IEC 60645-6:2022

Overview

IEC 60645-6:2022 - "Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions" - specifies requirements for instruments that measure otoacoustic emissions (OAEs) in the human external auditory meatus evoked by acoustic probe stimuli. The standard defines manufacturer-declared characteristics, mandatory functions for two instrument types, performance specifications, methods to demonstrate conformity, and guidance for routine/periodic calibration. Its aim is to ensure measurements from different compliant instruments are consistent under comparable test conditions.

Key Topics and Technical Requirements

• Instrument scope and mandatory functions: Defines two instrument types and the minimum set of functions manufacturers must provide.
• Acoustic stimulus system: Requirements for probe stimuli used to evoke OAEs, including stimulus types, frequency range, stimulus levels and permitted deviations.
• DPOAE and TEOAE specifics: Addresses both distortion-product OAEs (DPOAE) and transient-evoked OAEs (TEOAE); this 2022 edition updates nominal test frequency conventions, stimulus level and frequency-range definitions, harmonic distortion limits, and minimum measurement range for DPOAE.
• Measuring system performance: Specifications for measurement range, accuracy, frequency range, noise reduction and response detection/quality metrics.
• Test quality assurance: Stability of acoustic response in the ear canal, individual stimulus recording handling, and quality indicators to ensure reliable clinical data.
• Conformance and calibration: Prescribed methods to demonstrate instrument conformity and guidance on routine periodic calibration; maximum permitted measurement uncertainty requirements are defined.
• General device requirements: Marking, instruction manuals, safety, electromagnetic immunity, warm-up time and environmental operation constraints.

Applications and Who Uses This Standard

• Manufacturers of audiometric and OAE instruments use IEC 60645-6:2022 to design, document and declare device capabilities and to meet international performance benchmarks.
• Clinical audiologists and otologists rely on OAE instruments that conform to the standard for consistent diagnostic screening (newborn hearing screening, ototoxicity monitoring, cochlear function evaluation).
• Calibration and test laboratories use the conformity and calibration methods to verify device performance and maintain traceability.
• Regulatory bodies and procurement teams reference the standard when evaluating device safety, interoperability and measurement consistency.

Related Standards

• IEC 60318-4, IEC 60318-5 (ear/occluded-ear simulators and couplers) - used for acoustic coupling and probe verification.
• IEC 60601 series - medical electrical safety and EMC requirements relevant for clinical OAE instruments.

For implementation or procurement, obtain the full IEC 60645-6:2022 publication from IEC or your national standards body to access detailed test methods, normative values and calibration procedures.