SIST EN IEC 63412-1:2024
(Main)Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface (IEC 63412-1:2024)
Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface (IEC 63412-1:2024)
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 (IEC 63412-1:2024)
Ultrasons - élastographie par ondes de cisaillement - Partie 1: Spécifications pour l’interface utilisateur (IEC 63412-1:2024)
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)
Standard IEC 63412-1:2024 določa veličine in parametre, ki so bistveni za uporabnika sistemov elastografije s strižnimi valovi, pri čemer jih je veliko v naslovih slik.
Ta dokument se uporablja za medicinsko-diagnostične sisteme elastografije z ultrazvočnimi strižnimi valovi, ustvarjanje (notranjih ali zunanjih) strižnih valov in spremljanje njihovega širjenja v biološkem tkivu.
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
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 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
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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
may be required to implement this document. However, implementers are cautioned that this may not represent
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.
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.