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IEC 63009-ed.1.0
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz
Translate name
STANDARD published on 11.7.2019
The information about the standard:
Designation standards: IEC 63009-ed.1.0
Publication date standards: 11.7.2019
SKU: NS-953667
The number of pages: 73
Approximate weight : 219 g (0.48 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 63009-ed.1.0 :
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). LIEC 63009:2019 est applicable aux appareils a ultrasons, concus pour la physiotherapie, comprenant un transducteur ultrasonique fournissant des ultrasons dans la plage de frequences de 20 kHz a 500 kHz. Le present document ne traite que des appareils a ultrasons pour physiotherapie employant un seul transducteur circulaire plan sans focalisation par transducteur, produisant des faisceaux statiques perpendiculaires a la face du transducteur. Le present document specifie: • les methodes de mesure et la caracterisation de la sortie des appareils a ultrasons pour physiotherapie, reposant sur des methodes d’essai de reference; • les caracteristiques a preciser par les fabricants des appareils a ultrasons pour physiotherapie; • les methodes de mesure et la caracterisation de la sortie des appareils a ultrasons pour physiotherapie, reposant sur des methodes d’essai de routine; • les criteres d’aptitude concernant les divers aspects de la sortie des appareils a ultrasons pour physiotherapie. La valeur therapeutique et les modes d’utilisation des appareils a ultrasons pour physiotherapie ne relevent pas du domaine d’application du present document. Les appareils exclus comprennent entre autres: • les appareils avec lesquels les ondes ultrasonores sont destinees a detruire des conglomerats (par exemple, des calculs renaux ou biliaires) ou des tissus de tout type; • les appareils avec lesquels un outil est entraine par ultrasons (par exemple, scalpels chirurgicaux, phacoemulseurs, instruments a detartrer dentaires ou lithotriteurs intracorporels); • les appareils avec lesquels les ondes ultrasonores sont destinees a sensibiliser les tissus a d’autres therapies (par exemple, rayonnement ou chimiotherapie); • les appareils avec lesquels les ondes ultrasonores sont destinees a traiter les tissus cancereux (c’est-a-dire malins) ou precancereux, voire les masses benignes. Il s’agit par exemple des ultrasons focalises de haute intensite (HIFU, high intensity focused ultrasound) ou des ultrasons therapeutiques de haute intensite (HITU, high intensity therapeutic ultrasound).
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