Audiology - Related International Standards
The following non-harmonised international standards are related to Audiology for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-66:2019 | Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems | active | 14, 14.1 | Link |
| IEC 60645-1:2017 | Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry | active | 14, 18 | Link |
| IEC 60645-7:2025 | Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration | active | 14, 18 | Link |
| IEC 60645-5:2004 | Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance | active | 14, 18 | Link |
| IEC 60118-0:2022 | Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids | active | 14, 14.1, 14.2 | Link |