EN IEC 63009:2019 pdf download

EN IEC 63009:2019 pdf download.ULTRASONICS – PHYSIOTHERAPY SYSTEMS – FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 20 kHz TO 500 kHz
1 Scope
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).
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] 3.3 active area gradient m ratio of the difference of the beam cross-sectional area at z N , A BCS (z N ), and the beam cross-sectional area at 0,3 cm from the face of the treatment head, A BCS (0,3), divided by the difference of the respective distances 3.4 absolute maximum beam non-uniformity ratio beam non-uniformity ratio plus the 95 % confidence overall uncertainty in the beam non- uniformity ratio [SOURCE: IEC 61 689:201 3, 3.4] 3.5 absolute maximum effective intensity value of the effective intensity corresponding to the absolute maximum rated output power and the absolute minimum effective radiating area from the equipment [SOURCE: IEC 61 689:201 3, 3.5] 3.6 absolute minimum effective radiating area effective radiating area minus the 95 % confidence overall uncertainty in the effective radiating area [SOURCE: IEC 61 689:201 3, 3.6] 3.7 acoustic working frequency f awf frequency of an acoustic signal based on the observation of the output of a hydrophone placed in an acoustic field at the position corresponding to the spatial-peak temporal-peak acoustic pressure or 0,3 cm, whichever is greater Note 1 to entry: The signal is analysed using either the zero-crossing acoustic-working frequency technique or a spectrum analysis method. Acoustic-working frequencies are defined in 3.7.1 and 3.7.2. Note 2 to entry: In a number of cases the present definition is not very helpful or convenient, especially for broadband transducers. In that case a full description of the frequency spectrum should be given in order to enable any frequency-dependent correction to the signal.