EN IEC 63009:2019

Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz

IEC 63009:2019 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz. This document 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 document 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; • 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. The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document. Excluded equipment includes, but is not limited to: • equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type; • equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters); • equipment in which ultrasound waves are intended to sensitize tissue to further therapies (for example radiation or chemotherapy); • equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High Intensity Therapeutic Ultrasound (HITU).

Ultraschall - Physiotherapiesysteme - Feldspezifikationen und Messmethoden im Frequenzbereich 20 kHz bis 500 kHz

Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de mesure dans la plage de fréquences de 20 kHz à 500 kHz

L'IEC 63009:2019 est applicable aux appareils à ultrasons, conçus pour la physiothérapie, comprenant un transducteur ultrasonique fournissant des ultrasons dans la plage de fréquences de 20 kHz à 500 kHz. Le présent document ne traite que des appareils à ultrasons pour physiothérapie employant un seul transducteur circulaire plan sans focalisation par transducteur, produisant des faisceaux statiques perpendiculaires à la face du transducteur. Le présent document spécifie: • les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, reposant sur des méthodes d’essai de référence; • les caractéristiques à préciser par les fabricants des appareils à ultrasons pour physiothérapie; • les méthodes de mesure et la caractérisation de la sortie des appareils à ultrasons pour physiothérapie, reposant sur des méthodes d’essai de routine; • les critères d’aptitude concernant les divers aspects de la sortie des appareils à ultrasons pour physiothérapie. La valeur thérapeutique et les modes d’utilisation des appareils à ultrasons pour physiothérapie ne relèvent pas du domaine d’application du présent document. Les appareils exclus comprennent entre autres: • les appareils avec lesquels les ondes ultrasonores sont destinées à détruire des conglomérats (par exemple, des calculs rénaux ou biliaires) ou des tissus de tout type; • les appareils avec lesquels un outil est entraîné par ultrasons (par exemple, scalpels chirurgicaux, phacoémulseurs, instruments à détartrer dentaires ou lithotriteurs intracorporels); • les appareils avec lesquels les ondes ultrasonores sont destinées à sensibiliser les tissus à d’autres thérapies (par exemple, rayonnement ou chimiothérapie); • les appareils avec lesquels les ondes ultrasonores sont destinées à traiter les tissus cancéreux (c’est-à-dire malins) ou précancéreux, voire les masses bénignes. Il s’agit par exemple des ultrasons focalisés de haute intensité (HIFU, high intensity focused ultrasound) ou des ultrasons thérapeutiques de haute intensité (HITU, high intensity therapeutic ultrasound).

Ultrazvok - Fizioterapevtski sistemi - Poljske specifikacije in merilne metode v frekvenčnem območju od 20 kHz do 500 kHz (IEC 63009:2019)

Ta standard se navezuje na ultrazvočno opremo, namenjeno fizioterapiji, ki vključuje ultrazvočni pretvornik za ustvarjanje ultrazvoka v frekvenčnem območju od 20 kHz do 500 kHz. Ta dokument 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 dokument določa: – metode merjenja in karakterizacije izhoda ultrazvočne fizioterapevtske opreme na podlagi referenčnih preskusnih metod; – lastnosti, ki jih morajo navesti proizvajalci ultrazvočne fizioterapevtske opreme; – metode merjenja in karakterizacije izhoda ultrazvočne fizioterapevtske opreme na podlagi rutinskih preskusnih metod; – kriterije sprejemljivosti za vidike izhoda ultrazvočne fizioterapevtske opreme. Ta dokument ne zajema terapevtske vrednosti in metod uporabe opreme za ultrazvočno fizioterapijo. Izključena oprema med drugim zajema: – opremo, pri kateri so ultrazvočni valovi namenjeni uničenju konglomeratov (na primer kamnov v ledvicah ali mehurju) ali kakršnih koli tkiv; – opremo, pri kateri ultrazvok poganja orodje (na primer kirurški skalpeli, fakoemulzifikatorji, priprave za odstranjevanje zobnega kamna ali znotrajtelesni litotripterji); – opremo, pri kateri so ultrazvočni valovi namenjeni senzibilizaciji tkiva za nadaljnje zdravljenje (na primer obsevanje ali kemoterapijo); – opremo, pri kateri so ultrazvočni valovi namenjeni zdravljenju rakavih (tj. malignih) ali predrakavih tkiv ali benignih gmot, kot je izjemno intenziven in osredotočen ultrazvok (HIFU) ali izjemno intenziven terapevtski ultrazvok (HITU).

General Information

• Status: Published
• Publication Date: 19-Sep-2019
• Withdrawal Date: 14-Aug-2022
• ICS: 11.040.60 - Therapy equipment
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/SR 87 - CLC/SR 87
• Drafting Committee: IEC/TC 87 - IEC_TC_87
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 20-Sep-2019
• Completion Date: 20-Sep-2019
• Ref Project: SIST EN IEC 63009:2020 - Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz (IEC 63009:2019)

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2020
Ultrazvok - Fizioterapevtski sistemi - Poljske specifikacije in merilne metode v
frekvenčnem območju od 20 kHz do 500 kHz (IEC 63009:2019)
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement
in the frequency range 20 kHz to 500 kHz (IEC 63009:2019)
Ultraschall - Physiotherapiesysteme - Feldspezifikationen und Messmethoden im
Frequenzbereich 20 kHz bis 500 kHz (IEC 63009:2019)
Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de
mesure dans la plage de fréquences de 20 kHz à 500 kHz (IEC 63009:2019)
Ta slovenski standard je istoveten z: EN IEC 63009:2019
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 63009

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2019
ICS 17.140.50; 11.040.60
English Version
Ultrasonics - Physiotherapy systems - Field specifications and
methods of measurement in the frequency range 20 kHz to 500
kHz
(IEC 63009:2019)
Ultrasons - Systèmes de physiothérapie - Spécifications Ultraschall - Physiotherapiesysteme - Feldspezifikationen
des champs et méthodes de mesure dans la plage de und Messmethoden im Frequenzbereich 20 kHz bis 0,5
fréquences de 20 kHz à 500 kHz MHz
(IEC 63009:2019) (IEC 63009:2019)
This European Standard was approved by CENELEC on 2019-08-15. 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
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63009:2019 E
European foreword
The text of document 87/705/CDV, future edition 1 of IEC 63009, 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) 2020-05-15
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-08-15
document have to be withdrawn
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.

Endorsement notice
The text of the International Standard IEC 63009:2019 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 61689:2013 NOTE Harmonized as EN 61689:2013 (not modified)
IEC 61161 NOTE Harmonized as EN 61161
IEC 62127-3 NOTE Harmonized as EN 62127-3
IEC 62555 NOTE Harmonized as EN 62555

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 60565 -  Underwater acoustics - Hydrophones - Calibration in EN 60565 -
the frequency range 0,01 Hz to 1 MHz
IEC 60601-2-5 -  Medical electrical equipment - Part 2-5: Particular EN 60601-2-5 -
requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment
IEC 62127-1 -  Ultrasonics - Hydrophones - Part 1: Measurement EN 62127-1 -
and characterization of medical ultrasonic fields up to
40 MHz
IEC 62127-2 -  Ultrasonics - Hydrophones - Part 2: Calibration for EN 62127-2 -
ultrasonic fields up to 40 MHz

IEC 63009 ®
Edition 1.0 2019-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Physiotherapy systems – Field specifications and methods of

measurement in the frequency range 20 kHz to 500 kHz

Ultrasons – Systèmes de physiothérapie – Spécifications des champs et

méthodes de mesure dans la plage de fréquences de 20 kHz à 500 kHz

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50; 11.040.60 ISBN 978-2-8322-7153-7

– 2 – IEC 63009:2019  IEC 2019
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Symbols . 17
5 Ultrasonic field specifications . 18
6 Conditions of measurement and test equipment used for field measurements . 19
6.1 General . 19
6.2 Test vessel . 20
6.3 Hydrophone . 20
6.4 RMS or peak signal measurement . 20
7 Type testing reference procedures and measurements . 21
7.1 General . 21
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
A.1 General . 27
A.2 Rated output power . 27
A.3 Effective intensity. 27
A.4 Beam non-uniformity ratio . 27
A.4.1 General . 27
A.4.2 Rationale behind using a limiting value for the beam non-uniformity
ratio, R . 27
BN
Annex B (normative) Raster scan measurement and analysis procedures . 30
B.1 General . 30
B.2 Requirements for raster scans . 30
B.3 Requirements for analysis of raster scan data . 30
B.3.1 General . 30
B.3.2 Total mean square acoustic pressure . 31
B.3.3 Calculation of the beam cross-sectional area, A . 31
BCS
IEC 63009:2019  IEC 2019 – 3 –
Annex C (normative) Diametrical (line) scan measurement and analysis procedures. 32
C.1 General . 32
C.2 Requirements for line scans . 32
C.3 Analysis of line scans . 32
Bibliography . 35

Table C.1 – Constitution of the transformed array [B] used for the analysis of half-line
scans . 33

– 4 – IEC 63009:2019  IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – PHYSIOTHERAPY SYSTEMS – FIELD SPECIFICATIONS
AND METHODS OF MEASUREMENT IN THE FREQUENCY
RANGE 20 kHz TO 500 kHz
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
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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
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