IEC 60118-13:2016 PDF

Overview

IEC 60118-13:2016 is an international standard developed by the International Electrotechnical Commission (IEC) that addresses the electromagnetic compatibility (EMC) of hearing aids. This fourth edition, replacing the 2011 version, presents a comprehensive set of EMC requirements to ensure hearing aids can function reliably in environments with electromagnetic disturbances.

The standard primarily focuses on immunity and emissions related to electromagnetic phenomena, especially those caused by high-frequency fields from wireless digital devices like mobile phones. It recognizes the evolving technology in hearing aids, including the integration of radio frequency (RF) components such as digital signal processors and wireless transceivers, which introduce additional EMC compliance challenges.

Key Topics

• Scope of EMC for Hearing Aids The standard specifies the relevant electromagnetic disturbances impacting hearing aids, emphasizing both radiated emissions and immunity to various electromagnetic phenomena.

• Immunity Requirements IEC 60118-13 outlines immunity tests for hearing aids against:

  • High-frequency radiated RF electromagnetic fields, typically from mobile phones and other wireless devices.
  • Electrostatic discharge (ESD), ensuring hearing aids withstand sudden bursts of static electricity.
  • Power frequency magnetic fields, covering low-frequency electromagnetic interference.

• Emission Limits The standard defines radiated emission limits to prevent hearing aids from causing harmful electromagnetic interference to other devices.

• Test Procedures Detailed test methodologies are included for assessing:

  • Hearing aid response and gain under RF exposure.
  • ESD and power frequency magnetic field immunity tests.
  • Measurement set-ups, including the usage of GTEM cells and dipole antennas for uniform and standardized testing environments.

• Exclusion of Power and Signal Lines EMC requirements for connected power and signal lines are explicitly excluded, focusing the standard on the core device characteristics.

• Performance Criteria and Compliance The standard specifies criteria to determine whether hearing aids comply with EMC requirements, ensuring both bystander compatibility and user compatibility in real-world electromagnetic environments.

Applications

• Hearing Aid Design and Manufacturing IEC 60118-13:2016 guides manufacturers in designing hearing aids that maintain performance despite electromagnetic disturbances, facilitating product development that meets global EMC regulations.

• Product Testing and Certification Laboratories and certification bodies use this standard to test and certify hearing aids for electromagnetic immunity and emissions, ensuring compliance with international market requirements.

• Healthcare and Consumer Electronics By applying this standard, producers ensure hearing aids operate effectively alongside ubiquitous digital wireless devices, improving consumer satisfaction and reducing electromagnetic interference issues in healthcare environments.

• Regulatory Compliance The standard supports regulatory conformity in global markets, enabling hearing aid products to meet EMC directives and guidelines in various countries.

Related Standards

• IEC 60118 Series This part 13 of the IEC 60118 series complements other parts addressing various aspects of hearing aid electroacoustics.

• IEC Guide 107 Provides guidance on drafting EMC publications, under which IEC 60118-13 is classified as a product EMC standard.

• Electromagnetic Compatibility Standards for Electronic Devices IEC 60118-13 aligns with broader EMC standards that apply to electronic products, ensuring hearing aids conform to international electromagnetic interference and immunity benchmarks.

• ISO/IEC Directives, Part 2 The drafting of this standard follows these directives, which define procedures for developing international standards.

Keywords: IEC 60118-13, electromagnetic compatibility, EMC, hearing aids, electromagnetic immunity, radiated emissions, electrostatic discharge, RF electromagnetic fields, hearing aid testing, IEC standards, digital wireless devices, hearing aid design, product certification, EMC requirements