GB/T 14199-2010 English PDF (GBT14199-2010)

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GB/T 14199-2010: Electroacoustics -- General specification for hearing aids
GB/T 14199-2010
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 17.140.50
M 72
Replacing GB/T 14199-1993
Electroacoustics -
General specification for hearing aids
ISSUED ON. SEPTEMBER 2, 2010
IMPLEMENTED ON. APRIL 1, 2011
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Technical requirements ... 8
5 Measuring method ... 11
6 Inspection rules ... 16
7 Marking, packaging, transportation and storage ... 23
Electroacoustics -
General specification for hearing aids
1 Scope
This Standard specifies the technical requirements, measuring methods, inspection
rules, marking, packaging, transportation and storage for hearing aids.
This Standard applies to air- and bone-conduct hearing aids.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Standard, however, parties
who reach an agreement based on this Standard are encouraged to study if the latest
versions of these documents are applicable. For undated references, the latest edition
of the referenced document applies.
GB/T 2421.1, Environmental testing for electric and electronic products – General
and guidance
GB/T 2422, Environmental testing for electric and electronic products – Terms and
definitions
GB/T 2423.1, Environmental testing – Part 2. Test methods – Tests A. Cold (GB/T
2423.1-2008, IEC 60068-2-1.2007, IDT)
GB/T 2424, Environmental testing for electric and electronic products – Guidance
for high temperature and low temperature tests
GB/T 2828.1, Sampling procedures for inspection by attributes – Part 1. Sampling
schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T
2828.1-2003, ISO 2859-1.1999, IDT)
GB/T 2829, Sampling procedures and tables for periodic inspection by attributes
(Apply to inspection of process stability)
GB/T 6661, Nipples for insert earphones
3.4
box hearing aid
body-worn hearing aid
A hearing aid which is worn on the body of the hearer (not on the head).
3.5
behind-the-ear hearing aid; BTE
A hearing aid which is worn on the back of the auricle which is connected by an ear
hook.
3.6
in-the-ear hearing aid; ITE
A hearing aid which is customized in accordance with the shape of the cavity of concha
auriculae and worn in the concha auriculae of concha auriculae.
3.7
in-the-ear canal hearing aid
A hearing aid which is customized in accordance with the shape of the auditory meatus
and worn in the auditory meatus.
3.8
glasses hearing aid
A hearing aid which is installed on the frame legs of glasses, similar to the ear back
wearing method.
3.9
analog hearing aid
A hearing aid with which acoustic signals are converted into continuously variable
electrical signals (analog signals) by microphone and transmitted to earphone for
output after smoothing and amplification.
3.10
digital hearing aid
A hearing aid whose signal processing is carried out in the digital mode, i.e. acoustic
4.2.1 Sound pressure level when the input sound pressure level is 90 dB (OSPL90)
4.2.1.1 Maximum OSPL90
The nominal value is specified in the product standards or technical instructions of the
manufacturer; the actually measured test value shall not be + 3 dB greater than the
nominal value.
4.2.1.2 High-frequency average OSPL90
The nominal value is specified in the product standards or technical instructions of the
manufacturer; the allowable deviation of its actually measured test value is ± 4 dB.
4.2.2 Full-scale gain
The nominal value is specified in the product standards or technical instructions of the
manufacturer; the allowable deviation of its actually measured high-frequency average
is ± 5 dB.
4.2.3 Equivalent input noise level
The nominal value is specified in the product standard or technical instructions of the
manufacturer; its maximum actually measured test value shall not exceed 32 dB and
shall not be + 3 dB greater than the nominal value.
4.2.4 Total harmonic distortion
The nominal value is specified in the product standards or technical instructions of the
manufacturer; the maximum actually measured test value shall not exceed 10% and
shall not be greater than + 3%.
4.2.5 Frequency response range
The nominal range shall be as specified in the product standards or technical
instructions of the manufacturer.
4.2.6 Rated supply current consumption
The nominal value is specified in the product standards or technical instructions of the
manufacturer; the maximum actually measured test value shall not be greater than
120% of the rated value.
4.2.7 Sensitivity of inductive pickup coils
The rated value is specified in the product standards or technical instructions of the
manufacturer; the allowable deviation of its actually measured test value is ± 6 dB.
4.4.5 Free fall test
Load test sample in a packaging box for transportation; carry out fall test on five
surfaces in accordance with the masses and amplitudes specified in Table 1; after test,
it shall be as specified in 4.1 and 4.3.
4.5 Electromagnetic compatibility
The test results shall be as specified in GB/T 25102.13-2010.
5 Measuring method
5.1 Measuring conditions
5.1.1 Air-conduct hearing aids shall be as specified in Clause 5 of GB/T 25102.100-
2010; bone-conduct hearing aids shall be as specified in Clause 6 of SJ/Z 9143.2-
1987.
5.1.2 Use a 2 cm3 acoustic coupler complying with IEC 60318-5 or an occluded-ear
simulator complying with IEC 60711 to carry out measurement. However, the
manufacturer shall indicate which measuring coupler is to be used when it gives a
specified value.
5.1.3 Digital hearing aids shall be measured in the working state as specified by the
manufacturer.
5.2 Appearance, structural requirements, etc.
Use the visual inspection and hand feeling methods for inspection.
5.3 Electroacoustic performance measuring method
5.3.1 When the input sound pressure level is 90 dB, the output sound pressure level
(OSPL90) is measured as specified in 7.2 of GB/T 25102.100-2010.
5.3.2 The full-scale gain is measured as specified in 7.3 of GB/T 25102.100-2010.
5.3.3 The equivalent input noise level is measured as specified in 7.14 of GB/T
25102.100-2010.
5.3.4 The total harmonic distortion is measured as specified in 7.12.1 of GB/T
25102.100. the recommended frequencies for test are 500 Hz, 800 Hz and 1,600 Hz;
the input sound pressure level at 500 Hz and 800 Hz is 70 dB; the input sound pressure
level at 1,600 Hz is 65 dB.
5.3.5 Frequency response range.
temperature is 23°C ± 5°C, the relative humidity is 40% ~ 80% and the barometric
pressure is 101.3+5 -20 kPa.
5.4.2.2 Preconditioning method
Place unpackages sample into the test chamber complying with the preconditioning
conditions specified in 5.4.2.1; store for more than 1 h.
5.4.3 Inspection before environmental testing
Sample’s inspection before environmental testing includes appearance and structural
requirements and electroacoustic performance inspection. The inspection for
appearance, structural req...