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BS EN IEC 63009:2019

BS EN IEC 63009:2019

$167.15

Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz

Published By Publication Date Number of Pages
BSI 2019 42
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IEC 63009:2019 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).

PDF Catalog

PDF Pages PDF Title
2 National foreword
5 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
6 English
CONTENTS
8 FOREWORD
10 INTRODUCTION
11 1 Scope
2 Normative references
12 3 Terms and definitions
21 4 Symbols
22 5 Ultrasonic field specifications
23 6 Conditions of measurement and test equipment used for field measurements
6.1 General
24 6.2 Test vessel
6.3 Hydrophone
6.4 RMS or peak signal measurement
25 7 Type testing reference procedures and measurements
7.1 General
7.2 Rated output power
7.3 Hydrophone measurements
26 7.4 Effective radiating area
27 7.5 Reference type testing parameters
28 7.6 Acceptance criteria for reference type testing
8 Routine measurement procedure
8.1 General
8.2 Rated output power
29 8.3 Effective radiating area
8.4 Beam non-uniformity ratio
8.5 Effective intensity
8.6 Acceptance criteria for routine testing
30 9 Sampling and uncertainty determination
9.1 Reference type testing measurements
9.2 Routine measurements
9.3 Uncertainty determination
31 Annex A (informative) 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
34 Annex B (normative)Raster scan measurement and analysis procedures
B.1 General
B.2 Requirements for raster scans
B.3 Requirements for analysis of raster scan data
B.3.1 General
35 B.3.2 Total mean square acoustic pressure
B.3.3 Calculation of the beam cross-sectional area, ABCS
36 Annex C (normative)Diametrical (line) scan measurement and analysis procedures
C.1 General
C.2 Requirements for line scans
C.3 Analysis of line scans
37 Table C.1 – Constitution of the transformed array [B] used for the analysis of half-line scans
39 Bibliography

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BS EN IEC 63009:2019
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