CLC/SR 87 - CLC/SR 87

IEC 63412-1:2024 specifies quantities and parameters which it is essential to provide to the user of shear-wave elastography systems, many in the image headers. This document is applicable to medical-diagnostic, ultrasonic shear-wave elastography systems, exciting (internally or externally) shear waves and tracking their propagation within biological tissue.

IEC 63305:2024 specifies methods and procedures for calibration of vector receivers in the frequency range 5 Hz to 10 kHz, which are applicable to vector receivers based on the two different principles. In addition, it describes an absolute method of inertial vector receiver calibration in air using optical interferometry. Usually, acoustic wave vector receivers are designed and constructed based on one of two principles. One is the sound pressure difference (gradient) principle. When measuring with this sensor, the vector receiver is rigidly fixed on a mount and supported in water. The other is the co-vibrating (inertial) principle. When measuring with this sensor, the vector receiver is suspended on a mount and supported in water in a non-rigid manner, which allows the vector receiver co-vibrate in the same direction as the sound particle in the sound wave field. Many methods have been used to calibrate vector receivers, such as free-field calibration, calibration in standing wave tube and calibration in a travelling wave tube.

IEC 62127-3:2022 is available as IEC 62127-3:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 62127-3:2022 specifies relevant hydrophone characteristics. This document is applicable to: - hydrophones employing piezoelectric sensor elements, designed to measure the pulsed and continuous wave ultrasonic fields generated by ultrasonic equipment; - hydrophones used for measurements made in water; - hydrophones with or without an associated pre-amplifier. IEC 62127-3:2022 cancels and replaces the first edition published in 2007 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition. a) The upper frequency limit of 40 MHz has been removed. b) Hydrophone sensitivity definitions have been changed to recognize sensitivities as complex-valued quantities. c) Procedures to determine the effective hydrophone size have been changed according to the rationale outlined in Annex B. d) Requirements on the frequencies for which the effective hydrophone size shall be provided have been changed to achieve practicality for increased frequency bands. e) The new Annex B and Annex C have been added. f) Annex A has been updated to reflect the changes of the normative parts.

IEC 60565-2:2019 specifies the methods for low frequency pressure calibration of hydrophones at frequencies from 0,01 Hz to several kilohertz depending on calibration method. IEC 60565-2:2019, together with IEC 60565-1, replaces the second edition of IEC 60565 published in 2006. This edition constitutes a technical revision. IEC 60565-2:2019 includes the following significant technical changes with respect to the previous edition. 1) IEC 60565 has been divided into two parts: • Part 1: Procedures for free-field calibration; • Part 2: Procedures for low frequency pressure calibration (this document). 2) A relative calibration method has been added to Clause 8: Calibration by piezoelectric compensation. 3) A relative calibration method has been added to Clause 11: Calibration by vibrating column. 4) Clause 12: Calibration by static pressure transducer, has been added. 5) Annex A: Equivalent circuit of the excitation system for calibration with a vibrating column, has been deleted. 6) Subclauses 9.6, 9.7 and 9.8 have been moved to form a new Annex A: Advanced acoustic coupler calibration methods.

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).

IEC 62127-1:2022 is available as IEC 62127-1:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 62127-1:2022 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment including bandwidth criteria and calibration frequency range requirements in dependence on the spectral content of the fields to be characterized. This document: - defines a group of acoustic parameters that can be measured on a physically sound basis; - defines a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters; - defines a measurement procedure that can be used for the determination of acoustic pressure parameters; - defines the conditions under which the measurements of acoustic parameters can be made using calibrated hydrophones; - defines procedures for correcting for limitations caused by the use of hydrophones with finite bandwidth and finite active element size, and for estimating the corresponding uncertainties. IEC 62127-1:2022 cancels and replaces the first edition published in 2007 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition. a) The upper frequency limit of 40 MHz has been removed. b) Hydrophone sensitivity definitions have been changed to recognize sensitivities as complex-valued quantities. c) Procedures and requirements for narrow-band approximation and broadband measurements have been modified; details on waveform deconvolution have been added. d) Procedures for spatial averaging correction have been amended. e) Annex D, Annex E and bibliography have been updated to support the changes of the normative parts.

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.

IEC 61828:2020 - provides definitions for the transmitted field characteristics of focusing and nonfocusing transducers for applications in medical ultrasound; - relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers; - gives measurement methods for obtaining defined field characteristics of focusing and nonfocusing transducers; - specifies beam axis alignment methods appropriate for focusing and nonfocusing transducers. IEC 61828:2021 relates to focusing ultrasonic transducers operating in the frequency range appropriate to medical ultrasound (0,5 MHz to 40 MHz) for both therapeutic and diagnostic applications. It shows how the characteristics of the transmitted field of transducers can be described from the point of view of design, as well as measured by someone with no prior knowledge of the construction details of a particular device. The transmitted ultrasound field for a specified excitation is measured by a hydrophone in either a standard test medium (for example, water) or in a given medium. This document applies only to media where the field behaviour is essentially like that in a fluid (i.e. where the influence of shear waves and elastic anisotropy is small), including soft tissues and tissue-mimicking gels. Any aspects of the field that affect their theoretical description or are important in design are also included. These definitions would have use in scientific communications, system design and description of the performance and safety of systems using these devices. IEC 61828:2021 incorporates definitions from other related standards where possible, and supplies more specific terminology, both for defining focusing characteristics and for providing a basis for measurement of these characteristics. IEC 61828:2021 cancels and replaces the first edition published in 2001. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) Clause 6 on Measurement procedures has been replaced by Clause 6: "Acoustic field measurement: equipment" and Clause 7: "Measurement procedure" and related definitions. b) Reorganization of definitions and measurement section to accommodate specific sets of measurements for focusing, nonlinearity, beam axis alignment, beam area, beam maximum, numerical projection, plane wave, high intensity therapeutic ultrasound, multiple sources, spatial impulse response and compound plane waves. Clause 3 has been moved to Annex B. c) The normative references have been updated and the Bibliography has been expanded from 8 to 40 references. d) Twelve figures have been updated and seven new figures (B.1, B.3, B.7, B.10, B.11, B.12, B.13, B.14) have been added to facilitate measurements and be consistent with measurement terminology. e) New measurements have been added for time delays, arrays, plane waves and spatial impulse response. f) Annex A has been expanded to provide general guidance on pulsed waves, system responses, focusing gains and minimum beamwidth estimation. g) New annexes have been added: • Annex B (informative) Rationale for focusing and nonfocusing definitions • Annex E (informative) Uncertainties; • Annex F (informative) Transducer and hydrophone positioning systems; •

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).

IEC 60565-1:2020 specifies methods and procedures for free-field calibration of hydrophones, as well as individual electroacoustic transducers that can be used as hydrophones (receivers) and/or projectors (source transducers). Two general types of calibration are covered within this document: absolute calibration using the method of three-transducer spherical-wave reciprocity, and relative calibration by comparison with a reference device which has already been the subject of an absolute calibration. The maximum frequency range of the methods specified in this document is from 200 Hz to 1 MHz. The lowest acoustic frequency of application will depend on a number of factors, and will typically be in the range 200 Hz to 5 kHz depending mainly on the dimensions of the chosen test facility, The highest frequency of application for the methods described here is 1 MHz. Procedures for pressure hydrophone calibration at low frequencies can be found in IEC 60565 2 [1] . Procedures for hydrophone calibration at acoustic frequencies greater than 1 MHz are covered by IEC 62127-2 [2]. Excluded from the scope of this document are low-frequency pressure calibrations of hydrophones, which are described in IEC 60565-2 [1]. Also excluded are calibrations of digital hydrophones and systems, calibration of marine autonomous acoustic recorders, calibration of acoustic vector sensors such as particle velocity sensors and pressure gradient hydrophones, calibration of passive sonar arrays consisting of multiple hydrophones, and calibration of active sonar arrays consisting of projectors and hydrophones. This document presents a description of the requirements for free-field calibration in terms of test facility, equipment and instrumentation, signal processing, and frequency limitations. A description of achievable uncertainty and rules for the presentation of the calibration data are provided. Also included are informative annexes that provide additional guidance on • measurement of directional response of a hydrophone or projector, • measurement of electrical impedance of hydrophones and projectors, • electrical loading corrections, • acoustic far-field criteria in underwater acoustic calibration, • pulsed techniques in free-field calibrations, • assessment of uncertainty in the free-field calibration of hydrophones and projectors, • derivation of the formulae for three-transducer spherical-wave reciprocity calibrations, • calibration using travelling-wave tubes, • calibration of hydrophones using optical interferometry, and • calibrations in reverberant water tanks using continuous signals. IEC 60565-1:2020 together with IEC 60565-2:2019, cancels and replaces the second edition of IEC 60565 published in 2006. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: 1) removal of all descriptions of methods for pressure calibrations of hydrophones – these are now included in Part 2; 2) removal of the derivations of formulae for free-field reciprocity calibration (both amplitude sensitivity and phase sensitivity) and placement of these into an informative annex; 3) inclusion within the scope of the calibration of the transmitting response of individual source transducers and hydrophones (but not sonar arrays); 4) re-ordering of the sections within the document such that the more general procedures for calibration such as guidance on obtaining conditions of acoustic free-field, far-field, and stea

IEC 60500:2017 specifies the relevant characteristics and properties of hydrophones in the frequency range 1 Hz to 500 kHz, and specifies how to report these characteristics. Provides guidance on the choice of a hydrophone with appropriate performance for a specific application. This standard is applicable to: - hydrophones employing piezoelectric sensor elements, designed to respond to sound pressure in water and measure underwater acoustical signals; - hydrophones with or without an integral pre-amplifier. This new edition includes the following significant technical changes with respect to the previous edition: - the format and scope of IEC 60500 have been changed to be compatible with other IEC standards; - the upper limit of the frequency range of hydrophones has been expanded.

IEC 62555:2013 establishes general principles relevant to HITU fields for the use of radiation force balances in which an obstacle (target) intercepts the sound field to be measured; specifies a calorimetric method of determining the total emitted acoustic power of ultrasonic transducers based on the measurement of thermal expansion of a fluid-filled target; specifies requirements related to the statement of electrical power characteristics of ultrasonic transducers; provides guidance related to the avoidance of acoustic cavitation during measurement; provides guidance related to the measurement of HITU transducers of different construction and geometry, including collimated, diverging and convergent transducers, and multi-element transducers; provides guidance on the choice of the most appropriate measurement method; and provides information on assessment of overall measurement uncertainties. This International Standard is applicable to the measurement of ultrasonic power generated by HITU equipment up to 500 W in the frequency range from 0,5 MHz to 5 MHz. HITU equipment may generate convergent, collimated or divergent fields. For frequencies less than 500 kHz, no validations exist and the user should assess the uncertainties of the power measurement and measurement system at the frequencies of operation. This International Standard does not apply to ultrasound equipment used for physiotherapy, for lithotripsy for general pain relief.

87/499/RVC established on 2012-03-09: FDIS decided*2013-06-10: Publication allocated to cpalagi@cencenelec.eu

IEC 61689:2013 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous wave ultrasound in the frequency range 0,5 MHz to 5 MHz. 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; - and acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard. This third edition cancels and replaces the second edition published in 2007. It constitutes a technical revision which includes the following significant technical changes with respect to the previous edition: - restriction introduced of 0,2 W/cm2 effective intensity during hydrophone measurements for treatment heads with ka≤20, to limit the likelihood of cavitation; - change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333; - and change to SI units for terms and definitions.

This part of IEC 62127 specifies: absolute hydrophone calibration methods; relative (comparative) hydrophone calibration methods. Recommendations and references to accepted literature are made for the various relative and absolute calibration methods in the frequency range covered by this standard. This standard is applicable to hydrophones used for measurements made in water and in the ultrasonic frequency range up to 40 MHz; hydrophones employing circular piezoelectric sensor elements, designed to measure the pulsed wave and continuous wave ultrasonic fields generated by ultrasonic equipment; hydrophones with or without a hydrophone pre-amplifier.

This part of IEC 62127 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment operating
in the frequency range up to 40 MHz. The objectives of this standard are:
– to define a group of acoustic parameters that can be measured on a physically sound basis;
– to define a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters;
– to define a measurement procedure that may be used for the determination of acoustic pressure parameters;
– to define the conditions under which the measurements of acoustic parameters can be made in the frequency range up to 40 MHz using calibrated hydrophones;
– to define procedures for correcting, for limitations caused by the use of hydrophones with finite bandwidth and finite active element size.
NOTE 1 Throughout this standard, SI units are used. In the specification of certain parameters, such as beam areas and intensities, it may be convenient to use decimal multiples or submultiples. For example beam area may be specified in cm2 and intensities in W/cm2 or mW/cm2.
NOTE 2 The hydrophone as defined may be of a piezoelectric or an optic type. The introduction however implies that optical hydrophones are not covered.

IEC 61161:2013 specifies a method of determining the total emitted acoustic power of ultrasonic transducers based on the use of a radiation force balance; establishes general principles for the use of radiation force balances in which an obstacle (target) intercepts the sound field to be measured; establishes limitations of the radiation force method related to cavitation and temperature rise; establishes quantitative limitations of the radiation force method in relation to diverging and focused beams; provides information on estimating the acoustic power for diverging and focused beams using the radiation force method; and provides information on assessment of overall measurement uncertainties. This International Standard is applicable to the measurement of ultrasonic power up to 1 W based on the use of a radiation force balance in the frequency range from 0,5 MHz to 25 MHz; the measurement of ultrasonic power up to 20 W based on the use of a radiation force balance in the frequency range 0,75 MHz to 5 MHz; the measurement of total ultrasonic power in well-collimated, diverging and focused ultrasonic fields; and to the use of radiation force balances of the gravimetric type or force feedback type. This third edition cancels and replaces the second edition published in 2006. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - whereas the second edition tacitly dealt with circular transducers only, the present edition as far as possible deals with both circular and rectangular transducers, including a number of symbols for rectangular transducers; - attention is paid to focused cases and the influence of scanning has been added; - the method of calibrating the radiation force balance now depends on whether the set-up is used as a primary or as secondary measurement tool; - and Annex B (basic formulae) has been updated and in Annex C the buoyancy change method is mentioned (see also future IEC 62555).

This International Standard is applicable to medical diagnostic ultrasonic equipment.
– It provides a set of traceable acoustic parameters describing the acoustic fields.
– It defines a standard means and format for the reporting of the acoustic output information.
– It also describes a reduced dataset recommended for equipment generating low acoustic output levels.
NOTE The information tabulated in this standard format can be used for
a) exposure planning for biological effects studies;
b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to those reported in this standard. In the absence of actual exposure data for retrospective epidemiological studies, the information tabulated in this standard format might also be used with
cautionary comment.

IEC 62359:2010 is applicable to medical diagnostic ultrasound fields. It establishes: - parameters related to thermal and non-thermal exposure aspects of diagnostic ultrasonic fields; - methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound; - methods for the determination of an exposure parameter appropriate to certain non-thermal effects. This second edition cancels and replaces the first edition, published in 2005. It constitutes a technical revision. Major changes with respect to the previous edition include the following: - The methods of determination set out in the first edition of this standard were based on those contained in the American standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (ODS) and were intended to yield identical results. While this second edition also follows the ODS in principal and uses the same basic formulae and assumptions (see Annex A), it contains a few significant modifications which deviate from the ODS. - One of the primary issues dealt with in preparing this second edition of IEC 62359 was 'missing' TI equations. In Edition 1 there were not enough equations to make complete 'at-surface' and 'below-surface' summations for TIS and TIB in combined-operating modes. Thus major changes with respect to the previous edition are related to the introduction of new calculations of thermal indices to take into account both 'at-surface' and 'below-surface' thermal effects.

IEC 61391-2:2010(E) defines terms and specifies methods for measuring the maximum depth of penetration and the local dynamic range of real time ultrasound B MODE scanners. The types of transducers used with these scanners include: - mechanical probes; - electronic phased arrays; - linear arrays; - curved arrays; - two-dimensional arrays; - three-dimensional scanning probes based on a combination of the above types. All scanners considered are based on pulse-echo techniques. The test methodology is applicable for transducers operating in the 1 MHz to 15 MHz frequency range operating both in fundamental mode and in harmonic modes that extend to 15 MHz. However, testing of harmonic modes above 15 MHz is not covered by this standard.

Establishes requirements for the declaration of the acoustic output information: 1.to be presented in technical data sheets supplied to prospective purchasers of equipment by manufacturers; 2.to be declared in the accompanying literature/ manual supplied by manufacturers; 3.as background information to be made available on request to interested parties by manufacturers.

This part of IEC 62127 specifies: - absolute hydrophone calibration methods; - relative (comparative) hydrophone calibration methods. This standard is applicable to - hydrophones used for measurements made in water and in the ultrasonic frequency range up to 40 MHz; - hydrophones employing circular piezoelectric sensor elements, designed to measure the pulsed wave and continuous wave ultrasonic fields generated by ultrasonic equipment; - hydrophones with or without a hydrophone pre-amplifier. IEC 62127-1, IEC 62127-2 and IEC 62127-3 are being published simultaneously. Together these cancel and replace IEC 60866:1987, IEC 61101:1991, IEC 61102:1991, IEC 61220:1993 and IEC 62092:2001. The contents of the corrigendum of August 2008 have been included in this copy.

This part of IEC 62127 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment operating in the frequency range up to 40 MHz. The objectives of this standard are: - to define a group of acoustic parameters that can be measured on a physically sound basis; - to define a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters; - to define a measurement procedure that may be used for the determination of acoustic pressure parameters; - to define the conditions under which the measurements of acoustic parameters can be made in the frequency range up to 40 MHz using calibrated hydrophones; - to define procedures for correcting, for limitations caused by the use of hydrophones with finite bandwidth and finite active element size. IEC 62127-1, IEC 62127-2 and IEC 62127-3 are being published simultaneously. Together these cancel and replace IEC 60866:1987, IEC 61101:1991, IEC 61102:1991, IEC 61220:1993 and IEC 62092:2001. The contents of the corrigendum of August 2008 have been included in this copy.

Describes methods of calibrating the spatial measurement facilities and point-spread function of ultrasonic imaging equipment in the ultrasonic frequency range 0,5 MHz to 15 MHz. This standard is relevant for ultrasonic scanners based on the pulse echo principle of the types listed below: - mechanical sector scanners; - electronic phased-array sector scanners; - electronic linear-array scanners; - electronic curved-array sector scanners; - water bath scanners based on any of the above four scanning mechanisms; - 3D-volume reconstruction systems.

This Technical Specification describes means to allow "attenuated" acoustic quantities to be calculated under conditions where the associated acoustic measurements, made in water using standard procedures, may be accompanied by significant finite-amplitude effects. This Technical Specification establishes: - the general concept of the limits of applicability of acoustic measurements in water resulting from finite-amplitude acoustic effects; - a method to ensure that measurements are made under quasi-linear conditions in order to minimise finite-amplitude effects; - the definition of an acoustic quantity appropriate for establishing quasi-linear conditions; - a threshold value for the acoustic quantity as an upper limit for quasi-linear conditions; - a method for the estimation of attenuated acoustic quantities under conditions of nonlinear propagation in water.

Specifies parameters for a flow Doppler test object representing a blood vessel of known diameter at a certain depth in human tissue, carrying a steady flow. Establishes a flow Doppler test object which can be used to assess various aspects of the performance of Doppler diagnostic equipment.

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.

This standard specifies: - the essential non-thermal output characteristics of ultrasonic surgical units; - methods of measurement ot these output characteristics; - those characteristics which should be declared by the manufacturers of such equipment. This standard is applicable to equipment which meets the requirements of a, b and c below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and b) ultrasonic surgical systems, whose use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems, in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.

Is applicable to ultrasonic Doppler foetal heartbeat detectors which generate a single ultrasound beam and consist of a hand-held probe which is applied to the maternal abdomen to obtain information on foetal heart activity by means of the Doppler method using continuous wave (c.w) or quasi-continuous wave ultrasound. Establishes - methods of measurement of performances - requirements for the performance and the - reporting of performance

Describes the test methods for measuring the performance of continuous-wave ultrasonic Doppler flowmeters, velocimeters, or foetal heart detectors and special Doppler test objects for determining various performance properties of Doppler ultrasound systems. Does not include electrical safety and acoustic output. This publication has the status of a type 2 technical report.

Is applicable to ultrasonic equipment designed for physiotherapy consisting of an ultrasonic transducer generating continuous or quasi-continuous wave ultrasonic energy in the frequency range 0,5 MHz to 5 MHz. This standard only relates to ultrasonic physiotherapy equipment employing a single plane unfocused 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 based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard. This second edition cancels and replaces the first edition published in 1996 and constitutes a technical revision. This second edition is a result of maintenance on this standard and the referenced standards IEC 61161 (2006) and IEC 62127-1. A relatively large technical change is the determination of the effective radiating area. This is now no longer based on the measurement of four areas but only on one. This change was needed to improve the accuracy of the determination of this parameter for small transducers. Be aware that this change may alter the value obtained for this and related parameters.

This International Standard - specifies a method of determining the total emitted acoustic power of ultrasonic transducers based on the use of a radiation force balance; - establishes general principles for the use of radiation force balances in which an obstacle (target) intercepts the sound field to be measured; -establishes limitations of the radiation force method related to cavitation and temperature rise; - establishes quantitative limitations of the radiation force method in relation to diverging and focused beams; - provides information on assessment of overall measurement uncertainties. This International Standard is applicable to: - the measurement of ultrasonic power up to 1 W based on the use of a radiation force balance in the frequency range from 0,5 MHz to 25 MHz; - the measurement of ultrasonic power up to 20 W based on the use of a radiation force balance in the frequency range 0,75 MHz to 5 MHz; - the measurement of total ultrasonic power of transducers, preferably with well-collimated beams; - the use of radiation force balances of the gravimetric type or force feedback type.

Specifies methods for calibration of hydrophones or reversible transducers when used as a hydrophone, particularly in the frequency range from 0,01 Hz to 1 MHz. Rules for the presentation of the calibration data are established.

Is applicable to medical diagnostic ultrasound fields. This standard establishes - parameters related to thermal and non-thermal aspects of diagnostic ultrasonic fields; - methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound; - methods for the determination of an exposure parameter appropriate to certain non-thermal effects.

Applies to - hydrophones employing piezoelectric sensor elements, designed to measure the pulsed and continuous-wave ultrasonic fields generated by ultrasonic equipment; - hydrophones used for measurements made in water and in the frequency range between 15 MHz and 40 MHz; - hydrophones with or without an integral amplifier; - hydrophones with a circular piezoelectrically active element. Specifies - relevant hydrophone characteristics; - methods of determining directional response and hydrophone sensitivity based on relative or comparative measurements; and describes - absolute hydrophone calibration methods. Recommendations and references to accepted literature are made for the various relative and absolute calibration methods in the frequency range covered by this International Standard.

Provides definitions for the transmitted field characteristics of focusing transducers for applications in medical ultrasound; relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers. Gives measurement methods for obtaining defined characteristics of focusing transducers. Specifies beam axis alignment methods appropriate for focusing transducers.

Superseded by EN 61161:2007

This standard specifies : - methods of measurement and characterization of the output performance of ultrasonic physiotherapy equipment based on reference testing methods; - characteristics to be declared by manufacturers of ultrasonic physiotherapy equipment based on reference testing methods; - requirements for performance and safety of the ultrasonic field generated by ultrasonic physiotherapy equipment; - methods of measurement and characterization of the output performance of ultrasonic physiotherapy equipment based on routine testing methods; - acceptance criteria for aspects of performance of ultrasonic physiotherapy equipment based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard.

Provides guidance on the practical measurement of the acoustic output of various types of medical ultrasonic equipment. Contains also procedures for correcting limitations caused by the use of hydrophones with finite bandwidth and finite active element size.

Specifies a method of determining the total radiated acoustic power of ultrasonic transducters based on the use of a radiation force balance. Provides general principles for the use of radiation force balances in which an obstacle (target) intercepts the sound field to be measured.

Establishes requirements for the declaration of the acoustic output information: 1.to be presented in technical data sheets supplied to prospective purchasers of equipment by manufacturers; 2.to be declared in the accompanying literature/ manual supplied by manufacturers; 3.as background information to be made available on request to interested parties by manufacturers.

Specifies: -essential non-thermal output characteristics of ultrasonic dental descalers; -the methods of measurement of the output performance of ultrasonic dental descalers; -the characteristics to be declared by the manufacturers of ultrasonic dental descalers.

Superseded by EN 62127-1:2007 + EN 62127-2:2007 + EN 62127-3:2007

Specifies a method of absolute calibration of hydrophones based on the planar scanning technique in the frequency range 0,5 MHz to 15 MHz.