SIST EN IEC 62127-1:2022

SLOVENSKI STANDARD
SIST EN IEC 62127-1:2022
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
SIST EN IEC 62127-1:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 62127-1:2022

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SIST EN IEC 62127-1:2022


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

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SIST EN IEC 62127-1:2022
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
EN IEC 62127-1:2022.
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
2

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SIST EN IEC 62127-1:2022
EN IEC 62127-1:2022 (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 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)


3

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SIST EN IEC 62127-1:2022



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




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
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN IEC 62127-1:2022
– 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

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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 . 56
9 Conformity statement. 56
9.1 General . 56
9.2 Maximum probable values . 56
9.3 Sampling. 57
Annex A (informative) General rationale. 58
Annex B (informative) Hydrophones and positioning . 60
B.1 General . 60
B.2 Electrical loading considerations . 60
B.3 Hydrophone signal amplifier . 60
B.4 Hydrophone cable length and amplifiers . 60
B.5 Transducer positioning . 61
B.6 Alignment of hydrophones . 62
B.7 Water bath lining material . 62
B.8 Recommendations for ultrasonic equipment being characterized. 62
B.9 Types of hydrophones . 63
B.9.1 Ceramic needle hydrophones . 63
B.9.2 PVDF needle hydrophones . 63
B.9.3 PVDF membrane hydrophones . 63
B.9.4 Fibre-optic and optic hydrophones . 64
B.9.5 Relative performance of different types . 65
B.10 Typical specification data for hydrophones . 65
Annex C (informative) Acoustic pressure and intensity . 66
Annex D (informative) Voltage to pressure conversion . 68
D.1 General . 68
D.2 Hydrophone deconvolution procedure . 69
D.3 Converting the data between double-sided and single-sided spectra . 70
D.4 Use of hydrophone calibration data . 72
D.4.1 Calibration data interpolation . 72
D.4.2 Calibration data extrapolation . 72
D.4.3 Regularization filtering . 73
D.5 Implication of the hydrophone deconvolution process on measurement
duration . 74
D.6 Validation of deconvolution implementation . 75
Annex E (informative) Correction for spatial averaging . 76

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E.1 Linear and quasilinear fields . 76
E.2 Linear fields, quasilinear fields, and broadband nonlinearly distorted
waveforms . 78
Annex F (informative) Acoustic output parameters for multi-mode medical ultrasonic
fields in the absence of scan-frame synchronization . 81
F.1 General . 81
F.2 Current philosophy . 81
F.3 Need for an alternative approach . 82
F.4 Proposed approach . 82
F.4.1 Alternative philosophy . 82
F.4.2 Alternative parameters . 83
F.5 Measurement methods . 84
F.5.1 General . 84
F.5.2 Peak pressures . 84
F.5.3 Temporal-average intensity . 84
F.5.4 Frequency . 85
F.5.5 Power . 85
F.6 Discussion . 85
F.6.1 Relationship to existing standards . 85
F.6.2 Advantages . 86
F.6.3 Disadvantages . 86
Annex G (informative) Propagation medium and degassing. 87
Annex H (informative) Specific ultrasonic fields . 88
H.1 Diagnostic fields . 88
H.1.1 Useful relationships between acoustical parameters . 88
H.1.2 Pulsed wave diagnostic equipment . 89
H.1.3 Continuous wave diagnostic equipment . 89
H.2 Therapy fields . 90
H.2.1 Physiotherapy equipment. 90
H.2.2 High intensity therapeutic ultrasonic equipment . 90
H.2.3 Non-focused and weakly focused pressure pulses . 90
H.3 Surgical fields . 90
H.3.1 Lithotripters . 90
H.3.2 Low frequency surgical applications . 90
Annex I (informative) Assessment of uncertainty in the acoustic quantities obtained by

hydrophone measurements . 91
I.1 General . 91
I.2 Overall (expanded) uncertainty . 91
I.3 Common sources of uncertainty . 91
Annex J (informative) Transducer and hydrophone positioning systems . 93
Annex K (informative) Beamwidth midpoint method . 94
Bibliography . 95


Figure 1 – Schematic diagram of the different planes and lines in an ultrasonic field . 12
Figure 2 – Several apertures and planes for a transducer of unknown geometry . 26
Figure 3 – Parameters for describing a focusing transducer of known geometry. 29
Figure 4 – Schematic diagram of the method of determining pulse duration . 46
Figure D.1 – A flow diagram of the hydrophone deconvolution process . 70

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IEC 62127-1:2022 © IEC 2022 – 5 –
Figure D.2 – Example of waveform deconvolution . 74
Figure J.1 – Schematic diagram of the ultrasonic transducer and hydrophone degrees
of freedom . 93

Table 1 – Acoustic parameters appropriate to various types of medical ultrasonic

equipment . 45
Table B.1 – Typical specification data for hydrophones, in this case given at
1 MHz [69] . 65
Table C.1 – Properties of distilled or de-ionized water as a function of temperature [71] . 67
Table D.1 – Method of conversion from a double- to a single-sided spectrum . 71
Table D.2 – Method of conversion from a single- to a double-sided spectrum . 71
Table F.1 – Main basic parameters defined in this document or in IEC 61161 . 82
Table F.2 – List of parameters that are to be used or are to be deleted . 83
Table K.1 – Decibel beamwidth levels for determining midpoints . 94

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– 6 – IEC 62127-1:2022 © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ULTRASONICS – HYDROPHONES –

Part 1: Measurement and characterization of medical ultrasonic fields

FOREWORD
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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.
IEC 62127-1 has been prepared by IEC technical committee 87: Ultrasonics. It is an
International Standard.
This second edition 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 comple
...