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17.140.50 - Electroacoustics

ICS 17.140.50 Details

Electroacoustics

Elektroakustik

Électroacoustique

Elektroakustika

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17.140 - Acoustics and acoustic measurements

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Standardization Organization
Technical Committee
Directive
Mandate
50
CLC
EN IEC 61252:2025(Main)
Electroacoustics - Personal sound exposure meters
SIST EN IEC 61252:2026

IEC 61252:2025 specifies – performance specifications for personal sound exposure meters, – details of the tests necessary to verify conformance to all mandatory specifications for the purpose of pattern evaluation, and – procedures for periodic testing of a personal sound exposure meter. Personal sound exposure meters conforming to the requirements of this document have a specified frequency response for sound incident on the microphone from all directions. This document is applicable to instruments that are designed to be worn on a person in a configuration specified by the manufacturer for the measurement of sound immission resulting from steady, intermittent, fluctuating, irregular, or impulsive sounds. For reproducibility of results, specifications and tests for the response to sound waves apply without an operator present in the sound field. Pattern evaluation tests and periodic tests described in this this document apply to personal sound exposure meters for which the manufacturer claims conformance to the specifications given in this document. IEC 61252:2025 cancels and replaces the first edition published in 1993, Amendment 1:2000, and Amendment 2:2017. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) personal sound exposure meters are required to provide indications of time-averaged sound level and peak sound level; b) sound exposure is an optional quantity for indication; c) specifications for physical quantities that do not follow the principle of equal-energy exchange rate have been added; d) specifications for directional response have been added; e) specifications for frequency weightings apply to the relative diffuse-field frequency response; f) determination of conformance to specifications takes account of uncertainties of measurement; g) detailed requirements for pattern-evaluation tests and periodic testing have been added.

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SIST EN IEC 60645-7:2025(Main)
Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials (IEC 60645-7:2025)
EN IEC 60645-7:2025

IEC 60645-7:2025 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory nerve, and the brainstem, evoked by either acoustic or vibratory stimuli of short duration. This document defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instruments (screening and diagnostic/clinical), and specifies the functions to be provided on these types. It also specifies a means of describing the physical characteristics, in terms of electrical waveforms, of audiometric reference and test signals of short duration used with auditory evoked potential equipment and other equipment (e.g. otoacoustic emission instruments), and methods for their measurement. The purpose of this document is to ensure that measurements made under comparable test conditions with different instruments complying with this document will be consistent. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. Evoked response measurement using the application of electric stimuli to a subject is beyond the scope of this document.

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EN IEC 60645-7:2025(Main)
Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials
SIST EN IEC 60645-7:2025

IEC 60645-7:2025 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory nerve, and the brainstem, evoked by either acoustic or vibratory stimuli of short duration. This document defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instruments (screening and diagnostic/clinical), and specifies the functions to be provided on these types. It also specifies a means of describing the physical characteristics, in terms of electrical waveforms, of audiometric reference and test signals of short duration used with auditory evoked potential equipment and other equipment (e.g. otoacoustic emission instruments), and methods for their measurement. The purpose of this document is to ensure that measurements made under comparable test conditions with different instruments complying with this document will be consistent. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. Evoked response measurement using the application of electric stimuli to a subject is beyond the scope of this document.

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IEC 61252:2025(Main)
Electroacoustics - Personal sound exposure meters

IEC 61252:2025 specifies
– performance specifications for personal sound exposure meters,
– details of the tests necessary to verify conformance to all mandatory specifications for the purpose of pattern evaluation, and
– procedures for periodic testing of a personal sound exposure meter.
Personal sound exposure meters conforming to the requirements of this document have a specified frequency response for sound incident on the microphone from all directions.
This document is applicable to instruments that are designed to be worn on a person in a configuration specified by the manufacturer for the measurement of sound immission resulting from steady, intermittent, fluctuating, irregular, or impulsive sounds. For reproducibility of results, specifications and tests for the response to sound waves apply without an operator present in the sound field.
Pattern evaluation tests and periodic tests described in this this document apply to personal sound exposure meters for which the manufacturer claims conformance to the specifications given in this document.
IEC 61252:2025 cancels and replaces the first edition published in 1993, Amendment 1:2000, and Amendment 2:2017. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) personal sound exposure meters are required to provide indications of time-averaged sound level and peak sound level;
b) sound exposure is an optional quantity for indication;
c) specifications for physical quantities that do not follow the principle of equal-energy exchange rate have been added;
d) specifications for directional response have been added;
e) specifications for frequency weightings apply to the relative diffuse-field frequency response;
f) determination of conformance to specifications takes account of uncertainties of measurement;
g) detailed requirements for pattern-evaluation tests and periodic testing have been added.

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IEC 60645-7:2025(Main)
Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials

IEC 60645-7:2025 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory nerve, and the brainstem, evoked by either acoustic or vibratory stimuli of short duration. This document defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instruments (screening and diagnostic/clinical), and specifies the functions to be provided on these types. It also specifies a means of describing the physical characteristics, in terms of electrical waveforms, of audiometric reference and test signals of short duration used with auditory evoked potential equipment and other equipment (e.g. otoacoustic emission instruments), and methods for their measurement. The purpose of this document is to ensure that measurements made under comparable test conditions with different instruments complying with this document will be consistent. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. Evoked response measurement using the application of electric stimuli to a subject is beyond the scope of this document.

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SIST EN IEC 61847:2025(Main)
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics (IEC 61847:2025)
EN IEC 61847:2025

IEC 61847:2025 specifies:
– the essential non-thermal output characteristics of ultrasonic surgical units;
– methods of measurement of these output characteristics;
– those characteristics to be declared by the manufacturers of such equipment.
This document is applicable to equipment which meets the criteria of a), b) and c) below:
a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and
b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, 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.
This document is not applicable to:
– lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body;
– surgical systems used as part of the therapeutic process (hyperthermia systems);
– surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters;
– surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer;
– surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling.
This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients.
IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz.
b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach.
c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this.
d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed.
e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described.
f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics.
g) Guidance is provided with respect to measurement tank arrangements for different types of systems.
h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments.
i) Definitions for cavitation related terms were added.
j) Requirements for the measurement of directivity characteristics of the applicator tip were changed.
k) Annex A was modified and Figure A.1 wa

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EN IEC 61847:2025(Main)
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
SIST EN IEC 61847:2025

IEC 61847:2025 specifies: – the essential non-thermal output characteristics of ultrasonic surgical units; – methods of measurement of these output characteristics; – those characteristics to be declared by the manufacturers of such equipment. This document is applicable to equipment which meets the criteria of a), b) and c) below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, 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. This document is not applicable to: – lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body; – surgical systems used as part of the therapeutic process (hyperthermia systems); – surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters; – surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer; – surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling. This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients. IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz. b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach. c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this. d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed. e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described. f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics. g) Guidance is provided with respect to measurement tank arrangements for different types of systems. h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments. i) Definitions for cavitation related terms were added. j) Requirements for the measurement of directivity characteristics of the applicator tip were changed. k) Annex A was modified and Figure A.1 wa

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IEC 61847:2025(Main)
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

IEC 61847:2025 specifies:
– the essential non-thermal output characteristics of ultrasonic surgical units;
– methods of measurement of these output characteristics;
– those characteristics to be declared by the manufacturers of such equipment.
This document is applicable to equipment which meets the criteria of a), b) and c) below:
a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and
b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, 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.
This document is not applicable to:
– lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body;
– surgical systems used as part of the therapeutic process (hyperthermia systems);
– surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters;
– surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer;
– surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling.
This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients.
IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz.
b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach.
c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this.
d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed.
e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described.
f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics.
g) Guidance is provided with respect to measurement tank arrangements for different types of systems.
h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments.
i) Definitions for cavitation related terms were added.
j) Requirements for the measurement of directivity characteristics of the applicator tip were changed.
k) Annex A was modified and Figure A.1 was added.
l) New literature was added, and the references to other standards were updated.

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SIST EN IEC 61846:2025(Main)
Ultrasonics - Therapeutic focused short pressure pulse sources - Characteristics of fields (IEC 61846:2025)
EN IEC 61846:2025

IEC 61846:2025 is applicable to:
– therapy equipment using extracorporeally induced focused pressure pulse waves;
– therapy equipment producing focused mechanical energy excluding thermal energy.
This document does not apply to percutaneous and laser lithotripsy equipment.
This document does not apply to:
– histotripsy or other therapeutic ultrasound bursts of longer time duration than that of the pressure pulse;
– non-focused pressure pulse equipment.
This document specifies:
– measurable parameters which could be used in the declaration of the acoustic output of extracorporeal focused pressure pulse equipment;
– methods of measurement and characterization of the pressure field generated by focused pressure pulse equipment.
While this document has been developed for equipment intended for use in lithotripsy, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal focused pressure pulse equipment, this document can be used as a guideline.
IEC 61846:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) Change of title: "pressure pulse lithotripters" in the previous edition is changed to "therapeutic focused short pressure pulse sources" in order to take into account the development in the relevant technical and biomedical applications of such sources, which were originally used only for (kidney) lithotripsy, while recent applications include a wide range for the treatment of, for example, stone diseases, orthopaedic pain, tissue, cardiac and brain diseases.
The term "focused" was added to differentiate IEC 61846 from IEC 63045.
The term "short" was added to align the nomenclature to IEC 63045 and to differentiate IEC 61846 from standards in the HIFU and HITU fields.
b) Clause 1 and elsewhere in the document: The term "lithotripsy" is changed to "therapy" in order to account for the wide range of applications beyond stone diseases.
c) Clause 3: The "−6 dB" parameter definitions are replaced by "−n dB" to avoid misconceptions in the significance and use of these parameters and to account for newer findings in literature.
Additional "n MPa" parameters are introduced for the same reasons.
The definitions of "derived" parameters are aligned to those in recently published standards, for example IEC 62127-1.
New definitions were added which describe parameters appearing in newer relevant literature, for example "momentum", "average positive acoustic pressure", "cavitation induction index", "pulse to pulse variability", "total pressure pulse energy dose".
d) Clause 6: The terms "focus hydrophone" and "field hydrophone" were removed to account for newer technical developments. New terms distinguish between "hydrophones for pressure pulse measurements" and "hydrophones for quality assurance".
e) Annexes: Descriptions, tables and figures were edited to account for newer literature and standards as well as technical developments.

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SIST EN 61669:2016/A1:2025(Amendment)
Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids (IEC 61669:2015/AMD1:2025)
EN 61669:2016/A1:2025
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EN 61669:2016/A1:2025(Amendment)
Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids
SIST EN 61669:2016/A1:2025
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SIST EN IEC 62127-2:2025(Main)
Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields (IEC 62127-2:2025)
EN IEC 62127-2:2025

IEC 62127-2:2025 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 document.
This document is applicable to
- hydrophones used for measurements made in water and in the ultrasonic frequency range 50 kHz to 100 MHz;
- hydrophones employing 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 62127-2:2025 cancels and replaces the first edition published in 2007, Amendment 1:2013 and Amendment 2:2017. 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) directional response measurement and effective size determination procedures have been updated in 12.5.1 to align with recent changes in IEC 62127-3;
d) Annex F has been amended to comprise a calibration technique for high-frequency complex-valued calibration;
e) the reciprocity method description in Annex K was extended to also comprise focusing transducers.

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EN IEC 62127-2:2025(Main)
Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields
SIST EN IEC 62127-2:2025

IEC 62127-2:2025 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 document. This document is applicable to - hydrophones used for measurements made in water and in the ultrasonic frequency range 50 kHz to 100 MHz; - hydrophones employing 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 62127-2:2025 cancels and replaces the first edition published in 2007, Amendment 1:2013 and Amendment 2:2017. 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) directional response measurement and effective size determination procedures have been updated in 12.5.1 to align with recent changes in IEC 62127-3; d) Annex F has been amended to comprise a calibration technique for high-frequency complex-valued calibration; e) the reciprocity method description in Annex K was extended to also comprise focusing transducers.

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IEC 61669:2015(Main)
Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids

IEC 61669:2015 gives recommendations and requirements for the measurement and estimation of the real-ear acoustical performance characteristics of air-conduction hearing aids and for the measurement of certain acoustic properties of the ear related to the application of hearing aids. Measurements of real-ear acoustical characteristics of hearing aids which apply non-linear or analytical processing techniques are valid only for the test signals used and conditions employed. The purpose of this standard is to ensure that measurements of real-ear acoustical performance characteristics of a given hearing aid on a given human ear can be replicated in other locations with other test equipment. This second edition cancels and replaces the first edition of IEC 61669:2001 and the first edition of ISO 12124:2001. This edition constitutes a technical revision.

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IEC 61669:2015/AMD1:2025(Amendment)
Amendment 1 - Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids
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IEC 62127-2:2025(Main)
Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields

IEC 62127-2:2025 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 document.
This document is applicable to
- hydrophones used for measurements made in water and in the ultrasonic frequency range 50 kHz to 100 MHz;
- hydrophones employing 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 62127-2:2025 cancels and replaces the first edition published in 2007, Amendment 1:2013 and Amendment 2:2017. 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) directional response measurement and effective size determination procedures have been updated in 12.5.1 to align with recent changes in IEC 62127-3;
d) Annex F has been amended to comprise a calibration technique for high-frequency complex-valued calibration;
e) the reciprocity method description in Annex K was extended to also comprise focusing transducers.

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SIST EN IEC 60601-2-37:2025(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2024)
EN IEC 60601-2-37:2024

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx,
b) technical and editorial changes as a result of maintenance to normative references;
c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

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EN IEC 60601-2-37:2024(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
SIST EN IEC 60601-2-37:2025

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

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SIST EN IEC 63412-1:2024(Main)
Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface (IEC 63412-1:2024)
EN IEC 63412-1:2024

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.

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EN IEC 63412-1:2024(Main)
Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface
SIST EN IEC 63412-1:2024

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.

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IEC 63412-1:2024(Main)
Ultrasonics - Shear-wave elastography - Part 1: Specifications for the user interface

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.

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IEC
IEC 60601-2-37:2024(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx,
b) technical and editorial changes as a result of maintenance to normative references;
c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

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IEC
IEC 60317-47:2013(Main)
Specifications for particular types of winding wires - Part 47: Aromatic polyimide enamelled rectangular copper wire, class 240

IEC 60317-47:2013 specifies the requirements of enamelled rectangular copper winding wire of class 240 with a sole coating of aromatic polyimide resin. The range of nominal conductor dimensions covered by this standard is:
- width: min. 2,0 mm max. 16,0 mm;
- thickness: min. 0,80 mm max. 5,60 mm. Wires of grade 1 and grade 2 are included in this specification and apply to the complete range of conductors. The specified combinations of width and thickness, as well as the specified width/thickness ratio, are given in IEC 60317-0-2. This second edition cancels and replaces the first edition published in 1997. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- deletion of the "in some countries" statement in the scope;
- new subclause containing general notes on winding wire, formerly a part of the scope;
- new subclause containing requirements for appearance;
- revision to the notes in Clause 19, Dielectric dissipation factor;
- new Clause 23, Pin hole test. Keywords: requirements of enamelled rectangular copper winding wire, class 240, sole coating of aromatic polyimide resin.
This publication is to be read in conjunction with IEC 60317-0-2:2013.

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SIST
SIST EN IEC 60118-0:2024(Main)
Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids (IEC 60118-0:2022)
EN IEC 60118-0:2024

IEC 60118-0:2022 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids measured with an acoustic coupler or occluded ear simulator.
This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets.
This document is also applicable for the measurement of the performance characteristics of hearing aids for production, supply and delivery quality-assurance purposes.
The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use.
This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person's ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used.
This document also covers measurement of hearing aids with non-acoustic inputs, such as wireless, inductive or electrical input.
This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied.
This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied.
IEC 60118-0:2022 merges and updates the methods previously described in IEC 60118-0:2015 and IEC 60118-7:2005. It cancels and replaces the third edition of IEC 60118-0 published in 2015. This edition constitutes a technical revision.
Measurements for quality control as described in IEC 60118-7:2005 can be found in Clause 10 of this document.
This edition includes the following significant technical changes with respect to previous editions:
a) the default use of an acoustic coupler according to IEC 60318-5,
b) addition of the optional use of an occluded ear simulator according to IEC 60318-4,
c) addition of the optional use of an acoustic coupler according to IEC 60318-8 (new standard based on IEC TS 62886) when information about the response above 8 kHz is needed, or the optional use of the acoustic coupler according to IEC 60318-8 for deep insert hearing aids,
d) the addition of measurements of the performance of hearing aids for production, supply and delivery quality assurance purposes,
e) corrected and updated measurement configuration and methods, adding the use of a sequential measurement as preferred configuration,
f) updated and expanded measurement procedures for the non-acoustic inputs of the hearing aid.

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EN IEC 60118-0:2024(Main)
Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids
SIST EN IEC 60118-0:2024

IEC 60118-0:2022 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids measured with an acoustic coupler or occluded ear simulator. This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets. This document is also applicable for the measurement of the performance characteristics of hearing aids for production, supply and delivery quality-assurance purposes. The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use. This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person's ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used. This document also covers measurement of hearing aids with non-acoustic inputs, such as wireless, inductive or electrical input. This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied. This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied. IEC 60118-0:2022 merges and updates the methods previously described in IEC 60118-0:2015 and IEC 60118-7:2005. It cancels and replaces the third edition of IEC 60118-0 published in 2015. This edition constitutes a technical revision. Measurements for quality control as described in IEC 60118-7:2005 can be found in Clause 10 of this document. This edition includes the following significant technical changes with respect to previous editions: a) the default use of an acoustic coupler according to IEC 60318-5, b) addition of the optional use of an occluded ear simulator according to IEC 60318-4, c) addition of the optional use of an acoustic coupler according to IEC 60318-8 (new standard based on IEC TS 62886) when information about the response above 8 kHz is needed, or the optional use of the acoustic coupler according to IEC 60318-8 for deep insert hearing aids, d) the addition of measurements of the performance of hearing aids for production, supply and delivery quality assurance purposes, e) corrected and updated measurement configuration and methods, adding the use of a sequential measurement as preferred configuration, f) updated and expanded measurement procedures for the non-acoustic inputs of the hearing aid.

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SIST EN IEC 63305:2024(Main)
Underwater Acoustics - Calibration of acoustic wave vector receivers in the frequency range 5 Hz to 10 kHz (IEC 63305:2024)
EN IEC 63305:2024

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.

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EN IEC 63305:2024(Main)
Underwater acoustics - Calibration of acoustic wave vector receivers in the frequency range 5 Hz to 10 kHz
SIST EN IEC 63305:2024

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.

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IEC
IEC 63305:2024(Main)
Underwater acoustics - Calibration of acoustic wave vector receivers in the frequency range 5 Hz to 10 kHz

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.

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IEC
IEC TS 63001:2024(Main)
Measurement of cavitation noise in ultrasonic baths and ultrasonic reactors

IEC TS 63001:2024 provides a technique of measurement and evaluation of ultrasound in liquids for use in cleaning devices, equipment, and ultrasonic reactors. It specifies
- the cavitation measurement at frequencies between harmonics of the operating frequency f0,
- the cavitation measurement derived by integrating broadband cavitation noise energy,
- the cavitation measurement by extraction of broadband spectral components.
This document covers the measurement and evaluation of cavitation, but not its secondary effects (cleaning results, sonochemical effects, etc.). Further details regarding the generation of cavitation noise in ultrasonic baths and ultrasonic reactors are provided in Annex A.
IEC TS 63001:2024 cancels and replaces the first edition published in 2019. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) addition of a new method of measurement: the measurement of integrated broadband cavitation energy between two frequency bounds.

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IEC
IEC TS 62903:2023(Main)
Ultrasonics - Measurements of electroacoustical parameters and acoustic output power of spherically curved transducers using the self-reciprocity method

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.

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SIST
SIST EN IEC 62127-3:2023(Main)
Ultrasonics - Hydrophones - Part 3: Properties of hydrophones for ultrasonic fields (IEC 62127-3:2022)
EN IEC 62127-3:2023

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.

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SIST
SIST EN IEC 60318-7:2023(Main)
Electroacoustics - Simulators of human head and ear - Part 7: Head and torso simulator for the measurement of sound sources close to the ear (IEC 60318-7:2022)
EN IEC 60318-7:2022

This part of IEC 60318 describes a head and torso simulator, or manikin, intended for the measurement of sound sources placed close to the ear in the frequency range from 100 Hz to 16 000 Hz.
The manikin described in this part of IEC 60318 is intended for airborne acoustic measurements only. It is not suitable for measurements which depend upon vibration transmission paths such as bone conduction, or for measurements requiring the simulation of bone or tissue.
This document specifies the manikin in terms of both its geometrical dimensions and its acoustical properties. For conformance with this document, a manikin shall be compliant with both sets of specifications.

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EN IEC 60118-13:2020(Main)
Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices
SIST EN IEC 60118-13:2020

IEC 60118-13:2019 covers the relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency fields originating from digital wireless devices such as mobile phones was identified as one of the most relevant EMC phenomena impacting hearing aids. IEC 60118-13:2019 cancels and replaces the fourth edition published in 2016 and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) it introduces a new measurement method and set of EMC requirements for hearing aids immunity to mobile digital wireless devices; b) generic EMC requirements for hearing aids are no longer included – should be covered by other standards as appropriate.

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EN IEC 60601-2-66:2020(Main)
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
SIST EN IEC 60601-2-66:2020

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision of the definition about ESSENTIAL PERFORMANCE; b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances; c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V; d) correction of the drop test level from 1,5 m to 1,0 m; e) correction of the wording of IEC 60601-2-66:2015.

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EN IEC 62127-3:2023(Main)
Ultrasonics - Hydrophones - Part 3: Properties of hydrophones for ultrasonic fields
SIST EN IEC 62127-3:2023

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.

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IEC
IEC TS 62736:2023(Main)
Ultrasonics - Pulse-echo scanners - Simple methods for periodic testing to verify stability of an imaging system's elementary performance

IEC TS 62736:2023 specifies requirements and methods for periodic testing of the quality of diagnostic medical ultrasound systems using reflection-mode (pulse-echo) imaging. Image measurement and interpretation workstations are included. This document includes minimum sets of such tests intended for frequent users of medical ultrasound systems, for quality assurance professionals in their organizations, or those hired from other quality-control and/or service-provider organizations. The procedures are for a wide range of more common diagnostic ultrasound systems, currently operating from 1 MHz to 40 MHz, although available phantoms meet the specifications only from 1 MHz to 23 MHz.
The tests are defined in three levels, with the simplest and most cost-effective performed most frequently:
- Level 1 comprises five quick tests/observations to be performed daily to monthly by those normally operating the systems.
- Level 2 includes one necessary test for all systems in addition to those of Level 1, two Level 1 tests performed more rigorously, two tests that are for special situations or equipment, and one that is just optional, included because it is highly developed. Level 2 tests are performed annually by those with meaningful quality assurance training.
- Level 3 extends the two special situations tests to all systems, adds one optional test and includes a periodic review of the QA programme.
Frequent distance-measurement accuracy tests are recommended in this document only for certain classes of position encoding that are not now known to be highly stable and without bias. QA in all dimensions is recommended in this document as the first test for such systems.
The test methodology is applicable for transducers operating in the 1 MHz to 23 MHz frequency range. The types of transducers used with these scanners include
a) electronic phased arrays,
b) linear arrays,
c) convex arrays,
d) mechanical transducers,
e) two-dimensional arrays operated in a 2D imaging mode,
f) transducers operating in 3D imaging mode for a limited number of sets of reconstructed 2D images, and
g) three-dimensional scanning transducers based on a combination of the above types.
All tests on scanners considered here evaluate basic pulse-echo techniques and might detect most failures in other modes. Dedicated Doppler systems, or other systems for detection of blood motion, are excluded from this scope as specialized equipment is required to test them. Such test equipment can be specific to the intended application of the Doppler system. This document includes definition of terms and specifies methods for measuring the maximum relative depth of penetration of real-time ultrasound B MODE scanners, though this penetration measure is listed as less frequently applied.
IEC TS 62736:2023 cancels and replaces the first edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) expansion of the applicable types of transducers and the frequency range of application;
b) extension of test protocols and image assessments, including for very-low-echo spheres;
c) revision of phantom designs and their acoustic properties, consistent with the second edition of IEC TS 62791;
d) inclusion of luminance tests for system-image display consistency at scanner and remote monitors;
e) addition of special considerations for 3D-imaging transducers (Annex D) and workbook examples (Annex E).

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IEC
IEC 62127-3:2022(Main)
Ultrasonics - Hydrophones - Part 3: Properties of hydrophones for ultrasonic fields

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.

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EN IEC 60565-2:2019(Main)
Underwater acoustics - Hydrophones - Calibration of hydrophones - Part 2: Procedures for low frequency pressure calibration
SIST EN IEC 60565-2:2020

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.

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EN IEC 60118-9:2019(Main)
Electroacoustics - Hearing aids - Part 9: Methods of measurement of the performance characteristics of bone conduction hearing aids
SIST EN IEC 60118-9:2020

IEC 60118-9:2019 specifies methods for the measurement of bone conduction hearing aid characteristics. The methods described will produce a suitable basis for the exchange of information or for direct comparison of the electroacoustical characteristics of bone conduction hearing aids. These methods are chosen to be practical and reproducible and are based on selected fixed parameters. The results obtained by the methods specified in this document express the performance under the conditions of measurement; however, the performance of the hearing aid under practical conditions of use will depend upon a number of factors (e.g. effective load impedance, environmental conditions, acoustical environment, etc.). This document defines methods of measurement of characteristics of bone conduction hearing aids both for • transcutaneously coupled devices measured on a mechanical coupler, meeting the requirements of IEC 60318-6, and • bone coupled/bone anchored devices measured on a skull simulator. IEC 60118-9:2019 cancels and replaces the first edition published in 1985. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) includes bone coupled devices measured on a skull simulator; b) measurement frequency range increased to 8 000 Hz for bone coupled devices.

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IEC
IEC 60118-0:2022(Main)
Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids

IEC 60118-0:2022 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids measured with an acoustic coupler or occluded ear simulator.
This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets.
This document is also applicable for the measurement of the performance characteristics of hearing aids for production, supply and delivery quality-assurance purposes.
The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use.
This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person's ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used.
This document also covers measurement of hearing aids with non-acoustic inputs, such as wireless, inductive or electrical input.
This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied.
This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied.
IEC 60118-0:2022 merges and updates the methods previously described in IEC 60118-0:2015 and IEC 60118-7:2005. It cancels and replaces the third edition of IEC 60118-0 published in 2015. This edition constitutes a technical revision.
Measurements for quality control as described in IEC 60118-7:2005 can be found in Clause 10 of this document.
This edition includes the following significant technical changes with respect to previous editions:
a) the default use of an acoustic coupler according to IEC 60318-5,
b) addition of the optional use of an occluded ear simulator according to IEC 60318-4,
c) addition of the optional use of an acoustic coupler according to IEC 60318-8 (new standard based on IEC TS 62886) when information about the response above 8 kHz is needed, or the optional use of the acoustic coupler according to IEC 60318-8 for deep insert hearing aids,
d) the addition of measurements of the performance of hearing aids for production, supply and delivery quality assurance purposes,
e) corrected and updated measurement configuration and methods, adding the use of a sequential measurement as preferred configuration,
f) updated and expanded measurement procedures for the non-acoustic inputs of the hearing aid.

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EN IEC 63009:2019(Main)
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz
SIST EN IEC 63009:2020

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).

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EN IEC 60318-7:2022(Main)
Electroacoustics - Simulators of human head and ear - Part 7: Head and torso simulator for the measurement of sound sources close to the ear
SIST EN IEC 60318-7:2023

This part of IEC 60318 describes a head and torso simulator, or manikin, intended for the measurement of sound sources placed close to the ear in the frequency range from 100 Hz to 16 000 Hz. The manikin described in this part of IEC 60318 is intended for airborne acoustic measurements only. It is not suitable for measurements which depend upon vibration transmission paths such as bone conduction, or for measurements requiring the simulation of bone or tissue. This document specifies the manikin in terms of both its geometrical dimensions and its acoustical properties. For conformance with this document, a manikin shall be compliant with both sets of specifications.

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IEC
IEC TR 61094-10:2022(Main)
Electroacoustics - Measurement microphones - Part 10: Absolute pressure calibration of microphones at low frequencies using calculable pistonphones

IEC TR 61904-10:2022
- is applicable to laboratory standard microphones meeting the requirements of IEC 61094-1 and other types of measurement microphones,
- describes one possible absolute method for determining the complex pressure sensitivity, based on a device capable of generating a known sound pressure, especially at low frequencies, and
- provides a reproducible and accurate basis for the measurement of sound pressure at low frequencies.
All quantities are expressed in SI units.

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IEC
IEC TS 62791:2022(Main)
Ultrasonics - Pulse-echo scanners - Low-echo sphere phantoms and method for performance testing of grey-scale medical ultrasound scanners applicable to a broad range of transducer types

IEC TS 62791:2022 defines terms and specifies methods for quantifying detailed imaging performance of real-time, ultrasound B-mode scanners. Detail is assessed by imaging phantoms containing small, low-echo spherical targets in a tissue-mimicking background and analysing sphere detectability. Specifications are given for phantom properties. In addition, procedures are described for acquiring images, conducting qualitative analysis of sphere detectability, and carrying out quantitative analysis by detecting sphere locations and computing their contrast-to-noise ratios. With appropriate choices in design, results can be applied, for example:
• to assess the relative ability of scanner configurations (scanner make and model, scan head and console settings) to delineate the boundary of a tumour or identify specific features of tumours;
• to choose scanner control settings, such as frequency or the number and location of transmit foci, which maximize spatial resolution;
• to detect defects in probes causing enhanced sidelobes and spurious echoes.
The types of transducers used with these scanners include:
a) phased arrays,
b) linear arrays,
c) convex arrays,
d) mechanical sector scanners,
e) 3-D probes operating in 2-D imaging mode, and
f) 3-D probes operating in 3-D imaging mode for a limited number of sets of reconstructed 2 D images.
The test methodology is applicable for transducers operating in the 1 MHz to 23 MHz frequency range.
IEC TS 62791:2022 cancels and replaces the first edition published in 2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition.
a) It introduces necessary corrections to the analysis methods; these have been published in the literature.
b) It increases the range of contrast levels of low-echo spheres in phantoms that meet this Technical Specification. Previous specification was -20 dB, but two additional levels, -6 dB and either -30 dB or, if possible, -40 dB, are now specified.
c) It includes a wider range of uses of the methodology, including testing the effectiveness of scanner pre-sets for specific clinical tasks and detecting flaws in transducers and in beamforming.
d) It decreases the manufacturing cost by decreasing phantoms' dimensions and numbers of low-echo, backscattering spheres embedded in each phantom.

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IEC
IEC 60318-7:2022(Main)
Electroacoustics - Simulators of human head and ear - Part 7: Head and torso simulator for the measurement of sound sources close to the ear

IEC 60318-7:2022 describes a head and torso simulator, or manikin, intended for the measurement of sound sources placed close to the ear in the frequency range from 100 Hz to 16 000 Hz.
The manikin described in this document is intended for airborne acoustic measurements only. It is not suitable for measurements which depend upon vibration transmission paths such as bone conduction, or for measurements requiring the simulation of bone or tissue.
This document specifies the manikin in terms of both its geometrical dimensions and its acoustical properties. Only manikins compliant with both sets of specifications are in conformance with this document.
IEC 60318-7:2022 cancels and replaces IEC TS 60318-7:2017. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC TS 60318-7:2017:
a) changing the title;
b) extending the scope to sound sources close to the ear.

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SIST
SIST EN IEC 60318-8:2022(Main)
Electroacoustics - Simulators of human head and ear - Part 8: Acoustic coupler for highfrequency measurements of hearing aids and earphones coupled to the ear by means of ear inserts (IEC 60318-8:2022)
EN IEC 60318-8:2022

IEC 60318-8:2022 describes an acoustic coupler for loading a hearing aid or insert earphone with a specified acoustic impedance when testing its acoustic performance, in the frequency range up to 16 kHz. It is suitable for air-conduction hearing aids and earphones, coupled to the ear by means of ear inserts, earmoulds or similar devices.
The acoustic coupler does not simulate the human ear. However, it has an effective volume of only 0,4 cm3, which is small enough not to produce significant resonances in the coupler in the frequency range below 16 kHz. Therefore, it will load the earphone with a known acoustic impedance, which allows repeatable measurements with low uncertainty to be obtained on earphones used in extended high-frequency audiometry.

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EN IEC 60318-8:2022(Main)
Electroacoustics - Simulators of human head and ear - Part 8: Acoustic coupler for high-frequency measurements of hearing aids and earphones coupled to the ear by means of ear inserts
SIST EN IEC 60318-8:2022

IEC 60318-8:2022 describes an acoustic coupler for loading a hearing aid or insert earphone with a specified acoustic impedance when testing its acoustic performance, in the frequency range up to 16 kHz. It is suitable for air-conduction hearing aids and earphones, coupled to the ear by means of ear inserts, earmoulds or similar devices. The acoustic coupler does not simulate the human ear. However, it has an effective volume of only 0,4 cm3, which is small enough not to produce significant resonances in the coupler in the frequency range below 16 kHz. Therefore, it will load the earphone with a known acoustic impedance, which allows repeatable measurements with low uncertainty to be obtained on earphones used in extended high-frequency audiometry.

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SIST
SIST EN IEC 62127-1:2022(Main)
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields (IEC 62127-1:2022)
EN IEC 62127-1:2022

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.

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EN IEC 62127-1:2022(Main)
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
SIST EN IEC 62127-1:2022

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.

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SIST
SIST EN IEC 60118-16:2022(Main)
Electroacoustics - Hearing aids - Part 16: Definition and verification of hearing aid features (IEC 60118-16:2022)
EN IEC 60118-16:2022

This part of IEC 60118 gives definitions for common hearing aid features such as noise reduction or feedback reduction, etc. Only acoustical inputs are considered. Binaural features are currently not covered in this document. In addition, measurement procedures are described to verify hearing aid features. The objective is not to evaluate the performance of features but to verify their existence and functionality.
Furthermore, definitions and procedures are kept as general as possible so that this document can be applied to various types of hearing aids, e.g. air conduction hearing aids or bone conduction hearing aids. To this end, the general definition for hearing aid of IEC 60118-0:2015 is adopted, and this document does not refer to any specific ear simulator or acoustic coupler but uses a general definition of a coupler. However, if a general view is not applicable or leads to unclear or complex wording, the situation for an air conduction hearing aid is considered, only. Nevertheless, in Clause 4, an explanation is given on how this document can be applied to hearing aids which do not use air conduction.

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