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GB/T 14199-2010 PDF English

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GB/T 14199-2010: Electroacoustics - General specification for hearing aids
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GB/T 14199: Historical versions

Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
GB/T 14199-2010155 Add to Cart Auto, 9 seconds. Electroacoustics - General specification for hearing aids Valid
GB/T 14199-1993559 Add to Cart 4 days General specification for pocket hearing aids Obsolete

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GB/T 14199-2010: Electroacoustics - General specification for hearing aids

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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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