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BSI PD IEC/TS 62556:2014

BSI PD IEC/TS 62556:2014

$215.11

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

Published By Publication Date Number of Pages
BSI 2014 98
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This technical specification is applicable to high intensity therapeutic ultrasound (HITU) devices, specifying:

  • relevant parameters for quantifying the field;

  • measurement methods at relatively low output levels and methodology for extrapolating these to higher therapeutic level fields;

  • consideration of sidelobes and pre-focal maxima;

  • 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);

  • physiotherapy devices (see IEC 61689).

Throughout this technical specification SI units are used. In the specification of certain parameters, such as beam-areas and intensities, it may be convenient to use decimal multiples or sub-multiples. For example, beam-area may be specified in cm2 and intensities in W/cm2 or mW/cm2.

PDF Catalog

PDF Pages PDF Title
4 CONTENTS
8 FOREWORD
10 INTRODUCTION
11 1 Scope
2 Normative references
12 3 Terms and definitions
33 4 List of symbols
35 5 Independent measurement of total acoustic output power
6 Acoustic field measurement: equipment
6.1 Hydrophone
6.1.1 General
36 6.1.2 Sensitivity of a hydrophone
6.1.3 Directional response of a hydrophone
6.1.4 Effective hydrophone radius
6.1.5 Choice of the size of a hydrophone active element
37 6.1.6 Hydrophone pressure limits
6.1.7 Hydrophone intensity limits
38 6.1.8 Hydrophone cable length and amplifiers
6.2 Requirements for positioning and water baths
6.2.1 General
6.2.2 Positioning systems
39 6.2.3 Water bath
40 6.3 Requirements for data acquisition and analysis systems
41 6.4 Requirements and recommendations for ultrasonic equipment being characterized
7 Measurement procedure
7.1 General
7.2 Preparation and alignment
7.2.1 Initial adjustment to driving voltage
42 7.2.2 Preparation of source transducer
43 7.2.3 Aligning an ultrasonic transducer and hydrophone
7.2.4 Beam-axis scan
7.2.5 Measurements to be made at z = zp
45 7.2.6 Further evaluation for sidelobes and pre-focal maxima
46 7.3 Considerations for scanning transducers and transducers with multiple sources
7.3.1 Automatic scanning transducers
7.4 Linear extrapolation of field values
7.4.1 General
47 7.4.2 Calculation of Isal
7.4.3 Scaling for sidelobes and pre-focal maxima
7.5 Reporting
49 Figures
Figure 1 – Schematic diagram of the different planes and lines in an ultrasonic field for a rectangular HITU transducer
50 Figure 2 – Schematic diagram of the different planes and lines in an ultrasonic field for a circularly symmetric HITU transducer
51 Figure 3 – Schematic diagram of the different planes and lines in an ultrasonic field for a circularly symmetric HITU transducer with a circular hole in its center
52 Figure 4 – Schematic diagram of the different planes and lines in an ultrasonic field for a circularly symmetric HITU transducer with a rectangular hole in its center for a diagnostic transducer (HITU transducer azimuth axis aligned with azimuth scan axis of diagnostic transducer)
53 Figure 5 – Parameters for describing a focusing transducer of an unknown geometry (IEC 61828)
54 Figure 6 – Overall measurement scheme
55 Annex A (informative) Rationale
A.1 General
A.2 Detailed discussion of difficulties in HITU field measurements
A.2.1 Very high pressures
56 A.2.2 Very high intensities
A.2.3 Strong focusing
A.2.4 Nonlinear harmonics
57 A.2.5 Acoustic saturation and nonlinear loss
A.2.6 Damage to hydrophones may only be apparent at high pressures
A.3 Approach of this technical specification
59 Annex B (informative) Assessment of uncertainty in the acoustic quantities obtained by hydrophone measurements
B.1 General
B.2 Overall (expanded) uncertainty
B.3 Common sources of uncertainty
61 Annex C (informative) Transducer and hydrophone positioning systems
Figure C.1 – Schematic diagram of the ultrasonic transducer and hydrophone degrees of freedom. X, Y and Z denote the axis directions relative to the mounted hydrophone and ultrasonic transducer.
62 Annex D (informative) Rationale for Isal
D.1 General rationale
D.2 Determination of Pc,6 using hydrophone measurements and extrapolation from linear measurements.
D.3 Alternative determination of Pc,6 using an aperture in combination with a measurement of total acoustic output power
63 D.4 Special case of uniformly vibrating spherically shaped transducers
64 Annex E (normative) Propagation and back-propagation methods for field reconstruction: basic formulae and requirements
E.1 Motivation and background
E.2 Theory
E.2.1 General
65 Figure E.1 – Geometry of problem for forward and backward projection techniques.
66 E.2.2 Fourier projection approach
68 Figure E.2 – Transducer focused at –15mm, y = 48,16 mm, z = 56,85 mm
69 E.2.3 Rayleigh integral approach
70 E.3 Implementation
E.3.1 General
E.3.2 Recommendations for hydrophone
71 E.3.3 Recommendation for planar scan parameters
72 Figure E.3 – Selection of acquisition window
73 E.4 Assessment of uncertainties
Figure E.4 – Scanned field compared to its reconstruction from a finite window
75 Annex F (informative) Propagation and back-propagation methods for field reconstruction: examples and uses
F.1 Examples
F.1.1 Fourier projection example
Figure F.1 – Transducer inside 2-axis scanner setup
76 Figure F.2 – Pressure amplitude as scanned
77 Figure F.3 – Reconstructed pressure amplitude distribution in 3 orthogonal planes that contain the focal point
78 Figure F.4 – 3D representation of the focal beam for nominal focus at x = –0,85 mm, y = –0,25 mm, z = 58,95 mm
79 F.1.2 Rayleigh integral projection example
Figure F.5 – Reconstruction of pressure amplitudes on the transducer surface (transducer aperture plane)
80 Figure F.6 – Experimental arrangement
81 Figure F.7 – Amplitude and phase distribution of acoustic pressure measured at the scanning region
Figure F.8 – Amplitude and phase distribution of acoustic pressure reconstructed at the transducer aperture plane
82 Figure F.9 – Comparison of the axial distribution of pressure amplitudes as projected from the aperture plane (red) and as measured (blue)
83 F.2 Other propagation method applications
Figure F.10 –Comparison of the schlieren image (A) and the corresponding YZ distribution of acoustic pressure amplitudes projected from the transducer aperture plane (B)
84 Annex G (normative) Planar scanning of a hydrophone to determine acoustic output power
G.1 Introduction
G.2 General principle
85 G.3 Hydrophone scanning methodology
G.3.1 General methodology
86 G.3.2 Particular considerations for implementation for HITU fields
G.4 Corrections and sources of measurement uncertainty
G.4.1 Uncertainty in the hydrophone calibration
G.4.2 Planar scanning
87 G.4.3 Attenuation factor of water: unfocusing transducers
G.4.4 Attenuation factor of water: focusing transducers
G.4.5 Received hydrophone signal
88 G.4.6 Integration
G.4.7 Finite size of the hydrophone
G.4.8 partial extent of integration
G.4.9 Non-linear propagation
89 G.4.10 Directional response
G.4.11 Noise
G.4.12 Intensity approximated by derived intensity
90 Annex H (informative) Properties of water
H.1 General
Tables
Table H.1 – Speed of sound c [35, 36] and characteristic acoustic impedance,
ρ c, as a function of temperature, for propagation in water
91 H.2 Attenuation coefficient for propagation in water
92 Annex I (informative) Propagation medium and degassing
93 Bibliography

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BSI PD IEC/TS 62556:2014
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