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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
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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 .
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