EN 61689:2013
(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
IEC 61689:2013 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; - and 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 third edition cancels and replaces the second edition published in 2007. It constitutes a technical revision which includes the following significant technical changes with respect to the previous edition: - restriction introduced of 0,2 W/cm2 effective intensity during hydrophone measurements for treatment heads with ka≤20, to limit the likelihood of cavitation; - change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333; - and change to SI units for terms and definitions.
Ultraschall - Physiotherapiesysteme - Feldspezifikation 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
La CEI 61689:2013 est applicable aux appareils à ultrasons, conçus pour la physiothérapie, comprenant un transducteur ultrasonique fournissant des ultrasons à onde entretenue ou quasi-entretenue dans la gamme de fréquences de 0,5 MHz à 5 MHz. La présente norme ne traite que des appareils de physiothérapie à ultrasons employant un seul transducteur circulaire plan sans focalisation par projecteur ultrasonore, produisant des faisceaux statiques perpendiculaires à la face du projecteur ultrasonore. La présente norme spécifie: - les méthodes de mesure et la caractérisation de la sortie des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de référence; - les caractéristiques à déclarer par les fabricants des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de référence; - les lignes directrices de sécurité du champ ultrasonore créé par les appareils de physiothérapie à ultrasons; - les méthodes de mesure et la caractérisation de la sortie des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de routine; - et les critères d'aptitude concernant les divers aspects de la sortie des appareils de physiothérapie à ultrasons, reposant sur des méthodes d'essai de routine. La valeur thérapeutique et les modes d'utilisation des appareils de physiothérapie à ultrasons n'entrent pas dans le domaine d'application de la présente norme. Cette troisième édition annule et remplace la deuxième édition publiée en 2007, dont elle constitue une révision technique qui comprend les modifications techniques importantes suivantes par rapport à l'édition précédente: - introduction d'une limitation de l'intensité moyenne de 0,2 W/cm2 au cours des mesures de l'hydrophone pour les projecteurs ultrasonores avec ka≤20, pour limiter la probabilité de cavitation; - modification du facteur Fac, afin de déterminer la surface émettrice efficace entre 1,354 et 1,333; - et modification des unités SI dans les termes et définitions.
Ultrazvok - Fizioterapevtski sistemi - Specifikacije polja in merilne metode v frekvenčnem območju od 0,5 MHz do 5 MHz
Ta mednarodni standard se nanaša na ultrazvočno opremo, namenjeno fizioterapiji, ki vključuje ultrazvočni pretvornik, ki ustvarja neprekinjeno ali skoraj neprekinjeno ultrazvočno valovanja v frekvenčnem območju od 0,5 MHz do 5 MHz. Ta standard se nanaša samo na ultrazvočno fizioterapevtsko opremo, ki uporablja eno-ravninski ne-osrediščeni krožni pretvornik na glavo za obdelavo, ki proizvaja statične snope, pravokotne na ploskev glave za obdelavo. Ta standard določa:
• metode merjenja in karakterizacije izhoda ultrazvočne fizioterapevtske opreme na podlagi metod referenčnega testiranja;
• lastnosti, ki jih morajo specificirati proizvajalci ultrazvočne fizioterapevtske opreme na podlagi metod referenčnega testiranja;
• smernice za varnost ultrazvočnega polja, ki ga proizvaja oprema za ultrazvočno fizioterapijo;
• metode merjenja in karakterizacije izhoda ultrazvočne fizioterapevtske opreme na podlagi metod rutinskega testiranja;
• kriterije sprejemljivosti za vidike izhoda ultrazvočne fizioterapevtske opreme na podlagi metod rutinskega testiranja.
Ta standard ne zajema terapevtske vrednosti in metod uporabe opreme za ultrazvočno fizioterapijo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2013
1DGRPHãþD
SIST EN 61689:2008
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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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.
− 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.
- 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
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
– 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
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
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
B
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.