17.140.50 - Electroacoustics
ICS 17.140.50 Details
Electroacoustics
Elektroakustik
Électroacoustique
Elektroakustika
General Information
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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.
- Technical specification30 pagesEnglish languagesale 15% off
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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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; • Annex G (informative) Planar scanning of a hydrophone to determine acoustic output power; • Annex H (informative) Properties of water; In addition, Annex A was reorganized and new Clauses A.1, A.5 and A.6 were added. h) Guidelines for remaining within the manufacturer’s pressure and intensity hydrophone limits and the determination of the extent of nonlinearity in the field have been added.
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This part of IEC 60645 specifies a means of describing the physical characteristics, in terms of
electrical waveforms, of audiometric reference and test signals of short duration and methods
for their measurement.
The object of this document is to ensure that audiometric stimuli of short duration are specified
and measured in the same way and that the calibration of equipment using such signals is
carried out using defined methods.
This document does not describe the method of use of short-duration test signals.
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IEC 60645-3:2020 specifies a means of describing the physical characteristics, in terms of electrical waveforms, of audiometric reference and test signals of short duration and methods for their measurement.
The object of this document is to ensure that audiometric stimuli of short duration are specified and measured in the same way and that the calibration of equipment using such signals is carried out using defined methods.
This document does not describe the method of use of short-duration test signals.
IEC 60645-3:2020 cancels and replaces the second edition published in 2007. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) new figures of reference signals;
b) changes in definitions.
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This document specifies standard aspect ratios for logarithmic or level characteristics
expressed in decibels versus a logarithmic frequency axis and ranges for the radius of polar
diagrams of level. Applications include hard copy printouts, electronic files (e.g., PDF files),
scientific publications, screen displays in computer programs and apps, as well as graphs in
standards.
Informative examples of graphs that conform to the requirements in this document are found in
Annex A.
Although outside the scope of this document, graphs with a linear y-axis versus logarithmic
frequency (e.g., phase, group delay, etc.) often accompany the standard aspect ratio graphs of
level described in the normative part of this document. These are described in informative
Annex B.
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This part of IEC 60565 specifies methods and procedures for free-field calibration of
hydrophones, as well as individual electroacoustic transducers that can be used as
hydrophones (receivers) and/or projectors (source transducers). Two general types of
calibration are covered within this document: absolute calibration using the method of threetransducer
spherical-wave reciprocity, and relative calibration by comparison with a reference
device which has already been the subject of an absolute calibration.
The maximum frequency range of the methods specified in this document is from 200 Hz to
1 MHz. The lowest acoustic frequency of application will depend on a number of factors, and
will typically be in the range 200 Hz to 5 kHz depending mainly on the dimensions of the chosen
test facility, The highest frequency of application for the methods described here is 1 MHz.
Procedures for pressure hydrophone calibration at low frequencies can be found in
IEC 60565-2 [1]1. Procedures for hydrophone calibration at acoustic frequencies greater than
1 MHz are covered by IEC 62127-2 [2].
Excluded from the scope of this document are low-frequency pressure calibrations of
hydrophones, which are described in IEC 60565-2 [1]. Also excluded are calibrations of digital
hydrophones and systems, calibration of marine autonomous acoustic recorders, calibration
of acoustic vector sensors such as particle velocity sensors and pressure gradient
hydrophones, calibration of passive sonar arrays consisting of multiple hydrophones, and
calibration of active sonar arrays consisting of projectors and hydrophones.
This document presents a description of the requirements for free-field calibration in terms of
test facility, equipment and instrumentation, signal processing, and frequency limitations. A
description of achievable uncertainty and rules for the presentation of the calibration data are
provided. Also included are informative annexes that provide additional guidance on
• measurement of directional response of a hydrophone or projector,
• measurement of electrical impedance of hydrophones and projectors,
• electrical loading corrections,
• acoustic far-field criteria in underwater acoustic calibration,
• pulsed techniques in free-field calibrations,
• assessment of uncertainty in the free-field calibration of hydrophones and projectors,
• derivation of the formulae for three-transducer spherical-wave reciprocity calibrations,
• calibration using travelling-wave tubes,
• calibration of hydrophones using optical interferometry, and
• calibrations in reverberant water tanks using continuous signals.
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IEC 60263:2020 specifies standard aspect ratios for logarithmic or level characteristics expressed in decibels versus a logarithmic frequency axis and ranges for the radius of polar diagrams of level. Applications include hard copy printouts, electronic files (e.g., PDF files), scientific publications, screen displays in computer programs and apps, as well as graphs in standards.
Informative examples of graphs that conform to the requirements in this document are found in Annex A.
Although outside the scope of this document, graphs with a linear y-axis versus logarithmic frequency (e.g., phase, group delay, etc.) often accompany the standard aspect ratio graphs of level described in the normative part of this document. These are described in informative Annex B.
IEC 60263:2020 cancels and replaces the third edition published in 1982. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the scope is expanded to include electronic files (e.g., PDF), scientific publications, graphs in other standards, and screen displays in programs and apps;
b) a Terms and Definitions clause has been added;
c) aspect ratios of 20 dB/decade, and 0,5, 1, 1,25, and 2,5 decades/decade have been added;
d) ranges of 60 dB or 30 dB are specified for polar plots of absolute level; a 30 dB range is specified for polar plots of relative level;
e) as most graphs are now computer generated, tolerances and sizes have been removed;
f) all informative figures have been updated with contemporary examples;
g) an informative annex with information about linear y-axis vs. logarithmic frequency has been added.
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IEC 63045:2020 is applicable to
– therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses;
– therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy,
where the pressure pulses are released as single events of duration up to 25 µs.
This document does not apply to
– therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment;
– therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies
– measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field,
– methods of measurement and characterization of non-focused or weakly focused pressure pulse fields.
This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see IEC 60601 2-62 and IEC TR 62649).
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This part of IEC 60118 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.
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IEC 60565-1:2020 specifies methods and procedures for free-field calibration of hydrophones, as well as individual electroacoustic transducers that can be used as hydrophones (receivers) and/or projectors (source transducers). Two general types of calibration are covered within this document: absolute calibration using the method of three-transducer spherical-wave reciprocity, and relative calibration by comparison with a reference device which has already been the subject of an absolute calibration.
The maximum frequency range of the methods specified in this document is from 200 Hz to 1 MHz. The lowest acoustic frequency of application will depend on a number of factors, and will typically be in the range 200 Hz to 5 kHz depending mainly on the dimensions of the chosen test facility, The highest frequency of application for the methods described here is 1 MHz.
Procedures for pressure hydrophone calibration at low frequencies can be found in IEC 60565 2 [1] . Procedures for hydrophone calibration at acoustic frequencies greater than 1 MHz are covered by IEC 62127-2 [2].
Excluded from the scope of this document are low-frequency pressure calibrations of hydrophones, which are described in IEC 60565-2 [1]. Also excluded are calibrations of digital hydrophones and systems, calibration of marine autonomous acoustic recorders, calibration of acoustic vector sensors such as particle velocity sensors and pressure gradient hydrophones, calibration of passive sonar arrays consisting of multiple hydrophones, and calibration of active sonar arrays consisting of projectors and hydrophones.
This document presents a description of the requirements for free-field calibration in terms of test facility, equipment and instrumentation, signal processing, and frequency limitations. A description of achievable uncertainty and rules for the presentation of the calibration data are provided. Also included are informative annexes that provide additional guidance on
• measurement of directional response of a hydrophone or projector,
• measurement of electrical impedance of hydrophones and projectors,
• electrical loading corrections,
• acoustic far-field criteria in underwater acoustic calibration,
• pulsed techniques in free-field calibrations,
• assessment of uncertainty in the free-field calibration of hydrophones and projectors,
• derivation of the formulae for three-transducer spherical-wave reciprocity calibrations,
• calibration using travelling-wave tubes,
• calibration of hydrophones using optical interferometry, and
• calibrations in reverberant water tanks using continuous signals.
IEC 60565-1:2020 together with IEC 60565-2:2019, cancels and replaces the second edition of IEC 60565 published in 2006. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
1) removal of all descriptions of methods for pressure calibrations of hydrophones – these are now included in Part 2;
2) removal of the derivations of formulae for free-field reciprocity calibration (both amplitude sensitivity and phase sensitivity) and placement of these into an informative annex;
3) inclusion within the scope of the calibration of the transmitting response of individual source transducers and hydrophones (but not sonar arrays);
4) re-ordering of the sections within the document such that the more general procedures for calibration such as guidance on obtaining conditions of acoustic free-field, far-field, and steady-state, appear before the descriptions of procedures for absolute or relative calibrations;
5) revision of informative Annex A to include guidance on measurement of directional response of a hydrophone or projector;
6) addition of a new informative Annex B on measurement of electrical impedance of hydrophones and projectors;
7) revision of the previous informative annex on electrical loading corrections to include corrections to account for e
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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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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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IEC TS 63081:2019:
• defines key quantities relevant to ultrasonic materials characterization;
• specifies methods for direct measurement of many key ultrasonic materials parameters.
This document is applicable to all measurements of properties of passive acoustic materials under drive conditions that are not subject to nonlinear acoustic propagation. Whilst there are materials properties that may be of interest in a nonlinear drive regime, these are currently outside the scope of this document.
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This Standard specifies the methods for low frequency pressure calibration of hydrophones at frequencies from 0,01 Hz to several kilohertz depending on calibration method.
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This Standard 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.
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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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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 60118-13:2019 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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IEC TR 62809:2019 is available as IEC TR 62809:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC TR 62809:2019 provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. It is intended to assist various groups involved in the product lifecycles process - like designers and suppliers - to get an overview of the basic requirements without studying all involved standard documents in detail. The table includes not all but just the more common requirements and tests. It is crucial to understand that the summary in this document cannot serve as an input for a product requirement specification or as a test plan without consulting IEC 60601-2-66 itself. This document alone cannot be used to establish or assess compliance to IEC 60601-2-66.
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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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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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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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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 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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IEC 60255-181:2019 specifies the minimum requirements for functional and performance evaluation of frequency protection. This document also defines how to document and publish performance test results.
This document covers the functions based on frequency measurement or rate of change of frequency measurements. This document also covers frequency protection where additional blocking elements are used.
This document defines the influencing factors that affect the accuracy under steady state conditions and performance characteristics during dynamic conditions. The test methodologies for verifying performance characteristics and accuracy are also included in this document.
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IEC TS 63070:2019 is applicable to ultrasonic equipment designed for the medical field of application. It covers both diagnostic and therapeutic (physiotherapy and HITU) equipment.
This document describes transducer evaluation by the infrared imaging technique using a split TMM-phantom for qualitative and quantitative estimation of temperature distributions in tissue-mimicking material, resulting from absorption of ultrasound and from heating of the transducer itself.
This document also describes a method to measure transducer-surface temperature, while the transducer is driven under the still-air condition.
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IEC TS 63001:2019 provides a technique of measurement and evaluation of ultrasound in liquids for use in cleaning devices and equipment. It specifies
• the cavitation measurement at 2,25 f0 in the frequency range 20 kHz to 150 kHz, and
• the cavitation measurement by extraction of broadband spectral components in the frequency range 10 kHz to 5 MHz.
IEC TS 63001:2019 covers the measurement and evaluation of the cavitation, but not its secondary effects (cleaning results, sonochemical effects, etc.).
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This document 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.
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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 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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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 example, tonebursts. Requirements for
these other functions are not included in this document.
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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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IEC TS 62903:2018, which is a Technical Specification,
a) establishes the free-field convergent spherical wave self-reciprocity method for ultrasonic transducer calibration,
b) establishes the measurement conditions and experimental procedure required to determine the transducer's electroacoustic parameters and acoustic output power using the self-reciprocity method,
c) establishes the criteria for checking the reciprocity of these transducers and the linear range of the focused field, and
d) provides guiding information for the assessment of the overall measurement uncertainties for radiation conductance.
This document is applicable to:
i) circular spherically curved concave focusing transducers without a centric hole working in the linear amplitude range,
ii) measurements in the frequency range 0,5 MHz to 15 MHz, and
iii) acoustic pressure amplitudes in the focused field within the linear amplitude range.
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IEC 61754-7-2:2017 defines the standard interface dimensions for the type MPO family of connectors with two rows of fibres. This first edition of IEC 61754-7-2, along with the first edition of IEC 61754-7-1, cancels and replaces the third edition of IEC 61754-7 published in 2008. This first edition of IEC 61754-7-2 includes the two fibre row MPO variants including the addition of active device receptacles and up-angled plugs. The first edition of IEC 61754-7-1 includes the one fibre row MPO variants and related active device receptacles and up-angled plugs.
Keywords: interface dimensions for the type MPO family of connectors with two rows of fibres
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IEC 60942:2017 is also available as IEC 60942:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60942:2017 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. This fourth edition cancels and replaces the third edition published in 2003, of which it constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) deletion of the class designations, class LS/C, class 1/C and class 2/C;
b) addition of two further class designations, class LS/M and class 1/M, specifically for pistonphones;
c) addition of an amended criterion for assessing conformance to a specification: conformance is now demonstrated when (a) measured deviations from design goals do not exceed the applicable acceptance limits and (b) the uncertainty of measurement does not exceed the corresponding maximum-permitted uncertainty;
d) modification to the short-term level fluctuation test of the sound pressure level stability;
e) change to some environmental test conditions to avoid icing;
f) addition of an alternative test for immunity to radio-frequency fields using transverse electromagnetic (TEM) waveguides.
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