EN IEC 62127-1:2022

Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields

IEC 62127-1:2022 is available as IEC 62127-1:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 62127-1:2022 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment including bandwidth criteria and calibration frequency range requirements in dependence on the spectral content of the fields to be characterized. This document: - defines a group of acoustic parameters that can be measured on a physically sound basis; - defines a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters; - defines a measurement procedure that can be used for the determination of acoustic pressure parameters; - defines the conditions under which the measurements of acoustic parameters can be made using calibrated hydrophones; - defines procedures for correcting for limitations caused by the use of hydrophones with finite bandwidth and finite active element size, and for estimating the corresponding uncertainties. IEC 62127-1:2022 cancels and replaces the first edition published in 2007 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition. a) The upper frequency limit of 40 MHz has been removed. b) Hydrophone sensitivity definitions have been changed to recognize sensitivities as complex-valued quantities. c) Procedures and requirements for narrow-band approximation and broadband measurements have been modified; details on waveform deconvolution have been added. d) Procedures for spatial averaging correction have been amended. e) Annex D, Annex E and bibliography have been updated to support the changes of the normative parts.

Ultraschall - Hydrophone - Teil 1: Messung und Charakterisierung von medizinischen Ultraschallfeldern

Ultrasons - Hydrophones - Partie 1: Mesurage et caractérisation des champs ultrasoniques médicaux

IEC 62127-1:2022 est disponible sous forme de IEC 62127-1:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L’IEC 62127-1:2022 spécifie les méthodes d'utilisation des hydrophones étalonnés qui permettent de mesurer, dans des liquides, les champs acoustiques générés par des appareils médicaux à ultrasons, y compris les critères de largeur de bande et les exigences de plage de fréquences d’étalonnage en fonction du contenu spectral des champs à caractériser. Le présent document: - définit un groupe de paramètres acoustiques qui peuvent être mesurés sur une base physiquement sonore; - définit un second groupe de paramètres qui peuvent être déduits, dans le cadre de certaines hypothèses, de ces mesurages et appelés paramètres d'intensité dérivés; - définit un mode opératoire de mesure qui peut être utilisé pour déterminer les paramètres de pression acoustique; - définit les conditions dans lesquelles les mesurages des paramètres acoustiques peuvent être réalisés à l'aide d'hydrophones étalonnés; - définit les modes opératoires de correction, dans le cas de limitations provoquées par l'utilisation d'hydrophones à largeur de bande finie et de taille d'élément actif finie, ainsi que les modes opératoires d’estimation des incertitudes correspondantes. L’IEC 62127-1:2022 annule et remplace la première édition parue en 2007 ainsi que l’Amendement 1:2013. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente. a) La limite supérieure de fréquence de 40 MHz a été supprimée. b) Les définitions de la sensibilité des hydrophones ont été modifiées pour considérer les sensibilités comme des grandeurs à valeurs complexes. c) Les modes opératoires et les exigences concernant l’approximation à bande étroite et les mesurages à large bande ont été modifiés; des informations détaillées sur la déconvolution des formes d’onde ont été ajoutés. d) Les modes opératoires de correction de la moyenne spatiale ont été modifiés. e) L’Annexe D, l’Annexe E et la Bibliographie ont été mises à jour pour tenir compte des modifications apportées aux parties normatives.

Ultrazvok - Hidrofoni - 1. del: Meritve in karakterizacija medicinskih ultrazvočnih polj (IEC 62127-1:2022)

Ta del standarda IEC 62127 določa metode uporabe umerjenih hidrofonov za merjenje akustičnih polj, ki jih ustvarja medicinska ultrazvočna oprema v tekočinah, vključno z merili za pasovno širino in zahtevami za frekvenčni razpon umerjanja v odvisnosti od spektralne vsebine polj, ki jih je treba opredeliti. Ta dokument: – določa skupino akustičnih parametrov, ki jih je mogoče meriti na fizikalno utemeljeni podlagi; – opredeljuje drugo skupino parametrov, ki jih je mogoče pod določenimi predpostavkami izpeljati iz teh meritev in se imenujejo izpeljani parametri jakosti; – določa postopek merjenja, ki se lahko uporablja za določanje parametrov zvočnega tlaka; – določa pogoje, pod katerimi se lahko z umerjenimi hidrofoni izvajajo meritve akustičnih parametrov; – opredeljuje postopke oblikovanja popravkov zaradi omejitev, ki jih povzroča uporaba hidrofonov s končno pasovno širino in končno velikostjo aktivnega elementa, ter postopke za ocenjevanje ustreznih negotovosti. OPOMBA 1: V celotnem dokumentu se uporabljajo enote SI. V specifikaciji določenih parametrov, kot so območja in jakosti zvočnih snopov, je morda bolje uporabiti desetiške večkratnike oziroma manjkratnike. Območje snopa se na primer običajno določi v cm2, jakosti pa v W/cm2 ali mW/cm2. OPOMBA 2: Hidrofon, kakor je opredeljen, je lahko piezoelektričnega ali optičnega tipa.

General Information

• Status: Published
• Publication Date: 05-May-2022
• 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: 06-May-2022
• Completion Date: 06-May-2022
• Ref Project: SIST EN IEC 62127-1:2022 - Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields (IEC 62127-1:2022)

Relations

• Replaces: EN 62127-1:2007 - Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
• Effective Date: 23-Jan-2023
• Replaces: EN 62127-1:2007/A1:2013 - Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
• Effective Date: 10-May-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN 62127-1:2008
SIST EN 62127-1:2008/A1:2014
Ultrazvok - Hidrofoni - 1. del: Meritve in karakterizacija medicinskih ultrazvočnih
polj (IEC 62127-1:2022)
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical
ultrasonic fields (IEC 62127-1:2022)
Ultraschall - Hydrophone - Teil 1: Messung und Charakterisierung von medizinischen
Ultraschallfeldern (IEC 62127-1:2022)
Ultrasons - Hydrophones - Partie 1: Mesurage et caractérisation des champs
ultrasoniques médicaux jusqu'à (IEC 62127-1:2022)
Ta slovenski standard je istoveten z: EN IEC 62127-1:2022
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 62127-1

NORME EUROPÉENNE
EUROPÄISCHE NORM May 2022
ICS 17.140.50 Supersedes EN 62127-1:2007 + A1:2013
English Version
Ultrasonics - Hydrophones - Part 1: Measurement and
characterization of medical ultrasonic fields
(IEC 62127-1:2022)
Ultrasons - Hydrophones - Partie 1: Mesurage et Ultraschall - Hydrophone - Teil 1: Messung und
caractérisation des champs ultrasoniques médicaux Charakterisierung von medizinischen Ultraschallfeldern bis
(IEC 62127-1:2022) zu 40 MHz
(IEC 62127-1:2022)
This European Standard was approved by CENELEC on 2022-04-29. 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
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 62127-1:2022 E

European foreword
The text of document 87/783/FDIS, future edition 2 of IEC 62127-1, 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) 2023-01-29
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-04-29
document have to be withdrawn
This document supersedes EN 62127-1:2007 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.
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 62127-1:2022 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 60500 NOTE Harmonized as EN 60500
IEC 60601-2-5 NOTE Harmonized as EN 60601-2-5
IEC 60601-2-37 NOTE Harmonized as EN 60601-2-37
IEC 60601-2-62 NOTE Harmonized as EN 60601-2-62
IEC 61157 NOTE Harmonized as EN 61157
IEC 61161 NOTE Harmonized as EN 61161
IEC 61828 NOTE Harmonized as EN IEC 61828
IEC 61846 NOTE Harmonized as EN 61846
IEC 61847 NOTE Harmonized as EN 61847
IEC/TS 61949 NOTE Harmonized as CLC/TS 61949
IEC 62359 NOTE Harmonized as EN 62359
IEC 63045 NOTE Harmonized as EN IEC 63045
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 60565-1 - Underwater acoustics - Hydrophones - EN IEC 60565-1 -
Calibration of hydrophones - Part 1:
Procedures for free-field calibration of
hydrophones
IEC 61689 - Ultrasonics - Physiotherapy systems - Field EN IEC 61689 -
specifications and methods of
measurement in the frequency range 0,5
MHz to 5 MHz
IEC 62127-2 - Ultrasonics - Hydrophones - Part 2: EN 62127-2 -
Calibration for ultrasonic fields up to 40
MHz
IEC 62127-3 - Ultrasonics - Hydrophones - Part 3: EN 62127-3 -
Properties of hydrophones for ultrasonic
fields up to 40 MHz
IEC 63009 - Ultrasonics - Physiotherapy systems - Field EN IEC 63009 -
specifications and methods of
measurement in the frequency range 20
kHz to 500 kHz
ISO 16269-6 - Statistical interpretation of data – Part 6: - -
Determination of statistical tolerance
intervals
ISO/IEC Guide 98-3 2008 Uncertainty of measurement - Part 3: - -
Guide to the expression of uncertainty in
measurement (GUM:1995)
IEC 62127-1 ®
Edition 2.0 2022-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Hydrophones –
Part 1: Measurement and characterization of medical ultrasonic fields

Ultrasons – Hydrophones –
Partie 1: Mesurage et caractérisation des champs ultrasoniques médicaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50 ISBN 978-2-8322-1080-1

– 2 – IEC 62127-1:2022 © IEC 2022
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 Symbols . 32
5 Measurement requirements . 34
5.1 Requirements for hydrophones and amplifiers. 34
5.1.1 Preface . 34
5.1.2 General . 34
5.1.3 Sensitivity of a hydrophone . 35
5.1.4 Directional response of a hydrophone . 35
5.1.5 Effective hydrophone size . 35
5.1.6 Choice of the size of a hydrophone active element . 35
5.1.7 Bandwidth. 37
5.1.8 Linearity . 40
5.1.9 Hydrophone signal amplifier . 40
5.1.10 Hydrophone cable length and amplifiers . 40
5.2 Requirements for positioning and water baths . 41
5.2.1 General . 41
5.2.2 Positioning systems . 41
5.2.3 Water bath . 42
5.3 Requirements for data acquisition and analysis systems . 43
5.4 Recommendations for ultrasonic equipment being characterized. 43
6 Measurement procedure . 43
6.1 General . 43
6.2 Preparation and alignment . 44
6.2.1 Preparation . 44
6.2.2 Aligning an ultrasonic transducer and a hydrophone . 44
6.3 Measurement . 44
6.4 Analysis . 44
6.4.1 Corrections for restricted bandwidth and spatial resolution . 44
6.4.2 Uncertainties . 44
7 Beam characterization . 45
7.1 General . 45
7.2 Primary pressure parameters . 46
7.2.1 General . 46
7.2.2 Peak-compressional acoustic pressure and peak-rarefactional acoustic
pressure . 47
7.2.3 Spatial-peak RMS acoustic pressure . 47
7.2.4 Local distortion parameter . 48
7.3 Intensity parameters derived from acoustic pressure . 48
7.3.1 General . 48
7.3.2 Intensity parameters using pulse-pressure-squared integral . 49
8 Requirements for specific ultrasonic fields . 52

IEC 62127-1:2022 © IEC 2022 – 3 –
8.1 General . 52
8.2 Diagnostic fields . 52
8.2.1 Simplified procedures and guidelines . 52
8.2.2 Pulsed wave diagnostic equipment . 52
8.2.3 Continuous wave diagnostic equipment . 53
8.2.4 Diagnostic equipment with low acoustic output . 54
8.3 Therapy fields . 54
8.3.1 Physiotherapy equipment. 54
8.3.2 High intensity therapeutic ultrasonic fields . 55
8.3.3 Non-focused and weakly focused pressure pulses . 55
8.4 Surgical fields . 55
8.4.1 Lithotripters and pressure pulse sources for other therapeutic purposes . 55
8.4.2 Low frequency surgical applications . 56
8.5 Fields from other medical applications .
...