Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems

IEC TS 62556:2014 is a technical specification applicable to high intensity therapeutic ultrasound (HITU) devices. It specifies the relevant parameters for quantifying the field; the measurement methods at relatively low output levels and methodology for extrapolating these to higher therapeutic level fields; some considerations of sidelobes and pre-focal maxima; and parameters relevant to HITU transducers of different construction and geometry, including non-focusing, focusing with or without lenses, collimated, diverging and convergent transducers, multi-element transducers, scanning transducers and multiple sources. This technical specification is intended to support the ultrasonic measurement requirements given in IEC 60601-2-62. These specifications would have use in quality assurance, safety testing, and the standardization of communications regarding the clinical performance of HITU systems. Where possible, this technical specification incorporates specifications from other related standards. This technical specification does not apply to the following types of devices, which are covered by other standards: lithotripters (see IEC 61846); surgical equipment (see IEC 61847); and physiotherapy devices (see IEC 61689).

General Information

Status
Published
Publication Date
23-Apr-2014
Technical Committee
Drafting Committee
Current Stage
PPUB - Publication issued
Start Date
15-Jul-2014
Completion Date
24-Apr-2014
Ref Project

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IEC TS 62556:2014 - Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems
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IEC TS 62556 ®
Edition 1.0 2014-04
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Field characterization – Specification and measurement of field
parameters for high intensity therapeutic ultrasound (HITU) transducers and
systems
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IEC TS 62556 ®
Edition 1.0 2014-04
TECHNICAL
SPECIFICATION
colour
inside
Ultrasonics – Field characterization – Specification and measurement of field

parameters for high intensity therapeutic ultrasound (HITU) transducers and

systems
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XD
ICS 17.140.50 ISBN 978-2-8322-1505-0

– 2 – IEC TS 62556:2014 © IEC 2014
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 List of symbols . 31
5 Independent measurement of total acoustic output power . 33
6 Acoustic field measurement: equipment . 33
6.1 Hydrophone . 33
6.1.1 General . 33
6.1.2 Sensitivity of a hydrophone . 34
6.1.3 Directional response of a hydrophone . 34
6.1.4 Effective hydrophone radius . 34
6.1.5 Choice of the size of a hydrophone active element . 34
6.1.6 Hydrophone pressure limits . 35
6.1.7 Hydrophone intensity limits . 35
6.1.8 Hydrophone cable length and amplifiers . 36
6.2 Requirements for positioning and water baths . 36
6.2.1 General . 36
6.2.2 Positioning systems . 36
6.2.3 Water bath . 37
6.3 Requirements for data acquisition and analysis systems . 38
6.4 Requirements and recommendations for ultrasonic equipment being
characterized . 39
7 Measurement procedure . 39
7.1 General . 39
7.2 Preparation and alignment . 39
7.2.1 Initial adjustment to driving voltage . 39
7.2.2 Preparation of source transducer . 40
7.2.3 Aligning an ultrasonic transducer and hydrophone . 41
7.2.4 Beam-axis scan . 41
7.2.5 Measurements to be made at z = z . 41
p
7.2.6 Further evaluation for sidelobes and pre-focal maxima . 43
7.3 Considerations for scanning transducers and transducers with multiple
sources . 44
7.3.1 Automatic scanning transducers . 44
7.4 Linear extrapolation of field values . 44
7.4.1 General . 44
7.4.2 Calculation of I . 45
sal
7.4.3 Scaling for sidelobes and pre-focal maxima . 45
7.5 Reporting . 45
Annex A (informative) Rationale . 53
A.1 General . 53
A.2 Detailed discussion of difficulties in HITU field measurements . 53
A.2.1 Very high pressures . 53
A.2.2 Very high intensities . 54

A.2.3 Strong focusing . 54
A.2.4 Nonlinear harmonics . 54
A.2.5 Acoustic saturation and nonlinear loss . 55
A.2.6 Damage to hydrophones may only be apparent at high
pressures . 55
A.3 Approach of this technical specification . 55
Annex B (informative) Assessment of uncertainty in the acoustic quantities obtained
by hydrophone measurements . 57
B.1 General . 57
B.2 Overall (expanded) uncertainty . 57
B.3 Common sources of uncertainty . 57
Annex C (informative) Transducer and hydrophone positioning systems . 59
Annex D (informative) Rationale for I . 60
sal
D.1 General rationale . 60
D.2 Determination of P using hydrophone measurements and
c,6
extrapolation from linear measurements. 60
D.3 Alternative determination of P using an aperture in combination with a
c,6
measurement of total acoustic output power . 60
D.4 Special case of uniformly vibrating spherically shaped transducers . 61
Annex E (normative) Propagation and back-propagation methods for field
reconstruction: basic formulae and requirements . 62
E.1 Motivation and background . 62
E.2 Theory . 62
E.2.1 General . 62
E.2.2 Fourier projection approach . 64
E.2.3 Rayleigh integral approach . 67
E.3 Implementation . 68
E.3.1 General . 68
E.3.2 Recommendations for hydrophone . 68
E.3.3 Recommendation for planar scan parameters . 69
E.4 Assessment of uncertainties . 71
Annex F (informative) Propagation and back-propagation methods for field
reconstruction: examples and uses . 73
F.1 Examples . 73
F.1.1 Fourier projection example . 73
F.1.2 Rayleigh integral projection example . 77
F.2 Other propagation method applications . 81
Annex G (normative) Planar scanning of a hydrophone to determine acoustic output
power . 82
G.1 Introduction . 82
G.2 General principle. 82
G.3 Hydrophone scanning methodology . 83
G.3.1 General methodology . 83
G.3.2 Particular considerations for implementation for HITU fields . 84
G.4 Corrections and sources of measurement uncertainty . 84
G.4.1 Uncertainty in the hydrophone calibration . 84
G.4.2 Planar scanning . 84
G.4.3 Attenuation factor of water: unfocusing transducers . 85
G.4.4 Attenuation factor of water: focusing transducers . 85
G.4.5 Received hydrophone signal . 85

– 4 – IEC TS 62556:2014 © IEC 2014
G.4.6 Integration . 86
G.4.7 Finite size of the hydrophone . 86
G.4.8 partial extent of integration . 86
G.4.9 Non-linear propagation . 86
G.4.10 Directional response . 87
G.4.11 Noise . 87
G.4.12 Intensity approximated by derived intensity . 87
Annex H (informative) Properties of water . 88
H.1 General .
...

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