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IEC 63045:2020

Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields

Edition date: 2020-05-25
In Force
Available languages: English, French
Summary: IEC 63045:2020 is applicable to
– therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses;
– therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy,
where the pressure pulses are released as single events of duration up to 25 µs.
This document does not apply to
– therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment;
– therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies
– measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field,
– methods of measurement and characterization of non-focused or weakly focused pressure pulse fields.
This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see IEC 60601 2-62 and IEC TR 62649).

L'IEC 63045:2020 s’applique
– à l’appareil de traitement utilisant des impulsions de pression faiblement ou non focalisées générées de manière extracorporelle;
– à l’appareil de traitement produisant une énergie mécanique faiblement ou non focalisée générée de manière extracorporelle;
lorsque les impulsions de pression sont délivrées de manière unitaire pendant une durée allant jusqu’à 25 µs.
Le présent document ne s’applique pas
– à l’appareil de traitement utilisant des sources d’impulsions de pression focalisées tel que l’appareil de lithotritie extracorporelle;
– à l’appareil de traitement utilisant d’autres formes d'ondes acoustiques comme l’appareil de physiothérapie, l’appareil à ultrasons de basse intensité et l’appareil à ultrasons focalisés de haute intensité (HIFU, high intensity focussed ultrasounds) ou l’appareil à ultrasons thérapeutiques de haute intensité (HITU, high intensity therapeutic ultrasound).
Le présent document spécifie
– les paramètres mesurables qui sont utilisés dans la déclaration de la production acoustique des appareils extracorporels qui produisent un champ d'impulsions de pression faiblement ou non focalisées ,
– les méthodes de mesure et de caractérisation du champ de pression généré par les champs d’impulsions de pression faiblement ou non focalisées.
Le présent document a été élaboré pour les appareils dont l’utilisation prévue est la thérapie par impulsions de pression, par exemple le traitement des douleurs orthopédiques telles que les douleurs de l’épaule, les douleurs d’épicondylite, les douleurs de l’épine calcanéenne, le traitement musculaire des points de fibromyalgie, les douleurs lombaires, etc. Il n’est pas destiné à être utilisé pour l’appareil de lithotritie extracorporelle (comme cela est décrit dans l’IEC 61846), l’appareil de physiothérapie utilisant d’autres formes d’ondes (comme cela est décrit dans l’IEC 61689) et l’appareil HIFU/HITU (voir l’IEC 60601 2-62 et l’IEC TR 62649).
ICS: 17.140.50-Electroacoustics
CTN: TC 87 - 1281

Otras Relaciones

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