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CENELEC
EN 60645-6:2010

EN 60645-6:2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Superseded date

12-05-2022

Superseded by

EN IEC 60645-6:2022

Published date

08-01-2010

Publisher

European Committee for Standards - Electrical

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FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for specific instruments
5 General specifications
6 Demonstration of conformity with specifications
7 General requirements
8 Additional characteristics to be specified by the
  manufacturer
9 Routine calibration
Bibliography
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications

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
CLC/SR 29
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

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
EN 60645-3:2007 Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration
EN 60645-1:2017 Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
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
EN 60601-1-2:2015 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
EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
EN 60318-5 : 2006 ELECTROACOUSTICS - SIMULATORS OF HUMAN HEAD AND EAR - PART 5: 2 CM[3] COUPLER FOR THE MEASUREMENT OF HEARING AIDS AND EARPHONES COUPLED TO THE EAR BY MEANS OF EAR INSERTS
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
EN 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
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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