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).

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).

General Information

• Status: Published
• Publication Date: 10-Jul-2019
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.60 - Therapy equipment
• ICS: 17.140.50 - Electroacoustics
• ICS: 29.060.10 - Wires
• Technical Committee: TC 87 - Ultrasonics
• Drafting Committee: WG 8 - TC 87/WG 8
• Current Stage: PPUB - Publication issued
• Start Date: 12-Aug-2019
• Completion Date: 11-Jul-2019

Standards Content (Sample)

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

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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
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
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