WG 8 - TC 87/WG 8

IEC TS 62903:2023 is available as IEC TS 62903:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC TS 62903:2023:
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) provides guiding information for the assessment of the overall measurement uncertainties for radiation conductance.
This document is applicable to:
1) circular spherically curved concave focusing transducers without a centric hole working in the linear amplitude range,
2) measurements in the frequency range 0,5 MHz to 15 MHz, and
3) acoustic pressure amplitudes in the focused field within the linear amplitude range.
Characterization and sensitivity calibration of hydrophones using the reciprocity method are not addressed in this document but covered in IEC 62127-2 and IEC 60565-1.
IEC TS 62903:2023 cancels and replaces the first edition published in 2018. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) Several quantities are recognized as complex-valued quantities in the definitions and in the main text.
b) Annex I was added to provide typical measurement ranges and to provide example calibration results.

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 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.

IEC 61689:2022 is available as IEC 61689:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61689:2022 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. 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 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 within the scope of this document.
Ultrasonic physiotherapy equipment using ultrasound in the frequency range from 20 kHz to 500 kHz is dealt with in IEC 63009.
IEC 61689:2022 cancels and replaces the third edition published in 2013. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition.
a) The requirement on water oxygen content is specified in 6.1.
b) Former recommendations in 6.2 have been changed to become requirements.
c) Several definitions in Clause 3 have been updated in line with other TC 87 documents.
d) The formerly informative Annex A has been changed to become normative, and now contains details on how conformance with IEC 60601-2-5 requirements is checked.
e) Annex D has been considerably shortened and reference to a now withdrawn regulatory document has been removed.

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 document.

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 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) provides guiding information for the assessment of the overall measurement uncertainties for radiation conductance.
This document is applicable to:
i) circular spherically curved concave focusing transducers without a centric hole working in the linear amplitude range,
ii) measurements in the frequency range 0,5 MHz to 15 MHz, and
iii) acoustic pressure amplitudes in the focused field within the linear amplitude range.

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. The contents of the corrigendum of March 2011 have been included in this copy.

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 previous edition: it includes a novel method for periodic testing regarding possible changes of the effective radiating area using thermochromic absorbers in a new Annex E.

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. 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. The French version of this standard has not been voted upon.

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 publication is to be read in conjunction with IEC 60601-2-5:2009.

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).

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 to provide a unified source to establish a water treatment process for ultrasonic measurements. The quality and treatment methods for water used within a radiation force balance (RFB) may be different from that required for hydrophone based acoustic measurements. Chemical based methods of water treatment (e.g. algaecides) may be appropriate for these applications. However, in this document, chemical means are noted but appropriately discouraged for acoustic pressure/intensity measurements. This Technical Report describes methods for:
- degassing water to be used in ultrasonic measurements;
- to decrease the ionic content of water to be used in ultrasonic measurements;
- to decrease the biological content of water to be used in ultrasonic measurements; and
- to reduce the suspended particulate content of water to be used in ultrasonic measurements.

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 61101:1991, IEC 61102:1991, IEC 61220:1993 and IEC 62092:2001. The French version of this standard has not been voted upon.

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 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;
- and 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. The French version of this standard has not been voted upon.