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 transducer...
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    • Standard
      227 pages
      English and French language

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 wa...
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    • Standard
      61 pages
      English language

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 calibra...view more

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    • Standard
      183 pages
      English and French language

IEC TS 63081:2019:
• defines key quantities relevant to ultrasonic materials characterization;
• specifies methods for direct measurement of many key ultrasonic materials parameters.
This document is applicable to all measurements of properties of passive acoustic materials under drive conditions that are not subject to nonlinear acoustic propagation. Whilst there are materials properties that may be of interest in a nonlinear drive regime, these are currently outside the scope of this docume...
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    • Technical specification
      33 pages
      English language

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: Proce...
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    • Standard
      108 pages
      English and French language

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 phy...
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    • Standard
      73 pages
      English and French language

IEC TS 63070:2019 is applicable to ultrasonic equipment designed for the medical field of application. It covers both diagnostic and therapeutic (physiotherapy and HITU) equipment.
This document describes transducer evaluation by the infrared imaging technique using a split TMM-phantom for qualitative and quantitative estimation of temperature distributions in tissue-mimicking material, resulting from absorption of ultrasound and from heating of the transducer itself.
This document also descri...
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    • Technical specification
      26 pages
      English language

IEC TS 63001:2019 provides a technique of measurement and evaluation of ultrasound in liquids for use in cleaning devices and equipment. It specifies
• the cavitation measurement at 2,25 f0 in the frequency range 20 kHz to 150 kHz, and
• the cavitation measurement by extraction of broadband spectral components in the frequency range 10 kHz to 5 MHz.
IEC TS 63001:2019 covers the measurement and evaluation of the cavitation, but not its secondary effects (cleaning results, sonochemical effects,...
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    • Technical specification
      29 pages
      English language

IEC TS 62903:2018, which is a Technical Specification,
a) establishes the free-field convergent spherical wave self-reciprocity method for ultrasonic transducer calibration,
b) establishes the measurement conditions and experimental procedure required to determine the transducer's electroacoustic parameters and acoustic output power using the self-reciprocity method,
c) establishes the criteria for checking the reciprocity of these transducers and the linear range of the focused field, and
d...
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    • Technical specification
      47 pages
      English language
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    • Technical report
      31 pages
      English language
    • e-Library read for
      1 day

IEC TS 62462:2017(E) describes methods meant to assist users of ultrasound physiotherapy systems in checking the performance of such systems. It is applicable primarily to physiotherapists, general medical practitioners, chiropractors, osteopaths, beauty therapists, sports professionals, biomedical engineers, medical physicists, medical device service agents, commercial testers, test houses or manufacturers. This new edition includes the following significant technical change with respect to the...view more

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    • Technical specification
      30 pages
      English language

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...
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    • Standard
      47 pages
      English and French language

IEC TS 62736:2016(E) specifies requirements and methods for periodic testing of the quality of diagnostic medical ultrasound systems with linear array, curved linear array, single element, annular array, phased array, matrix linear array transducers and two-dimensional arrays.

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    • Technical specification
      38 pages
      English language

IEC TS 62791:2015(E) defines terms and specifies methods for quantifying the imaging performance of real-time, ultrasound B-mode scanners. The test methodology is applicable for transducers operating in the 2 MHz to 15 MHz frequency range.

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    • Technical specification
      60 pages
      English language

IEC TS 62556:2014 is a technical specification applicable to high intensity therapeutic ultrasound (HITU) devices. It specifies the relevant parameters for quantifying the field; the measurement methods at relatively low output levels and methodology for extrapolating these to higher therapeutic level fields; some considerations of sidelobes and pre-focal maxima; and parameters relevant to HITU transducers of different construction and geometry, including non-focusing, focusing with or without l...view more

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    • Technical specification
      93 pages
      English language

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...view more

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    • Standard
      113 pages
      English and French language

IEC/TR 62799:2013(E), which is a technical report, provides background information for users of IEC 62359 to understand the relative merits of several of the potential replacements for the thermal index as described in IEC 60601-2-37 and IEC 62359. The report discusses parameters related to thermal aspects of diagnostic ultrasonic fields; and methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of u...view more

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    • Technical report
      44 pages
      English language

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 characterizatio...
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    • Standard
      124 pages
      English and French language

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...view more

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    • Standard
      100 pages
      English and French language

IEC/TR 62781:2012(E), which is a technical report, is applicable to all measurements of ultrasonic fields where water is the transmission medium. Water provides an inexpensive and readily available medium with characteristic acoustic impedance comparable to biological tissue. However, basic tap water is far from optimum for ultrasonic measurement as it contains many dissolved, absorbed and suspended contaminants. Measurements can be affected in many ways by these impurities. This technical aims ...view more

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    • Technical report
      21 pages
      English language

IEC/TS 62558:2011(E) specifies essential characteristics of a phantom and method for the measurement of void-detectability ratio for medical ultrasound systems and related transducers. It is restricted to the aspect of long-term reproducibility of testing results. Medical diagnostic ultrasound systems and related transducers need periodic testing as the quality of medical decisions based on ultrasonic images may decrease over time due to progressive degradation of essential systems characteristi...view more

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    • Technical specification
      49 pages
      English language

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 th...
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    • Standard
      136 pages
      English and French language

IEC/TR 62649:2010(E) is relevant to the measurement and specification of ultrasound fields intended for medical therapeutic purposes. Lithotripsy and physiotherapy are excluded, since there are existing International Standards for these applications. IEC/TR 62649:2010 establishes:
- topics where there is a consensus that the development of International Standards would benefit the industries and/or patients;
- topics where the writing of standards should start immediately;
- topics where the ...
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    • Technical report
      93 pages
      English language

IEC 61391-2:2010 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 methodol...
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    • Standard
      74 pages
      English and French language

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 q...view more

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    • Technical specification
      31 pages
      English language

IEC 62127-1:2007 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 de...
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    • Standard
      166 pages
      English and French language

IEC 62127-3:2007 specifies relevant hydrophone characteristics. This standard 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; and hydrophones with or without an associated 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 61101:1...view more

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    • Standard
      41 pages
      English and French language

IEC 62127-2:2007 specifies absolute hydrophone calibration methods and 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;
- and hydrophones with or without a hydrophone pre-amplifier. IE...
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    • Standard
      172 pages
      English and French language

IEC 61157:2007 specifies a standard means and format for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting purposes represent the average values for the maximum output conditions for a given discrete- or combined-operating mode and are derived from measurements made in water. Intensity parameters are specified in this standard, but these are regarded as derived quantities that are meaningful only under certain assumptions related ...view more

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    • Standard
      66 pages
      English and French language

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 scann...view more

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    • Standard
      91 pages
      English and French language

This Technical Specification is applicable to medical diagnostic ultrasonic fields. This Technical Specification establishes: - the important characteristics and terminology for test objects containing an embedded thermal sensor to determine ultrasonic heating; - requirements for defining particular types of test object for specific applications; - examples of design features which will ensure that the performance specifications are achieved; - validation procedures; - general test methods for u...view more

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    • Technical specification
      75 pages
      English and French language

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.

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    • Standard
      36 pages
      English language

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. This International Standard relates to foc...view more

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    • Standard
      103 pages
      English and French language

This technical specification describes: - test methods for measuring the performance of pulsed Doppler ultrasound systems; - Doppler test objects for carrying out these tests; and applies to - tests made on an overall pulsed Doppler ultrasound system, a system which is not disassembled or disconnected; - tests made on pulsed Doppler ultrasound systems whether they are stand-alone or as part of another ultrasound equipment.

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    • Technical specification
      32 pages
      English language

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.

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    • Standard
      26 pages
      English language

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 cutt...view more

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    • Standard
      31 pages
      English language