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GB/T 7341.5-2018: Electroacoustics -- Audiometric equipment -- Part 5: Instruments for the measurement of aural acoustic impedance/admittance
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Electroacoustics -- Audiometric equipment -- Part 5: Instruments for the measurement of aural acoustic impedance/admittance
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Basic data | Standard ID | GB/T 7341.5-2018 (GB/T7341.5-2018) | | Description (Translated English) | Electroacoustics -- Audiometric equipment -- Part 5: Instruments for the measurement of aural acoustic impedance/admittance | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A59 | | Classification of International Standard | 17.140.50 | | Word Count Estimation | 26,256 | | Date of Issue | 2018-06-07 | | Date of Implementation | 2019-01-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 7341.5-2018: Electroacoustics -- Audiometric equipment -- Part 5: Instruments for the measurement of aural acoustic impedance/admittance
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Electroacoustics--Audiometric equipment--Part 5. Instruments for the measurement of aural acoustic impedance/admittance
ICS 17.140.50
A59
National Standards of People's Republic of China
Replace GB/T 15953-1995
Electroacoustic audiometry equipment
Part 5. Measuring instruments for otoacoustic impedance/admittance
Part 5.Instrumentsforthemeasurementofauralacousticimpedance/admittance
(IEC 60645-5.2004, IDT)
Published on.2018-06-07
2019-01-01 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements for the specified type of instrument 4
5 General Technical Specifications 5
6 Verification in accordance with technical specifications 8
7 calibration chamber 10
8 General requirements 10
9 Symbols, forms and formats of acoustic impedance/admittance data 12
10 Manufacturer's Supplementary Performance 13
Appendix A (informative) General calibration 16
Appendix B (informative) Units and terminology 17
Appendix C (informative) Total time characteristics 19
Reference 21
Foreword
GB/T 7341 "Electrical Acoustic Audiometry Equipment" is divided into the following parts.
--- Part 1. Pure tone audiometer;
--- Part 2. Language audiometry equipment;
--- Part 3. Short continuous auditory test signals for audiometry and neurology;
--- Part 4. Extending high-frequency audiometry equipment;
---Part 5. Measuring instruments for otoacoustic impedance/admittance;
--- Part 6. Measuring instruments for otoacoustic emissions;
--- Part 7. Measuring instruments for auditory brainstem response.
This part is the fifth part of GB/T 7341.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 15953-1995 "Earing Impedance/Admittance Measuring Instrument". Compared with GB/T 15953-1995, mainly
The technical content changes as follows.
--- Modify the "probe buckle" to "ear plug" (see 3.13 and.1995 version 3.13);
--- Revised the contents of Chapter 4 and listed it as Chapter 10 (see Chapter 10 and Chapter 4 of the.1995 edition);
--- Revised the contents of Chapter 5, and modified 5.1 into Chapter 4 (see Chapter 4 and Chapter 5 of the.1995 edition);
--- Revised the contents of Chapter 6, and revised 6.1.2 to Appendix C (see Appendix C and Chapter 6 of the.1995 edition);
--- Increased measurement expansion uncertainty and maximum allowable value content (see 6.6);
--- Added an overview of Chapter 7 (see 7.1);
--- Modified the contents of 8.3 (see 8.3 and.1995 edition 8.3).
This part uses the translation method equivalent to IEC 60645-5.2004 "Electrical Acoustic Audiometry Equipment Part 5. Otoacoustic Impedance/Admittance
measuring instrument".
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
GB -9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1.1988 A1.1991
A2..1995, IDT)
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part was proposed by the Ministry of Industry and Information Technology of the People's Republic of China.
This part is under the jurisdiction of the National Electroacoustic Standardization Technical Committee (SAC/TC23).
This section drafted by. The General Hospital of the People's Liberation Army, Otolaryngology Institute, China Institute of Metrology, China Electronics Technology Group Corporation
Three Research Institutes, Shanghai Institute of Metrology and Testing Technology, Jiangxi Lianchuang Hongsheng Electronics Co., Ltd.
The main drafters of this section. Yu Liming, Yan Fei, Chen Hongwen, Zhong Bo, Xu Huan, Wen Tailai, An Zhaoliang, Xiao Xueyang.
The previous versions of the standards replaced by this section are.
---GB/T 15953-1995.
Introduction
In the field of audiometry and diagnostics, a series of specially designed instruments are used with their sound detection signals with different frequency and time characteristics.
No. to evaluate the acoustic impedance/admittance of the human ear. The practical application of such instruments is largely related to the measurement of otoacoustic impedance/admittance changes.
Otoacoustic impedance/admittance changes are caused by changes in the air pressure of the external auditory canal or by excitation of the middle ear muscles.
Electroacoustic audiometry equipment
Part 5. Measuring instruments for otoacoustic impedance/admittance
1 Scope
This part of GB/T 7341 specifies the performance of three types of otoacoustic impedance/admittance measuring instruments and the facilities provided for these instruments.
Conditions, and test methods used for acceptance testing and to guide routine calibration.
This section applies to instruments that measure the acoustic impedance/admittance in the external auditory canal using the specified pure tone detection signal. It is also suitable for other explorations.
This type of instrument for measuring signals.
This section is intended to ensure consistency with all types of instruments in this section under comparable test conditions. This section is not intended to constrain new features
The development or introduction does not hinder the innovation of technical methods.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 7341.1-2010 Electroacoustic audiometry equipment - Part 1. Pure tone audiometer (IEC 60645-1.2001, IDT)
IEC 60126 IEC reference coupler for measuring hearing aids using earphones that are plugged in with the human ear (IEC reference)
Couplerforthemeasurementofhearingaidsusingearphonescoupledtotheearbymeansofearin-
Serts)1)
IEC 60601-1 Medical electronic devices - Part 1. General safety requirements (Medicalelectricalequipment-Part 1.
Generalrequirementsforsafety)
IEC 60601-1-2 Medical electronic devices - Part 1-2. General safety requirements Secondary standard. Electromagnetic compatibility requirements and testing
(Medicalelectricalequipment-Part 1-2. Generalrequirementsforsafety-Colateralstandard.Elec-
tromagneticcompatibility-Requirementsandtests)
IEC 60601-1-4 Medical electronic devices - Part 1-4. General safety requirements
(Medicalelectricalequipment-Part 1-4. Generalrequirementsforsafety-Colateralstandard.Pro-
Grammableelectricalmedicalsystems)
BIPM/IEC /IFCC/ISO /IUPAC/IUPAP/OIML Guidance for the Expression of Measurement Uncertainty [Guidetothe
Expressionofuncertaintyinmeasurement(GUM)].
1) The subsequent revision will be IEC 60318-5.
3 Terms and definitions
The following terms and definitions apply to this document.
Note. The units in this section are consistent with the International System of Units (SI) units, but the audiology test results are often used to other units in order to convert them.
Into the International System of Units (SI) unit, special preparation of Appendix B.
3.1
Ear impedance/admittance auralimpedance/admittance
A generic term covering all aspects of otoacoustic impedance/admittance.
Note. In addition to the special provisions of the document, this part uses ear impedance/admittance as a general term, which covers all aspects of otoacoustic impedance/admittance.
3.2
Acoustic impedance acousticimpedance
The ratio of the sound pressure to the volumetric velocity through the surface at a defined surface.
Note 1. The symbol is Za, and the unit is Pas per cubic meter (Pa·s/m3).
Note 2. The amount usually measured is the modulus.
3.3
Acoustic resistance
The real component of the complex acoustic impedance.
Note. The symbol is Ra, and the unit is Pas per cubic meter (Pa·s/m3).
3.4
Acoustic resistance
The imaginary component of the complex acoustic impedance.
Note. The symbol is Xa and the unit is Pas per cubic meter (Pa·s/m3).
3.5
Acoustic admittance acousticadmittance
In a prescribed plane, the reciprocal of the acoustic impedance of the plane.
Note 1. The symbol is Ya, and the unit is cubic meters per pascal [m3/(Pa·s)].
Note 2. Acoustic admittance on a certain surface is the complex ratio of the volume velocity flowing through the surface to the sound pressure uniformly distributed on the surface. Usually, the measured amount is the modulus.
3.6
Acoustic conductance
The real component of the complex acoustic admittance.
Note. The symbol is Ga, and the unit is cubic meters per pascal [m3/(Pa·s)].
3.7
Sonar acousticususceptance
The imaginary component of the complex acoustic admittance.
Note. The symbol is Ba, and the unit is cubic meters per pascal [m3/(Pa·s)].
3.8
Acoustic quality
The ratio of the stimulating sound pressure to the rate of change of the resulting volumetric velocity.
Note. Sound quality is also called sonar. The symbol is Ma, and the unit is Pascal square second per cubic meter (Pa·s2/m3).
3.9
Acoustic compliancecompliance
The ratio of volume displacement to sound pressure.
Note. The symbol is Ca, and the unit is cubic meters per pen (m3/Pa).
3.10
Equivalent volume equivalentvolume
Provides the volume of a hard-walled cylindrical air cavity with equivalent acoustic impedance/admittance.
Note 1. This volume is expressed by the formula.
Ve=γ·ps·Ca=ρ·c2·Ca
In the formula.
Ve---equivalent volume in cubic meters (m3);
γ --- air constant pressure specific heat ratio to constant heat (approx. 1.40);
Ps---atmospheric pressure, the unit is Pa (Pa);
ρ --- the air density at the time of measurement and the atmospheric pressure, in kilograms per cubic meter (kg/m3);
c --- the speed of sound at the time of measurement and atmospheric pressure, in meters per second (m/s);
Ca---sounding, in cubic meters per kPa (m3/Pa).
Note 2. In practical applications, the ear impedance/admittance of the detected audio frequency of 226 Hz is taken as the equivalent volume of air.
Note 3. For a sound frequency of 226 Hz, as long as the physical volume does not exceed 5 cm3, the equivalent volume of air is equal to its physical volume.
3.11
Relative pressure in the external auditory canal relativepressureinexternalacousticmeatus
The difference between the pressure in the external auditory canal and the atmospheric pressure.
Note. The relative pressure unit is ten Pa (daPa).
3.12
Probe probe
A coupling device for insertion of the external auditory canal to connect the instrument to the human ear.
3.13
Earplug eartip
A device used to seal the probe from the external auditory canal.
3.14
Probe signal probesignal
An acoustic signal sent by the probe to the external auditory canal.
Note. This signal is used to measure acoustic impedance/admittance.
3.15
Probe ear probear
There are ears that are inserted into the probe.
3.16
Measuring plane measurementplane
The plane at the front surface of the probe perpendicular to the volumetric velocity vector.
3.17
Tympanometry
Measurement of acoustic impedance/admittance in the external auditory canal with air pressure.
Note. The measured acoustic impedance/admittance value will be related to the rate of change and direction of air pressure; also the time required to maintain a certain atmospheric pressure in the external auditory canal.
related.
3.17.1
Measurement plane tympanometry measurementplanetympanometry
The measurement of the ear impedance/admittance change in the measurement plane, including the impedance/admittance of the middle ear and part of the external ear canal combination.
3.17.2
Otometer compensation tympanometry measurement metus-compensatedtympanometry
For the specified suitable probe, the otoacoustic impedance/admittance obtained at the specified reference pressure and the test pressure in the external auditory canal
Measurement of the amount difference.
Note 1. The reference pressure should be effective in eliminating the influence of the middle ear.
Note 2. The reference pressure is usually.200daPa and the indicated pressure difference. It can also be set to.200daPa relative to the ambient pressure, which gives the maximum admittance or minimum.
Impedance indication.
3.18
Tympanogram
A graphical representation showing the magnitude of the impedance/admittance of the middle ear in the ear canal as a function of atmospheric pressure.
3.19
Middle ear muscle reflection middle-earmusclereflex
Changes in middle ear muscle tone when responding to stimuli.
Note. This change can be measured by changes in acoustic impedance/admittance in the external auditory canal.
3.19.1
Acoustic reflection
Middle ear muscle reflex induced by acoustic stimulation.
3.19.2
Non-acoustic reflex
Middle ear muscle reflex induced by non-stimulus.
3.20
Acoustic reflex stimuli acousticreflexactivatingstimulus
Acoustic stimuli used to induce acoustic reflection.
3.21
Stimulated ear stimulusear
An ear that is stimulated by acoustic reflection to induce reflection of the middle ear muscle.
3.22
Ipsilateral reflection ipsilateralreflex
Middle ear muscle reflex induced in the stimulated ear.
3.23
Contralateral reflection
Middle ear muscle reflex induced in the opposite ear of the stimulated ear.
4 Requirements for the specified type of instrument
The most basic mandatory functions specified for the three different types of otoacoustic impedance/admittance instruments are given in Table 1, and other functions are not excluded. This
The three types are related to the basic applications they envision.
Table 1 Mandatory functions of the ear impedance/admittance instrument
Types of
Diagnostic/clinical tympanometry/reflex screening tympanometry screening
Detection signal frequency 226Hz × × ×
Ear impedance/admittance measurement system
Measuring plane tympanometry × a × a × a
Ear canal compensation tympanometry × a × a × a
Pneumatic system
Manual pressure change ×
Automatic pressure change × × ×
Acoustic reflex stimulation system
Contralateral stimulation ×
Ipsilateral stimulation × ×
Table 1 (continued)
Types of
Diagnostic/clinical tympanometry/reflex screening tympanometry screening
Sound stimulation.
Pure tone × ×
Broadband noise ×
Stimulus level control ×
Result representation
Display or visual indicator × × ×
Print output ×
Data interface ×
a Any of the two should be provided.
5 General technical specifications
5.1 Measurement System
5.1.1 Unit of measurement
The instrument can be designed to measure one or more ear impedance/admittance components. Should use the International System of Units (SI) unit or the International System of Units
(SI) Export unit. The unit of measurement should be indicated on the front panel of the instrument.
5.1.2 Detection signal
Type 1, Type 2 and Type 3 instruments shall provide a pure tone detection signal of 226 Hz. The deviation between the actual frequency and the nominal frequency should satisfy. Type 1
The device should be less than ±1%, and the Type 2 and Type 3 instruments should be less than ±2%. The total harmonic distortion of the Type 1 instrument should be small when measured in accordance with the provisions of Chapter 6.
For 1%, Type 2 and Type 3 instruments should be less than 3%. If you use pure tone signals other than 226Hz, frequency accuracy and harmonic distortion
This requirement should be met.
Note. When performing tests such as multi-frequency tympanometry, where the frequency accuracy requirement is better than the specified 1%, the manufacturer should specify the frequency of the test.
Exact.
5.1.3 Sound level of sound signal
For pure tone, stable wideband and unsteady detection signals of any frequency, the signal is required to excite the possibility of middle ear muscle reflection
The signal level should be small enough to be acceptable. For a 226 Hz pure tone detection signal, the sound pressure level measured in Chapter 6 should be 90 dB or less.
Note. When using the detection signal as the excitation and reflection stimulus, the required signal level is less than a sufficient amount of the middle ear acoustic reflex threshold level of the otological young adult population (25 people).
The mean is subtracted by 2 standard deviations. The normal otology defined by ISO 389-1 is “normal health, no symptoms of ear disease, no obstruction of the ear canal,
No history of excessive noise exposure, no history of ototoxic drug use or familial hearing loss."
5.1.4 Measurement range
For a 226 Hz probe sound, the minimum range expressed by the equivalent air volume should be. the measurement plane tympanogram is 0.2 cm3 to 5 cm3.
For the external ear tympanic compensation map, Type 1 and Type 2 are 0cm3~2cm3, and Type 3 is 0cm3~1.2cm3.
The manufacturer shall state the sensitivity of the acoustic reflection measurement system, as well as the level of stimulation that may occur with it. Pseudo-changes will be the same as induced reflex stimuli
Step display.
Note. Analog measurements of hard-walled cavities do not require the presence of conditions in the human ear. Therefore, it is not prescribed to imitate the method of measurement in the human ear.
5.1.5 Measurement accuracy
The difference between the impedance/admittance indication value and the actual value shall not exceed ±5% or ±0.1cm3 of the equivalent volume, or ±10-9m3/(Pa·s),
The larger one will prevail. The manufacturer shall state the deviations and measurement methods between dynamic and static operating methods.
5.1.6 Time characteristics
The various time response parameters defined in 10.1.6 and measured in accordance with the procedures described in Appendix C shall not exceed 50 ms, overshoot and owe
The rush should not exceed 10%.
Note. For detection frequencies above 226 Hz, shorter reaction times are preferred.
5.2 Pneumatic system
5.2.1 Pressure range
For Type 1 instruments, the relative pressure range should be at least.200 daPa to -600 daPa; for Type 2 and Type 3 instruments, the range should be at least
200daPa~-200daPa.
5.2.2 Maximum limit
When measured in a 0.5 cm3 chamber, the relative pressure limit should be -800 daPa and 600 daPa. This limit should apply to all types of instruments
Device. All instruments should have means to prevent the pressure from suddenly reaching or exceeding this limit.
5.2.3 Accuracy of the relative pressure gauge
For Type 1 instruments, the deviation of the actual relative pressure generated in the 0.5cm3~5cm3 cavity from the indicated relative pressure shall not exceed
±10daPa or ±10%, whichever is greater.
For Type 2 and Type 3 instruments, the actual relative pressure produced in a 0.5 cm3 to 2 cm3 cavity, and the deviation from the indicated relative pressure,
Should exceed ±10daPa or ±15%, whichever is greater.
The above provisions shall be in accordance with the rate of pressure change provided.
5.2.4 Pressure change rate
For type 1 instruments, at least 0.5cm3~5cm3 cavity should be measured, and the relative pressure should be changed at the calibration rate (50±10) daPa/s.
Strong (increase/decrease) possibility.
Note. Other rate of change can be provided and specified by the manufacturer. This regulation also applies to Type 2 and Type 3 instruments.
5.3 Acoustic reflex stimulation system
5.3.1 General requirements
Except as provided below, the acoustic reflection stimulation system given in Chapters 6, 8 and 10 of GB/T 7341.1-2010 shall be followed.
Provisions.
Note. For instruments designed for hearing threshold measurement, all provisions of GB/T 7341.1-2010 should be applicable to the instrument.
5.3.2 Stimulation signal
5.3.2.1 pure tone signal
When using a fixed frequency, it should be selected from the standard listening frequency. For Type 1 instruments, at least 500 Hz, 1000 Hz,.2000 Hz should be provided.
And the same side and contralateral acoustic reflection stimulation and measurement of 4000 Hz; for type 2 instruments should provide at least 500 Hz, 1000 Hz or.2000 Hz
Ipsilateral acoustic reflection stimulation and measurement. The frequency deviation of the type 1 instrument should not exceed ±1%, and should not exceed ±3% for the type 2 instrument.
5.3.2.2 Pure tone harmonic distortion
For the stimulation frequency and stimulus sound pressure level given in Table 2, the stimulation level reaches 110dB in the frequency range of 500Hz~4000Hz.
In the case of hearing level, the total harmonic distortion of the earphones should not exceed 2.5%; the probe type earphones should not exceed ±5%. For higher levels of stimulation,
The total harmonic distortion of earphones should not exceed 5%; the total harmonic distortion of plug-in or probe headphones should not exceed 10%.
Note. If the maximum output of the instrument is less than 110dB hearing level, the above requirements should be applied to the maximum output level of the instrument.
Table 2 For the Type 1 instrument, the minimum hearing range for different stimuli
Stimulus level 500Hz~2000Hz 4000Hz noise
Earphone range of the earphones a/dB
Hearing range a/dB for plug-in or probe headphones
50~120
50~100
50~120
50~80
50~115
50~90
Note. For children, the level of stimulation in the external auditory canal may be higher than the index value of the stimulation controller.
a If it is a noise stimulus, it can also be expressed by the sound pressure level.
5.3.2.3 Wideband noise
If broadband noise is provided, the spectral level obtained by acoustic measurement is in the frequency range of 500 Hz to 4000 Hz versus 1000 Hz.
Out of step, the unevenness of the earphones should be within ±5dB; the unevenness of the plug-in or probe-type headphones should be within ±10dB.
5.3.2.4 Other types of stimulation
If other types of stimuli are provided, the manufacturer should state its characteristics.
5.3.3 Stimulus level control
5.3.3.1 Marking
Instruments calibrated according to this section should be identifiable on the front panel or stimulus controller. Signal level controller should be "hearing level
(HL)" or the national equivalent mark is marked. The 0dB mark of the hearing level controller should be transposed with the transducer involved in ISO 389.
The reference equivalent threshold is consistent. Other types of headphones or other reference values can be used if they are given in the relevant part of ISO 389.
The manufacturer shall state the origin and basis of the reference level, including the ear simulator or coupler used in the calibration and the calibration process. Should also indicate the frequency
The maximum output level of the rate and broadband noise.
5.3.3.2 Interval and minimum range
For Type 1 instruments, the stimulation control shall include at least the ranges listed in Table 2. Stimulus level readings are indicated using a 5 dB or smaller interval.
For Type 2 instruments, the stimulation level can be fixed and should be specified by the manufacturer.
5.3.3.3 Stimulus level control accuracy
For earphones, in the frequency range of 500Hz~4000Hz, stimulate the sound pressure level generated by the transducer and any block of the stimulation level controller.
The deviation of the indication should be better than ±3dB, and should be better than ±5dB for noise stimulation. For plug-in or probe headphones, at 500Hz~2000Hz
Should be better than ± 5dB, should be within 5dB ~ -10dB at 4000Hz.
5.3.4 Stimulus display controller
5.3.4.1 Overview
The instrument should provide a stimulus signal using a manual or automatic switch. The switch and its associated circuitry should reflect the stimulus signal, not the transient
Or other noise.
5.3.4.2 On/off ratio and signal to noise ratio
The on/off ratio and signal-to-noise ratio should be at least 70 dB, but when the A-weighted residual sound pressure level is used, the stimulus display switch is in the "off" position.
It does not have to be less than 25dB.
5.3.4.3 Rise/fall time
When the stimulus display controller is in different states, the rise/fall time is specified as.
a) "on" status
When the stimulus display controller is switched to the "on" position, the sound pressure level produced by the transducer reaches -1 dB relative to its final stable level.
The time required, calculated from the moment when the stimulus display controller changes, should not exceed 100ms, and the sound pressure level is relative to its final stable level.
The time required to gradually increase from -20dB to -1dB should not be less than 5ms. In the "pass" position, when the pure tone rises or falls, change
The sound level produced by the energy device should not exceed 1 dB at any time relative to the...
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