GB/T 14199-2010 PDF English
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| GB/T 14199-2010 | English | 155 |
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Electroacoustics - General specification for hearing aids
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| GB/T 14199-1993 | English | 559 |
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General specification for pocket hearing aids
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GB/T 14199-2010: Electroacoustics - General specification for hearing aids---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT14199-2010
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
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)
3 Terms and definitions
For the purposes of this document, the following terms and definitions AND those
established in GB/T 25102.100, GB/T 25102.1 and GB/T 2422, apply.
3.1
hearing aid
an electronic device which is used to amplify sound and compensate for hearing loss,
which normally consists of microphone, amplifier and earphone and which is powered
a low-voltage battery
3.2
air-conduct hearing aid
A hearing aid with which the sound, amplified using the air-conduct method, is
conducted to the internal ear through the air in the auditory meatus.
3.3
bone-conduct hearing aid
A hearing aid with which the sound amplified is conducted to the internal ear using
method of mechanical vibration of mastoid process or skull.
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.
4 Technical requirements
4.1 Appearance and structural requirements
4.2 Technical parameter requirements of electroacoustic performance
4.2.1 Sound pressure level when the input sound pressure level is 90 dB (OSPL90)
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.
4.3 Requirements for electroacoustic performance technical parameters after
environmental testing
4.3.1 The output sound pressure level when the input sound pressure level is 90 dB
(OSPL90).
4.3.2 Full-scale gain
The difference between the test values before and after environmental testing is not
greater than ± 4 dB.
4.3.3 The test value of equivalent input noise sound level is not greater than 35 dB.
4.3.4 The test value of total harmonic distortion is not greater than 12%.
4.3.5 The test value of frequency response range shall be as specified in 4.2.5.
4.3.6 The test value of rated supply current consumption shall be as specified in 4.2.6.
4.3.7 The test value of the sensitivity of inductive pickup coils shall be as specified in
4.2.7.
4.4 Environmental durability
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.
5.2 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.
5.3.5 Frequency response range.
5.3.7 The sensitivity of inductive pickup coils is measured as specified in 4.5 of GB/T
25102.100-2010; the recommended measuring frequency is 1,600 Hz or the high-
frequency average.
5.3.8 Bone-conduct hearing aids are measured as specified in SJ/Z 9143.2, Hearing
aids – Part 9.Methods of measurement of characteristics of hearing aids with bone
vibrator output.
5.4 Environmental testing
5.4.1 Items and sequence of environmental testing
Environmental testing is carried out in the following sequence.
5.4.2 Sample preconditioning
5.4.5 Low-temperature load and storage test
5.4.6 High-temperature load and storage test
5.4.6.1 Place test sample at room temperature into the test chamber, which is not
packaged, not powered on and is in the normal working position. Then the temperature
of the test chamber is room temperature.
5.4.6.2 When the temperature of the test chamber increases to 40°C ± 2°C at the
average rate of 1°C/min, switch on the power of the hearing aid; cut off the power
supply after working continuously for 4 h; continue to increase the temperature of the
test chamber to 55°C ± 2°C; remain for 4 h after sample achieves temperature
stabilization.
5.4.6.3 The temperature of the test chamber reduces to the test conditions specified
5.4.8 Vibration (sinusoidal) test
5.4.9 Free fall test
5.4.9.1 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.
Table 1 – Fall test parameters
5.5 Electromagnetic compatibility
Testing shall be carried out using the method specified in GB/T 25102.13.
6 Inspection rules
6.1 Acceptance inspection
6.1.1 Scope of application
Acceptance inspection applies to lots submitted by the production workshop, which is
carried out by the quality inspection department of the manufacturer.
6.1.3 Formation of inspection lots
Each lot shall be formed by products of the same model number, grade, type,
dimensions and ingredients, which are made at the almost the same time under
identical conditions.
6.1.4 Sampling scheme
6.1.5 Nonconformity classification and criteria
6.1.5.1 Nonconformity classification
6.1.5.2 Nonconformity criteria
For the nonconformity criteria of sample inspection see Table 2.
6.1.6 Classification of nonconformity-product
6.1.8 Handlings of inspection results
6.1.9 Handlings of samples
For samples passing the acceptance inspection. all qualified-samples shall be
delivered for use as qualified-products after repackaging; all unqualified-samples can
be repaired by the manufacturer and then packaged and delivered for use after they
pass reinspection.
6.2 Periodic inspection
6.2.2 Environmental testing
6.2.3 Division of period
Each half year is a period.
6.2.4 Sampling scheme
6.2.4.1 The sampling scheme is as specified in GB/T 2829-2002.For the determination
levels, rejection quality levels, sampling scheme types and determination arrays for all
inspection items see Table 5.
6.2.5 Nonconformity classification and determination criteria
6.2.5.1 The classification of nonconformities is as in 6.1.5.1.
6.2.5.2 For the criteria for nonconformities see Table 4.
6.2.6 Classification of nonconformity-products
The classification of nonconformity-products is as in 6.1.6.
6.2.7 Criteria for acceptance and rejection of periodic inspection
6.2.7.2 When all environmental testing items are determined to be acceptable as
specified in 6.2.7.1, the inspection of a period is acceptable; or else, it is unacceptable.
6.2.8 Handlings of nonconformity-product lots in periodic inspection
6.2.8.1 When the manufacturer receives the notice of periodic rejection, the
submission of the products from the production lines for acceptance inspection shall
be suspended immediately; the products submitted can be as agreed on by both sides;
the products in storage shall not be put into use.
6.2.9 Handlings of samples
No samples shall not be put into storage or use as acceptable products after periodic
inspection.
7 Marking, packaging, transportation and storage
7.1 Marking
7.1.1 The enclosure of products shall be marked with manufacturer name or registered
trademark and product model number.
7.2 Packaging
7.2.1 The packaging box shall contain certificate of compliance, instructions for use,
accessories and other related technical documents (such as warranty cards) (the
instructions for use and other related documents shall comply with relevant national
regulations).
7.2.2 The types and capacities of packages for transportation shall be designed by the
manufacturer by itself, but they shall ensure products are in a perfect condition after
normal transportation and handling. A packing list shall be enclosed in the packaging
box.
7.3 Transportation and storage
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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