GB/T 14199-2010Electroacoustics - General specification for hearing aid (English PDF)

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.

5.1 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.

5.4.6 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.

5.4.9 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.

6.1 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.

6.1.5.1 Nonconformity classification

6.1.5.2 Nonconformity criteria For the nonconformity criteria of sample inspection see Table 2.

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.

6.2.2 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.

7.1 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.