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  • IEC 60118-13:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  31-12-2021

    Language(s):  English - French

    Published date:  06-01-2016

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Operation and function of the hearing aid
    5 Specification of EMC environment
    6 Requirements for electromagnetic emissions
    7 Requirements for electromagnetic immunity
    8 Test procedures for immunity to radiated RF
      electromagnetic fields
    9 Measurement uncertainty for immunity to
      radiated RF electromagnetic fields
    Annex A (informative) - Background for establishing
            test methods, performance criteria and test
            levels
    Annex B (informative) - Rationale for particular
            clauses and subclauses
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC 60118-13:2016 covers relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency fields originating from digital wireless devices such as mobile phones was originally identified as the most relevant EMC phenomena impacting hearing aids. Since the inclusion of RF generating components within hearing aids, such as digital signal processors or wireless transceivers, additional EMC compliance requirements apply. The EMC requirements now included are radiated emissions and immunity to electrostatic discharge, power frequency magnetic fields, and radiated RF electromagnetic fields. Requirements associated with connected power and signal lines are not included. This fourth edition cancels and replaces the third edition published in 2011 and constitutes a technical revision.

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

    Committee TC 29
    Development Note Stability Date: 2017. (01/2016)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    CSA C22.2 No. 60601-2-66 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
    BS EN 61000-4-20:2003 Electromagnetic Compatibility (EMC) Testing and measurement techniques. Emission and immunity testing in transverse electromagnetic (TEM) waveguides
    S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
    CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
    I.S. EN 60601-2-66:2015 MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
    EN 61000-4-20:2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-20: TESTING AND MEASUREMENT TECHNIQUES - EMISSION AND IMMUNITY TESTING IN TRANSVERSE ELECTROMAGNETIC (TEM) WAVEGUIDES
    CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    10/30240267 DC : 0 BS EN 60601-2-66 ED.1 - ELECTROACOUSTICS - PART 2-66: HEARING INSTRUMENTS AND HEARING SYSTEMS - GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    14/30315340 DC : 0 BS EN 60601-2-66 ED.2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS
    UNE-EN 60601-2-66:2016 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
    BS EN 60601-2-66:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
    CEI EN 61000-4-20 : 2013 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-20: TESTING AND MEASUREMENT TECHNIQUES - EMISSION AND IMMUNITY TESTING IN TRANSVERSE ELECTROMAGNETIC (TEM) WAVEGUIDES
    IEEE/ANSI C63.19-2011 REDLINE American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids
    TR 102 612 : 1.1.1 HUMAN FACTORS (HF); EUROPEAN ACCESSIBILITY REQUIREMENTS FOR PUBLIC PROCUREMENT OF PRODUCTS AND SERVICES IN THE ICT DOMAIN (EUROPEAN COMMISSION MANDATE M 376, PHASE 1)
    IEC 60601-2-66:2015 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
    PD 6545:2005 Intended use of human head and ear simulators-guide
    ES 200 381-1 : 1.2.1 TELEPHONY FOR HEARING IMPAIRED PEOPLE; INDUCTIVE COUPLING OF TELEPHONE EARPHONES TO HEARING AIDS; PART 1: FIXED-LINE SPEECH TERMINALS
    ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    I.S. EN 61000-4-20:2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-20: TESTING AND MEASUREMENT TECHNIQUES - EMISSION AND IMMUNITY TESTING IN TRANSVERSE ELECTROMAGNETIC (TEM) WAVEGUIDES
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    UNE-EN 61000-4-20:2011 Electromagnetic compatibility (EMC) -- Part 4-20: Testing and measurement techniques - Emission and immunity testing in Transverse Electromagnetic (TEM) waveguides - Basic EMC publication
    IEC 61000-4-20:2010 Electromagnetic compatibility (EMC) - Part 4-20: Testing and measurement techniques - Emission and immunity testing in transverse electromagnetic (TEM) waveguides
    UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    IEEE DRAFT C63.19 : 2005 METHODS OF MEASUREMENT OF COMPATIBILITY BETWEEN WIRELESS COMMUNICATIONS DEVICES AND HEARING AIDS
    PD IEC/TR 62809:2013 Summary of requirements and tests for products in the scope of IEC 60601-2-66
    IEC TR 62809:2013 Summary of requirements and tests to products in the scope of IEC 60601-2-66
    EN 60601-2-66:2015 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

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

    IEC 61000-4-8 : 2.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    IEC 60118-7:2005 Electroacoustics - Hearing aids - Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality assurance purposes
    IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    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 cm3 coupler for the measurement of hearing aids and earphones coupled to the ear by means of ear inserts
    IEC 61000-4-20:2010 Electromagnetic compatibility (EMC) - Part 4-20: Testing and measurement techniques - Emission and immunity testing in transverse electromagnetic (TEM) waveguides
    IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    IEC 60118-15:2012 Electroacoustics - Hearing aids - Part 15: Methods for characterising signal processing in hearing aids with a speech-like signal
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    IEC 60118-4:2014+AMD1:2017 CSV Electroacoustics - Hearing aids - Part 4: Induction-loop systems for hearing aid purposes - System performance requirements
    IEEE/ANSI C63.19-2011 REDLINE American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids
    IEC 60118-0:2015 Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids
    IEC 60601-2-66:2015 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
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