EN 62127-1:2007

Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz

This part of IEC 62127 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment operating in the frequency range up to 40 MHz. The objectives of this standard are: - to define a group of acoustic parameters that can be measured on a physically sound basis; - to define a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters; - to define a measurement procedure that may be used for the determination of acoustic pressure parameters; - to define the conditions under which the measurements of acoustic parameters can be made in the frequency range up to 40 MHz using calibrated hydrophones; - to define procedures for correcting, for limitations caused by the use of hydrophones with finite bandwidth and finite active element size. IEC 62127-1, IEC 62127-2 and IEC 62127-3 are being published simultaneously. Together these cancel and replace IEC 60866:1987, IEC 61101:1991, IEC 61102:1991, IEC 61220:1993 and IEC 62092:2001. The contents of the corrigendum of August 2008 have been included in this copy.

Ultraschall - Hydrophone - Teil 1: Messung und Charakterisierung von medizinischen Ultraschallfeldern bis zu 40 MHz

Ultrasons - Hydrophones - Partie 1: Mesurage et caractérisation des champs ultrasoniques médicaux jusqu'à 40 MHz

La CEI 62127-1:2007 spécifie les méthodes d'utilisation des hydrophones étalonnés permettant de mesurer, dans des liquides, les champs acoustiques générés par des appareils médicaux à ultrasons fonctionnant dans la gamme de fréquences jusqu'à 40 MHz. La présente norme a pour objectifs de: - définir un groupe de paramètres acoustiques pouvant être mesurés sur une base physiquement sonore; - définir un second groupe de paramètres pouvant être déduits, dans le cadre de certaines hypothèses, de ces mesures et appelés paramètres d'intensité dérivés; - définir un mode opératoire de mesure permettant de déterminer les paramètres de pression acoustique; - définir les conditions dans lesquelles les mesures des paramètres acoustiques peuvent être réalisées dans la gamme de fréquences jusqu'à 40 MHz à l'aide d'hydrophones étalonnés; - et définir 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. La CEI 62127-1, la CEI 62127-2 et la CEI 62127-3 ont été publiées conjointement. Ensemble, elles annulent et remplacent la CEI 60866:1987, la CEI 61101:1991, la CEI 61102:1991, la CEI 61220:1993 et la CEI 62092:2001. Le contenu du corrigendum (août 2008, disponible en anglais seulement) a été inclus dans cette norme. La version française n'a pas été soumise au vote.

Ultrazvok - Hidrofoni - 1. del: Meritve in karakterizacija medicinskih ultrazvočnih polj do 40 MHz (IEC 62127-1:2007)

General Information

• Status: Published
• Publication Date: 04-Oct-2007
• Withdrawal Date: 31-Aug-2010
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/SR 87 - CLC/SR 87
• Drafting Committee: IEC/TC 87 - IEC_TC_87
• Parallel Committee: IEC/TC 87 - IEC_TC_87
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 05-Oct-2007
• Completion Date: 05-Oct-2007
• Ref Project: SIST EN 62127-1:2008 - Ultrasonics - Hydrophones -- Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz

Relations

• Replaces: EN 61102:1993/A1:1994 - Measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0,5 MHz to 15 MHz
• Effective Date: 28-Jan-2023
• Replaces: EN 61101:1993 - The absolute calibration of hydrophones using the planar scanning technique in the frequency range 0,5 MHz to 15 MHz
• Effective Date: 28-Jan-2023
• Replaces: EN 61102:1993 - Measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0,5 MHz to 15 MHz
• Effective Date: 28-Jan-2023
• Replaces: EN 62092:2001 - Ultrasonics - Hydrophones - Characteristics and calibration in the frequency range from 15 MHz to 40 MHz
• Effective Date: 28-Jan-2023
• Replaces: EN 61220:1995 - Ultrasonics - Fields - Guidance for the measurement and characterization of ultrasonic fields generated by medical ultrasonic equipment using hydrophones in the frequency range 0,5 MHz to 15 MHz
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 62127-1:2022 - Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
• Effective Date: 23-Jan-2023
• Amended By: EN 62127-1:2007/A1:2013 - Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2008
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SIST EN 61101:2002
SIST EN 61220:2002
SIST EN 62092:2002
8OWUD]YRN+LGURIRQLGHO0HULWYHLQNDUDNWHUL]DFLMDPHGLFLQVNLKXOWUD]YRþQLK
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Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical
ultrasonic fields up to 40 MHz (IEC 62127-1:2007)
Ultraschall - Hydrophone - Teil 1: Messung und Charakterisierung von medizinischen
Ultraschallfeldern bis zu 40 MHz (IEC 62127-1:2007)
Ultrasons - Hydrophones - Partie 1: Mesures et caractérisation des champs ultrasonores
médicaux jusqu'a 40 Mhz (IEC 62127-1:2007)
Ta slovenski standard je istoveten z: EN 62127-1:2007
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 62127-1
NORME EUROPÉENNE
October 2007
EUROPÄISCHE NORM
ICS 17.140.50 Partially supersedes EN 61101:1993, EN 61102:1993 + A1:1994, EN 61220:1995 and EN 62092:2001

English version
Ultrasonics -
Hydrophones -
Part 1: Measurement and characterization
of medical ultrasonic fields up to 40 MHz
(IEC 62127-1:2007)
Ultrasons -  Ultraschall -
Hydrophones - Hydrophone -
Partie 1: Mesures et caractérisation Teil 1: Messung und Charakterisierung
des champs ultrasonores médicaux von medizinischen Ultraschallfeldern
jusqu'à 40 Mhz bis zu 40 MHz
(CEI 62127-1:2007) (IEC 62127-1:2007)

This European Standard was approved by CENELEC on 2007-09-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62127-1:2007 E
Foreword
The text of document 87/352/CDV, future edition 1 of IEC 62127-1, prepared by IEC TC 87, Ultrasonics,
was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by
CENELEC as EN 62127-1 on 2007-09-01.
EN 62127-1, EN 62127-2 and EN 62127-3 are being published simultaneously. Together these European
Standards cancel and replace EN 61101:1993, EN 61102:1993 + A1:1994, EN 61220:1995 and
EN 62092:2001.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-06-01
– latest date by which the national standards conflicting
(dow) 2010-09-01
with the EN have to be withdrawn
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62127-1:2007 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 60601-2-37 NOTE  Harmonized as EN 60601-2-37:2001 (not modified).
IEC 61157 NOTE  Harmonized as EN 61157:1994 (not modified).
IEC 61161 NOTE  Harmonized as EN 61161:2007 (not modified).
IEC 62359 NOTE  Harmonized as EN 62359:2005 (not modified).
__________
- 3 - EN 62127-1:2007
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60050-801 1994 International Electrotechnical Vocabulary - -
(IEV) -
Chapter 801: Acoustics and electroacoustics

1) 2)
IEC 60565 - Underwater acoustics - Hydrophones - EN 60565 2007
Calibration in the frequency range 0,01 Hz
to 1 MHz
IEC/TR 60854 1986 Methods of measuring the performance of - -
ultrasonic pulse-echo diagnostic equipment

1)
IEC 61689 - Ultrasonics - Physiotherapy systems - Field EN 61689 2007
specifications and methods of measurement
in the frequency range 0,5 MHz to 5 MHz

1) 2)
IEC 61828 - Ultrasonics - Focusing transducers - EN 61828 2001
Definitions and measurement methods
for the transmitted fields
1) 2)
IEC 61846 - Ultrasonics - Pressure pulse lithotripters - EN 61846 1998
Characteristics of fields
1) 2)
IEC 61847 - Ultrasonics - Surgical systems - EN 61847 1998
Measurement and declaration of the basic
output characteristics
1) 2)
IEC 62127-2 - Ultrasonics - Hydrophones - EN 62127-2 2007
Part 2: Calibration for ultrasonic fields
up to 40 MHz
1) 2)
IEC 62127-3 - Ultrasonics - Hydrophones - EN 62127-3 2007
Part 3: Properties of hydrophones for
ultrasonic fields up to 40 MHz

ISO 16269-6 2005 Statistical interpretation of data - - -
Part 6: Determination of statistical tolerance
intervals
ISO/IEC Guide 98 1995 Guide to the expression of uncertainty in - -
measurement
1)
Undated reference.
2)
Valid edition at date of issue.

IEC 62127-1
Edition 1.0 2007-08
INTERNATIONAL
STANDARD
Ultrasonics – Hydrophones –
Part 1: Measurement and characterization of medical ultrasonic fields up to
40 MHz
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XC
ICS 17.140.50 ISBN 2-8318-9276-7

– 2 – 62127-1 © IEC:2007(E)
CONTENTS
FOREWORD.5
INTRODUCTION.7

1 Scope and object.8
2 Normative references .8
3 Terms, definitions and symbols .9
4 List of symbols .24
5 Measurement requirements .26
5.1 Requirements for hydrophones and amplifiers .26
5.1.1 Introduction .26
5.1.2 General .26
5.1.3 Sensitivity of a hydrophone.26
5.1.4 Directional response of a hydrophone.26
5.1.5 Effective hydrophone radius .27
5.1.6 Choice of the size of a hydrophone active element .27
5.1.7 Bandwidth .28
5.1.8 Linearity .28
5.1.9 Hydrophone signal amplifier .29
5.1.10 Hydrophone cable length and amplifiers .29
5.2 Requirements for positioning and water baths .29
5.2.1 General .29
5.2.2 Positioning systems.30
5.2.3 Water bath.31
5.3 Requirements for data acquisition and analysis systems .32
5.4 Recommendations for ultrasonic equipment being characterized .32
6 Measurement procedure.32
6.1 General .32
6.2 Preparation and alignment.33
6.2.1 Preparation.33
6.2.2 Aligning an ultrasonic transducer and a hydrophone.33
6.3 Measurement .33
6.4 Analysis .33
6.4.1 Corrections for restricted bandwidth and spatial resolution .33
6.4.2 Uncertainties .33
7 Beam characterization.34
7.1 General .34
7.2 Primary pressure parameters .35
7.2.1 General .35
7.2.2 Peak-compressional acoustic pressure and peak-rarefactional
acoustic pressure .36
7.2.3 Spatial-peak rms acoustic pressure .36
7.2.4 Non-linear propagation parameter .36
7.2.5 Intensity parameters using instantaneous acoustic pressure.37
7.2.6 Intensity parameters using pulse-pressure-squared integral .37
7.2.7 Derived ultrasonic power .39
8 Requirements for specific ultrasonic fields.40

62127-1 © IEC:2007(E) – 3 –
8.1 General .40
8.2 Diagnostic fields.40
8.2.1 Simplified procedures and guidelines.40
8.2.2 Pulsed wave diagnostic equipment .41
8.2.3 Continuous wave diagnostic equipment .41
8.3 Therapy fields .42
8.3.1 Physiotherapy equipment .42
8.3.2 Hyperthermia.42
8.4 Surgical fields .42
8.4.1 Lithotripters and pressure pulse sources for other therapeutic
purposes .42
8.4.2 Low frequency surgical applications .43
8.5 Fields from other medical applications.43
9 Compliance statement .43
9.1 General .43
9.2 Maximum probable values .43
9.3 Sampling .44

Annex A (informative) General rationale .45
Annex B (informative) Hydrophones and positioning .47
Annex C (informative) Acoustic pressure and intensity.53
Annex D (informative) Voltage to pressure conversion .55
Annex E (informative) Correction for spatial averaging.60
Annex F (informative) Acoustic output parameters for multi-mode medical ultrasonic
fields in the absence of scan-frame synchronization .
...