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BS EN IEC 61689:2022

BS EN IEC 61689:2022

$215.11

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 72
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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
2 undefined
5 Annex ZA (normative)Normative references to international publicationswith their corresponding European publications
6 Blank Page
7 English
CONTENTS
10 FOREWORD
12 INTRODUCTION
13 1 Scope
2 Normative references
14 3 Terms and definitions
23 4 Symbols
24 5 Ultrasonic field specifications
25 6 Conditions of measurement and test equipment used
6.1 General
6.2 Test vessel
26 6.3 Hydrophone
27 6.4 RMS peak signal measurement
7 Type testing reference procedures and measurements
7.1 General
28 7.2 Rated output power
7.3 Hydrophone measurements
29 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
30 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
31 7.5 Reference type testing parameters
7.6 Acceptance criteria for reference type testing
32 8 Routine measurement procedure
8.1 General
8.2 Rated output power
8.3 Effective radiating area
8.4 Beam non-uniformity ratio
33 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
34 9.3 Uncertainty determination
35 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)
38 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
39 Figure A.2 – Histogram of RBN values for 37 treatment heads of various diameters and frequencies
40 Annex B (normative) Raster scan measurement and analysis procedures
B.1 General
B.2 Requirements for raster scans
41 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
42 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
44 Tables
Table C.1 – Constitution of the transformed array [B] used for the analysis of half-line scans
46 Annex D (informative) Rationale concerning the beam cross-sectional area definition
47 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)
48 Figure E.1 – Conversion factor Fac as a function of the ka product for ka product between 40 and 160
49 Annex F (informative) Determining acoustic power through radiation force measurements
50 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])
51 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
52 Annex H (informative) Influence of hydrophone effective diameter
53 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
54 Annex I (informative) Effective radiating area measurements using a radiation force balance and absorbing apertures
I.1 General
I.2 Concept of aperture method
55 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
56 I.4 Measurement procedure for determining the effective radiating area
57 I.5 Analysis of raw data to derive the effective radiating area
58 Table I.1 – Aperture measurement check sheet
59 Figure I.2 – Measured power as a function of aperture diameter for commercially available 1 MHz physiotherapy treatment heads
60 Table I.2 – Annular power contributions
Table I.3 – Annular intensity contributions
61 Table I.4 – Annular intensity contributions, sorted in descending order
Table I.5 – Annular power contributions, sorted in descending order of intensity contribution
62 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
63 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
64 I.7 Relationship of results to reference testing method
65 Annex J (informative) Guidance on uncertainty determination
67 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
68 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)
69 Bibliography

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