SIST EN 61689:2013

SLOVENSKI STANDARD
SIST EN 61689:2013
01-julij-2013
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SIST EN 61689:2008
8OWUD]YRN)L]LRWHUDSHYWVNLVLVWHPL6SHFLILNDFLMHSROMDLQPHULOQHPHWRGHY
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Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement
in the frequency range 0,5 MHz to 5 MHz
Ultraschall - Physiotherapiesysteme - Feldspezifikation und Messverfahren im
Frequenzbereich von 0,5 MHz bis 5 MHz
Ultrasons - Systèmes de physiothérapie - Spécifications de champ et méthodes de
mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz
Ta slovenski standard je istoveten z: EN 61689:2013
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 61689:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61689:2013

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SIST EN 61689:2013

EUROPEAN STANDARD
EN 61689

NORME EUROPÉENNE
April 2013
EUROPÄISCHE NORM

ICS 11.040.60 Supersedes EN 61689:2007


English version


Ultrasonics -
Physiotherapy systems -
Field specifications and methods of measurement in the frequency range
0,5 MHz to 5 MHz
(IEC 61689:2013)


Ultrasons -  Ultraschall -
Systèmes de physiothérapie - Physiotherapiesysteme -
Spécifications des champs et méthodes Feldspezifikation und Messverfahren im
de mesure dans la gamme de fréquences Frequenzbereich von 0,5 MHz bis 5 MHz
de 0,5 MHz à 5 MHz (IEC 61689:2013)
(CEI 61689:2013)





This European Standard was approved by CENELEC on 2013-04-02. 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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey 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


© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61689:2013 E

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SIST EN 61689:2013
EN 61689:2013 - 2 -
Foreword
The text of document 87/522/FDIS, future edition 3 of IEC 61689, prepared by IEC TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61689:2013.
The following dates are fixed:
• latest date by which the document has (dop) 2014-01-02
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2016-04-02
• latest date by which the national
standards conflicting with the

document have to be withdrawn

This document supersedes EN 61689:2007.
EN 61689:2013 includes the following significant technical changes with respect to EN 61689:2007:
2
− restriction introduced of 0,2 W/cm effective intensity during hydrophone measurements for treatment
heads with ka ≤ 20, to limit the likelihood of cavitation;
− a change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333;
− change to SI units for terms and definitions;
− closer alignment and re-ordered, updated definitions in line with standards in EN 62127 series;
− minor arithmetical errors corrected in data analysis;
− inconsistencies and errors in symbol usage removed throughout;
− large number of editorial and formal corrections made;
− changes introduced to references in the bibliography.

This standard should be read in conjunction with EN 60601-2-5, which, as indicated in its preface, will
itself be revised in order to be compatible with this standard.

NOTE The following print types are used:
− Requirements: in Arial 10 point
− Notes: in Arial 8 point
− Words in bold in the text are defined in Clause 3
− Symbols and formulae: Times New Roman + Italic
− Compliance clauses : in Arial Italic

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
Endorsement notice
The text of the International Standard IEC 61689:2013 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 61828 NOTE  Harmonized as EN 61828.
IEC 62127-2 NOTE  Harmonized as EN 62127-2.
IEC 62127-3 NOTE  Harmonized as EN 62127-3.

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SIST EN 61689:2013
- 3 - EN 61689:2013
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 60601-1 - Medical electrical equipment - EN 60601-1 -
Part 1: General requirements for basic safety
and essential performance


IEC 60601-2-5 - Medical electrical equipment - EN 60601-2-5 -
Part 2-5: Particular requirements for the basic
safety and essential performance of ultrasonic
physiotherapy equipment


IEC 61161 2013 Ultrasonics - Power measurement - EN 61161 2013
Radiation force balances and performance
requirements


IEC 62127-1 2007 Ultrasonics - Hydrophones - EN 62127-1 2007
+ corr. August 2008 Part 1: Measurement and characterization of
+ A1 2013 medical ultrasonic fields up to 40 MHz + A1 2013

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SIST EN 61689:2013

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SIST EN 61689:2013



IEC 61689

®


Edition 3.0 2013-02




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Ultrasonics – Physiotherapy systems – Field specifications and methods of

measurement in the frequency range 0,5 MHz to 5 MHz




Ultrasons – Systèmes de physiothérapie – Spécifications des champs et

méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX XB


ICS 11.040.60 ISBN 978-2-83220-657-7



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 61689:2013
– 2 – 61689 © IEC:2013


CONTENTS


FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 List of symbols . 16
5 Ultrasonic field specifications . 18
6 Conditions of measurement and test equipment used . 19
6.1 General . 19
6.2 Test vessel . 19
6.3 Hydrophone . 20
6.4 rms or peak signal measurement . 20
7 Type testing reference procedures and measurements . 20
7.1 General . 20
7.2 Rated output power . 21
7.3 Hydrophone measurements . 21
7.4 Effective radiating area. 22
7.5 Reference type testing parameters . 23
7.6 Acceptance criteria for reference type testing . 24
8 Routine measurement procedure . 24
8.1 General . 24
8.2 Rated output power . 24
8.3 Effective radiating area. 25
8.4 Beam non-uniformity ratio . 25
8.5 Effective intensity . 25
8.6 Acceptance criteria for routine testing . 25
9 Sampling and uncertainty determination . 26
9.1 Reference type testing measurements . 26
9.2 Routine measurements . 26
9.3 Uncertainty determination . 26
Annex A (informative) Guidance for performance and safety . 27
Annex B (normative) Raster scan measurement and analysis procedures . 31
Annex C (normative) Diametrical or line scan measurement and analysis procedures . 33
Annex D (informative) Rationale concerning the beam cross-sectional area definition . 36
Annex E (informative) Factor used to convert the beam cross-sectional area (A ) at
BCS
the face of the treatment head to the effective radiating area (A ) . 41
ER
Annex F (informative) Determining acoustic power through radiation force
measurements . 43
Annex G (informative) Validity of low-power measurements of the beam cross-
sectional area (A ) . 45
BCS
Annex H (informative) Influence of hydrophone effective diameter . 46
Annex I (informative) Effective radiating area measurement using a radiation force
balance and absorbing apertures . 48

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SIST EN 61689:2013
61689 © IEC:2013 – 3 –
Annex J (informative) Guidance on uncertainty determination . 58
Bibliography . 60

Figure A.1 – Normalized, time-averaged values of acoustic intensity (unbroken line)
and of one of its plane-wave approximations (broken line), existing on the axis of a
2
circular piston source of ka = 30, versus the normalized distance s , where s = λz/a . 30
n n
Figure A.2 – Histogram of R values for 37 treatment heads of various diameter and
BN
frequency . 30
Figure D.1 – Iso-pressure lines of a typical physiotherapy treatment head of small
geometrical area (ka = 17) . 38
Figure D.2 – Plot of beam cross-sectional area against different limit values for a
small range of values in distance along the beam alignment axis, z . 38
Figure D.3 – Normalized values of beam cross-sectional area for IEC and FDA limit
values for five transducers of different ka values . 39
Figure D.4 – Range of values of the beam cross-sectional area (A ) with distance
BCS
from the face of the treatment head . 40
Figure D.5 – Range of values of the normalized beam cross-sectional area (A ) with
BCS
transducer ka . 40
Figure E.1 – Conversion factor F as a function of the ka product for ka product
ac
between 40 and 160 . 42
Figure I.1 – Schematic representation of aperture measurement set-up . 49
Figure I.2 – Measured power as a function of aperture diameter for commercially-
available 1 MHz physiotherapy treatment heads . 53
Figure I.3 – Cumulative sum of annular power contributions, previously sorted in
descending order of intensity contribution, plotted against the cumulative sum of their
respective annular areas . 56

Table C.1 – Constitution of the transformed array [B] used for the analysis of half-line
scans . 34
Table F.1 – Necessary target size, expressed as the minimum target radius b, as a
function of the ultrasonic frequency, f, the effective radius of the treatment head, a ,
1
and the target distance, z, calculated according to A.5.3 of IEC 61161: 2013 (see [6]) . 44
Table G.1 – Variation of the beam cross-sectional area (A (z)) with the indicated
BCS
output power from two transducers . 45
Table H.1 – Comparison of measurements of the beam cross-sectional area (A (z))
BCS
made using hydrophones of geometrical active element radii 0,3 mm, 0,5 mm and
2,0 mm . 47
Table I.1 – Aperture measurement check sheet . 52
Table I.2 – Annular power contributions . 54
Table I.3 – Annular intensity contributions. 54
Table I.4 – Annular intensity contributions, sorted in descending order . 55
Table I.5 – Annular power contributions, sorted in descending order of intensity
contribution . 55
Table I.6 – Cumulative sum of annular power contributions, previously sorted in
descending order of intensity contribution, and the cumulative sum of their respective
annular areas . 56

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SIST EN 61689:2013
– 4 – 61689 © IEC:2013
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ULTRASONICS –
PHYSIOTHERAPY SYSTEMS –
FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT
IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz

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.
International Standard IEC 61689 has been prepared by IEC technical committee 87:
Ultrasonics.
This third edition cancels and replaces the second edition published in 2007. It constitutes a
technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
2
effective intensity during hydrophone measurements
• restriction introduced of 0,2 W/cm
for treatment heads with ka ≤ 20, to limit the likelihood of cavitation;
• a change in the factor F , to determine the effective radiating area, from 1,354 to 1,333;
ac
• change to SI units for terms and definitions;
• closer alignment and re-ordered, updated definitions in line with standards in IEC 62127
series;

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SIST EN 61689:2013
61689 © IEC:2013 – 5 –
• minor arithmetical errors corrected in data analysis;
• inconsistencies and errors in symbol usage removed throughout;
• large number of editorial and formal corrections made;
• changes introduced to references in the bibliography.
This standard should be read in conjunction with IEC 60601-2-5, which, as indicated in its
preface, will itself be revised in order to be compatible with this standard.
The text of this standard is based on the following documents:
FDIS Report on voting
87/522/FDIS 87/529/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.
NOTE The following print types are used:
• Requirements: in Arial 10 point
• Notes: in Arial 8 point
• Words in bold in the text are defined in Clause 3
• Symbols and formulae: Times New Roman + Italic
• Compliance clauses : in Arial Italic
The committee has decided that the contents of this publication will remain unchanged until
the stability 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.

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SIST EN 61689:2013
– 6 – 61689 © IEC:2013
INTRODUCTION
Ultrasound at low megahertz frequencies is widely used in medicine for the purposes of
physiotherapy. Such equipment consists of a generator of high frequency electrical energy
and usually a hand-held treatment head, often referred to as an applicator. The treatment
head contains a transducer, usually a disk of piezoelectric material, for converting the
electrical energy to ultrasound and is often designed for contact with the human body.

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SIST EN 61689:2013
61689 © IEC:2013 – 7 –
ULTRASONICS –
PHYSIOTHERAPY SYSTEMS –
FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT
IN THE FREQUENCY RANGE 0,5 MHz TO 5 MHz



1 Scope
This International Standard is applicable to ultrasonic equipment designed for physiotherapy
containing an ultrasonic transducer generating continuous or quasi-continuous wave
ultrasound in the frequency range 0,5 MHz to 5 MHz.
This standard only relates to ultrasonic physiotherapy equipment employing a single plane
non-focusing circular transducer per treatment head, producing static beams perpendicular
to the face of the treatment head.
This standard specifies:
• methods of measurement and characterization of the output of ultrasonic physiotherapy
equipment based on reference testing methods;
• characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment
based on reference testing methods;
• guidelines for safety of the ultrasonic field generated by ultrasonic physiotherapy
equipment;
• methods of measurement and characterization of the output of ultrasonic physiotherapy
equipment based on routine testing methods;
• acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment
based on routine testing methods.
Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not
covered by the scope of this standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-2-5, Medical electrical equipment – Part 2-5: Particular requirements for the basic
safety and essential performance of ultrasonic physiotherapy equipment
IEC 61161: 2013, Ultrasonics – Power measurement – Radiation force balances and
performance requirements
IEC 62127-1: 2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterization
of medical ultrasonic fields up to 40 MHz
Amendment 1: 2013

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SIST EN 61689:2013
– 8 – 61689 © IEC:2013
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE SI units (see ISO/IEC Directives – Part 2:2011, Annex I b) are used in the Notes to entry below certain
parameter definitions for defining certain parameters, such as beam areas and intensities. It may be convenient to
use decimal multiples or submultiples in practice but care should be taken in using decimal prefixes in combination
2
with units when using and calculating numerical data. For example, beam area may be specified in cm and
2 2
intensities in W/cm or mW/cm .
3.1
absolute maximum rated output power
sum of the rated output power, the 95 % confidence overall uncertainty in the rated output
power, and the maximum increase in the rated output power for a ± 10 % variation in the
rated value of the mains voltage
Note 1 to entry: The possibility of variation in the rated output power resulting from ± 10 % variation in the rated
value of the mains voltage should be checked by using a variable output transformer between the mains voltage
supply and the ultrasonic physiotherapy equipment. See Clause A.2 for further guidance.
Note 2 to entry: Absolute maximum rated output power is expressed in watt (W).
3.2
active area coefficient
Q
quotient of the active area gradient, m, and the beam cross-sectional area at 0,3 cm from
the face of the treatment head, A (0,3)
BCS
–1
Note 1 to entry: Active area coefficient is expressed in per metre (m ).
3.3
active area gradient
m
gradient of the line connecting the beam cross-sectional area at 0,3 cm from the face of the
treatment head, A (0,3), and the beam cross-sectional area at the position of the last
BCS
axial maximum acoustic pressure, A (z ), versus distance
BCS N
Note 1 to entry: Active area gradient is expressed in metre (m).
3.4
absolute maximum beam non-uniformity ratio
beam non-uniformity ratio plus the 95 % confidence overall uncertainty in the beam non-
uniformity ratio
3.5
absolute maximum effective intensity
value of the effective intensity corresponding to the absolute maximum rated output
power and the absolute minimum effective radiating area from the equipment
3.6
absolute minimum effective radiating area
effective radiating area minus the 95 % confidence overall uncertainty in the effective
radiating area
3.7
acoustic frequency
acoustic-working frequency
f
awf
frequency of an acoustic signal based on the observation of the output of a hydrophone
placed in an acoustic field at the position corresponding to the spatial-peak temporal-peak
acoustic pressure

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SIST EN 61689:2013
61689 © IEC:2013 – 9 –
Note 1 to entry: The signal is analysed using either the zero-crossing acoustic-working frequency technique or
a spectrum analysis method. Acoustic-working frequencies are defined in 3.7.1 and 3.7.2.
Note 2 to entry: In a number of cases the present definition is not very helpful or convenient, especially for
broadband transducers. In that case a full description of the frequency spectrum should be given in order to
enable any frequency-dependent correction to the signal.
Note 3 to entry: Acoustic frequency is expressed in hertz (Hz).
[SOURCE: IEC 62127-1:2007 Amendment
...