EN 62359:2005
(Main)Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
Is applicable to medical diagnostic ultrasound fields. This standard establishes - parameters related to thermal and non-thermal aspects of diagnostic ultrasonic fields; - methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound; - methods for the determination of an exposure parameter appropriate to certain non-thermal effects.
Ultraschall - Charakterisierung von Feldern - Prüfverfahren für die Ermittlung des thermischen und des mechanischen Indexes bezogen auf medizinisch-diagnostische Ultraschallfelder
Ultrasons - Caractérisation du champ - Essais pour la détermination des indices d'échauffement et mécaniques des champs d'ultrasons utilisés pour le diagnostic médical
Is applicable to medical diagnostic ultrasound fields. This standard establishes - parameters related to thermal and non-thermal aspects of diagnostic ultrasonic fields; - methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound; - methods for the determination of an exposure parameter appropriate to certain non-thermal effects.
Ultrazvok - Karakterizacija polj - Preskusne metode za ugotavljanje termičnih in mehanskih znakov glede medicinskih diagnostičnih ultrazvočnih polj (IEC 62359:2005)
General Information
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Standards Content (Sample)
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EUROPEAN STANDARD
EN 62359 NORME EUROPÉENNE EUROPÄISCHE NORM
October 2005 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
© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62359:2005 E
ICS 17.140.50
English version
Ultrasonics –
Field characterization –
Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2005)
Ultrasons –
Caractérisation du champ –
Essais pour la détermination des indices d'échauffement et mécaniques
des champs d'ultrasons utilisés
pour le diagnostic médical (CEI 62359:2005)
Ultraschall –
Charakterisierung von Feldern - Prüfverfahren für die Ermittlung des thermischen und des mechanischen Indexes bezogen auf medizinisch-diagnostische Ultraschallfelder (IEC 62359:2005)
This European Standard was approved by CENELEC on 2005-09-13. 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
at national level by publication of an identical
national standard or by endorsement
(dop)
2006-07-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2008-10-01 Annex ZA has been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 62359:2005 was approved by CENELEC as a European Standard without any modification. __________
- 3 - EN 62359:2005
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 Where an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60601-2-37 - 1) Medical electrical equipment Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
EN 60601-2-37 2001 2) IEC 61102 1991 Measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0,5 MHz to 15 MHz
EN 61102 1993 IEC 61157 1992 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
EN 61157 1994 IEC 61161 1992 Ultrasonic power measurement in liquids in the frequency range 0,5 MHz to
25 MHz EN 61161 1994 A1 1998
A1 1998
1) Undated reference. 2) Valid edition at date of issue.
INTERNATIONAL STANDARD IEC62359 First edition2005-04 Ultrasonics – Field characterization – Test methods for the determination of
thermal and mechanical indices related
to medical diagnostic ultrasonic fields
IEC 2005
Copyright - all rights reserved 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 the publisher. International Electrotechnical Commission,
3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, SwitzerlandTelephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch
Web: www.iec.ch X For price, see current cataloguePRICE CODE
Commission Electrotechnique InternationaleInternational Electrotechnical Commission
– 2 – 62359 IEC:2005(E) CONTENTS FOREWORD.3 INTRODUCTION.5
1 Scope.6 2 Normative references.6 3 Terms and definitions.6 4 List of symbols.15 5 Test methods for determining the mechanical index and the thermal index.16 5.1 General.16 5.2 Determination of mechanical index.17 5.3 Determination of thermal index – general.17 5.4 Determination of thermal index in non-scanning mode.17 5.5 Determination of thermal index in scanning mode.19 5.6 Calculations for combined-operating mode.19 5.7 Summary of measured quantities for index determination.20
Annex A (informative)
Relationships with other standards.22 Annex B (informative)
Guidance notes for measurement of output power
in scanning mode.23 Annex C (informative)
Rationale and derivation of index models.27 Annex D (informative)
Guidance on the interpretation of TI and MI.40
Bibliography.41
Figure B.1 – Suggested 1 cm-wide aperture mask.25 Figure B.2 – Suggested orientation of transducer, mask slit and RFB target.25 Figure B.3 – Suggested orientation of transducer and 1 cm RFB target.25 Figure C.1 – Focused transducer with a large aperture.35 Figure C.2 – Focused transducer with smaller aperture (≥1 cm2).35 Figure C.3 – Focused transducer with a weak focus (Aeq > 1 cm2).36 Figure C.4 – Weakly focused transducer.36
Table 1 – Summary of combination formulae for each of the THERMAL INDEX categories.20 Table 2 – Summary of the acoustic quantities required for the determination of the indices.21 Table C.1 – THERMAL INDEX categories and models.29 Table C.2 – Thermal index formulae.33
62359 IEC:2005(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
ULTRASONICS –
FIELD CHARACTERIZATION –
TEST METHODS FOR THE DETERMINATION OF THERMAL
AND MECHANICAL INDICES RELATED TO
MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
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 requirements 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 62359 has been prepared by IEC technical committee 87: Ultrasonics The text of this standard is based on the following documents: FDIS Report on voting 87/300/FDIS 87/305/RVD
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. This standard may be used to support the requirements of IEC 60601-2-37.
– 4 – 62359 IEC:2005(E) 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 standard may be issued at a later date.
62359 IEC:2005(E) – 5 –
INTRODUCTION Medical diagnostic ultrasonic equipment is widely used in clinical practice for imaging and monitoring purposes. Equipment normally operates at frequencies in the low megahertz frequency range and comprises an ultrasonic transducer acoustically coupled to the patient and associated electronics. There is an extremely wide range of different types of systems in current clinical practice.
The ultrasound entering the patient interacts with the patient's tissue and this interaction can be considered in terms of both thermal and non-thermal effects. The purpose of this International Standard is to specify methods of determining thermal and non-thermal exposure indices which can be used to help in assessing the hazard caused by exposure to a particular ultrasonic field used for medical diagnosis or monitoring. It is recognised that these indices have limitations and a knowledge of the indices at the time of an examination is not sufficient in itself to make an informed clinical risk assessment. It is intended that these limitations will be addressed in future revisions of this standard and as scientific understanding increases. Under certain conditions specified in IEC 60601-2-37 these indices are displayed on medical ultrasonic equipment intended for these purposes.
– 6 – 62359 IEC:2005(E) ULTRASONICS –
FIELD CHARACTERIZATION –
TEST METHODS FOR THE DETERMINATION OF THERMAL
AND MECHANICAL INDICES RELATED TO
MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
1 Scope This International Standard is applicable to medical diagnostic ultrasound fields. This standard establishes – parameters related to thermal and non-thermal aspects of diagnostic ultrasonic fields; – methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound; – methods for the determination of an exposure parameter appropriate to certain non-thermal effects. NOTE In this standard where multiples or submultiples of SI units are used this is clearly stated and the
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