EN IEC 61828:2021

Ultrasonics - Transducers - Definitions and measurement methods regarding focusing for the transmitted fields

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following significant technical changes with respect to the previous edition: a) Clause 6 on Measurement procedures has been replaced by Clause 6: "Acoustic field measurement: equipment" and Clause 7: "Measurement procedure" and related definitions.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

Ultrasons - Transducteurs - Définitions et méthodes de mesure pour la focalisation des champs transmis

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: 04-Feb-2021
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/SR 87 - CLC/SR 87
• Drafting Committee: IEC/TC 87 - IEC_TC_87
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 05-Feb-2021
• Completion Date: 05-Feb-2021
• Ref Project: SIST EN IEC 61828:2021 - Ultrasonics - Transducers - Definitions and measurement methods regarding focusing for the transmitted fields (IEC 61828:2020)

Relations

• Replaces: EN 61828:2001 - Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
• Effective Date: 10-Oct-2017

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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
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)
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)
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

– 2 – IEC 61828:2020 © IEC 2020
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

IEC 61828:2020 © IEC 2020 – 3 –
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 .
...