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Program of Pattern Evaluation for Measuring Instruments of Aural Acoustic Impedance/Admittance
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Basic data
| Standard ID | JJF 1771-2019 (JJF1771-2019) |
| Description (Translated English) | Program of Pattern Evaluation for Measuring Instruments of Aural Acoustic Impedance/Admittance |
| Sector / Industry | Metrology & Measurement Industry Standard |
| Classification of Chinese Standard | A59 |
| Classification of International Standard | 17.140 |
| Word Count Estimation | 35,380 |
| Date of Issue | 2019 |
| Date of Implementation | 2020-03-31 |
| Issuing agency(ies) | State Administration for Market Regulation |
JJF 1771-2019: Program of Pattern Evaluation for Measuring Instruments 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.
Program of Pattern Evaluation for Measuring Instruments of Aural Acoustic Impedance/Admittance
National Measurement Technical Specification of the People's Republic of China
Impedance audiometer (otoacoustic impedance/admittance measuring instrument)
Type evaluation outline
Published on December 31,.2019
2020-03-31 Implementation
Issued by the State Administration of Market Supervision and Administration
Impedance audiometer
(Otoacoustic impedance/admittance measuring instrument)
Type evaluation outline
Centralized unit. National Acoustic Metrology Technical Committee
Main drafting unit. China Academy of Metrology
China Institute of Food and Drug test
Participated in the drafting unit. Shanghai Institute of Metrology and Testing Technology
Chinese People's Liberation Army Medical Acoustic Measurement and Research General Station
This specification is entrusted to the National Acoustic Metrology Technical Committee for interpretation
The main drafters of this specification.
Zhong Bo (Chinese Academy of Metrology)
Hao Ye (China Food and Drug Administration)
Participating drafters.
Zhao Zhengyi (Chinese Academy of Metrology)
Deng Zheng (Shanghai Institute of Metrology and Testing Technology)
Ji Fei (General Station of Medical Acoustic Measurement and Research of the Chinese People's Liberation Army)
table of Contents
Introduction (Ⅳ)
1 Scope (1)
2 References (1)
3 Overview (1)
4 Legal management requirements (1)
4.1 Unit of measurement (1)
4.2 Classification (2)
4.3 Measurement legal signs and measurement instrument marks (2)
4.4 Seal structure (2)
4.5 Key parts and materials (2)
5 Measurement requirements (2)
5.1 Human ear acoustic impedance/admittance measurement system (2)
5.1.1 Unit of measurement (2)
5.1.2 Detection sound (2)
5.1.3 Measurement range of cavity volume (2)
5.1.4 Indication error of cavity volume (3)
5.2 Pneumatic system (3)
5.2.1 Pressure range (3)
5.2.2 Pressure indication error (3)
5.2.3 Pressure change rate (3)
5.3 Acoustic reflex stimulation system (3)
5.3.1 Acoustic reflection pure tone stimulation signal (3)
5.3.2 Broadband noise stimulus signals (4)
5.3.3 Stimulation level controller (4)
5.4 Warm-up time (4)
6 General technical requirements (4)
6.1 Appearance and structure (4)
6.1.1 Appearance, signs (4)
6.1.2 Operating Instructions (5)
6.2 Functional requirements (5)
6.3 Climate and environmental requirements (6)
6.4 Mechanical environmental requirements (6)
6.5 Power adaptability requirements (6)
6.5.1 Public grid power supply (if applicable) (6)
6.5.2 Battery powered (if applicable) (6)
6.6 EMC requirements (6)
7 Type evaluation item table (7)
8 Provide the number of prototypes and how to use them (8)
9 Test methods and conditions of test items, data processing and qualification criteria (8)
9.1 Environmental conditions of the test (8)
9.2 Measurement performance test (8)
9.2.1 Unit of measurement (8)
9.2.2 Detection tone signal frequency (9)
9.2.3 Sound pressure level of detection sound signal (9)
9.2.4 Harmonic distortion of detected sound signal (10)
9.2.5 Indication error of cavity volume (10)
9.2.6 Cavity volume measurement range (11)
9.2.7 Pressure range (11)
9.2.8 Pressure indication error (11)
9.2.9 Rate of pressure change (12)
9.2.10 Sound reflection pure tone stimulation signal frequency (12)
9.2.11 Sound reflection pure tone stimulus signal sound pressure level (13)
9.2.12 Sound reflection pure tone stimulation signal harmonic distortion (13)
9.2.13 Broadband noise stimulation signal spectrum (14)
9.2.14 Broadband noise stimulation signal sound pressure level (14)
9.2.15 Stimulation level controller (14)
9.2.16 Warm-up time (15)
9.3 Climate environment test (15)
9.3.1 Test purpose (15)
9.3.2 Test equipment (15)
9.3.3 Test procedure (15)
9.3.4 Qualification criteria (16)
9.4 Mechanical environmental test (16)
9.4.1 Test purpose (16)
9.4.2 Test equipment (16)
9.4.3 Test procedure (16)
9.4.4 Qualification criteria (17)
9.5 Power adaptability test (17)
9.5.1 Public grid power supply (17)
9.5.2 Battery Powered (17)
9.6 Electromagnetic compatibility test (17)
9.6.1 Test purpose (17)
9.6.2 Test equipment (17)
9.6.3 Test procedure (18)
9.6.4 Qualification criteria (19)
10 Judgment principles for type evaluation results (19)
11 Table of measuring instruments and equipment used in the test project (19)
Appendix A. Original Record Format of Impedance Audiometer Type Evaluation (20)
Introduction
JJF 1002-2010 "Rules for Compiling National Measurement Verification Regulations", JJF 1001-2011 "General Measurement Terms and
"Definition" and JJF 1059.1-2012 "Measurement Uncertainty Evaluation and Expression" together form the basis for the formulation of this outline
Series specifications.
This outline is in accordance with GB/T 7341.5-2018 "Electroacoustic Audiometry Equipment Part 5.Otoacoustic Impedance/Admittance
The content of the "Measuring Instruments" was compiled, and reference was made to JJG991-2017 "Auric Resistance of Audiometry Equipment"
"Anti-admittance measuring instrument" can make an objective, comprehensive and effective evaluation of the performance of the impedance audiometer.
The structure of this outline is arranged in accordance with JJF 1016-2014 "Guidelines for the Compilation of Outlines for Measuring Apparatus Type Evaluation,"
Each chapter is in accordance with JJF 1015-2014 "General Specification for Type Evaluation of Measuring Instruments" and JJF 1002-2010 "National
Compilation of the Regulations for the Quantification Verification Regulations.
Impedance audiometer (otoacoustic impedance/admittance measuring instrument)
Type evaluation outline
1 Scope
This outline is applicable to impedance audiometers (also called otoacoustic impedance/admittance measuring instruments) with classification code 28121000
Type evaluation.
2 Reference documents
This specification refers to the following documents.
JJG991-2017 audiometry equipment otoacoustic impedance/admittance measuring instrument
JJF 1001-2011 General Measurement Terms and Definitions
JJF 1034 Terms and Definitions of Acoustic Measurement Terms
JJF 1592-2016 Pure tone audiometer type evaluation outline
GB/T 3102.7 Acoustic quantities and units
GB 4824-2013 Industrial, Scientific and Medical (ISM) Radio Frequency Equipment Disturbance Characteristics Limits and Measurement Methods
GB/T 6113 Specification for radio disturbance and immunity measuring equipment and measuring methods
GB/T 7341.1-2010 Electroacoustic audiometry equipment Part 1.Pure tone audiometer
GB/T 7341.5-2018 Electroacoustic audiometry equipment Part 5.Measuring instruments for otoacoustic impedance/admittance
GB/T 14710-2009 Environmental requirements and test methods for medical appliances
GB/T 17626.2-2018 Electromagnetic Compatibility Test and Measurement Technology Electrostatic Discharge Immunity Test
GB/T 17626.3-2016 Electromagnetic compatibility test and measurement technology RF electromagnetic field radiation immunity test
GB/T 17626.4-2018 electromagnetic compatibility test and measurement technology electrical fast transient burst immunity
test
GB/T 17626.5-2019 EMC test and measurement technology surge (shock) immunity test
GB/T 17626.8-2006 EMC test and measurement technology power frequency magnetic field immunity test
GB/T 17626.11-2008 Electromagnetic compatibility test and measurement technology Voltage sag, short interruption and voltage
Varying immunity test
For dated reference documents, only the dated version applies to this specification; for those without date references
The latest version (including all amendments) is applicable to this specification.
3 Overview
Impedance audiometer is a medical measurement to understand the functional state of middle ear by measuring the acoustic impedance or admittance of human ear
instrument. It is mainly composed of human ear acoustic impedance/admittance measurement system, pressure system, acoustic reflex stimulation system and other parts.
4 Legal management requirements
4.1 Unit of measurement
The unit of the sound pressure level of the detection sound of the impedance audiometer and the sound pressure level of the ipsilateral/contralateral sound reflection stimulation is decibel (dB)
...
