IEC 63045:2020
(Main)Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields
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).
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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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.140.50 ISBN 978-2-8322-8340-0
– 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
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
– 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 .
...
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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Switzerland
About the IEC
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International Standards for all electrical, electronic and related technologies.
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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
– 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
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 .
...
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