SIST EN 61689:2008
(Main)Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
This International Standard is applicable to ultrasonic equipment designed for physiotherapy consisting of an ultrasonic transducer generating continuous or quasi-continuous wave ultrasonic energy in the frequency range 0,5 MHz to 5 MHz. This standard only relates to ultrasonic physiotherapy equipment employing a single plane unfocused 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.
Ultraschall - Physiotherapiesysteme - Feldspezifikationen und Messverfahren im Frequenzbereich von 0,5 MHz bis 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
Ultrazvok - Fizioterapevtski sistemi - Specifikacije polja in merilne metode v frekvenčnem območju od 0,5 MHz do 5 MHz (IEC 61689:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 61689:2008
01-februar-2008
1DGRPHãþD
SIST EN 61689:2002
8OWUD]YRN)L]LRWHUDSHYWVNLVLVWHPL6SHFLILNDFLMHSROMDLQPHULOQHPHWRGHY
IUHNYHQþQHPREPRþMXRG0+]GR0+] ,(&
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement
in the frequency range 0,5 MHz to 5 MHz (IEC 61689:2007)
Ultraschall - Physiotherapiesysteme - Feldspezifikationen und Messverfahren im
Frequenzbereich von 0,5 MHz bis 5 MHz (IEC 61689:2007)
Ultrasons - Systemes de physiothérapie - Spécifications des champs et méthodes de
mesure dans la gamme de fréquences de 0,5 MHz a 5 MHz (IEC 61689:2007)
Ta slovenski standard je istoveten z: EN 61689:2007
ICS:
11.040.60
SIST EN 61689:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN 61689
NORME EUROPÉENNE
November 2007
EUROPÄISCHE NORM
ICS 11.040.60 Supersedes EN 61689:1996
English version
Ultrasonics -
Physiotherapy systems -
Field specifications and methods of measurement
in the frequency range 0,5 MHz to 5 MHz
(IEC 61689:2007)
Ultrasons - Ultraschall -
Systèmes de physiothérapie - Physiotherapiesysteme -
Spécifications des champs et méthodes Feldspezifikationen 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 61689:2007)
(CEI 61689:2007)
This European Standard was approved by CENELEC on 2007-10-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61689:2007 E
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EN 61689:2007 – 2 –
Foreword
The text of document 87/351/CDV, future edition 2 of IEC 61689, prepared by IEC TC 87, Ultrasonics,
was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by
CENELEC as EN 61689 on 2007-10-01.
This European Standard supersedes EN 61689:1996.
EN 61689:2007 is a result of maintenance on this standard and the referenced standards EN 61161:2007
and EN 62127-1. A relatively large technical change is the determination of the effective radiating area.
This is now no longer based on the measurement of four areas but only on one. This change was needed
to improve the accuracy of the determination of this parameter for small transducers. Be aware that this
change may alter the value obtained for this and related parameters.
This standard is to be used in conjunction with EN 60601-2-5.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-07-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2010-10-01
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.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61689:2007 was approved by CENELEC as a European
Standard without any modification.
__________
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– 3 – EN 61689:2007
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60050-801 1994 International Electrotechnical Vocabulary – –
(IEV) -
Chapter 801: Acoustics and electroacoustics
IEC 60469-1 1987 Pulse techniques and apparatus - – –
Part 1: Pulse terms and definitions
1) 2)
IEC 60601-1 – Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
IEC 60601-2-5 2000 Medical electrical equipment - EN 60601-2-5 2000
Part 2-5: Particular requirements for the
safety of ultrasonic physiotherapy equipment
IEC 61161 2006 Ultrasonics - Power measurement - EN 61161 2007
Radiation force balances and performance
requirements
IEC 62127-1 2007 Ultrasonics - Hydrophones - EN 62127-1 2007
Part 1: Measurement and characterization of
medical ultrasonic fields up to 40 MHz using
hydrophones
IEC 62127-3 2007 Ultrasonics - Hydrophones - EN 62127-3 2007
Part 3: Properties of hydrophones for
ultrasonic fields up to 40 MHz
1)
Undated reference.
2)
Valid edition at date of issue.
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IEC 61689
Edition 2.0 2007-08
INTERNATIONAL
STANDARD
Ultrasonics – Physiotherapy systems – Field specifications and methods of
measurement in the frequency range 0,5 MHz to 5 MHz
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XB
ICS 11.040.60 ISBN 2-8318-9256-2
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– 2 – 61689 © IEC:2007(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms and definitions .8
4 List of symbols .15
5 Ultrasonic field specifications .16
6 Conditions of measurement and test equipment used .17
6.1 General .17
6.2 Test vessel.18
6.3 Hydrophone.18
6.4 RMS or peak signal measurement .18
7 Type testing reference procedures and measurements.19
7.1 General .19
7.2 Rated output power .19
7.3 Hydrophone measurements.19
7.4 Effective radiating area .20
7.5 Reference type testing parameters .22
7.6 Acceptance criteria for reference type testing.22
8 Routine measurement procedure.23
8.1 General .23
8.2 Rated output power .23
8.3 Effective radiating area .23
8.4 Beam non-uniformity ratio .24
8.5 Effective intensity.24
8.6 Acceptance criteria for routine testing .24
9 Sampling and uncertainty determination .24
9.1 Reference type testing measurements.24
9.2 Routine measurements.24
9.3 Uncertainty determination.25
Annex A (informative) Guidance for performance and safety.26
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 ) .42
ER
Annex F (informative) Determining acoustic power through radiation force
measurements.44
Annex G (informative) The validity of low-power measurements of the beam cross-
sectional area (A ).46
BCS
Annex H (informative) Influence of hydrophone effective diameter .47
Annex I (informative) Effective radiating area measurement using a radiation force
balance and absorbing apertures.49
Annex J (informative) Guidance on uncertainty determination .59
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61689 © IEC:2007(E) – 3 –
Bibliography.61
Figure A.1 – The normalized, time-averaged values of the acoustic intensity (unbroken
line) and of one of its plane-wave approximations (broken line), existing on the axis of
2
a circular piston source of ka = 30, versus the normalized distance s, where s = λz/a .29
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 variation in distance along the beam alignment axis, z .39
Figure D.3 – Normalized values of beam cross-sectional area for IEC and FDA limit
values for five transducers of different ka values, z = 0,5 cm .40
Figure D.4 – Variation of the beam cross-sectional area (A ) with distance from the
BCS
41
face of the treatment head .
Figure D.5 – Variation of the normalized beam cross-sectional area (A ) with
BCS
transducer ka .41
Figure E.1 – Conversion factor F as a function of the ka product for ka product
ac
between 40 and 160 .43
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 .54
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.57
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
45
and the target distance, z, calculated according to 5.3 of IEC 61161 (see [5]). .
Table G.1 – Variation of the beam cross-sectional area (A (z)) with the indicated
BCS
output power from two transducers .46
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 .48
Table I.1 – Aperture measurement check sheet .53
Table I.2 – Annular power contributions .55
Table I.3 – Annular intensity contributions .55
Table I.4 – Annular intensity contributions, sorted in descending order .56
Table I.5 – Annular power contributions, sorted in descending order of intensity
contribution.56
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.57
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– 4 – 61689 © IEC:2007(E)
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 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 61689 has been prepared by IEC technical committee 87:
Ultrasonics.
This second edition cancels and replaces the first edition published in 1996 and constitutes a
technical revision.
This second edition is a result of maintenance on this standard and the referenced standards
IEC 61161 (2006) and IEC 62127-1. A relatively large technical change is the determination of
the effective radiating area. This is now no longer based on the measurement of four areas
but only on one. This change was needed to improve the accuracy of the determination of this
parameter for small transducers. Be aware that this change may alter the value obtained for
this and related parameters.
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61689 © IEC:2007(E) – 5 –
The text of this standard is based on the following documents:
CDV Report on voting
87/351/CDV 87/370/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
This standard should be read in conjunction with IEC 60601-2-5, which, as indicated in its
preface, will be revised in order to be compatible with this standard.
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.
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– 6 – 61689 © IEC:2007(E)
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 consists of 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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61689 © IEC:2007(E) – 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
consisting of an ultrasonic transducer generating continuous or quasi-continuous wave
ultrasonic energy in the frequency range 0,5 MHz to 5 MHz.
This standard only relates to ultrasonic physiotherapy equipment employing a single plane
unfocused 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 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 (IEV) – Chapter 801:
Acoustics and electroacoustics
IEC 60469-1:1987, Pulse techniques and apparatus – Part 1: Pulse terms and definitions
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-2-5:2000, Medical electrical equipment – Part 2-5: Particular requirements for the
safety of ultrasonic physiotherapy equipment
IEC 61161:2006, Ultrasonics – Power measurement – Radiation force balances and
performance requirements
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– 8 – 61689 © IEC:2007(E)
IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of
medical ultrasonic fields up to 40 MHz using hydrophones
IEC 62127-3:2007, Ultrasonics – Hydrophones – Part 3: Properties of hydrophones for
ultrasonic fields up to 40 MHz
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acoustic pulse waveform
temporal waveform of the instantaneous acoustic pressure at a specified position in an
acoustic field and displayed over a period sufficiently long to include all significant acoustic
information in a single pulse or tone-burst, or one or more cycles in a continuous wave
NOTE 1 Temporal waveform is a representation (e.g. oscilloscope presentation or equation) of the instantaneous
acoustic pressure.
NOTE 2 Definition adopted from IEC 60469-1.
3.2
acoustic repetition period
arp
pulse repetition period for non-automatic scanning systems and the scan repetition period
for automatic scanning systems, equal to the time interval between corresponding points of
consecutive cycles for continuous wave systems
NOTE 1 Acoustic repetition period is expressed in seconds (s).
NOTE 2 Definition adopted from IEC 62127-1.
3.3
acoustic frequency
acoustic-working frequency
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
NOTE 1 The signal is analysed using either the zero-crossing acoustic-working frequency technique or a
spectrum analysis method. Acoustic-working frequencies are defined in 3.3.1 and 3.3.2.
NOTE 2 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 Acoustic frequency is expressed in hertz (Hz).
NOTE 4 Definition adopted from IEC 62127-1.
3.3.1
zero-crossing acoustic-working frequency
f
awf
this is determined according to the procedure specified in IEC/TR 60854.
NOTE This frequency is intended for continuous wave systems only.
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61689 © IEC:2007(E) – 9 –
3.3.2
arithmetic-mean acoustic-working frequency
f
awf
arithmetic mean of the most widely separated frequencies f and f , within the range of three
1 2
times f , at which the magnitude of the acoustic pressure spectrum is 3 dB below the peak
1
magnitude
NOTE 1 This frequency is intended for pulse-wave systems only.
NOTE 2 It is assumed that f < f .
1 2
3.4
amplitude modulated wave
wave in which the ratio p / √2p at any point in the far field on the beam alignment axis is
p rms
greater than 1,05, where p is the temporal-peak acoustic pressure and p is the r.m.s.
p rms
acoustic pressure
3.5
attachment head
accessory intended to be attached to the treatment head for the purpose of modifying the
ultrasonic beam characteristics
NOTE Definition adopted from IEC 60601-2-5.
3.6
beam alignment axis
straight line joining two points of spatial-peak temporal-peak acoustic pressure on two plane
surfaces parallel to the faces of the treatment head. One plane is at a distance of
approximately A /(πλ) where A is the nominal value of the effective radiating area of
ERN ERN
the treatment head and λ is the wavelength of the ultrasound corresponding to the nominal
value of the acoustic working frequency. The second plane surface is at a distance of either
2A /(πλ) or A /(3πλ), whichever is the more appropriate. For the purposes of alignment,
ERN ERN
this line may be projected to the face of the treatment head
NOTE 1 If the nominal value of the effective radiating area is unknown, then another suitable area may be used
to define the beam alignment axis such as the area of the active element of the ultrasonic transducer.
NOTE 2 As the beam alignment axis is used purely for the purposes of alignment, the definitions of specific
distances may be relaxed slightly to reflect the constraints of the measurement system employed. For example,
some treatment heads will have A /(πλ) considerably greater than 12 cm, in which case a maximum distance of
ERN
12 cm may be used to define the first plane. General guidelines for determining the beam alignment axis are
given in 8.3.
3.7
beam cross-sectional area
A
BCS
minimum area in a specified plane perpendicular to the beam alignment axis for which the
sum of the mean square acoustic pressure is 75 % of the total mean square acoustic
pressure
2
NOTE Beam cross-sectional area is expressed in centimetre squared (cm ).
3.8
beam maximum intensity
product of the beam non-uniformity ratio and effective intensity
2
NOTE Beam maximum intensity is expressed in watt per centimetre squared (W/cm ).
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– 10 – 61689 © IEC:2007(E)
3.9
beam non-uniformity ratio
R
BN
ratio of the square of the maximum r.m.s. acoustic pressure to the spatial average of the
square of the r.m.s. acoustic pressure, where the spa
...
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