BS EN IEC 61689:2022 – TC
$280.87
Tracked Changes. Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
| Published By | Publication Date | Number of Pages |
| BSI | 2022 | 164 |
This International Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. 211 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 based on reference testing methods; – guidelines for safety of the ultrasonic field generated by 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 224 based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30455899 |
| 93 | A-30431424 |
| 94 | undefined |
| 97 | Annex ZA (normative)Normative references to international publicationswith their corresponding European publications |
| 98 | Blank Page |
| 99 | English CONTENTS |
| 102 | FOREWORD |
| 104 | INTRODUCTION |
| 105 | 1 Scope 2 Normative references |
| 106 | 3 Terms and definitions |
| 115 | 4 Symbols |
| 116 | 5 Ultrasonic field specifications |
| 117 | 6 Conditions of measurement and test equipment used 6.1 General 6.2 Test vessel |
| 118 | 6.3 Hydrophone |
| 119 | 6.4 RMS peak signal measurement 7 Type testing reference procedures and measurements 7.1 General |
| 120 | 7.2 Rated output power 7.3 Hydrophone measurements |
| 121 | 7.4 Effective radiating area 7.4.1 Effective radiating area measurements 7.4.2 Hydrophone positioning 7.4.3 Beam cross-sectional area determination 7.4.4 Active area gradient determination |
| 122 | 7.4.5 Beam type determination 7.4.6 Effective radiating area calculation 7.4.7 Beam non-uniformity ratio calculation 7.4.8 Testing requirements |
| 123 | 7.5 Reference type testing parameters 7.6 Acceptance criteria for reference type testing |
| 124 | 8 Routine measurement procedure 8.1 General 8.2 Rated output power 8.3 Effective radiating area 8.4 Beam non-uniformity ratio |
| 125 | 8.5 Effective intensity 8.6 Acceptance criteria for routine testing 9 Sampling and uncertainty determination 9.1 Reference type testing measurements 9.2 Routine measurements |
| 126 | 9.3 Uncertainty determination |
| 127 | Annexes Annex A (normative) Guidance for performance and safety A.1 General A.2 Rated output power A.3 Effective intensity A.4 Beam non-uniformity ratio A.4.1 General A.4.2 Rationale behind using a limiting value for the beam non-uniformity ratio (RBN) |
| 130 | Figures Figure A.1 – Normalized, time-averaged values of acoustic intensity (solid line) and of one of its plane-wave approximations (broken line), existing on the axis of a circular piston source of ka = 30, plotted against the normalized distance sn, where sn = λz/a2 |
| 131 | Figure A.2 – Histogram of RBN values for 37 treatment heads of various diameters and frequencies |
| 132 | Annex B (normative) Raster scan measurement and analysis procedures B.1 General B.2 Requirements for raster scans |
| 133 | B.3 Requirements for analysis of raster scan data B.3.1 General B.3.2 Total mean square acoustic pressure B.3.3 Calculation of the beam cross-sectional area, ABCS |
| 134 | Annex C (normative) Diametrical or line scan measurement and analysis procedures C.1 General C.2 Requirements for line scans C.3 Analysis of scans |
| 136 | Tables Table C.1 – Constitution of the transformed array [B] used for the analysis of half-line scans |
| 138 | Annex D (informative) Rationale concerning the beam cross-sectional area definition |
| 139 | Annex E (informative) Factor used to convert the beam cross-sectional area (ABCS) at the face of the treatment head to the effective radiating area (AER) |
| 140 | Figure E.1 – Conversion factor Fac as a function of the ka product for ka product between 40 and 160 |
| 141 | Annex F (informative) Determining acoustic power through radiation force measurements |
| 142 | Table F.1 – Necessary target size, expressed as the minimum target radius b, as a function of the ultrasonic frequency, f, the effective radius of the treatment head, a1, and the target distance, z, calculated in accordance with A.5.3.1 of IEC 61161:2013(see [8]) |
| 143 | Annex G (informative) Validity of low-power measurements of the beam cross-sectional area (ABCS) Table G.1 – Variation of the beam cross-sectional area ABCS(z) with the indicated output power from two transducers |
| 144 | Annex H (informative) Influence of hydrophone effective diameter |
| 145 | Table H.1 – Comparison of measurements of the beam cross-section alarea ABCS(z) made using hydrophones of geometrical active elemen tradii 0,3 mm, 0,5 mm and 2,0 mm |
| 146 | Annex I (informative) Effective radiating area measurements using a radiation force balance and absorbing apertures I.1 General I.2 Concept of aperture method |
| 147 | I.3 Requirements for the aperture method I.3.1 Radiation force balance I.3.2 Apertures Figure I.1 – Schematic representation of aperture measurement set-up |
| 148 | I.4 Measurement procedure for determining the effective radiating area |
| 149 | I.5 Analysis of raw data to derive the effective radiating area |
| 150 | Table I.1 – Aperture measurement check sheet |
| 151 | Figure I.2 – Measured power as a function of aperture diameter for commercially available 1 MHz physiotherapy treatment heads |
| 152 | Table I.2 – Annular power contributions Table I.3 – Annular intensity contributions |
| 153 | Table I.4 – Annular intensity contributions, sorted in descending order Table I.5 – Annular power contributions, sorted in descending order of intensity contribution |
| 154 | Table I.6 – Cumulative sum of annular power contributions, previously sorted in descending order of intensity contribution, and the cumulative sum of their respective annular areas |
| 155 | I.6 Implementation of the aperture technique Figure I.3 – Cumulative sum of annular power contributions, previously sorted in descending order of intensity contributions, plotted against the cumulative sum of their respective annular areas |
| 156 | I.7 Relationship of results to reference testing method |
| 157 | Annex J (informative) Guidance on uncertainty determination |
| 159 | Annex K (informative) Examples of pulse duration and pulse repetition period of amplitude modulated waves Figure K.1 – Example 1: Tone-burst (i.e. rectangular modulation waveform) Figure K.2 – Example 2: Half-wave modulation with no filtering of the AC mains voltage Figure K.3 – Example 3: Full-wave modulation with no filtering of the AC mains voltage |
| 160 | Figure K.4 – Example 4: Half-wave modulation with filtering of the AC mains voltage; filtering insufficient to define the wave as continuous wave (3.17) Figure K.5 – Example 5: Full-wave modulation with filtering of the AC mains voltage; filtering insufficient to define the wave as continuous wave (3.17) |
| 161 | Bibliography |
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