Overview
IEC 60601-2-66:2019 - Medical electrical equipment Part 2-66 - sets the particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems. This third edition (2019) cancels and replaces the 2015 edition and is a technical revision of the IEC 60601 family. It amends and supplements the general medical electrical equipment standard IEC 60601-1 and references electromagnetic compatibility requirements in IEC 60601-1-2:2014.
This standard is focused on safety, essential performance, testing and documentation for medical electrical (ME) hearing instruments and ME systems, and includes informative guidance in Annex AA. The redline edition highlights key changes from the previous edition.
Key Topics and Requirements
- Scope & applicability: Requirements for basic safety of hearing aids and hearing-aid systems; accessories for home use are addressed by applicable consumer or safety standards when relevant.
- Essential performance: Definition revised in this edition - the concept guides which functions must be maintained to avoid unacceptable clinical risk.
- Electromagnetic compatibility (EMC): Updated application of IEC 60601-1-2:2014 for electromagnetic disturbances specific to hearing devices.
- Electrical and mechanical safety:
- Correction of nominal battery/operating voltage for hearing aids from 1.6 V to 4.5 V.
- Drop-test height corrected from 1.5 m to 1.0 m.
- Requirements for protection against electrical, mechanical, thermal and radiation hazards.
- Testing & measurement: Clauses cover leakage current measurement, instrument accuracy, mechanical hazard analysis, and fault-condition handling.
- Programmable systems (PEMS): Lifecycle, documentation and validation requirements for programmable medical electrical systems used in hearing devices.
- Identification, marking & documentation: Labelling, user and service documentation, and risk management references are specified.
- Annexes: Provide examples (leakage-current circuits), normative rules (insulation, winding wires), and helpful informative material (essential performance, EMC guidance).
Applications and Users
This standard is essential for:
- Hearing-aid manufacturers (design, safety and compliance)
- Test laboratories conducting conformity and EMC testing
- Regulatory and certification bodies assessing medical device safety
- Design and QA engineers implementing risk management per IEC 60601 series
- Product managers preparing technical documentation for market approval
Use IEC 60601-2-66 when demonstrating conformity to medical device safety requirements, preparing test plans, or designing hearing instruments to meet international safety and EMC expectations.
Related Standards
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 (EMC)
- Applicable consumer or safety standards for accessories (e.g., chargers, streamers) where relevant
Keywords: IEC 60601-2-66, hearing aids standard, medical electrical equipment, essential performance, basic safety, EMC, leakage current, drop test, 4.5 V, PEMS, IEC 60601 series.