UNE EN IEC 63009:2019
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz (Endorsed by Asociación Española de Normalización in November of 2019.)
Ultrasonidos. Sistemas de fisioterapia. Especificaciones de campo y métodos de medición en el rango de frecuencia de 20 kHz a 0,5 MHz (Ratificada por la Asociación Española de Normalización en noviembre de 2019.)
| Standard number: | UNE EN IEC 63009:2019 |
| Pages: | 45 |
| Released: | 2019-11-01 |
| Status: | Standard |
UNE EN IEC 63009:2019
This International Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz. 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; " 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. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard. 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).
