• EN 60645-6:2010

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions

    Available format(s): 

    Superseded date:  12-05-2022

    Language(s): 

    Published date:  08-01-2010

    Publisher:  European Committee for Standards - Electrical

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CLC/SR 29
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    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 cm3 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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