EN 62359:2011

Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

IEC 62359:2010 is applicable to medical diagnostic ultrasound fields. It establishes: - parameters related to thermal and non-thermal exposure 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. This second edition cancels and replaces the first edition, published in 2005. It constitutes a technical revision. Major changes with respect to the previous edition include the following: - The methods of determination set out in the first edition of this standard were based on those contained in the American standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (ODS) and were intended to yield identical results. While this second edition also follows the ODS in principal and uses the same basic formulae and assumptions (see Annex A), it contains a few significant modifications which deviate from the ODS. - One of the primary issues dealt with in preparing this second edition of IEC 62359 was 'missing' TI equations. In Edition 1 there were not enough equations to make complete 'at-surface' and 'below-surface' summations for TIS and TIB in combined-operating modes. Thus major changes with respect to the previous edition are related to the introduction of new calculations of thermal indices to take into account both 'at-surface' and 'below-surface' thermal effects.

Ultraschall - Charakterisierung von Feldern - Prüfverfahren für die Ermittlung des thermischen und des mechanischen Indexes bezogen auf medizinische Ultraschalldiagnostikfelder

Ultrasons – Caractérisation du champ – Méthodes d'essai pour la détermination d'indices thermique et mécanique des champs d'ultrasons utilisés pour le diagnostic médical

La CEI 62359:2010 est applicable aux champs d'ultrasons utilisés pour le diagnostic médical. Elle définit: - des paramètres relatifs aux aspects thermiques et non thermiques des champs ultrasonores de diagnostic; - des méthodes de détermination d'un paramètre d'exposition relatif à l'échauffement dans les modèles théoriques équivalents aux tissus, résultant de l'absorption d'ultrasons; - des méthodes de détermination d'un paramètre d'exposition approprié pour certains effets non thermiques. Cette deuxième édition annule et remplace la première édition publiée en 2005. Elle constitue une révision technique. Les modifications majeures par rapport à l'édition précédente incluent ce qui suit: - Les méthodes de détermination présentées dans la première de la présente norme étaient basées sur celles contenues dans la Norme américaine relative à l'affichage en temps réel des Indices d'émission acoustiques thermique et mécanique des appareils de diagnostics à ultrasons (ODS) et devaient fournir des résultats identiques. Bien que l'édition seconde suive également l'ODS dans le principe et utilise les mêmes formules et hypothèses fondamentales (voir Annexe A), elle comporte quelques modifications significatives s'écartant de l'ODS. - L'une des principales questions traitées lors de l'élaboration de l'édition seconde de la CEI 62359 norme faisait référence aux équations de TI 'manquantes'. Elles n'étaient pas suffisantes dans l'édition 1 afin d'effectuer des sommations 'à la surface' et 'sous la surface' complètes pour TIS et TIB en modes de fonctionnement combinés. Ainsi, les modifications majeures par rapport à l'édition précédente sont liées à l'introduction de nouveaux calculs d'indices thermiques pour prendre en compte les effets thermiques 'à la surface' et 'sous la surface'.

Ultrazvok - Karakterizacija polj - Preskusne metode za ugotavljanje termičnih in mehanskih znakov glede medicinskih diagnostičnih ultrazvočnih polj (IEC 62359:2010)

Ta mednarodni standard velja za medicinska diagnostična ultrazvočna polja. Ta standard vzpostavlja: – parametre, povezane z vidiki toplotne izpostavljenosti ali izpostavljenosti, ki ni toplotna, diagnostičnim ultrazvočnim poljem, – metode za določanje parametrov izpostavljanja, povezanih z dvigom temperature v teoretičnih tkivu enakih modelov, ki nastanejo zaradi vpijanja ultrazvoka, – metode za določanje parametrov izpostavljanja do določenih učinkov, ki niso toplotni.

General Information

• Status: Published
• Publication Date: 10-Feb-2011
• Withdrawal Date: 31-Jan-2014
• 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: 11-Feb-2011
• Completion Date: 11-Feb-2011
• Ref Project: SIST EN 62359:2011 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2010)

Relations

• Replaces: EN 62359:2005 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
• Effective Date: 28-Jan-2023
• Amended By: EN 62359:2011/A1:2018 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2011
1DGRPHãþD
SIST EN 62359:2007
8OWUD]YRN.DUDNWHUL]DFLMDSROM3UHVNXVQHPHWRGH]DXJRWDYOMDQMHWHUPLþQLKLQ
PHKDQVNLK]QDNRYJOHGHPHGLFLQVNLKGLDJQRVWLþQLKXOWUD]YRþQLKSROM,(&

Ultrasonics - Field characterization - Test methods for the determination of thermal and
mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2010)
Ultraschall - Charakterisierung von Feldern - Prüfverfahren für die Ermittlung des
thermischen und des mechanischen Indexes bezogen auf medizinische
Ultraschalldiagnostikfelder (IEC 62359:2010)
Ultrasons - Caractérisation du champ - Méthodes d'essai pour la détermination d'indices
thermique et mécanique des champs d'ultrasons utilisés pour le diagnostic médical (CEI
62359:2010)
Ta slovenski standard je istoveten z: EN 62359:2011
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 62359
NORME EUROPÉENNE
February 2011
EUROPÄISCHE NORM
ICS 17.140.50 Supersedes EN 62359:2005

English version
Ultrasonics -
Field characterization -
Test methods for the determination of thermal and mechanical indices
related to medical diagnostic ultrasonic fields
(IEC 62359:2010)
Ultrasons – Caractérisation du champ – Ultraschall -
Méthodes d'essai pour la détermination Charakterisierung von Feldern -
d'indices thermique et mécanique des Prüfverfahren für die Ermittlung des
champs d'ultrasons utilisés pour le thermischen und des mechanischen
diagnostic médical Indexes bezogen auf medizinische
(CEI 62359:2010) Ultraschalldiagnostikfelder
(IEC 62359:2010)
This European Standard was approved by CENELEC on 2011-02-01. 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, Croatia, 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

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62359:2011 E
Foreword
The text of document 87/445/FDIS, future edition 2 of IEC 62359, prepared by IEC TC 87, Ultrasonics,
was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62359 on
2011-02-01.
This European Standard supersedes EN 62359:2005.
Major changes with respect to EN 62359:2005 include the following:
– The methods of determination set out in EN 62359:2005 were based on those contained in the
American standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment (ODS) and were intended to yield identical results. While
EN 62359:2010 also follows the ODS in principal and uses the same basic formulae and assumptions
(see Annex A), it contains a few significant modifications which deviate from the ODS.
– One of the primary issues dealt with in preparing EN 62359:2010 was “missing” TI equations. In
EN 62359:2005 there were not enough equations to make complete “at-surface” and “below-surface”
summations for TIS and TIB in combined-operating modes. Thus major changes with respect to
EN 62359:2005 are related to the introduction of new calculations of thermal indices to take into account
both "at-surface" and "below-surface" thermal effects.
For the specific technical changes involved please see Annex E.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
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) 2011-11-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2014-02-01
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62359:2010 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 61689 NOTE  Harmonized as EN 61689.
__________
- 3 - EN 62359:2011
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 60601-2-37 - Medical electrical equipment - EN 60601-2-37 -
Part 2-37: Particular requirements for the
basic safety and essential performance of
ultrasonic medical diagnostic and monitoring
equipment
IEC 61157 2007 Standard means for the reporting of the EN 61157 2007
acoustic output of medical diagnostic
ultrasonic equipment
IEC 61161 2006 Ultrasonics - Power measurement - Radiation EN 61161 2007
force balances and performance requirements

IEC 61828 2001 Ultrasonics - Focusing transducers - EN 61828 2001
Definitions and measurement methods for the
transmitted fields
IEC 62127-1 2007 Ultrasonics - Hydrophones - EN 62127-1 2007
Part 1: Measurement and characterization of
medical ultrasonic fields up to 40 MHz

IEC 62127-2 2007 Ultrasonics - Hydrophones - EN 62127-2 2007
Part 2: Calibration of hydrophones to be used
in ultrasonic fields up to 40 MHz

IEC 62127-3 2007 Ultrasonics - Hydrophones - EN 62127-3 2007
Part 3: Properties of hydrophones for
ultrasonic fields up to 40 MHz

IEC 62359 ®
Edition 2.0 2010-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Ultrasonics – Field characterization – Test methods for the determination of
thermal and mechanical indices related to medical diagnostic ultrasonic fields

Ultrasons – Caractérisation du champ – Méthodes d'essai pour la détermination
d'indices thermique et mécanique des champs d'ultrasons utilisés pour le
diagnostic médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 17.140.50 ISBN 978-2-88912-181-6
– 2 – 62359 © IEC:2010
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms and definitions .8
4 List of symbols .21
5 Test methods for determining the mechanical index and the thermal index .23
5.1 General .23
5.2 Determination of mechanical index .23
5.2.1 Determination of attenuated peak-rarefactional acoustic pressure .23
5.2.2 Calculation of mechanical index .23
5.3 Determination of thermal index – general .24
5.4 Determination of thermal index in non-scanning mode.24
5.4.1 Determination of soft tissue thermal index for non-scanning modes .24
5.4.2 Determination of bone thermal index, TIB, for non-scanning modes .25
5.5 Determination of thermal index in scanning modes .26
5.5.1 Determination of soft tissue thermal index for scanning modes .26
5.5.2 Determination of bone thermal index for scanning modes .27
5.6 Calculations for combined-operating mode .28
5.6.1 Acoustic working frequency .28
5.6.2 Thermal index.28
5.6.3 Mechanical index.29
5.7 Summary of measured quantities for index determination .29
Annex A (informative)  Rationale and derivation of index models .30
Annex B (informative) Guidance notes for measurement of output power in combined
modes, scanning modes and in 1 cm × 1 cm windows.51
Annex C (informative) The contribution of transducer self-heating to the temperature
rise occurring during ultrasound exposure.58
Annex D (informative) Guidance on the interpretation of TI and MI .59
Annex E (informative) Differences from IEC 62359 Edition 1.61
Bibliography.64

Figure 1 – Schematic diagram of the different planes and lines in an ultrasonic field
(modified from IEC 61828 and IEC 62127-1).12
Figure A.1 – Focusing transducer with a f-number of about 7.37
Figure A.2 – Strongly focusing transducer with a low f-number of about 1.37
Figure A.3 – Focusing transducer (f-number ≈ 10) with severe undulations close to the
transducer .38
Figure A.4 – Focusing transducer .44
Figure A.5 – Focusing transducer with smaller aperture than that of Figure A.4 .44
Figure A.6 – Focusing transducer with a weak focus near z .45
bp
Figure A.7 – Weakly focusing transducer .45
Figure B.1 – Example of curved linear array in scanning mode .53
Figure B.2 – Suggested 1 cm × 1 cm square-aperture mask.56

62359 © IEC:2010 – 3 –
Figure B.3 – Suggested orientation of transducer, mask aperture and RFB target.56
Figure B.4 – Suggested orientation of transducer and 1 cm-square RFB target.57

Table 1 – Summary of combination formulae for each of the THERMAL INDEX categories.28
Table 2 – Summary of the acoustic quantities required for the determination of the
indices .29
Table A.1 – Thermal index categories and models .36
Table A.2 – Consolidated thermal index formulae .41
Table E.1 – Summary of differences .63

– 4 – 62359 © IEC:2010
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 S
...