CEI EN IEC 63009 PDF

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 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).