IEC 60645-7:2025 PDF

Overview

IEC 60645-7:2025 - "Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials" specifies requirements for instruments that measure auditory evoked potentials (AEPs) from the inner ear, auditory nerve and brainstem, evoked by short-duration acoustic or vibratory stimuli. The standard defines manufacturer-declared characteristics, performance requirements for two instrument classes (screening and diagnostic/clinical), stimulus and reference-signal descriptions (electrical waveforms), calibration and measurement methods, and verification of measurement uncertainty. The document is designed to ensure consistent, comparable AEP measurements across compliant instruments while allowing innovation. Note: AEPs evoked by applied electrical stimulation are outside the scope.

Key topics and technical requirements

• Instrument classes: performance and functional requirements for screening and diagnostic/clinical AEP instruments.
• Measuring system: units, measurement ranges and time resolution for AEP recordings.
• Stimulus system: general requirements and supported stimulus types (clicks, tone-bursts, broadband and octave‑band chirps, and vibratory stimuli of short duration).
• Reference signals: electrical waveform definitions and measurement methods for reference click, tone-burst, broadband chirp and octave‑band chirps.
• Test quality assurance: recording conditions, automated response detection, and quality estimates to support reliable results.
• Calibration & measurement: procedures for short‑duration signals and periodic calibration requirements, including maximum permitted expanded uncertainty of measurement (Umax).
• Presentation & documentation: required presentation of results and documentation of test conditions, parameters and outcomes.
• General requirements: marking, instruction manuals, safety, immunity to power/RF fields, warm‑up, and environmental/voltage-variation performance.
• Conformity demonstration: methods to show compliance (tolerance vs acceptance limits and uncertainty considerations).

Practical applications and users

IEC 60645-7:2025 is intended for:

• Manufacturers of audiometric and AEP measurement systems (product specification and design verification).
• Clinical engineers and medical device test laboratories performing calibration and conformity testing.
• Audiology clinics and hospitals using screening or diagnostic AEP instruments for objective hearing assessment.
• Regulators and procurement teams defining performance criteria for medical audiometric equipment. The standard helps ensure reproducible AEP recordings for newborn hearing screening, neuro‑audiological assessment and clinical diagnostic workflows when acoustic or vibratory short‑duration stimuli are used.

Related standards

Key normative references include IEC 60601‑1, IEC 60645‑1, the IEC 60318 series (head/ear simulators and couplers), ISO 389‑6 (reference thresholds for short‑duration test signals) and ISO/IEC Guide 98‑3 (GUM: uncertainty of measurement).