Ultrasonics - Transducers - Definitions and measurement methods regarding focusing for the transmitted fields (IEC 61828:2020)

IEC 61828:2020
- provides definitions for the transmitted field characteristics of focusing and nonfocusing transducers for applications in medical ultrasound;
- relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers;
- gives measurement methods for obtaining defined field characteristics of focusing and nonfocusing transducers;
- specifies beam axis alignment methods appropriate for focusing and nonfocusing transducers.
IEC 61828:2021 relates to focusing ultrasonic transducers operating in the frequency range appropriate to medical ultrasound (0,5 MHz to 40 MHz) for both therapeutic and diagnostic applications. It shows how the characteristics of the transmitted field of transducers can be described from the point of view of design, as well as measured by someone with no prior knowledge of the construction details of a particular device. The transmitted ultrasound field for a specified excitation is measured by a hydrophone in either a standard test medium (for example, water) or in a given medium. This document applies only to media where the field behaviour is essentially like that in a fluid (i.e. where the influence of shear waves and elastic anisotropy is small), including soft tissues and tissue-mimicking gels. Any aspects of the field that affect their theoretical description or are important in design are also included. These definitions would have use in scientific communications, system design and description of the performance and safety of systems using these devices.
IEC 61828:2021 incorporates definitions from other related standards where possible, and supplies more specific terminology, both for defining focusing characteristics and for providing a basis for measurement of these characteristics.
IEC 61828:2021 cancels and replaces the first edition published in 2001. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) Clause 6 on Measurement procedures has been replaced by Clause 6: "Acoustic field measurement: equipment" and Clause 7: "Measurement procedure" and related definitions.
b) Reorganization of definitions and measurement section to accommodate specific sets of measurements for focusing, nonlinearity, beam axis alignment, beam area, beam maximum, numerical projection, plane wave, high intensity therapeutic ultrasound, multiple sources, spatial impulse response and compound plane waves. Clause 3 has been moved to Annex B.
c) The normative references have been updated and the Bibliography has been expanded from 8 to 40 references.
d) Twelve figures have been updated and seven new figures (B.1, B.3, B.7, B.10, B.11, B.12, B.13, B.14) have been added to facilitate measurements and be consistent with measurement terminology.
e) New measurements have been added for time delays, arrays, plane waves and spatial impulse response.
f) Annex A has been expanded to provide general guidance on pulsed waves, system responses, focusing gains and minimum beamwidth estimation.
g) New annexes have been added:

• Annex B (informative) Rationale for focusing and nonfocusing definitions

• Annex E (informative) Uncertainties;

• Annex F (informative) Transducer and hydrophone positioning systems;

Ultraschall - Fokussierende Wandler - Definitionen und Messverfahren mit Bezug auf die Fokussierung für die erzeugten Felder (IEC 61828:2020)

Ultrasons - Transducteurs - Définitions et méthodes de mesure pour la focalisation des champs transmis (IEC 61828:2020)

L'IEC 61828:2020
– donne les définitions des caractéristiques du champ transmis de transducteurs focalisants et non focalisants pour des applications ultrasonores médicales;
– établit la relation entre ces définitions et les descriptions théoriques, la conception et le mesurage des champs transmis par des transducteurs focalisants;
– donne des méthodes de mesure pour l'obtention de caractéristiques du champ définies des transducteurs focalisants et non focalisants;
– donne des méthodes d'alignement de l'axe du faisceau adaptées aux transducteurs focalisants et non focalisants.
Le présent document se réfère à des transducteurs ultrasoniques focalisants fonctionnant dans la plage de fréquences appropriée pour des applications ultrasonores médicales (soit de 0,5 MHz à 40 MHz) aussi bien thérapeutiques que diagnostiques. Le présent document spécifie comment les caractéristiques du champ transmis par les transducteurs peuvent être décrites du point de vue de la conception et mesurées par une personne n'ayant aucune connaissance préalable des détails de construction d'un appareil spécifique. Le champ ultrasonique émis pour une excitation spécifiée est mesuré par un hydrophone dans un milieu d'essai normalisé (de l'eau, par exemple) ou dans un milieu donné. Le présent document s'applique uniquement à des milieux dans lesquels le comportement du champ est essentiellement similaire à celui constaté dans un fluide (c'est-à-dire dans lesquels l'influence des ondes tourbillonnaires et de l'anisotropie élastique est faible), cela comprenant les tissus mous et les gels imitant un tissu. Tous les aspects du champ affectant leur description théorique ou qui sont importants pour la conception sont aussi inclus. Ces définitions sont utiles dans des communications scientifiques, pour la conception d'appareils et pour la description du rendement et de la sécurité de systèmes utilisant ces dispositifs.
Le présent document reprend, lorsque c’est possible, quelques définitions d'autres normes connexes et fournit une terminologie plus spécifique, aussi bien pour la définition des caractéristiques de focalisation que pour procurer une base pour le mesurage de ces caractéristiques.
L'IEC 61828:2020 annule et remplace la première édition parue en 2001. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) L'Article 6 relative aux procédures de mesure a été remplacé par l'Article 6: "Mesurage du champ acoustique: équipement", et par l'Article 7: "Procédure de mesure" et définitions connexes.
b) Réorganisation des définitions et de la section relative aux mesurages pour établir un ensemble spécifique de mesurages pour la focalisation, la non-linéarité, l'alignement de l'axe du faisceau, la surface du faisceau, le maximum de faisceau, la projection numérique, l'onde plane, les ultrasons thérapeutiques de haute intensité, les sources multiples, la réponse impulsionnelle spatiale et les ondes planes composées. L’Article 3 a été transféré à l’Annexe B.
c) Les références normatives ont été mises à jour et la Bibliographie étendue de 8 à 40 références.
d) Douze figures ont été mises à jour et sept autres (Figures B.1, B.3, B.7, B.10, B.11, B.12, B.13, B.14) ont été ajoutées pour faciliter les mesurages et assurer la cohérence avec la terminologie de mesure.
e) De nouveaux mesurages ont été ajoutés pour les délais de réponse, les réseaux, les ondes pl

Ultrazvok - Pretvorniki - Definicije in merilne metode glede fokusiranja oddanih polj (IEC 61828:2020)

General Information

Status
Published
Publication Date
03-Mar-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
12-Feb-2021
Due Date
19-Apr-2021
Completion Date
04-Mar-2021

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SLOVENSKI STANDARD
SIST EN IEC 61828:2021
01-april-2021
Nadomešča:
SIST EN 61828:2002
Ultrazvok - Pretvorniki - Definicije in merilne metode glede fokusiranja oddanih
polj (IEC 61828:2020)
Ultrasonics - Transducers - Definitions and measurement methods regarding focusing for
the transmitted fields (IEC 61828:2020)
Ultraschall - Fokussierende Wandler - Definitionen und Messverfahren mit Bezug auf die
Fokussierung für die erzeugten Felder (IEC 61828:2020)
Ultrasons - Transducteurs - Définitions et méthodes de mesure pour la focalisation des
champs transmis (IEC 61828:2020)
Ta slovenski standard je istoveten z: EN IEC 61828:2021
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
SIST EN IEC 61828:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 61828:2021

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SIST EN IEC 61828:2021


EUROPEAN STANDARD EN IEC 61828

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2021
ICS 17.140.50 Supersedes EN 61828:2001 and all of its amendments
and corrigenda (if any)
English Version
Ultrasonics - Transducers - Definitions and measurement
methods regarding focusing for the transmitted fields
(IEC 61828:2020)
Ultrasons - Transducteurs - Définitions et méthodes de Ultraschall - Fokussierende Wandler - Definitionen und
mesure pour la focalisation des champs transmis Messverfahren mit Bezug auf die Fokussierung für die
(IEC 61828:2020) erzeugten Felder
(IEC 61828:2020)
This European Standard was approved by CENELEC on 2021-01-19. 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,
Turkey 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 61828:2021 E

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SIST EN IEC 61828:2021
EN IEC 61828:2021 (E)
European foreword
The text of document 87/746/FDIS, future edition 2 of IEC 61828, prepared by IEC/TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 61828:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-10-19
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-01-19
document have to be withdrawn
This document supersedes EN 61828:2001 and all of its amendments and corrigenda (if any).
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.
Endorsement notice
The text of the International Standard IEC 61828:2020 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 62127-1:2007 NOTE Harmonized as EN 62127-1:2007 (not modified)
IEC 60601-2-62:2013 NOTE Harmonized as EN 60601-2-62:2015 (not modified)
IEC/TS 61949:2007 NOTE Harmonized as CLC/TS 61949:2008 (not modified)
2

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SIST EN IEC 61828:2021
EN IEC 61828:2021 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 61161 - Ultrasonics - Power measurement - EN 61161 -
Radiation force balances and performance
requirements
IEC 61689 2013 Ultrasonics - Physiotherapy systems - Field EN 61689 2013
specifications and methods of
measurement in the frequency range 0,5
MHz to 5 MHz
IEC 62127-3 2007 Ultrasonics - Hydrophones - Part 3: EN 62127-3 2007
Properties of hydrophones for ultrasonic
fields up to 40 MHz
IEC 62555 - Ultrasonics - Power measurement - High EN 62555 -
intensity therapeutic ultrasound (HITU)
transducers and systems
IEC/TS 62556 2014 Ultrasonics - Field characterization - - -
Specification and measurement of field
parameters for high intensity therapeutic
ultrasound (HITU) transducers and
systems
ISO/IEC Guide 98-3 2008 Uncertainty of measurement - Part 3: - -
Guide to the expression of uncertainty in
measurement (GUM:1995)

3

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SIST EN IEC 61828:2021

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SIST EN IEC 61828:2021




IEC 61828

®


Edition 2.0 2020-12




INTERNATIONAL



STANDARD




NORME


INTERNATIONALE
colour

inside










Ultrasonics – Transducers – Definitions and measurement methods

regarding focusing for the transmitted fields



Ultrasons – Transducteurs – Définitions et méthodes de mesure

pour la focalisation des champs transmis
















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 17.140.50 ISBN 978-2-8322-9019-4




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
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SIST EN IEC 61828:2021
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CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 Symbols . 41
5 Independent measurement of total acoustic output power . 44
6 Acoustic field measurement: equipment . 44
6.1 Hydrophone . 44
6.1.1 General . 44
6.1.2 Sensitivity of a hydrophone . 44
6.1.3 Directional response of a hydrophone . 45
6.1.4 Effective hydrophone radius . 45
6.1.5 Choice of the size of a hydrophone active element . 45
6.1.6 Hydrophone pressure limits . 46
6.1.7 Hydrophone intensity limits . 46
6.1.8 Hydrophone cable length and amplifiers . 47
6.2 Requirements for positioning and water baths . 47
6.2.1 General . 47
6.2.2 Positioning systems . 47
6.2.3 Water bath . 48
6.3 Requirements for data acquisition and analysis systems . 49
6.4 Requirements and recommendations for ultrasonic equipment being
characterized . 50
7 Measurement procedure . 50
7.1 General . 50
7.2 Preparation and alignment . 50
7.2.1 General drive and field conditions . 50
7.2.2 Initial adjustment to driving voltage . 51
7.2.3 Preparation of source transducer . 52
7.2.4 Aligning an ultrasonic transducer and hydrophone . 52
7.2.5 Finding the beam axis . 53
7.2.6 Measurements to determine field level conditions . 55
7.2.7 Determining if transducer is focusing . 56
7.2.8 Measuring other beamwidth parameters of a focusing transducer . 57
7.2.9 Measuring the beam area parameters . 58
7.2.10 Measuring additional beam maximum based parameters . 59
7.2.11 Alternative: calculation of focal parameters using numerical projection . 60
7.2.12 Plane wave transmitted fields . 61
7.2.13 Steered plane waves . 61
7.2.14 Measurements of high intensity therapeutic ultrasound fields . 61
7.2.15 Calculation of I . 62
sa
7.2.16 Further evaluation for sidelobes and pre-focal maxima . 63
7.3 Considerations for scanning transducers and transducers with multiple
sources . 65
7.3.1 Automatic scanning transducers . 65

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7.4 Spatial impulse response and beamplots . 65
7.4.1 General . 65
7.4.2 Point target . 66
7.4.3 Beamplots and beam contour plots . 66
7.5 Plane wave compounding . 66
Annex A (informative) Background for the transmission/ Characteristics of focusing
transducers . 67
A.1 General . 67
A.2 Field of piston source . 68
A.3 Focusing with a lens . 68
A.4 Focusing with a concave transducer . 71
A.5 Geometric focusing gains . 73
A.6 Beamwidth estimation . 74
Annex B (informative) Rationale for focusing and nonfocusing definitions . 79
B.1 Overview. 79
B.1.1 Background information . 79
B.1.2 General . 79
B.1.3 Focusing transducers . 79
B.1.4 Focusing methods . 80
B.1.5 Known and unknown focusing transducers . 81
B.1.6 Focusing and beamwidth . 81
B.1.7 Focusing parameter definitions . 82
B.1.8 Applications of focusing definitions . 82
B.1.9 Relation of present definitions to physiotherapy transducers (treatment
heads) . 82
B.1.10 Relation of present definitions to therapeutic transducers . 82
B.2 System and measurement requirements . 83
B.2.1 General . 83
B.2.2 Transmitted pressure waveforms . 83
B.2.3 Transmitted fields . 83
B.2.4 The scan plane and the steering of beams . 83
B.2.5 Pulse echo field measurements . 84
Annex C (informative) Methods for determining the beam axis for well-behaved beams . 94
C.1 Comparisons of beam axis search methods . 94
C.2 Beamwidth midpoint method . 95
Annex D (informative) Methods for determining the beam axis for beams that are not
well behaved . 97
Annex E (informative) Uncertainties . 99
E.1 General . 99
E.2 Overall (expanded) uncertainty . 99
E.3 Common sources of uncertainty . 99
Annex F (informative) Transducer and hydrophone positioning systems . 101
Annex G (informative) Planar scanning of a hydrophone to determine acoustic output
power . 102
G.1 Overview. 102
G.2 General principle . 102
G.3 Hydrophone scanning methodology. 103
G.3.1 General methodology . 103
G.3.2 Particular considerations for implementation for HITU fields . 104

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G.4 Corrections and sources of measurement uncertainty . 104
G.4.1 Uncertainty in the hydrophone calibration . 104
G.4.2 Planar scanning . 104
G.4.3 Attenuation factor of water: unfocusing transducers . 104
G.4.4 Attenuation factor of water: focusing transducers . 105
G.4.5 Received hydrophone signal . 105
G.4.6 Integration . 105
G.4.7 Finite size of the hydrophone . 106
G.4.8 Partial extent of integration . 106
G.4.9 Non-linear propagation . 106
G.4.10 Directional response . 106
G.4.11 Noise . 107
G.4.12 Intensity approximated by derived intensity . 107
Annex H (informative) Properties of water . 108
H.1 General . 108
H.2 Attenuation coefficient for propagation in water . 109
Bibliography . 110

Figure A.1 – Beam contour plot: contours at −6 dB, −12 dB, and −20 dB for a 5 MHz
transducer with a radius of curvature of D = 50 mm centred at location 0,0 (bottom
centre of graph) . 76
Figure A.2 – Types of geometric focusing . 76
Figure A.3 – Transducer options . 77
Figure A.4 – Parameters for describing a focusing transducer of known geometry . 78
Figure A.5 – Path difference parameters for describing a focusing transducer of known
geometry . 78
Figure B.1 – Electronic focusing along z by transmit beamforming in the scan plane xz . 84
Figure B.2 – Field parameters for a nonfocusing transducer of known geometry. For
example, for a circularly symmetric geometry, transducers have a diameter 2a and a

beam axis along z . 85
Figure B.3 – Phased array geometry and construction for electronic focusing in the
azimuth plane and mechanical lens focusing in the elevation plane . 85
Figure B.4 – Field parameters for a focusing transducer of known geometry . 86
Figure B.5 – Definitions for pressure-based field measurements for an unknown
transducer geometry . 86
Figure B.6 – Beamwidth focus for transducers of known and unknown geometry . 87
Figure B.7 – Beam maximum parameters . 88
Figure B.8 – Pressure focus for a transducer of known geometry (design case) . 88
Figure B.9 – Pressure focus for a transducer of unknown geometry (measurement

case) . 89
Figure B.10 – Beam area parameters . 89
Figure B.11 – Beam axis parameters: pulse-pressure-squared-integral level relative to
the beam maximum in decibels (dB) plotted against axial distance . 90
Figure B.12 – Beamplot parameters . 91
Figure B.13 – Schematic diagram of the different planes and lines in an ultrasonic field
for a rectangular transducer . 92
Figure B.14 – Schematic diagram of the different planes and lines in an ultrasonic field

for a circular transducer . 93

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SIST EN IEC 61828:2021
IEC 61828:2020 © IEC 2020 – 5 –
Figure C.1 – x-axis scan at 9 cm depth for the first focal zone with beam centre . 95
Figure C.2 – x-axis scan at 4,4 cm depth for the second focal zone . 95
Figure D.1 – Asymmetric beam showing relative acoustic pressure versus sample
number for the beamwidth midpoint method . 98
Figure F.1 – Schematic diagram of the ultrasonic transducer and hydrophone degrees
of freedom . 101

Table C.1 – Standard deviations for x and y scans using three methods of determining
the centre of the beam . 94
Table C.2 – Decibel beamwidth levels for determining midpoints . 96
Table H.1 – Speed of sound, c, and characteristic acoustic impedance, ρ c, as a
function of temperature, for propagation in water . 108

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– 6 – IEC 61828:2020 © IEC 2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ULTRASONICS –TRANSDUCERS – DEFINITIONS AND MEASUREMENT
METHODS REGARDING FOCUSING FOR THE TRANSMITTED FIELDS

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,
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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
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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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61828 has been prepared by IEC technical committee 87:
Ultrasonics.
This second edition cancels and replaces the first edition published in 2001. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) Clause 6 on Measurement procedures has been replaced by Clause 6: "Acoustic field
measurement: equipment" and Clause 7: "Measurement procedure" and related definitions.
b) Reorganization of definitions and measurement section to accommodate specific sets of
measurements for focusing, nonlinearity, beam axis alignment, beam area, beam maximum,
numerical projection, plane wave, high intensity therapeutic ultrasound, multiple sources,
spatial impulse response and compound plane waves. Clause 3 has been moved to
Annex B.
c) The normative references have been updated and the Bibliography has been expanded from
8 to 40 references.

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SIST EN IEC 61828:2021
IEC 61828:2020 © IEC 2020 – 7 –
d) Twelve figures have been updated and seven new figures (B.1, B.3, B.7, B.10, B.11, B.12,
B.13, B.14) have been added to facilitate measurements and be consistent with
measurement terminology.
e) New measurements have been added for time delays, arrays, plane waves and spatial
impulse response.
f) Annex A has been expanded to provide general guidance on pulsed waves, system
responses, focusi
...

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