17.140.50 - Electroacoustics
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Electroacoustics
Elektroakustik
Électroacoustique
Elektroakustika
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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.
- Standard41 pagesEnglish and French languagesale 15% off
IEC 60601-2-37:2024 is available as IEC 60601-2-37:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-37:2024 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.
- Standard181 pagesEnglish languagesale 15% off
- Standard118 pagesEnglish and French languagesale 15% off
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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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.
- Standard77 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard77 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard65 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard65 pagesEnglish languagesale 10% offe-Library read for1 day
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 TS 63001:2024 is available as IEC TS 63001:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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.
- Technical specification36 pagesEnglish languagesale 15% off
- Technical specification85 pagesEnglish languagesale 15% off
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.
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- Technical specification109 pagesEnglish languagesale 15% off
IEC 62127-3:2022 is available as IEC 62127-3:2022 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.
- Standard34 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard34 pagesEnglish languagesale 10% offe-Library read for1 day
IEC TS 62736:2023 is available as IEC TS 62736:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC TS 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).
- Technical specification66 pagesEnglish languagesale 15% off
- Technical specification139 pagesEnglish languagesale 15% off
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.
- Standard96 pagesEnglish languagesale 15% off
- Standard62 pagesEnglish and French languagesale 15% off
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.
- Standard56 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard150 pagesEnglish and French languagesale 15% off
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).
- Standard39 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
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 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 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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This part of IEC 60318 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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
This part of IEC 62127 specifies methods of use of calibrated hydrophones for the
measurement in liquids of acoustic fields generated by ultrasonic medical equipment 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.
NOTE 1 Throughout this document, SI units are used. In the specification of certain parameters, such as beam
areas and intensities, it can be convenient to use decimal multiples or submultiples. For example, beam area is
likely to be specified in cm2 and intensities in W/cm2 or mW/cm2.
NOTE 2 The hydrophone as defined can be of a piezoelectric or an optic type.
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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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
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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This part of IEC 60645 applies to instruments designed primarily for the measurement of
otoacoustic emissions in the human external auditory meatus evoked by acoustic probe stimuli.
This document defines the characteristics to be specified by the manufacturer, specifies
minimum mandatory functions for two types of instruments and provides performance
specifications applicable to both instrument types. This document describes methods to be used
to demonstrate conformance with the specifications in this document and guidance on methods
for periodic calibration.
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.
Instruments can provide a measurement function not specifically within the scope of this
document and still comply with the relevant requirements of this document for the functions that
are within the scope. This document is not intended to restrict development or incorporation of
new features, nor to discourage innovative approaches.
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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.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
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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IEC 60645-6:2022 is available as IEC 60645-6:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 606045-6:2022 applies to instruments designed primarily for the measurement of otoacoustic emissions in the human external auditory meatus evoked by acoustic probe stimuli. This document defines the characteristics to be specified by the manufacturer, specifies minimum mandatory functions for two types of instruments and provides performance specifications applicable to both instrument types. This document describes methods to be used to demonstrate conformance with the specifications in this document and guidance on methods for periodic calibration. 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. Instruments can provide a measurement function not specifically within the scope of this document and still comply with the relevant requirements of this document for the functions that are within the scope. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. IEC 606045-6:2022 cancels and replaces the first edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the nominal test frequency used in DPOAE is now defined as the higher of the two frequencies, f2; b) the permitted deviation of the stimulus signal for TEOAE has been specified; c) the frequency range for DPOAE stimulus signals has been redefined, d) the stimulus level requirements for TEOAE have been redefined; e) the stimulus level requirements for DPOAE have been redefined; f) the harmonic distortion requirements for DPOAE have been redefined; g) a minimum measurement range for DPOAE has been added.
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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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No scope available
- Amendment9 pagesEnglish languagesale 10% offe-Library read for1 day
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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No scope available
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IEC 60118-16:2022 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, for example, air-conduction hearing aids or bone conduction hearing aids. To this end, the general definition for the term "hearing aid" given in IEC 60118-0 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 only is considered. Nevertheless, an explanation is given on how this document can be applied to hearing aids which do not use air conduction.
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IEC 60645-6:2022 is available as IEC 60645-6:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 606045-6:2022 applies to instruments designed primarily for the measurement of otoacoustic emissions in the human external auditory meatus evoked by acoustic probe stimuli. This document defines the characteristics to be specified by the manufacturer, specifies minimum mandatory functions for two types of instruments and provides performance specifications applicable to both instrument types. This document describes methods to be used to demonstrate conformance with the specifications in this document and guidance on methods for periodic calibration. 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. Instruments can provide a measurement function not specifically within the scope of this document and still comply with the relevant requirements of this document for the functions that are within the scope. This document is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. IEC 606045-6:2022 cancels and replaces the first edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the nominal test frequency used in DPOAE is now defined as the higher of the two frequencies, f2;
b) the permitted deviation of the stimulus signal for TEOAE has been specified;
c) the frequency range for DPOAE stimulus signals has been redefined,
d) the stimulus level requirements for TEOAE have been redefined;
e) the stimulus level requirements for DPOAE have been redefined;
f) the harmonic distortion requirements for DPOAE have been redefined;
g) a minimum measurement range for DPOAE has been added.
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IEC 61094-2:2009 is applicable to laboratory standard microphones meeting the requirements of IEC 61094-1 and other types of condenser microphone having the same mechanical dimensions and specifies a primary method of determining the complex pressure sensitivity so as to establish a reproducible and accurate basis for the measurement of sound pressure. This second edition cancels and replaces the first edition published in 1992. This second edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- an update of Clause 6 to fulfil the requirements of ISO/IEC Guide 98-3;
- an improvement of the heat conduction theory in Annex A;
- a revision of Annex F: Physical properties of humid air.
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IEC 61265:2018 specifies requirements for the electroacoustical performance of systems of instruments used to measure sound for the purposes of aircraft noise certification, and for other comparisons among aircraft models, and provides methods by which tests can be made periodically to verify that the performance continues to conform to the requirements within stated limits. In general, a sound measurement system for this purpose comprises a combination of instruments extending from a microphone, including its windscreen and other accessories, through data recording and processing devices to a suitable output. Different measurement systems, regardless of their composition, perform the necessary functions in different ways and operate on either analogue or digital principles. IEC 61265:2018 cancels and replaces the first edition published in 1995. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) addition of guidance for measurements for aircraft other than large transport aeroplanes; b) addition of microphones used in ground plane measurement systems; c) addition of weighted sound level measurements other than one-third-octave band measurements, for certain aircraft types; d) revision and clarification of requirements for digital audio recording; e) addition of requirements for evaluation of measurement uncertainty.
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IEC 60364-7-710:2021 applies to electrical installations in medical locations so as to provide safety of patients and medical staff. These requirements refer to:
– hospitals and clinics or equivalent institutions (including equivalent transportable and mobile locations);
which, subject to assessment (710.30), can also include:
– sanatoriums and health clinics;
– dedicated locations in homes for senior citizens and aged care homes, where patients receive medical care;
– medical centres, outpatients' clinics and departments, casualty wards;
– other outpatients' institutions (industrial, sports and others);
– medical and dental practices;
– dedicated medical rooms in the workplace;
– other locations where medical electrical equipment is used;
– veterinary clinics;
– rooms in existing installations where a change of utilization for medical applications occur.
This list is not exhaustive.
The requirements of this document do not apply to ME equipment or ME systems.
This edition includes the following significant technical changes with respect to the previous edition:
a) the scope provides improved information to the application of this document;
b) some terms and definitions have been revised;
c) the validity of the respective parts of the IEC 60364 series has been verified and clauses updated;
d) Clause 710.30 has been extended;
e) Clause 710.41 has been updated;
f) Clause 710.413 has been renumbered as Clause 710.411;
g) in 710.411 insulation fault location systems have been added;
h) Clause 710.421 has been extended to include arc fault detection devices;
i) Clause 710.44 has been added;
j) Clause 710.51 has been updated and now covers distribution boards and electrical operating areas;
k) Clause 710.514, has been extended and includes separate subclauses on diagrams, documentation and operating instructions;
l) Subclauses 710.531 to 710.537 have been added;
m) Clause 710.55 has been updated;
n) Clause 710.56 has been added;
o) Clause 710.6, Verification, has been revised;
p) Annex A was deleted, and the contents integrated into 710.560.4;
q) former Annex B is now Annex A and has been updated;
r) an informative Annex B on guidance concerning electromagnetic interferences (EMI) in installations of buildings has been added
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IEC TS 60695-2-20:2021 describes a test method that applies to solid electrical insulating materials of which test specimens can be provided. The test measures the time required to ignite a test specimen when it is affected by heat from an electrically heated wire wound around the test specimen. If the test specimen drips, the time at which this occurs is also recorded.
The test method can be used to provide classifications which can be used for quality assurance, the preselection of materials of products as described in IEC 60695-1-30, or to verify the required minimum classification of materials used in end products.
This basic safety publication is intended for use by technical committees in the preparation of standards in accordance with the principles laid down in IEC Guide 104 and ISO/IEC Guide 51.
One of the responsibilities of a technical committee is, wherever applicable, to make use of basic safety publications in the preparation of its publications. The requirements, test methods or test conditions of this basic safety publication will not apply unless specifically referred to or included in the relevant publications.
This third edition of IEC TS 60695-2-20 cancels and replaces the second edition of IEC TS 60695-2-20 published in 2004. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
– Contents page added
– Updated Scope (Clause 1)
– Updated Terms and Definitions, added new relevant terms (Clause 3)
– Updated Principle (Clause 4)
– Updated Apparatus (Clause 5; recommendation to change the power source from a.c. to d.c. with a constant current output. Reason for this recommendation: d.c. technology is easier to obtain and to handle, which has been found to improve the Repeatability and Reproducibility of the test.
– Updated Test specimen dimensions (6.2)
– Revised Test procedure (Clause 8)
– Revised Observations and measurements (Clause 9)
– Revised Evaluation of test results (Clause 10)
– Revised Test report (Clause 11)
– Revised Annex A: Deletion of conformational test; Guidance on verification of the heater wire winding before testing
– Addition of normative Annex B: HWCT PLC Classes
– Addition of informative Annex C: Calibration curve to determine test current (Ic) in a spreadsheet program
– Addition of informative Annex D: Precision data
It has the status of a basic safety publication in accordance with IEC Guide 104 and ISO/IEC Guide 51.
This basic safety publication is intended for use by technical committees in the preparation of standards in accordance with the principles laid down in IEC Guide 104 and ISO/IEC Guide 51.
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IEC 61828:2020
- provides definitions for the transmitted field characteristics of focusing and nonfocusing transducers for applications in medical ultrasound;
- relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers;
- gives measurement methods for obtaining defined field characteristics of focusing and nonfocusing transducers;
- specifies beam axis alignment methods appropriate for focusing and nonfocusing transducers.
IEC 61828:2021 relates to focusing ultrasonic transducers operating in the frequency range appropriate to medical ultrasound (0,5 MHz to 40 MHz) for both therapeutic and diagnostic applications. It shows how the characteristics of the transmitted field of transducers can be described from the point of view of design, as well as measured by someone with no prior knowledge of the construction details of a particular device. The transmitted ultrasound field for a specified excitation is measured by a hydrophone in either a standard test medium (for example, water) or in a given medium. This document applies only to media where the field behaviour is essentially like that in a fluid (i.e. where the influence of shear waves and elastic anisotropy is small), including soft tissues and tissue-mimicking gels. Any aspects of the field that affect their theoretical description or are important in design are also included. These definitions would have use in scientific communications, system design and description of the performance and safety of systems using these devices.
IEC 61828:2021 incorporates definitions from other related standards where possible, and supplies more specific terminology, both for defining focusing characteristics and for providing a basis for measurement of these characteristics.
IEC 61828:2021 cancels and replaces the first edition published in 2001. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) Clause 6 on Measurement procedures has been replaced by Clause 6: "Acoustic field measurement: equipment" and Clause 7: "Measurement procedure" and related definitions.
b) Reorganization of definitions and measurement section to accommodate specific sets of measurements for focusing, nonlinearity, beam axis alignment, beam area, beam maximum, numerical projection, plane wave, high intensity therapeutic ultrasound, multiple sources, spatial impulse response and compound plane waves. Clause 3 has been moved to Annex B.
c) The normative references have been updated and the Bibliography has been expanded from 8 to 40 references.
d) Twelve figures have been updated and seven new figures (B.1, B.3, B.7, B.10, B.11, B.12, B.13, B.14) have been added to facilitate measurements and be consistent with measurement terminology.
e) New measurements have been added for time delays, arrays, plane waves and spatial impulse response.
f) Annex A has been expanded to provide general guidance on pulsed waves, system responses, focusing gains and minimum beamwidth estimation.
g) New annexes have been added:
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IEC 61828:2020 - provides definitions for the transmitted field characteristics of focusing and nonfocusing transducers for applications in medical ultrasound; - relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers; - gives measurement methods for obtaining defined field characteristics of focusing and nonfocusing transducers; - specifies beam axis alignment methods appropriate for focusing and nonfocusing transducers. IEC 61828:2021 relates to focusing ultrasonic transducers operating in the frequency range appropriate to medical ultrasound (0,5 MHz to 40 MHz) for both therapeutic and diagnostic applications. It shows how the characteristics of the transmitted field of transducers can be described from the point of view of design, as well as measured by someone with no prior knowledge of the construction details of a particular device. The transmitted ultrasound field for a specified excitation is measured by a hydrophone in either a standard test medium (for example, water) or in a given medium. This document applies only to media where the field behaviour is essentially like that in a fluid (i.e. where the influence of shear waves and elastic anisotropy is small), including soft tissues and tissue-mimicking gels. Any aspects of the field that affect their theoretical description or are important in design are also included. These definitions would have use in scientific communications, system design and description of the performance and safety of systems using these devices. IEC 61828:2021 incorporates definitions from other related standards where possible, and supplies more specific terminology, both for defining focusing characteristics and for providing a basis for measurement of these characteristics. IEC 61828:2021 cancels and replaces the first edition published in 2001. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) Clause 6 on Measurement procedures has been replaced by Clause 6: "Acoustic field measurement: equipment" and Clause 7: "Measurement procedure" and related definitions. b) Reorganization of definitions and measurement section to accommodate specific sets of measurements for focusing, nonlinearity, beam axis alignment, beam area, beam maximum, numerical projection, plane wave, high intensity therapeutic ultrasound, multiple sources, spatial impulse response and compound plane waves. Clause 3 has been moved to Annex B. c) The normative references have been updated and the Bibliography has been expanded from 8 to 40 references. d) Twelve figures have been updated and seven new figures (B.1, B.3, B.7, B.10, B.11, B.12, B.13, B.14) have been added to facilitate measurements and be consistent with measurement terminology. e) New measurements have been added for time delays, arrays, plane waves and spatial impulse response. f) Annex A has been expanded to provide general guidance on pulsed waves, system responses, focusing gains and minimum beamwidth estimation. g) New annexes have been added: • Annex B (informative) Rationale for focusing and nonfocusing definitions • Annex E (informative) Uncertainties; • Annex F (informative) Transducer and hydrophone positioning systems; •
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This document specifies the performance requirements for three classes of sound calibrator: class LS (Laboratory Standard), class 1 and class 2. Acceptance limits are smallest for class LS and greatest for class 2 instruments. Class LS sound calibrators are normally used only in the laboratory; class 1 and class 2 are considered as sound calibrators for field use. A class 1 sound calibrator is primarily intended for use with a class 1 sound level meter and a class 2 sound calibrator primarily with a class 2 sound level meter, as specified in IEC 61672-1. The acceptance limits for class LS sound calibrators are based on the use of a laboratory standard microphone, as specified in IEC 61094-1, for demonstrations of conformance to the requirements of this document. The acceptance limits for class 1 and class 2 sound calibrators are based on the use of a working standard microphone, as specified in IEC 61094-4, for demonstrations of conformance to the requirements of this document. To promote consistency of testing of sound calibrators and ease of use, this document contains three normative annexes – Annex A "Pattern evaluation tests", Annex B "Periodic tests", Annex C "Pattern evaluation report", and two informative Annexes – Annex D "Relationship between tolerance interval, corresponding acceptance interval and the maximum-permitted uncertainty of measurement" and Annex E "Example assessments of conformance to specifications of this document". This document does not include requirements for equivalent free-field or random-incidence sound pressure levels, such as can be used in the overall sensitivity adjustment of a sound level meter. A sound calibrator can provide other functions, for exammple, tonebursts. Requirements for these other functions are not included in this document.
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