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BS 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Instruments for the measurement of otoacoustic emissions

Available format(s)

Hardcopy , PDF

Superseded date

26-05-2022

Language(s)

English

Published date

28-02-2010

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

Pertains to instruments designed primarily for the measurement of otoacoustic emissions in the human external acoustic meatus evoked by acoustic probe pulses or tones.

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
EPL/29
DevelopmentNote
Supersedes 07/30173580 DC. (02/2010)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 60645-6:2010 Identical
IEC 60645-6:2009 Identical
EN 62041:2003 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
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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