IEC 60645-6:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
10-03-2022
English - French, Spanish, Castilian
29-04-2009
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for specific instruments
5 General specifications
5.1 Acoustic stimulus system
5.1.1 General requirements
5.1.2 Stimulus types
5.1.3 Stimulus frequency range
5.1.4 Stimulus level
5.1.5 Harmonic distortion
5.2 Test quality assuring system
5.2.1 General
5.2.2 Test quality assurance
5.2.3 Individual stimulus recordings
5.3 Measuring system
5.3.1 Units of measurement
5.3.2 Measurement range
5.3.3 Accuracy of measurement
5.3.4 Frequency range
5.3.5 Noise reduction
5.3.6 Response detection
5.3.7 Quality estimates
5.3.8 Normative values
5.4 Presentation of results
5.4.1 General
5.4.2 Primary results
5.4.3 Secondary results
6 Demonstration of conformity with specifications
6.1 General
6.2 Probe signal
6.2.1 Probe signal spectrum
6.2.2 Probe signal level and harmonic distortion
6.3 Maximum permitted expanded uncertainty of
measurements U[max]
6.4 Function of the complete system
7 General requirements
7.1 Marking
7.2 Instruction manual
7.3 Safety requirements
7.4 Immunity to power and radiofrequency fields
7.5 Warm-up time
7.6 Voltage supply variation and environmental conditions
7.6.1 Mains operation
7.6.2 Battery operation
7.6.3 Environmental conditions
8 Additional characteristics to be specified by the
manufacturer
9 Routine calibration
Bibliography
IEC 60645-6:2009 applies to instruments designed primarily for the measurement of otoacoustic emissions in the human external acoustic meatus evoked by acoustic probe pulses or tones. This standard defines the characteristics to be specified by the manufacturer, lays down performance specifications for two types of instruments and specifies the functions to be provided on these types. IEC 60645-6:2009 describes methods of test to be used for approval testing and guidance on methods for undertaking routine calibration. The purpose of IEC 60645-6:2009 is to ensure that measurements made under comparable test conditions with different instruments complying with the standard will be consistent. Instruments which provide a measurement function not specifically within the scope of the standard shall still comply with any relevant requirements. This standard is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches.
Committee |
TC 29
|
DevelopmentNote |
Stability Date: 2020. (09/2017)
|
DocumentType |
Standard
|
Pages |
32
|
PublisherName |
International Electrotechnical Committee
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
OVE/ONORM EN 60645-6 : 2010 | Identical |
NBN EN 60645-6 : 2010 | Identical |
NF EN 60645-6 : 2010 | Identical |
NEN EN IEC 60645-6 : 2010 | Identical |
I.S. EN 60645-6:2010 | Identical |
PN EN 60645-6 : NOV 2010 | Identical |
UNE-EN 60645-6:2010 | Identical |
BS EN 60645-6:2010 | Identical |
CEI EN 60645-6 : 2013 | Identical |
EN 60645-6:2010 | Identical |
DIN EN 60645-6:2010-08 | Identical |
IEC 60318-4:2010 | Electroacoustics - Simulators of human head and ear - Part 4: Occluded-ear simulator for the measurement of earphones coupled to the ear by means of ear inserts |
IEC 60645-3:2007 | Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 60645-1:2017 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 60318-5:2006 | Electroacoustics - Simulators of human head and ear - Part 5: 2 cm<sup>3</sup> coupler for the measurement of hearing aids and earphones coupled to the ear by means of ear inserts |
ISO 389-6:2007 | Acoustics Reference zero for the calibration of audiometric equipment Part 6: Reference threshold of hearing for test signals of short duration |
IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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