EN 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.
Ultraschall - Scherwellen-Elastographie - Teil 1: Spezifikationen für die Benutzerschnittstelle
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.
Ultrazvok - Elastografija s strižnimi valovi - 1. del: Specifikacije za uporabniški vmesnik (IEC 63412-1:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2024
Ultrazvok - Elastografija s strižnimi valovi - 1. del: Specifikacije za uporabniški
vmesnik (IEC 63412-1:2024)
Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface (IEC
63412-1:2024)
Ultraschall - Scherwellen-Elastographie - Teil 1: Spezifikationen für die
Benutzerschnittstelle (IEC 63412-1:2024)
Ultrasons - élastographie par ondes de cisaillement - Partie 1: Spécifications pour
l’interface utilisateur (IEC 63412-1:2024)
Ta slovenski standard je istoveten z: EN IEC 63412-1:2024
ICS:
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 63412-1
NORME EUROPÉENNE
EUROPÄISCHE NORM September 2024
ICS 17.140.50
English Version
Ultrasonics - Shear-wave elastography - Part 1: Specifications
for the user interface
(IEC 63412-1:2024)
Ultrasons - Élastographie par ondes de cisaillement - Partie Ultraschall - Scherwellen-Elastographie - Teil 1:
1: Spécifications pour l'interface utilisateur Spezifikationen für die Benutzerschnittstelle
(IEC 63412-1:2024) (IEC 63412-1:2024)
This European Standard was approved by CENELEC on 2024-08-20. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
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© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63412-1:2024 E
European foreword
The text of document 87/851/FDIS, future edition 1 of IEC 63412-1, prepared by IEC/TC 87
"Ultrasonics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-05-20
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-08-20
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 63412-1:2024 was approved by CENELEC as a European
Standard without any modification.
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
IEC 63412-1:2024 © IEC 2024 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS –
SHEAR-WAVE ELASTOGRAPHY –
Part 1: Specifications for the user interface
FOREWORD
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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.
IEC 63412-1:2024 © IEC 2024 – 5 –
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
para
...
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