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JJF 1771-2019 English PDF

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JJF 1771-2019: Program of Pattern Evaluation for Measuring Instruments of Aural Acoustic Impedance/Admittance
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JJF 1771-2019809 Add to Cart 7 days Program of Pattern Evaluation for Measuring Instruments of Aural Acoustic Impedance/Admittance Valid

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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: 35,313
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)
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