EN IEC 63009-2019 pdf download.Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz (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 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).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60565, Underwater acoustics – Hydrophones – Calibration in the frequency range 0,01 Hz to 1 MHz
IEC 60601 -2-5, Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 621 27-1 , Ultrasonics – Hydrophones – Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
IEC 621 27-2, Ultrasonics – Hydrophones – Part 2: Calibration for ultrasonic fields up to
40 MHz
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1 absolute maximum rated output power
sum of the rated output power, the 95 % confidence overall uncertainty in the rated output power, and the maximum increase in the rated output power for a ±1 0 % variation in the rated value of the mains voltage
Note 1 to entry: The possibility of variation in the rated output power resulting from ±1 0 % variation in the rated value of the mains voltage should be checked by using a variable output transformer between the mains voltage supply and the ultrasonic physiotherapy equipment. See Clause A.2 for further guidance.
Note 2 to entry: Absolute maximum rated output power is expressed in watts (W).
[SOURCE: IEC 61 689:201 3, 3.1 ]
3.2 active area coefficient
Q quotient of the active area gradient, m, and the beam cross-sectional area at 0,3 cm from the face of the treatment head, A BCS (0,3)
Note 1 to entry: Active area coefficient is expressed in units of one per metre (m –1 ).
[SOURCE: IEC 61 689:201 3, 3.2].EN IEC 63009 pdf download.