IEC 60118-13:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
31-12-2021
English - French
06-01-2016
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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
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.
| Committee |
TC 29
|
| DevelopmentNote |
Stability Date: 2017. (01/2016)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| VDE 0750-11 : 2012 | Identical |
| DIN EN IEC 60118-13:2021-03 | Identical |
| VDE 0750-11:2021-03 | Identical |
| PNE-FprEN 60118-13 | Identical |
| NF EN 60118-13 : 2012 | Identical |
| CEI EN 60118-13 : 2012 | Identical |
| BS EN 60118-13:2011 | Identical |
| NBN EN 60118-13 : 2011 | Identical |
| EN 60118-13:2011 | Identical |
| SN EN 60118-13 : 1997 | Identical |
| DIN EN 60118-13 : 2012 | Identical |
| UNE-EN 60118-13:2012 | Identical |
| PN EN 60118-13 : 2013 | Identical |
| NEN EN IEC 60118-13 : 2011 | Identical |
| I.S. EN 60118-13:2011 | Identical |
| 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 |
| 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 cm<sup>3</sup> 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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