IEC 61157:2007
(Main)Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
IEC 61157:2007 specifies a standard means and format for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting purposes represent the average values for the maximum output conditions for a given discrete- or combined-operating mode and are derived from measurements made in water. Intensity parameters are specified in this standard, but these are regarded as derived quantities that are meaningful only under certain assumptions related to the ultrasonic field being measured. This International Standard is applicable to medical diagnostic ultrasonic equipment. It provides a set of traceable acoustic parameters describing the acoustic fields. It defines a standard means and format for the reporting of the acoustic output information. It also describes a reduced dataset recommended for equipment generating low acoustic output levels. This second edition cancels and replaces the first edition published in 1992. This edition constitutes a minor revision. The changes with respect to the previous edition are listed hereafter:
- maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1;
- and a clause on compliance has been added. The contents of the corrigendum of August 2008 have been included in this copy. The French version of this standard has not been voted upon.
Critères normalisés de déclaration des émissions acoustiques des appareils de diagnostic médical à ultrasons
La CEI 61157:2007 spécifie les critères et un format normalisés de déclaration des émissions acoustiques des appareils de diagnostic médical à ultrasons. Les valeurs numériques de déclaration représentent les valeurs moyennes des conditions d'émission maximale pour un mode opératoire discret ou combiné donné et proviennent de mesures réalisées dans l'eau. Les paramètres d'intensité sont spécifiés dans la présente norme. Cependant, ils sont considérés comme des grandeurs dérivées qui sont significatives uniquement dans le cadre de certaines hypothèses liées au champ ultrasonique mesuré. La présente Norme internationale s'applique aux appareils de diagnostic médical à ultrasons. Elle offre un jeu de paramètres acoustiques traçables décrivant les champs acoustiques. Elle définit des critères et un format normalisés de déclaration des informations relatives aux émissions acoustiques. Elle décrit également un jeu de données d'exemption pour les appareils générant de bas niveaux d'émissions acoustiques. Cette deuxième édition annule et remplace la première édition parue en 1992. La présente édition constitue une révision mineure. Les principaux changements effectués par rapport à l'édition précédente sont les suivants:
- mise à jour de la présente norme et des références aux normes CEI 61161 et CEI 62127-1;
- et un article relatif à la conformité a été ajouté. 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.
General Information
Relations
Buy Standard
Standards Content (Sample)
IEC 61157
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: csc@iec.ch
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
IEC 61157
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
V
ICS 11.040.50; 11.140.50 ISBN 2-8318-9257-0
– 2 – 61157 © IEC:2007(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5
1 Scope.6
2 Normative references .6
3 Terms, definitions and symbols .6
4 Requirements .16
4.1 General .16
4.2 Requirements for the reporting of acoustic output information .17
4.2.1 Technical data sheets information format .17
4.2.2 Detailed operating mode data sheets information format .18
4.2.3 Background information.19
4.2.4 Diagnostic fields in the absence of scan-frame synchronization.20
4.2.5 Dataset for low acoustic output equipment.20
5 Compliance statement .21
5.1 General .21
5.2 Maximum probable values .21
5.3 Sampling .21
6 Test methods .22
7 Presentation of results.22
Annex A (normative) Presentation of acoustic output information.23
Annex B (informative) Reporting requirements for extensive systems .25
Annex C (informative) Rationale .26
Index of defined terms .30
Bibliography.32
Figure C.1 – Schematic diagram showing the relationship between the various defined
surfaces and distances for a mechanical sector scanner with water stand-off distance
when applied to a patient .27
Figure C.2 – Schematic diagram showing the relationship between the various defined
parameters and distances for a mechanical sector scanner during the measurement of
acoustic output .27
Figure C.3 – Schematic diagram showing various defined parameters associated with
the distribution of the scan lines in a linear array scanner and mechanically-scanned
sector scanner .28
Figure C.4 – Schematic diagram illustrating the peak-rarefactional acoustic pressure
during an acoustic pulse .29
Table 1 – List of symbols .15
Table A.1 – An example of reporting of the acoustic output of a 3,5 MHz scan-head for
a phased-array sector scanner in accordance with this standard.24
61157 © IEC:2007(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
STANDARD MEANS FOR THE REPORTING
OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC
ULTRASONIC EQUIPMENT
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, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their 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
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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 61157 has been prepared by IEC technical committee 87:
Ultrasonics.
This second edition cancels and replaces the first edition published in 1992. This edition
constitutes a minor revision.
The changes with respect to the previous edition are listed below:
• maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1.
• a clause on compliance has been added.
The text of this standard is based on the following documents:
Enquiry draft Report on voting
87/356/CDV 87/374/RVC
– 4 – 61157 © IEC:2007(E)
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
NOTE The following print types are used:
– Requirements: in roman type
– Test specifications: in italic type
– Notes: in small roman type
– Words in bold in the text are defined in Clause 3.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.
The contents of the corrigendum of August 2008 have been included in this copy.
61157 © IEC:2007(E) – 5 –
INTRODUCTION
This International Standard specifies a standard means and format for the reporting of the
acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting
purposes represent the average values for the maximum output conditions for a given
discrete- or combined-operating mode and are derived from measurements made in water.
Intensity parameters are specified in this standard, but these are regarded as derived
quantities that are meaningful only under certain assumptions related to the ultrasonic field
being measured.
– 6 – 61157 © IEC:2007(E)
STANDARD MEANS FOR THE REPORTING
OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC
ULTRASONIC EQUIPMENT
1 Scope
This International Standard is applicable to medical diagnostic ultrasonic equipment.
– It provides a set of traceable acoustic parameters describing the acoustic fields.
– It defines a standard means and format for the reporting of the acoustic output information.
– It also describes a reduced dataset recommended for equipment generating low acoustic
output levels.
NOTE The information tabulated in this standard format can be used for
a) exposure planning for biological effects studies;
b) exposure data for prospective epidemiological studies conducted using exposure conditions similar
to those reported in this standard. In the absence of actual exposure data for retrospective
epidemiological studies, the information tabulated in this standard format might also be used with
cautionary comment.
2 Normative references
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.
IEC 60050-801:1994 International Electrotechnical Vocabulary – Chapter 801: Acoustics and
electroacoustics
IEC 61161, Ultrasonics – Power measurement – Radiation force balances and performance
requirements
IEC 62127-1, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of
medical 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 (GUM)
3 Terms, definitions and symbols
For the purposes of this document, the terms and definitions given in IEC 62127-1, IEC 61161,
the Index of defined terms at the end of this standard and the following definitions apply.
Figures C.1 to C.4 illustrate some of the defined parameters given below.
3.1
acoustic output freeze
condition of a system for which the acoustic output is disabled
...
IEC 61157 ®
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
Critères normalisés de déclaration des émissions acoustiques des appareils
de diagnostic médical à ultrasons
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les
microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.
IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: csc@iec.ch.
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
Liens utiles:
Recherche de publications CEI - www.iec.ch/searchpub Electropedia - www.electropedia.org
La recherche avancée vous permet de trouver des Le premier dictionnaire en ligne au monde de termes
publications CEI en utilisant différents critères (numéro de électroniques et électriques. Il contient plus de 30 000
référence, texte, comité d’études,…). termes et définitions en anglais et en français, ainsi que
Elle donne aussi des informations sur les projets et les les termes équivalents dans les langues additionnelles.
publications remplacées ou retirées. Egalement appelé Vocabulaire Electrotechnique
International (VEI) en ligne.
Just Published CEI - webstore.iec.ch/justpublished
Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications de la CEI.
Just Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur
Disponible en ligne et aussi une fois par mois par email. cette publication ou si vous avez des questions
contactez-nous: csc@iec.ch.
IEC 61157 ®
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
Critères normalisés de déclaration des émissions acoustiques des appareils
de diagnostic médical à ultrasons
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX V
ICS 11.040.50; 17.140.50 ISBN 978-2-83220-132-9
– 2 – 61157 IEC:2007
CONTENTS
FOREWORD. 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions and symbols . 6
4 Requirements . 16
4.1 General . 16
4.2 Requirements for the reporting of acoustic output information . 17
4.2.1 Technical data sheets information format . 17
4.2.2 Detailed operating mode data sheets information format . 18
4.2.3 Background information . 19
4.2.4 Diagnostic fields in the absence of scan-frame synchronization . 20
4.2.5 Dataset for low acoustic output equipment . 20
5 Compliance statement . 21
5.1 General . 21
5.2 Maximum probable values . 21
5.3 Sampling . 21
6 Test methods . 22
7 Presentation of results . 22
Annex A (normative) Presentation of acoustic output information . 23
Annex B (informative) Reporting requirements for extensive systems . 25
Annex C (informative) Rationale . 26
Index of defined terms . 30
Bibliography . 32
Figure C.1 – Schematic diagram showing the relationship between the various defined
surfaces and distances for a mechanical sector scanner with water stand-off distance
when applied to a patient . 27
Figure C.2 – Schematic diagram showing the relationship between the various defined
parameters and distances for a mechanical sector scanner during the measurement of
acoustic output . 27
Figure C.3 – Schematic diagram showing various defined parameters associated with
the distribution of the scan lines in a linear array scanner and mechanically-scanned
sector scanner . 28
Figure C.4 – Schematic diagram illustrating the peak-rarefactional acoustic pressure
during an acoustic pulse . 29
Table 1 – List of symbols . 15
Table A.1 – An example of reporting of the acoustic output of a 3,5 MHz scan-head for
a phased-array sector scanner in accordance with this standard . 24
61157 IEC:2007 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
STANDARD MEANS FOR THE REPORTING
OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC
ULTRASONIC EQUIPMENT
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, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their 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
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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 61157 has been prepared by IEC technical committee 87:
Ultrasonics.
This second edition cancels and replaces the first edition published in 1992. This edition
constitutes a minor revision.
The changes with respect to the previous edition are listed below:
• maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1.
• a clause on compliance has been added.
This bilingual version (2012-06) corresponds to the monolingual English version, published in
2007-08.
– 4 – 61157 IEC:2007
The text of this standard is based on the following documents:
Enquiry draft Report on voting
87/356/CDV 87/374/RVC
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
The French version of this standard has not been voted upon.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
NOTE The following print types are used:
– Requirements: in roman type
– Test specifications: in italic type
– Notes: in small roman type
– Words in bold in the text are defined in Clause 3.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
...
IEC 61157 ®
Edition 2.1 2013-01
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
Critères normalisés de déclaration des émissions acoustiques des appareils de
diagnostic médical à ultrasons
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les
microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.
IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: csc@iec.ch.
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
Liens utiles:
Recherche de publications CEI - www.iec.ch/searchpub Electropedia - www.electropedia.org
La recherche avancée vous permet de trouver des Le premier dictionnaire en ligne au monde de termes
publications CEI en utilisant différents critères (numéro de électroniques et électriques. Il contient plus de 30 000
référence, texte, comité d’études,…). termes et définitions en anglais et en français, ainsi que
Elle donne aussi des informations sur les projets et les les termes équivalents dans les langues additionnelles.
publications remplacées ou retirées. Egalement appelé Vocabulaire Electrotechnique
International (VEI) en ligne.
Just Published CEI - webstore.iec.ch/justpublished
Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications de la CEI.
Just Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur
Disponible en ligne et aussi une fois par mois par email. cette publication ou si vous avez des questions
contactez-nous: csc@iec.ch.
IEC 61157 ®
Edition 2.1 2013-01
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
Critères normalisés de déclaration des émissions acoustiques des appareils de
diagnostic médical à ultrasons
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50, 17.140.50 ISBN 978-2-8322-0634-8
– 2 – 61157 IEC:2007+A1:2013
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions and symbols . 6
4 Requirements . 17
4.1 General . 17
4.2 Requirements for the reporting of acoustic output information . 19
4.2.1 Technical data sheets information format . 19
4.2.2 Detailed operating mode data sheets information format . 19
4.2.3 Background information . 21
4.2.4 Diagnostic fields in the absence of scan-frame synchronization . 22
4.2.5 Dataset for low acoustic output equipment . 22
5 Compliance statement . 22
5.1 General . 22
5.2 Maximum probable values . 23
5.3 Sampling . 23
6 Test methods . 23
7 Presentation of results . 23
Annex A (normative) Presentation of acoustic output information . 24
Annex B (informative) Reporting requirements for extensive systems . 26
Annex C (informative) Rationale . 27
Index of defined terms . 31
Bibliography . 33
Figure C.1 – Schematic diagram showing the relationship between the various defined
surfaces and distances for a mechanical sector scanner with water stand-off distance
when applied to a patient . 28
Figure C.2 – Schematic diagram showing the relationship between the various defined
parameters and distances for a mechanical sector scanner during the measurement of
acoustic output . 28
Figure C.3 – Schematic diagram showing various defined parameters associated with
the distribution of the scan lines in a linear array scanner and mechanically-scanned
sector scanner . 29
Figure C.4 – Schematic diagram illustrating the peak-rarefactional acoustic pressure
during an acoustic pulse . 30
Table 1 – List of symbols . 16
Table A.1 – An example of reporting of the acoustic output of a 3,5 MHz scan-head for
a phased-array sector scanner in accordance with this standard . 25
61157 IEC:2007+A1:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
STANDARD MEANS FOR THE REPORTING
OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC
ULTRASONIC EQUIPMENT
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, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their 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
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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.
This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 61157 edition 2.1 contains the second edition (2007) [documents 87/356/CDV and 87/374/
RVC], its amendment 1 (2013) [documents 87/517/FDIS and 87/523/RVD] and its corrigendum of
August 2008.
A vertical line in the margin shows where the base publication has been modified by
amendment 1. Additions and deletions are displayed in red, with deletions being struck
through.
– 4 – 61157 IEC:2007+A1:2013
International Standard IEC 61157 has been prepared by IEC technical committee 87:
Ultrasonics.
The changes with respect to the previous edition are listed below:
• maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1.
• a clause on compliance has been added.
This bilingual version (2012-06) corresponds to the monolingual English version, published in
2007-08.
The French version of this standard has not been voted upon.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
NOTE The following print types are used:
– Requirements: in roman type
– Test specifications: in italic type
– Notes: in small roman type
– Words in bold in the text are defined in Clause 3.
The committee has decided that t
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.