EN 61846:1998
(Main)Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
Applies to - lithotripsy equipment using extracorporeally induced pressure waves; - lithotripsy equipment producing focused mechanical energy. Specifies - measurable parameters which could be used in the declaration of the acoustic output of extracorporeal lithotripsy equipment, - methods of measurement and characterization of the pressure field generated by lithotripsy equipment.
Ultraschall - Druckpuls-Lithotripter - Feldcharakterisierung
Ultrasons - Lithotripteurs à ondes de pression - Caractérisation des champs
Ultrasonics - Pressure pulse lithotripters -Characteristics of field (IEC 61846:1998)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ultrasonics - Pressure pulse lithotripters -Characteristics of field (IEC 61846:1998)Ultraschall - Druckpuls-Lithotripter - FeldcharakterisierungUltrasons - Lithotripteurs à ondes de pression - Caractérisation des champsUltrasonics - Pressure pulse lithotripters - Characteristics of fields17.140.50ElektroakustikaElectroacoustics11.040.50Radiografska opremaRadiographic equipmentICS:Ta slovenski standard je istoveten z:EN 61846:1998SIST EN 61846:2002en01-september-2002SIST EN 61846:2002SLOVENSKI
STANDARD
INTERNATIONALSTANDARDIEC61846First edition1998-04Ultrasonics –Pressure pulse lithotripters –Characteristics of fieldsUltrasons –Lithotripteurs à ondes de pression –Caractérisation des champs Commission Electrotechnique Internationale International Electrotechnical
Commission IEC 1998
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catalogueSIST EN 61846:2002
– 2 –61846 © IEC:1998(E)CONTENTSPageFOREWORD.3INTRODUCTION.4Clause1 Scope.52 Normative references.53 Definitions.64 List of symbols.105 Conditions of measurement.106 Test equipment.116.1Test chamber.116.2Hydrophone.116.3Voltage measurement.127 Measurement procedure.127.1Spatial measurements.127.2Temporal measurements.147.3Acoustic energy measurements.14AnnexesAAcoustic wave lithotripsy.16BTypes of pressure wave transducers.18CField measurement.20DBibliography.25SIST EN 61846:2002
61846 © IEC:1998(E)– 3 –INTERNATIONAL ELECTROTECHNICAL COMMISSION___________ULTRASONICS –PRESSURE PULSE LITHOTRIPTERS –CHARACTERISTICS OF FIELDSFOREWORD1)The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprisingall national electrotechnical committees (IEC National Committees). The object of the IEC is to promoteinternational co-operation on all questions concerning standardization in the electrical and electronic fields. Tothis end and in addition to other activities, the IEC publishes International Standards. Their preparation isentrusted to technical committees; any IEC National Committee interested in the subject dealt with mayparticipate in this preparatory work. International, governmental and non-governmental organizations liaisingwith the IEC also participate in this preparation. The IEC collaborates closely with the International Organizationfor Standardization (ISO) in accordance with conditions determined by agreement between the twoorganizations.2)The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, aninternational consensus of opinion on the relevant subjects since each technical committee has representationfrom all interested National Committees.3)The documents produced have the form of recommendations for international use and are published in the formof standards, technical reports or guides and they are accepted by the National Committees in that sense.4)In order to promote international unification, IEC National Committees undertake to apply IEC InternationalStandards transparently to the maximum extent possible in their national and regional standards. Anydivergence between the IEC Standard and the corresponding national or regional standard shall be clearlyindicated in the latter.5)The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for anyequipment declared to be in conformity with one of its standards.6)Attention is drawn to the possibility that some of the elements of this International Standard may be the subjectof patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 61846 has been prepared by IEC technical committee 87:Ultrasonics.The text of this standard is based on the following documents:FDISReport on voting87/115/FDIS87/118/RVDFull information on the voting for the approval of this standard can be found in the report onvoting indicated in the above table.Annexes A, B, C and D are for information only.In this standard, the following print types are used:–requirements and definitions: in roman type;–NOTES: in smaller roman type;–compliance: in italic type;–terms used throughout this standard which have been defined in clause 3: small caseroman bold type.A bilingual version of this standard may be issued at a later date.SIST EN 61846:2002
– 4 –61846 © IEC:1998(E)INTRODUCTIONExtracorporeal lithotripsy is used for the clinical treatment of renal, ureteric and biliary stones.Lithotripsy employs high-intensity acoustic waves to produce disintegration of the stonesthrough a process of sequential application of pressure waves. Several different forms oflithotripsy equipment are now commercially available from a number of manufacturers.This International Standard specifies methods of measuring and characterizing the acousticpressure field generated by lithotripsy equipment.SIST EN 61846:2002
61846 © IEC:1998(E)– 5 –ULTRASONICS –PRESSURE PULSE LITHOTRIPTERS –CHARACTERISTICS OF FIELDS1 ScopeThis International Standard is applicable to–lithotripsy equipment using extracorporeally induced pressure waves;–lithotripsy equipment producing focused mechanical energy.This International Standard does not apply to percutaneous and laser lithotripsy equipment.This International Standard specifies–measurable parameters which could be used in the declaration of the acoustic output ofextracorporeal lithotripsy equipment,–methods of measurement and characterization of the pressure field generated bylithotripsy equipment.NOTE – The parameters defined in this International Standard do not – at the present time – allow quantitativestatements to be made about effectiveness and possible hazard. In particular, it is not possible to make astatement about the limits for these effects.While this particular standard has been developed for equipment intended for use inlithotripsy, it has been developed such that, as long as no other specific standards areavailable to be used for other medical applications of therapeutic extracorporeal pressurepulse equipment, this standard may be used as a guideline.2 Normative referencesThe following normative documents contain provisions which, through reference in this text,constitute provisions of this International Standard. At the time of publication, the editionsindicated were valid. All normative documents are subject to revision, and parties toagreements based on this International Standard are encouraged to investigate the possibilityof applying the most recent editions of the normative documents indicated below. Members ofIEC and ISO maintain registers of currently valid International Standards.IEC 60050(801):1994, International Electrotechnical Vocabulary (IEV) – Chapter 801: Acousticsand electroacousticsIEC 60866:1987, Characteristics and calibration of hydrophones for operation in the frequencyrange 0,5 MHz to 15 MHzIEC 61102:1991, Measurement and characterisation of ultrasonic fields using hydrophones inthe frequency range 0,5 MHz to 15 MHzSIST EN 61846:2002
– 6 –61846 © IEC:1998(E)3 DefinitionsFor the purpose of this International Standard, the following definitions apply.3.1 acoustic pulse energy3.1.1derived acoustic pulse energyspatial integral of the derived pulse-intensity integral over a circular cross-sectional area ofradius R in the x-y plane which contains the focusSymbol: ERUnit: joule, J3.1.2derived focal acoustic pulse energyspatial integral of the derived pulse-intensity integral over the focal cross-sectional areaSymbol: EfUnit: joule, JNOTE – This definition may overestimate E if the aperture of the pressure pulse generator is large.3.2beam axisline passing through the geometric centre of the aperture of the pressure pulse generator andthe focusNOTE – This line is taken as the z axis. See 6.1 and clause 7.3.3compressional pulse durationtime interval beginning at the first time the instantaneous acoustic pressure exceeds 50 % ofthe peak-positive acoustic pressure and ending at the next time the instantaneousacoustic pressure has that value (see figure C.1)Symbol: tFWHMp+ Unit: second, sNOTE – The subscript "FWHM" stands for "full width, half maximum".3.4derived pulse-intensity integraltime integral of the instantaneous intensity at a particular point in a pressure pulse field overthe pressure pulse waveform (see 3.31 of IEC 61102)Symbol: PIIUnit: joule per metre squared, J/m23.5end-of-cable loaded sensitivity of a hydrophoneratio of the voltage at the end of any integral cable or connector of a hydrophone, whenconnected to a specified electrical input impedance, to the instantaneous acoustic pressurein the undisturbed free field of a plane wave in the position of the acoustic centre of thehydrophone if the hydrophone were removed (see 3.14 of IEC 61102)Symbol: MLUnit: volt per pascal, V Pa–1SIST EN 61846:2002
61846 © IEC:1998(E)– 7 –3.6focal cross-sectional areaarea of the peak-compressional acoustic pressure contour which is –6 dB relative to thevalue at the focus and is in the plane, perpendicular to the beam axis, which contains thefocusSymbol: AfUnit: metre squared, m23.7focal extentshortest distance along the z axis that connects points on the –6 dB contour of peak-positiveacoustic pressure in the x-z plane on either side of the focusSymbol: fzUnit: metre, m3.8focal volumevolume in space contained within the surface defined by the –6 dB (relative to the value at thefocus) peak-compressional acoustic pressure contours measured around the focusSymbol: Vf Unit: metre cubed, m3NOTE – It is difficult to measure –6 dB points throughout the volume around the focus. It is reasonable in practiceto approximate the focal volume from measurements taken in three orthogonal directions: the beam axis (z axis);the direction of maximum beam diameter (x axis); the axis perpendicular to the x axis (y axis).3.9focal width, maximummaximum width of the –6 dB contour of p+ around the focus in the x-y plane which containsthe focusSymbol: fxUnit: metre, m3.10focal width, orthogonalwidth of the –6 dB contour of p+ around the focus, in the x-y plane which contains the focus,in the direction perpendicular to fxSymbol: fyUnit: metre, m3.11focuslocation in the pressure pulse field of the maximum peak-positive acoustic pressure3.12hydrophonetransducer that produces electrical signals in response to waterborne acoustic signals[IEV 801-32-26] (see also IEC 60866)SIST EN 61846:2002
– 8 –61846 © IEC:1998(E)3.13instantaneous acoustic pressurepressure minus the ambient pressure at a particular instant in time and at a particular point inan acoustic field (see also 801-21-19 of IEC 60050(801))Symbol: pUnit: pascal, Pa3.14instantaneous intensityacoustic energy transmitted per unit time in the direction of acoustic wave propagation per unitarea normal to this direction at a particular instant in time and at a particular point in anacoustic fieldFor measurement purposes referred to in this standard, where far-field conditions may beassumed, the instantaneous intensity, I, is expressed as:IpZ=2wherepis the instantaneous acoustic pressure;Zis the characteristic acoustic impedance of the medium.(See also 3.21 of IEC 61102.)Symbol: IUnit: watt per metre squared, W/m23.15lithotripsy equipmentdevice for disintegrating calculi and other concretions within the bodyNOTE – Known applications include renal stones, gallstones, pancreatic duct stones, salivary stones, orthopaedicpain and calcification in tendons.3.16peak-negative acoustic pressure, peak-rarefactional acoustic pressuremaximum of the modulus of the rarefactional acoustic pressure at any spatial location in thepressure pulse field (see 3.26 of IEC 61102)Symbol: p– Unit: pascal, Pa3.17peak-positive acoustic pressure, peak-compressional acoustic pressuremaximum compressional acoustic pressure at any spatial location in the pressure pulse field(see 3.27 of IEC 61102)Symbol: p+Unit: pascal, Pa3.18pressure pulseacoustic wave emitted by the lithotripsy equipmentSIST EN 61846:2002
61846 © IEC:1998(E)– 9 –3.19pressure pulse waveformtemporal waveform of the instantaneous acoustic pressure at a specified position in apressure pulse field and displayed over a period sufficiently long to include all significantacoustic information in the pressure pulse3.20pulse-pressure-squared integraltime integral of the square of the instantaneous acoustic pressure over the p
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