Overview - IEC TR 62809:2019 (Summary of requirements and tests)
IEC TR 62809:2019 is a Technical Report published by the IEC that provides a concise overview of the requirements and tests from IEC 60601-2-66 (particular requirements for hearing instrument aids) together with applicable sections of IEC 60601-1 and the IEC 60601 collateral standards. This edition (Edition 2.0, 2019) is a redline/summary document intended to help stakeholders quickly understand the more common requirements and test topics without reading all full standard texts. It is not a substitute for the full standards and cannot be used alone to establish or assess compliance.
Key topics and technical requirements
The TR summarizes practical, commonly referenced requirements and tests, including:
- Accessories: Requirements for accessories (remote controls, chargers, power supplies, streamers) and when an accessory forms a hearing instrument aid system. Documentation and safety-standard compliance for accessories are highlighted.
- Type tests: Guidance on representative sampling, family testing strategies, and testing under least-favourable and reasonably foreseeable misuse conditions.
- Risk management: Requirement to apply a formal risk management process (ISO 14971). Where IEC 60601-2-66 addresses particular risks, alternative mitigations are acceptable if residual risk is justified.
- Essential performance: Identification of functions considered essential performance must be done via the manufacturer’s risk analysis.
- Expected service life: Manufacturers must state expected service life in the risk management file.
- Components and reliability: Use of components whose failure could create hazards must follow their ratings and relevant IEC/ISO safety requirements; means of protection must be assessed for reliability.
- Markings and durability: Markings must remain legible for expected service life and resist cleaning solvents and handling.
- Edition-specific changes called out in this TR include the introduction of FITTED OSPL90 (fitted maximum output sound pressure level) and that allowable output limits are based on fitted output; also that essential performance is determined by risk analysis.
Practical applications - who uses this TR
This Technical Report is aimed at:
- Designers and manufacturers of hearing instrument aids for early-stage product planning and design reviews.
- Suppliers and accessory vendors to understand interaction and system-level requirements.
- Test labs and regulatory assessors as an overview to focus testing and documentation efforts before consulting full standards.
- Quality and compliance teams preparing risk management files and technical documentation.
How to use this TR (and limitations)
- Use IEC TR 62809:2019 as a summary and roadmap to the relevant clauses of IEC 60601-2-66 and IEC 60601-1.
- Do not use the TR alone to write product requirements, test plans, or to certify compliance - always consult the full IEC 60601-2-66 and referenced standards.
Related standards (selected)
Keywords: IEC TR 62809:2019, IEC 60601-2-66, hearing instrument aids, medical electrical equipment, risk management, type tests, essential performance, FITTED OSPL90, compliance.
