champs (IEC 63045:2020)
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).
Ultrazvok - Viri nefokusiranih kratkih impulzov tlaka, vključno z viri balističnih impulzov tlaka - Karakteristike polj (IEC 63045:2020)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 63045:2020
01-november-2020
Ultrazvok - Viri nefokusiranih kratkih impulzov tlaka, vključno z viri balističnih
impulzov tlaka - Karakteristike polj (IEC 63045:2020)
Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure
pulse sources - Characteristics of fields (IEC 63045:2020)
Ultraschall - Quellen für nicht fokussierte kurze Druckimpulse einschließlich
pneumatischen und ballistischen Druckpulsquellen - Feldcharakterisierung (IEC
63045:2020)
Ultrasons - Sources d'impulsions de pression courtes sans focalisation, y compris les
sources d'impulsions de pression balistiques - Caractéristiques des champs (IEC
63045:2020)
Ta slovenski standard je istoveten z: EN IEC 63045:2020
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN IEC 63045:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 63045:2020
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SIST EN IEC 63045:2020
EUROPEAN STANDARD EN IEC 63045
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2020
ICS 17.140.50
English Version
Ultrasonics - Non-focusing short pressure pulse sources
including ballistic pressure pulse sources - Characteristics of
fields
(IEC 63045:2020)
Ultrasons - Sources d'impulsions de pression courtes sans Ultraschall - Quellen für nicht fokussierte kurze
focalisation, y compris les sources d'impulsions de pression Druckimpulse einschließlich pneumatischen und
balistiques - Caractéristiques des champs ballistischen Druckpulsquellen - Feldcharakterisierung
(IEC 63045:2020) (IEC 63045:2020)
This European Standard was approved by CENELEC on 2020-06-29. 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
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63045:2020 E
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SIST EN IEC 63045:2020
EN IEC 63045:2020 (E)
European foreword
The text of document 87/741/FDIS, future edition 1 of IEC 63045, prepared by IEC/TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 63045:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-03-29
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-06-29
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 63045:2020 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 60601-2-62 NOTE Harmonized as EN 60601-2-62
IEC 60601-2-36 NOTE Harmonized as EN 60601-2-36
IEC 61689 NOTE Harmonized as EN 61689
IEC 61828:2001 NOTE Harmonized as EN 61828:2001 (not modified)
IEC 63009 NOTE Harmonized as EN IEC 63009
2
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SIST EN IEC 63045:2020
EN IEC 63045:2020 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60565-1 - Underwater acoustics - Hydrophones - EN IEC 60565-1 -
Calibration of hydrophones - Part 1:
Procedures for free-field calibration of
hydrophones
IEC 60565-2 - Underwater acoustics - Hydrophones - EN IEC 60565-2 -
Calibration of hydrophones - Part 2:
Procedures for low frequency pressure
calibration
IEC 62127-1 2007 Ultrasonics - Hydrophones - Part 1: EN 62127-1 2007
Measurement and characterization of medical
ultrasonic fields up to 40 MHz
IEC 62127-2 2007 Ultrasonics - Hydrophones - Part 2: Calibration EN 62127-2 2007
for ultrasonic fields up to 40 MHz
IEC 62127-3 - Ultrasonics - Hydrophones - Part 3: Properties EN 62127-3 -
of hydrophones for ultrasonic fields up to 40
MHz
3
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SIST EN IEC 63045:2020
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SIST EN IEC 63045:2020
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
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SIST EN IEC 63045:2020
– 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
c
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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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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SIST EN IEC 63045:2020
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,
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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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.
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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.
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SIST EN IEC 63045:2020
– 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.
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SIST EN IEC 63045:2020
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.
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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
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...
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