BS EN IEC 63045:2020
$198.66
Ultrasonics. Non-focusing short pressure pulse sources including ballistic pressure pulse sources. Characteristics of fields
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 68 |
IEC 63045:2020 is applicable to – therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses; – therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy, where the pressure pulses are released as single events of duration up to 25 µs. This document does not apply to – therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment; – therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment. This document specifies – measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field, – methods of measurement and characterization of non-focused or weakly focused pressure pulse fields. This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see IEC 60601 2-62 and IEC TR 62649).
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 5 | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications |
| 8 | CONTENTS |
| 11 | FOREWORD |
| 13 | INTRODUCTION |
| 14 | 1 Scope 2 Normative references |
| 15 | 3 Terms and definitions |
| 26 | 4 List of symbols |
| 28 | 5 Conditions of measurement 5.1 General 5.2 Measurements in the water test chamber 5.3 Measurements in the dry test bench 6 Test equipment 6.1 Water test chamber |
| 29 | 6.1.1 Coordinate system 6.1.2 Hydrophone for water test chamber measurements 6.1.3 Hydrophone for pressure pulse measurements |
| 30 | 6.2 Dry test bench 6.3 Voltage measurement 6.3.1 Oscilloscope or transient recorder |
| 31 | 6.3.2 Pressure pulse waveform recording 7 Measurement procedure Figures Figure 1 – Typical pressure pulse waveform at 2 mm distancefrom a ballistic pressure pulse source |
| 32 | 7.1 Measurement procedure in the water test chamber 7.1.1 General 7.1.2 Spatial measurements |
| 33 | Figure 2 – Typical pressure distribution along the beamaxis of a non-focusing pressure pulse source |
| 34 | 7.1.3 Non-focusing source Figure 3 – Typical pressure distribution along the beam axisof a weakly focusing pressure pulse source |
| 35 | 7.1.4 Weakly focusing source 7.1.5 Beam plots of peak-positive acoustic pressure 7.1.6 Beam plots of peak-negative acoustic pressure |
| 36 | 7.1.7 Measurement centre point and beam axis 7.1.8 Beam width measurements Figure 4 – Typical lateral pressure distributions of pc at the beampressure maximum of two ballistic pressure pulse sources |
| 37 | 7.1.9 Beam pressure maximum extent measurements 7.1.10 Beam cross-sectional area and beam pressure maximum cross-sectional area 7.1.11 Beam pressure maximum volume measurements 7.1.12 Beam volume 7.2 Temporal measurements |
| 38 | 7.3 Acoustic energy measurements 7.3.1 General 7.3.2 Pulse-pressure-squared integral 7.3.3 Derived pulse-intensity integral 7.3.4 Derived beam −n dB pressure maximum acoustic pulse energy |
| 39 | 7.3.5 Derived acoustic pulse energy 7.4 Dry test bench measurements |
| 40 | Annex A (informative) Acoustic pressure pulse therapy A.1 Background A.1.1 General A.1.2 Development of relevant measurement standard A.1.3 Current knowledge on biomedical effects A.1.4 Availability of clinical and technical data |
| 41 | A.2 Other treatment devices and methods not subject to this document A.2.1 Percutaneous continuous and modulated wave systems A.2.2 Extracorporeal shock wave lithotripsy A.2.3 Further exclusions |
| 42 | Annex B (informative)Types of pressure pulse transducers B.1 Overview B.1.1 General B.1.2 Principle of ballistic pressure pulse sources B.1.3 Rail gun principle |
| 43 | B.1.4 Further generation principles B.2 Non-focusing and focusing transducers |
| 44 | B.3 Examples of pressure pulse sources and their parameter sets |
| 45 | Figure B.1 – Applicator directly coupled to the patient Figure B.2 – Pressure pulse source, non-symmetric (linear),directly coupled to the patient |
| 46 | Figure B.3 – Pressure pulse source, symmetric, distant from the patient Figure B.4 – Applicatorcoupled to patient Figure B.5 – Non-focusedpressure pulse field |
| 47 | Figure B.6 – Non-focused pressure pulse field -n dB parameters (example: n = 6) Figure B.7 – Non-focused pressure pulse field isobars |
| 48 | Figure B.8 – Weakly-focused pressure pulse field −6 dB contour and parameters Figure B.9 – Weakly-focused pressure pulse field volume and isobar parameters |
| 49 | B.4 Positioning and targeting methods Figure B.10 – Weakly-focused pressure pulse field parameters |
| 50 | Annex C (informative)Field measurement C.1 Measurement probes and hydrophones |
| 51 | Tables Table C.1 – Hydrophone types for pressure pulse measurements |
| 52 | C.2 Water test chamber C.2.1 General C.2.2 Degassing procedures C.3 Dry test bench C.3.1 General Table C.2 – Measurement techniques and probes for quality assurance purposes |
| 53 | Figure C.1 – Design example of a dry test bench in two views |
| 54 | C.3.2 Selection and attachment of the hydrophone Figure C.2 – Detail of the measurement chamber item of the dry test bench |
| 55 | C.3.3 Attachment of the hand piece C.3.4 Proof of the similarity of measurements in water and the dry test bench C.3.5 Special measurements with the dry test bench |
| 56 | C.4 Acoustic pulse energy C.4.1 General |
| 57 | C.4.2 Extrapolation of the applicator surface pressure value |
| 58 | Annex D (informative)Lists of parameters Table D.1 – List of device parameters |
| 59 | Table D.2 – Pressure pulse parameters |
| 61 | Table D.3 – Additional parameters useful for the correlation with biological effects |
| 62 | Table D.4 – Graphical representations of pressure pulse data |
| 63 | Table D.5 – Data of hydrophones and measurement conditions |
| 65 | Bibliography |
