EN 61689:2007
(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
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. 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.
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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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.
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.
__________
– 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.
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
– 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
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
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
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 ,
and the target distance, z, calculated according to 5.3 of
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.