IEC 63412-1:2024
(Main)Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface
Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface
IEC 63412-1:2024 specifies quantities and parameters which it is essential to provide to the user of shear-wave elastography systems, many in the image headers.
This document is applicable to medical-diagnostic, ultrasonic shear-wave elastography systems, exciting (internally or externally) shear waves and tracking their propagation within biological tissue.
Ultrasons - Élastographie par ondes de cisaillement - Partie 1: Spécifications pour l’interface utilisateur
l'IEC 63412-1:2024 spécifie les grandeurs et les paramètres qu’il est essentiel de fournir aux utilisateurs des systèmes d'élastographie par ondes de cisaillement, souvent situés dans les en-têtes d'images.
Le présent document s'applique aux systèmes médicaux de diagnostic utilisant l'élastographie par ondes de cisaillement ultrasonores qui excitent (intérieurement ou extérieurement) des ondes de cisaillement et qui suivent leur propagation dans les tissus biologiques.
General Information
Standards Content (Sample)
IEC 63412-1 ®
Edition 1.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Ultrasonics – Shear-wave elastography –
Part 1: Specifications for the user interface
Ultrasons – Élastographie par ondes de cisaillement –
Partie 1: Spécifications pour l’interface utilisateur
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IEC 63412-1 ®
Edition 1.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Ultrasonics – Shear-wave elastography –
Part 1: Specifications for the user interface
Ultrasons – Élastographie par ondes de cisaillement –
Partie 1: Spécifications pour l’interface utilisateur
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50 ISBN 978-2-8322-9224-2
– 2 – IEC 63412-1:2024 © IEC 2024
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Symbols . 8
5 Values presented to the user . 8
5.1 Required parameters on the user interface . 8
5.2 Required parameters in the user manual or accompanying product
documentation . 8
5.2.1 Elastic moduli . 8
5.2.2 Shear-wave excitation . 9
5.2.3 Shear-wave propagation . 9
5.2.4 Shear-wave speed dispersion effects . 10
5.3 Colour coding . 10
Annex A (informative) Rationale for the definition of a standard colour map . 11
A.1 Colour map background . 11
A.2 Description of colour map . 12
Bibliography . 20
Figure 1 – Examples of directions of tissue displacement induced by shear wave (blue)
and shear wave propagation (red) . 9
Figure A.1 – Example for a typical colour map used in commercially available
ultrasonic elastography systems . 11
Figure A.2 – Composition of the colour-map test image (example with grey colour map) . 11
Figure A.3 – Test image mapped using a typical colour map currently used in
commercial elastography applications . 12
Figure A.4 – Test image mapped using the proposed colour map . 12
Figure A.5 – Proposed perceptually uniform, colour map visualized as colour bar . 13
Figure A.6 – Plot of the RGB components of the proposed colour map with respect to
intensity ranged from 0 to 1 . 13
Table A.1 – RGB values of recommended perceptual uniform colour map . 13
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS –
SHEAR-WAVE ELASTOGRAPHY –
Part 1: Specifications for the user interface
FOREWORD
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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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
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the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 63412-1 has been prepared by IEC technical committee 87: Ultrasonics. It is an
International Standard.
The text of this International Standard is based on the following documents:
Draft Report on voting
87/851/FDIS 87/871/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
– 4 – IEC 63412-1:2024 © IEC 2024
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
A list of all parts in the IEC 63412 series, published under the general title Ultrasonics – Shear-
wave elastography, can be found on the IEC website.
Terms defined in Clause 3 are written in bold throughout this document.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IMPORTANT – The "colour inside" logo on the cover page of this document 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.
INTRODUCTION
The IEC 63412 series specifies, with respect to shear-wave elastography systems, test
procedures for the evaluation of accuracy, precision and performance of shear-wave speed
measurements.
This document specifies quantities and parameters which are essential for users of shear-wave
elastography systems. A future Part 2 will specify the requirements on test objects (elastic and
viscoelastic phantoms), their preparation and characterization. A future Part 3 will define test
parameters and procedures to determine performance and constancy of shear-wave
elastography systems.
Elastography imaging (EI) in general and shear-wave elastography (imaging) in particular have
become a state-of-the-art measurement and quantitative imaging methodology. The relevant
measurand is the speed of the shear waves travelling within the tissue under investigation,
which is related to its elasticity. Even though ultrasound elastography is already used in clinical
diagnosis, no IEC standard exists describing the relevant metrological tools, the traceable
characterization of elastography phantoms and methods for EI system testing and quality
assurance.
The determined shear-wave speeds (and so the derived elastic moduli) depend on many
technical, operator-related and patient-related factors, such as the device used and method,
the measurement depth, the size and shape of the region of interest (ROI), the number of
averaged samples, the patient's position, breathing phase, body-mass index (BMI), diet, blood
pressure and also the operator's experience. To underpin and further establish shear-wave
elastography as a well understood, accurate and reproducible quantitative-imaging modality
requires the metrological assessment of the method and devices. Thus, the IEC 63412 series
allows comparison of elastography images and determined quantitative parameters as a
function of time, across different types of equipment and patients. This procedure likely will lead
to advances in the sensitivity and specificity of clinical diagnosis, improving patient care and
ensuring efficient use of resources.
– 6 – IEC 63412-1:2024 © IEC 2024
ULTRASONICS –
SHEAR-WAVE ELASTOGRAPHY –
Part 1: Specifications for the user interface
1 Scope
This part of IEC 63412 specifies quantities and parameters which it is essential to provide to
the user of shear-wave elastography systems, many in the image headers.
This document is applicable to medical, diagnostic, ultrasonic shear-wave elastography
systems, exciting (internally or externally) shear waves and tracking their propagation within
biological tissue.
NOTE This document focuses on liver applications of shear-wave elastography but does not exclude its application
to other organs (e.g. breast, thyroid, prostate, kidney, muscle).
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
shear wave
transverse wave
wave in which the direction of displacement of particles is perpendicular to the direction of the
propagation of the wave
[SOURCE: ISO 5577:2017, 3.3.2, modified – Note 1 to entry has been deleted.]
3.2
shear-wave speed
c
s
distance travelled per unit time by a shear wave as it propagates through a tissue or medium
−1
Note 1 to entry: The shear-wave speed is expressed in units of metre per second (m s ).
Note 2 to entry: SWS is a common abbreviation for shear-wave speed.
3.3
Poisson ratio
ν
ratio of the relative contraction or extension of a tissue or medium in directions perpendicular
to the relative extension or contraction in the direction of loading
3.4
shear modulus derived from shear-wave speed
shear modulus
modulus of rigidity
μ
G
quotient of shear stress and shear strain
Note 1 to entry: For tissue or medium assumed to be isotropic, purely elastic (no viscosity) and linearly elastic in
the range of the given shear-wave deflection, shear modulus is calculated according to
(1)
μ=ρc
s
where ρ is the density of the tissue or medium.
Note 2 to entry: The shear modulus is expressed in pascals (Pa).
−3
Note 3 to entry: The tissue or medium density ρ is expressed in units of kilogram per cubic meter (kg m ).
Note 4 to entry: In general, the complex shear modulus consists of a real and imaginary part.
3.5
Young's modulus derived from shear-wave speed
Young's modulus
elastic modulus
E
quotient of normal tensile stress and tensile strain
Note 1 to entry: For tissue or medium assumed to be incompressible (Poisson ratio ν = 0,5), Young's modulus is
calculated according to
E=2 (1+νμ)=3μ
(2)
Note 2 to entry: The Young’s modulus is expressed in pascals (Pa).
Note 3 to entry: In general, the complex modulus consists of the real storage modulus and the imaginary loss
modulus.
3.6
excitation frequency of source
f
s
excitation frequency of an external or internal source that produces the shear wave
Note 1 to entry: For tissue displacement due to acoustic radiation force impulses (ARFI), the push pulses are
regarded as internal sources.
Note 2 to entry: For pulse excitation, the excitation frequency of source is not defined.
Note 3 to entry: The excitation frequency of source is expressed in hertz (Hz).
– 8 – IEC 63412-1:2024 © IEC 2024
3.7
excitation duration of source
t
s
excitation duration of an external or internal source that produces the shear wave, which is
1,25 times the interval between the time when the time integral of the square of instantaneous
acoustic pressure of an external or internal source reaches 10 % and 90 % of its final value
Note 1 to entry: For continuous excitations, the excitation duration of source is infinite.
Note 2 to entry: The excitation duration of source is expressed in seconds (s).
4 Symbols
c shear-wave speed (3.2)
s
E Young's modulus derived from shear-wave speed (elastic modulus) (3.5)
f excitation frequency of source (3.6)
s
t excitation duration of source (3.7)
s
μ (or G) shear modulus derived from shear-wave speed (modulus of rigidity) (3.4)
ν Poisson ratio (3.3)
ρ tissue density (3.4)
5 Values presented to the user
5.1 Required parameters on the user interface
The basic measurement value of all commercially available ultrasound elastography systems is
−1
the shear-wave speed c in units of metre per second (ms ). Therefore, the shear-wave
s
speed value with the unit shall always be provided to the user. Both the name or abbreviation
and the unit shall be visible on the user interface.
If vendors provide additional values derived from the shear-wave speed (e.g. shear modulus
or Young’s modulus derived from shear-wave speed) on their system, both name and unit
shall be visible on the user interface.
5.2 Required parameters in the user manual or accompanying product documentation
5.2.1 Elastic moduli
If vendors provide additional values derived from the shear-wave speed (e.g. shear modulus
or Young’s modulus) on their system, they must clarify which value is presented, the
corresponding unit, how this value was derived from shear-wave speed and the underlying
assumptions.
EXAMPLE
Value: µ in kPa
Formula: μ= ρc
s
−3
Assumptions: ρ = 1 000 kg m , no viscosity, linear elasticity, isotropy
or:
Value: E in kPa
E 21(+ν) ρc
Formula:
s
−3
Assumptions: ρ = 1 000 kg m , no viscosity, linear elasticity, isotropy, incompressibility (v = 0,5)
The manufacturer shall provide the information in the accompanying product documentation.
5.2.2 Shear-wave excitation
For the harmonization of the methods to determine shear-wave speed and related elastic
moduli, the excitation frequency of source or excitation duration of source or both are
relevant and shall be provided in the accompanying product documentation.
When conditions are different for each probe, all cases shall be specified.
5.2.3 Shear-wave propagation
The assumed direction of shear-wave propagation and tissue displacement in relation to the
transducer orientation [1] shall be provided in the user manual or accompanying product
documentation by means of an image such as the one presented in Figure 1. This information
is relevant in cases where the tissue or medium is anisotropic, e.g. muscle.
a) ARFI based methods b) Transient elastography
Figure 1 – Examples of directions of tissue displacement induced by shear wave (blue)
and shear wave propagation (red)
The push pulse direction and position or positions should be indicated in the B-mode image to
support the user in avoiding exposure of sensitive tissue to the intense push pulses for safety
reasons. This feature can be switched on and off by the user.
In addition, the area outside the ROI in the lateral direction which is affected by high intensity
focused push pulses shall be declared in the user manual (or accompanying product
documentation).
___________
Numbers in square brackets refer to the Bibliography.
=
– 10 – IEC 63412-1:2024 © IEC 2024
5.2.4 Shear-wave speed dispersion effects
Shear-wave speed estimates in viscoelastic tissue can be significantly different as a function
of shear-wave frequency content due to the dispersion introduced by the tissue viscosity. Group
shear-wave speeds that contain all frequency content of the shear-wave field, in contrast to
phase velocities that are reported at specific frequencies, can be biased if based on the use of
particle-velocity based shear-wave data rather than particle-displacement based shear-wave
data [2]. More specifically, particle velocity data have a positive bias in frequency compared to
displacement data in dispersive media. Therefore, it should be stated in the accompanying
product documentation, whether the method used for the estimation of the shear-wave speed
is particle-displacement based or particle-velocity based or both, depending on the application.
Additionally, any filtering applied to the shear-wave data prior to speed estimation which is
applied to the shear-wave data and could impact the bandwidth of the shear-wave data should
also be disclosed.
Given the variety of shear-wave speed estimation signal processing steps that can be
implemented on a given system, a more detailed description of the frequency dependence of
the shear-wave speed estimate could include reporting a phase velocity at a specific frequency
or presenting phase velocities over a range of frequencies. The spectral content of shear-wave
is dependent on the stiffness of the medium being imaged, which means that this frequency
range will change as a function of the tissue target and disease state.
NOTE Acoustic radiation force-based imaging systems tend to generate higher frequency passbands than other
shear-wave elasticity imaging systems being clinically used, e.g. magnetic resonance elastography (MRE) and
transient elastography (TE) [3].
5.3 Colour coding
For the representation of shear-wave speeds acquired in two dimensions, including shear-
wave elastography imaging methods, the vendors shall allow the user to select a standard
colour map [4]. For details see Annex A. For display of images of derived moduli, the standard
colour-map intensity shall vary linearly with shear-wave speed so that the image of derived
moduli appears identical to the image of shear-wave speed.
The required standard colour map is optimized with respect to the perceptual contrast. The
availability and application of the standard colour map are fundamental for comparison of image
representations of 2D shear-wave speed maps acquired with different devices.
Annex A
(informative)
Rationale for the definition of a standard colour map
A.1 Colour map background
Annex A contains background information on the current and new colour maps. At least seven
of the commercially available ultrasonic elastography systems use a colour map equivalent or
approximately equivalent to that presented as colour bar in Figure A.1 and in Figure A.3 [5].
Figure A.1 – Example for a typical colour map used in commercially
available ultrasonic elastography systems
All these colour maps have "flat spots" with very low perceptual contrast and perceptual
discontinuities, which cause "false features" that are not in the mapped data (see Figure A.3).
A detailed analysis can be found in https://colorcet.com and [4].
The intensity ramp (linear increase of intensity with respect to normalized colour index representing the data range)
is superimposed with sinusoidal features with increasing magnitude.
Figure A.2 – Composition of the colour-map test image (example with grey colour map)
– 12 – IEC 63412-1:2024 © IEC 2024
For identification of perceptual flat spots and zones with perceptual discontinuities, a test image
is used (Figure A.2). The data set of the test image is composed of a ramp (linear increase of
pixel intensity from 0 to 1) and a superimposed sinusoidal oscillation which modulates the pixel
intensity and represents features in the image [4]. The peak-to-peak magnitude of the feature
intensity ranges from zero to 10 % of the total data range (here linear increase from 0 to 0,1).
The current colour maps have major disadvantages and are suboptimal for medical diagnostics.
Features disappear in zones with low perceptual contrast (flat spots) and false features appear,
which are not in the data (Figure A.3). Therefore, a new colour map is proposed (Figure A.4)
which overcomes many of the current problems and whose visual appearance (rainbow colours)
is still close to that of the established maps.
Examples of flat spots and false features are marked with arrows.
Figure A.3 – Test image mapped using a typical colour map currently used in
commercial elastography applications
The parts with too little or too much perceptual contrast are much less pronounced in comparison to the current
colour map (Figure A.3).
Figure A.4 – Test image mapped using the proposed colour map
A.2 Description of colour map
Figure A.5 shows the proposed perceptually uniform, colour map as colour bar. Figure A.6
shows the red, green and blue (RGB) components of the proposed colour map plotted against
the intensity, ranged from 0 to 1. Table A.1 lists the corresponding pixel indices, intensities and
RGB values.
Figure A.5 – Proposed perceptually uniform, colour map visualized as colour bar
Figure A.6 – Plot of the RGB components of the proposed colour map
with respect to intensity ranged from 0 to 1
Table A.1 – RGB values of recommended perceptual uniform colour map
Index Intensity R G B
1 0,000 0 0,000 0 0,203 9 0,962 5
2 0,003 9 0,000 0 0,215 2 0,951 4
3 0,007 8 0,000 0 0,226 1 0,940 3
4 0,011 8 0,000 0 0,236 5 0,929 2
5 0,015 7 0,000 0 0,246 5 0,918 2
6 0,019 6 0,000 0 0,256 2 0,907 1
7 0,023 5 0,000 0 0,265 6 0,896 1
8 0,027 5 0,000 0 0,274 6 0,885 1
9 0,031 4 0,000 0 0,283 5 0,874 0
10 0,035 3 0,000 0 0,292 1 0,863 1
11 0,039 2 0,000 0 0,300 5 0,852 1
12 0,043 1 0,000 0 0,308 7 0,841 1
13 0,047 1 0,000 0 0,316 7 0,830 1
14 0,051 0 0,000 0 0,324 6 0,819 2
15 0,054 9 0,000 0 0,332 3 0,808 2
16 0,058 8 0,000 0 0,339 9 0,797 3
17 0,062 7 0,000 0 0,347 4 0,786 4
18 0,066 7 0,000 0 0,354 7 0,775 5
19 0,070 6 0,000 0 0,361 9 0,764 6
20 0,074 5 0,000 0 0,369 0 0,753 7
– 14 – IEC 63412-1:2024 © IEC 2024
Index Intensity R G B
21 0,078 4 0,000 0 0,376 0 0,742 8
22 0,082 4 0,000 0 0,382 9 0,731 9
23 0,086 3 0,000 0 0,389 7 0,721 1
24 0,090 2 0,000 0 0,396 4 0,710 3
25 0,094 1 0,000 0 0,402 9 0,699 5
26 0,098 0 0,000 0 0,409 3 0,688 7
27 0,102 0 0,000 0 0,415 6 0,678 0
28 0,105 9 0,000 0 0,421 7 0,667 4
29 0,109 8 0,000 0 0,427 7 0,656 8
30 0,113 7 0,000 0 0,433 4 0,646 4
31 0,117 6 0,000 0 0,439 0 0,636 1
32 0,121 6 0,000 0 0,444 3 0,625 8
33 0,125 5 0,000 0 0,449 4 0,615 7
34 0,129 4 0,000 0 0,454 4 0,605 8
35 0,133 3 0,000 0 0,459 1 0,596 0
36 0,137 3 0,004 3 0,463 7 0,586 3
37 0,141 2 0,029 6 0,468 1 0,576 7
38 0,145 1 0,055 8 0,472 4 0,567 2
39 0,149 0 0,077 1 0,476 5 0,557 7
40 0,152 9 0,095 3 0,480 6 0,548 4
41 0,156 9 0,111 2 0,484 6 0,539 0
42 0,160 8 0,125 3 0,488 7 0,529 7
43 0,164 7 0,138 0 0,492 6 0,520 4
44 0,168 6 0,149 4 0,496 6 0,511 1
45 0,172 5 0,159 6 0,500 5 0,501 8
46 0,176 5 0,169 0 0,504 5 0,492 4
47 0,180 4 0,177 5 0,508 5 0,483 1
48 0,184 3 0,185 2 0,512 5 0,473 7
49 0,188 2 0,192 2 0,516 5 0,464 3
50 0,192 2 0,198 6 0,520 5 0,454 8
51 0,196 1 0,204 4 0,524 5 0,445 3
52 0,200 0 0,209 7 0,528 5 0,435 8
53 0,203 9 0,214 6 0,532 6 0,426 2
54 0,207 8 0,219 0 0,536 6 0,416 5
55 0,211 8 0,223 1 0,540 7 0,406 8
56 0,215 7 0,226 7 0,544 7 0,397 0
57 0,219 6 0,230 0 0,548 8 0,387 1
58 0,223 5 0,233 0 0,552 9 0,377 2
59 0,227 5 0,235 7 0,557 0 0,367 2
60 0,231 4 0,238 0 0,561 1 0,357 0
61 0,235 3 0,240 1 0,565 3 0,346 8
62 0,239 2 0,241 9 0,569 4 0,336 4
63 0,243 1 0,243 3 0,573 5 0,325 9
64 0,247 1 0,244 6 0,577 7 0,315 2
Index Intensity R G B
65 0,251 0 0,245 6 0,581 9 0,304 4
66 0,254 9 0,246 3 0,586 0 0,293 4
67 0,258 8 0,246 8 0,590 2 0,282 1
68 0,262 7 0,247 1 0,594 4 0,270 7
69 0,266 7 0,247 1 0,598 6 0,259 0
70 0,270 6 0,247 0 0,602 7 0,247 0
71 0,274 5 0,246 8 0,606 9 0,234 7
72 0,278 4 0,246 5 0,611 1 0,222 2
73 0,282 4 0,246 2 0,615 2 0,209 4
74 0,286 3 0,246 0 0,619 4 0,196 3
75 0,290 2 0,246 0 0,623 4 0,183 0
76 0,294 1 0,246 4 0,627 4 0,169 7
77 0,298 0 0,247 5 0,631 4 0,156 3
78 0,302 0 0,249 3 0,635 2 0,143 0
79 0,305 9 0,252 0 0,638 9 0,130 0
80 0,309 8 0,255 7 0,642 5 0,117 4
81 0,313 7 0,260 6 0,645 9 0,105 6
82 0,317 6 0,266 6 0,649 3 0,094 7
83 0,321 6 0,273 7 0,652 4 0,084 9
84 0,325 5 0,281 8 0,655 4 0,076 5
85 0,329 4 0,290 8 0,658 3 0,069 8
86 0,333 3 0,300 4 0,661 1 0,064 5
87 0,337 3 0,310 6 0,663 8 0,060 9
88 0,341 2 0,321 1 0,666 4 0,058 7
89 0,345 1 0,331 9 0,669 0 0,057 7
90 0,349 0 0,342 7 0,671 4 0,057 7
91 0,352 9 0,353 6 0,673 9 0,058 4
92 0,356 9 0,364 4 0,676 3 0,059 7
93 0,360 8 0,375 1 0,678 7 0,061 1
94 0,364 7 0,385 7 0,681 0 0,063 0
95 0,368 6 0,396 3 0,683 4 0,064 8
96 0,372 5 0,406 7 0,685 7 0,066 7
97 0,376 5 0,416 9 0,688 0 0,068 6
98 0,380 4 0,427 1 0,690 3 0,070 5
99 0,384 3 0,437 1 0,692 7 0,072 4
100 0,388 2 0,447 0 0,694 9 0,074 4
101 0,392 2 0,456 8 0,697 2 0,076 2
102 0,396 1 0,466 6 0,699 5 0,078 1
103 0,400 0 0,476 2 0,701 8 0,080 0
104 0,403 9 0,485 8 0,704 0 0,081 9
105 0,407 8 0,495 3 0,706 3 0,083 8
106 0,411 8 0,504 7 0,708 5 0,085 6
107 0,415 7 0,514 1 0,710 8 0,087 5
108 0,419 6 0,523 3 0,713 0 0,089 3
– 16 – IEC 63412-1:2024 © IEC 2024
Index Intensity R G B
109 0,423 5 0,532 6 0,715 2 0,091 2
110 0,427 5 0,541 8 0,717 4 0,092 9
111 0,431 4 0,550 9 0,719 6 0,094 8
112 0,435 3 0,560 0 0,721 8 0,096 6
113 0,439 2 0,569 0 0,724 0 0,098 4
114 0,443 1 0,578 0 0,726 1 0,100 2
115 0,447 1 0,587 0 0,728 3 0,102 0
116 0,451 0 0,595 9 0,730 4 0,103 9
117 0,454 9 0,604 8 0,732 6 0,105 6
118 0,458 8 0,613 6 0,734 7 0,107 4
119 0,462 7 0,622 5 0,736 8 0,109 2
120 0,466 7 0,631 3 0,738 9 0,111 0
121 0,470 6 0,640 0 0,741 0 0,112 8
122 0,474 5 0,648 7 0,743 1 0,114 5
123 0,478 4 0,657 5 0,745 2 0,116 4
124 0,482 4 0,666 1 0,747 3 0,118 1
125 0,486 3 0,674 8 0,749 4 0,119 9
126 0,490 2 0,683 4 0,751 4 0,121 6
127 0,494 1 0,692 1 0,753 5 0,123 4
128 0,498 0 0,700 6 0,755 5 0,125 2
129 0,502 0 0,709 2 0,757 6 0,126 9
130 0,505 9 0,717 8 0,759 6 0,128 7
131 0,509 8 0,726 3 0,761 6 0,130 5
132 0,513 7 0,734 9 0,763 6 0,132 2
133 0,517 6 0,743 4 0,765 6 0,134 0
134 0,521 6 0,751 9 0,767 6 0,135 7
135 0,525 5 0,760 4 0,769 5 0,137 5
136 0,529 4 0,768 8 0,771 5 0,139 2
137 0,533 3 0,777 3 0,773 5 0,141 0
138 0,537 3 0,785 8 0,775 4 0,142 7
139 0,541 2 0,794 2 0,777 4 0,144 4
140 0,545 1 0,802 6 0,779 3 0,146 2
141 0,549 0 0,811 0 0,781 2 0,147 9
142 0,552 9 0,819 5 0,783 1 0,149 7
143 0,556 9 0,827 9 0,785 0 0,151 4
144 0,560 8 0,836 3 0,786 9 0,153 1
145 0,564 7 0,844 7 0,788 8 0,154 9
146 0,568 6 0,853 0 0,790 7 0,156 6
147 0,572 5 0,861 4 0,792 5 0,158 3
148 0,576 5 0,869 8 0,794 3 0,160 0
149 0,580 4 0,878 1 0,796 1 0,161 8
150 0,584 3 0,886 5 0,797 9 0,163 5
151 0,588 2 0,894 8 0,799 5 0,165 1
152 0,592 2 0,903 0 0,801 1 0,166 7
Index Intensity R G B
153 0,596 1 0,911 2 0,802 5 0,168 2
154 0,600 0 0,919 2 0,803 6 0,169 6
155 0,603 9 0,927 0 0,804 6 0,170 9
156 0,607 8 0,934 6 0,805 1 0,172 0
157 0,611 8 0,941 8 0,805 3 0,172 9
158 0,615 7 0,948 7 0,805 0 0,173 5
159 0,619 6 0,955 1 0,804 2 0,173 9
160 0,623 5 0,960 9 0,802 9 0,174 0
161 0,627 5 0,966 1 0,801 0 0,173 7
162 0,631 4 0,970 7 0,798 5 0,173 2
163 0,635 3 0,974 7 0,795 5 0,172 3
164 0,639 2 0,978 0 0,792 0 0,171 2
165 0,643 1 0,980 8 0,788 1 0,169 9
166 0,647 1 0,983 1 0,783 8 0,168 3
167 0,651 0 0,985 0 0,779 3 0,166 5
168 0,654 9 0,986 6 0,774 5 0,164 6
169 0,658 8 0,987 9 0,769 6 0,162 7
170 0,662 7 0,989 0 0,764 5 0,160 6
171 0,666 7 0,989 9 0,759 3 0,158 5
172 0,670 6 0,990 7 0,754 1 0,156 3
173 0,674 5 0,991 5 0,748 8 0,154 1
174 0,678 4 0,992 1 0,743 6 0,152 0
175 0,682 4 0,992 8 0,738 2 0,149 8
176 0,686 3 0,993 4 0,732 9 0,147 6
177 0,690 2 0,994 0 0,727 6 0,145 4
178 0,694 1 0,994 5 0,722 2 0,143 2
179 0,698 0 0,995 1 0,716 9 0,141 0
180 0,702 0 0,995 6 0,711 5 0,138 8
181 0,705 9 0,996 1 0,706 1 0,136 6
182 0,709 8 0,996 6 0,700 7 0,134 4
183 0,713 7 0,997 1 0,695 3 0,132 2
184 0,717 6 0,997 6 0,689 9 0,130 1
185 0,721 6 0,998 0 0,684 5 0,127 8
186 0,725 5 0,998 4 0,679 1 0,125 6
187 0,729 4 0,998 8 0,673 6 0,123 4
188 0,733 3 0,999 2 0,668 1 0,121 2
189 0,737 3 0,999 6 0,662 7 0,119 0
190 0,741 2 0,999 9 0,657 2 0,116 8
191 0,745 1 1,000 0 0,651 7 0,114 6
192 0,749 0 1,000 0 0,646 1 0,112 4
193 0,752 9 1,000 0 0,640 6 0,110 2
194 0,756 9 1,000 0 0,635 0 0,108 0
195 0,760 8 1,000 0 0,629 5 0,105 8
196 0,764 7 1,000 0 0,623 9 0,103 6
– 18 – IEC 63412-1:2024 © IEC 2024
Index Intensity R G B
197 0,768 6 1,000 0 0,618 2 0,101 3
198 0,772 5 1,000 0 0,612 6 0,099 1
199 0,776 5 1,000 0 0,607 0 0,096 9
200 0,780 4 1,000 0 0,601 3 0,094 7
201 0,784 3 1,000 0 0,595 6 0,092 5
202 0,788 2 1,000 0 0,589 9 0,090 3
203 0,792 2 1,000 0 0,584 2 0,088 0
204 0,796 1 1,000 0 0,578 4 0,085 7
205 0,800 0 1,000 0 0,572 6 0,083 5
206 0,803 9 1,000 0 0,566 8 0,081 3
207 0,807 8 1,000 0 0,561 0 0,079 0
208 0,811 8 1,000 0 0,555 1 0,076 7
209 0,815 7 1,000 0 0,549 2 0,074 5
210 0,819 6 1,000 0 0,543 3 0,072 2
211 0,823 5 1,000 0 0,537 4 0,070 0
212 0,827 5 1,000 0 0,531 4 0,067 7
213 0,831 4 1,000 0 0,525 4 0,065 4
214 0,835 3 1,000 0 0,519 4 0,063 2
215 0,839 2 1,000 0 0,513 3 0,060 8
216 0,843 1 1,000 0 0,507 2 0,058 5
217 0,847 1 1,000 0 0,501 0 0,056 2
218 0,851 0 1,000 0 0,494 9 0,053 8
219 0,854 9 1,000 0 0,488 6 0,051 5
220 0,858 8 1,000 0 0,482 4 0,049 2
221 0,862 7 1,000 0 0,476 0 0,046 8
222 0,866 7 1,000 0 0,469 7 0,044 4
223 0,870 6 1,000 0 0,463 3 0,042 1
224 0,874 5 1,000 0 0,456 8 0,039 6
225 0,878 4 1,000 0 0,450 3 0,037 3
226 0,882 4 1,000 0 0,443 7 0,034 9
227 0,886 3 1,000 0 0,437 1 0,032 5
228 0,890 2 1,000 0 0,430 4 0,030 3
229 0,894 1 1,000 0 0,423 7 0,028 2
230 0,898 0 1,000 0 0,416 9 0,026 1
231 0,902 0 1,000 0 0,410 0 0,024 1
232 0,905 9 1,000 0 0,403 0 0,022 2
233 0,909 8 1,000 0 0,395 9 0,020 3
234 0,913 7 1,000 0 0,388 8 0,018 5
235 0,917 6 0,999 9 0,381 6 0,016 8
236 0,921 6 0,999 6 0,374 3 0,015 1
237 0,925 5 0,999 3 0,366 9 0,013 5
238 0,929 4 0,998 9 0,359 3 0,011 9
239 0,933 3 0,998 6 0,351 7 0,010 2
240 0,937 3 0,998 2 0,343 9 0,008 7
Index Intensity R G B
241 0,941 2 0,997 8 0,336 0 0,007 4
242 0,945 1 0,997 4 0,328 0 0,006 0
243 0,949 0 0,997 0 0,319 8 0,004 7
244 0,952 9 0,996 5 0,311 4 0,003 5
245 0,956 9 0,996 1 0,302 8 0,002 4
246 0,960 8 0,995 6 0,294 1 0,001 2
247 0,964 7 0,995 2 0,285 1 0,000 2
248 0,968 6 0,994 7 0,275 9 0,000 0
249 0,972 5 0,994 2 0,266 4 0,000 0
250 0,976 5 0,993 7 0,256 6 0,000 0
251 0,980 4 0,993 2 0,246 5 0,000 0
252 0,984 3 0,992 6 0,236 1 0,000 0
253 0,988 2 0,992 1 0,225 1 0,000 0
254 0,992 2 0,991 6 0,213 7 0,000 0
255 0,996 1 0,991 0 0,201 7 0,000 0
256 1,000 0 0,990 4 0,189 0 0,000 0
– 20 – IEC 63412-1:2024 © IEC 2024
Bibliography
[1] Doherty, J. R. et al. (2013), Acoustic radiation force elasticity imaging in diagnostic
ultrasound. IEEE-UFFC Vol. 60(4), doi: 10.1109/TUFFC.2013.2617
[2] Deng, Y. et al. (2017), Ultrasonic Shear Wave Elasticity Imaging Sequencing and Data
Processing Using a Verasonics Research Scanner. IEEE-UFFC Vol. 64 (1), doi:
10.1109/TUFFC.2016.2614944
[3] Palmeri, M. L. et al. (2021), Radiological Society of North America/Quantitative Imaging
Biomarker Alliance Shear Wave Speed Bias Quantification in Elastic and Viscoelastic
Phantoms. Journal of ultrasound in medicine, 40(3), 569–581.
https://doi.org/10.1002/jum.15609
[4] Kovesi, P. (2015), Good Colour Maps: How to Design Them. arXiv:1509.03700 [cs.GR]
[5] RSNA: QIBA Profile, Ultrasound Measurement of Shear Wave Speed for Estimation of
Liver Fibrosis (2019),
http://qibawiki.rsna.org/images/b/b7/QIBA_US_SWS_Profile_10.21.19.pdf
___________
– 22 – IEC 63412-1:2024 © IEC 2024
SOMMAIRE
AVANT-PROPOS . 23
INTRODUCTION . 25
1 Domaine d'application . 26
2 Références normatives . 26
3 Termes et définitions . 26
4 Symboles . 28
5 Valeurs présentées à l’utilisateur . 28
5.1 Paramètres exigés sur l'interface utilisateur . 28
5.2 Paramètres exigés dans le manuel de l'utilisateur ou dans la documentation
d'accompagnement du produit . 29
5.2.1 Modules élastiques . 29
5.2.2 Excitation des ondes de cisaillement . 29
5.2.3 Propagation des ondes de cisaillement . 29
5.2.4 Effets de dispersion de la vitesse d’onde de cisaillement . 30
5.3 Code couleur . 31
Annexe A (informative) Justification de la définition d'une carte normalisée des
couleurs . 32
A.1 Contexte de la carte des couleurs . 32
A.2 Description de la carte des couleurs . 34
Bibliographie . 41
Figure 1 – Exemples de directions de déplacement du tissu induit par l’onde
de cisaillement (bleu) et de propagation des ondes de cisaillement (rouge) . 30
Figure A.1 – Exemple de carte des couleurs type utilisée dans les systèmes
d'élastographie par ultrasons disponibles sur le marché . 32
Figure A.2 – Composition de l'image d’essai de la carte des couleurs (exemple avec
une carte des couleurs grises) .
...
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