EN IEC 61689:2022
(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 containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. 211 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 224 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 - 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 plage de fréquences de 0,5 MHz à 5 MHz
IEC 61689:2022 est disponible sous forme de IEC 61689:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 61689:2022 est applicable aux appareils à ultrasons, conçus pour la physiothérapie, qui comprennent un transducteur ultrasonique fournissant des ultrasons à onde entretenue ou quasi entretenue (par exemple, salve d’impulsions) dans la plage de fréquences de 0,5 MHz à 5 MHz. Le présent document ne traite que des appareils à ultrasons pour physiothérapie qui emploient un seul transducteur circulaire plan sans focalisation par transducteur, produisant des faisceaux statiques perpendiculaires à la face de ce même transducteur. Le présent document spécifie: - les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, qui reposent sur des méthodes d’essai de référence; - les caractéristiques à spécifier par les fabricants des appareils à ultrasons pour physiothérapie qui reposent sur des méthodes d’essai de référence; - les lignes directrices de sécurité du champ ultrasonique créé par les appareils à ultrasons pour physiothérapie; - les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, qui reposent sur des méthodes d’essai individuel de série; - les critères d’aptitude relatifs aux aspects de la sortie des appareils à ultrasons pour physiothérapie, qui reposent sur des méthodes d’essai individuel de série. La valeur thérapeutique et les modes d’utilisation des appareils à ultrasons pour physiothérapie n’entrent pas dans le domaine d’application du présent document. Les appareils à ultrasons pour physiothérapie qui utilisent des ultrasons dont la plage de fréquences est comprise entre 20 kHz et 500 kHz sont couverts par l’IEC 63009. L'IEC 61689:2022 annule et remplace la troisième édition parue en 2013. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente. a) L’exigence relative à la teneur en oxygène de l’eau est spécifiée en 6.1. b) Les anciennes recommandations spécifiées en 6.2 ont été modifiées pour constituer des exigences. c) Plusieurs définitions de l’Article 3 ont été actualisées conformément à d’autres documents qui relèvent du CE 87. d) L’ancienne Annexe A informative a été modifiée en annexe normative, et contient désormais des informations détaillées sur la méthode selon laquelle la conformité aux exigences de l’IEC 60601-2-5 est vérifiée. e) L’Annexe D a été raccourcie de manière importante et la référence à un document réglementaire désormais supprimé a été retirée.
Ultrazvok - Fizioterapevtski sistemi - Specifikacije polja in merilne metode v frekvenčnem območju od 0,5 MHz do 5 MHz (IEC 61689:2022)
Ta mednarodni standard se navezuje na ultrazvočno opremo, namenjeno fizioterapiji, ki vključuje ultrazvočni pretvornik, ki ustvarja neprekinjeno ali skoraj neprekinjeno (npr. tonski izbruh) ultrazvočno valovanje v frekvenčnem območju od 0,5 MHz do 5 MHz. 211
Ta standard se navezuje samo na ultrazvočno fizioterapevtsko opremo, ki uporablja enoravninski neosrediščeni 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 preskušanja;
– lastnosti, ki jih morajo specificirati proizvajalci ultrazvočne fizioterapevtske opreme na podlagi metod referenčnega preskušanja;
– smernice za varnost ultrazvočnega polja, ki ga proizvaja oprema za ultrazvočno fizioterapijo;
– metode merjenja in karakterizacije izhoda ultrazvočne fizioterapevtske opreme na podlagi metod rutinskega preskušanja;
– kriterije sprejemljivosti za vidike izhoda ultrazvočne fizioterapevtske opreme 224 na podlagi metod rutinskega preskušanja.
Ta standard ne zajema terapevtske vrednosti in metod uporabe opreme za ultrazvočno fizioterapijo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2022
Nadomešča:
SIST EN 61689:2013
Ultrazvok - Fizioterapevtski sistemi - Specifikacije polja in merilne metode v
frekvenčnem območju od 0,5 MHz do 5 MHz (IEC 61689:2022)
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement
in the frequency range 0,5 MHz to 5 MHz (IEC 61689:2022)
Ultraschall - Physiotherapiesysteme - Feldspezifikation und Messverfahren im
Frequenzbereich von 0,5 MHz bis 5 MHz (IEC 61689:2022)
Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de
mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz (IEC 61689:2022)
Ta slovenski standard je istoveten z: EN IEC 61689:2022
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 IEC 61689
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2022
ICS 11.040.60 Supersedes EN 61689:2013
English Version
Ultrasonics - Physiotherapy systems - Field specifications and
methods of measurement in the frequency range 0,5 MHz to 5
MHz
(IEC 61689:2022)
Ultrasons - Systèmes de physiothérapie - Spécifications Ultraschall - Physiotherapiesysteme - Feldspezifikation und
des champs et méthodes de mesure dans la plage de Messverfahren im Frequenzbereich von 0,5 MHz bis 5 MHz
fréquences de 0,5 MHz à 5 MHz (IEC 61689:2022)
(IEC 61689:2022)
This European Standard was approved by CENELEC on 2022-04-12. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61689:2022 E
European foreword
The text of document 87/784/FDIS, future edition 4 of IEC 61689, prepared by IEC/TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-01-12
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2025-04-12
document have to be withdrawn
This document supersedes EN 61689:2013 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61689:2022 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 IEC 61828
IEC 62127-2 NOTE Harmonized as EN 62127-2
IEC 62127-3 NOTE Harmonized as EN 62127-3
IEC 62555 NOTE Harmonized as EN 62555
IEC 63009 NOTE Harmonized as EN IEC 63009
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-1 - Medical electrical equipment - Part 1: General EN 60601-1 -
requirements for basic safety and essential
performance
IEC 60601-2-5 - Medical electrical equipment - Part 2-5: EN 60601-2-5 -
Particular requirements for the basic safety
and essential performance of ultrasonic
physiotherapy equipment
IEC 61161 - Ultrasonics - Power measurement - Radiation EN 61161 -
force balances and performance requirements
IEC 62127-1 - Ultrasonics - Hydrophones - Part 1: - -
Measurement and characterization of medical
ultrasonic fields
IEC 61689 ®
Edition 4.0 2022-03
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 plage de fréquences de 0,5 MHz à 5 MHz
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-1080-0
– 2 – IEC 61689:2022 © IEC 2022
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Symbols . 18
5 Ultrasonic field specifications . 19
6 Conditions of measurement and test equipment used . 20
6.1 General . 20
6.2 Test vessel . 20
6.3 Hydrophone . 21
6.4 RMS peak signal measurement . 22
7 Type testing reference procedures and measurements . 22
7.1 General . 22
7.2 Rated output power . 23
7.3 Hydrophone measurements . 23
7.4 Effective radiating area . 24
7.4.1 Effective radiating area measurements . 24
7.4.2 Hydrophone positioning . 24
7.4.3 Beam cross-sectional area determination . 24
7.4.4 Active area gradient determination . 24
7.4.5 Beam type determination . 25
7.4.6 Effective radiating area calculation . 25
7.4.7 Beam non-uniformity ratio calculation . 25
7.4.8 Testing requirements . 25
7.5 Reference type testing parameters. 26
7.6 Acceptance criteria for reference type testing . 26
8 Routine measurement procedure . 27
8.1 General . 27
8.2 Rated output power . 27
8.3 Effective radiating area . 27
8.4 Beam non-uniformity ratio . 27
8.5 Effective intensity. 28
8.6 Acceptance criteria for routine testing . 28
9 Sampling and uncertainty determination . 28
9.1 Reference type testing measurements . 28
9.2 Routine measurements . 28
9.3 Uncertainty determination . 29
Annex A (normative) Guidance for performance and safety . 30
A.1 General . 30
A.2 Rated output power . 30
A.3 Effective intensity. 30
A.4 Beam non-uniformity ratio . 30
A.4.1 General . 30
IEC 61689:2022 © IEC 2022 – 3 –
A.4.2 Rationale behind using a limiting value for the beam non-uniformity ratio
(R ) . 30
BN
Annex B (normative) Raster scan measurement and analysis procedures . 35
B.1 General . 35
B.2 Requirements for raster scans . 35
B.3 Requirements for analysis of raster scan data . 36
B.3.1 General . 36
B.3.2 Total mean square acoustic pressure . 36
B.3.3 Calculation of the beam cross-sectional area, A . 36
BCS
Annex C (normative) Diametrical or line scan measurement and analysis procedures . 37
C.1 General . 37
C.2 Requirements for line scans . 37
C.3 Analysis of scans . 37
Annex D (informative) Rationale concerning the beam cross-sectional area definition . 41
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) Validity of low-power measurements of the beam cross-
sectional area (A ) .
...
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