SIST EN IEC 60645-6:2022/kFprA1:2026

Akustik - Audiometer - Teil 6: Geräte zur Messung von otoakustischen Emissionen

électroacoustique - équipements audiométriques - Partie 6: Instruments pour la mesure des émissions otoacoustiques

Elektroakustika - Avdiometrična oprema - 6. del: Instrumenti za merjenje ušesnoakustičnih emisij - Dopolnilo A1

General Information

• Status: Not Published
• Public Enquiry End Date: 28-Feb-2026
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: I11 - Imaginarni 11
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 09-Jun-2026
• Due Date: 28-Jul-2026
• Directive: Harmonized Standard2014/35/EU - Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
• Mandate: M/511 - Mandate to CEN, CENELEC and ETSI relating to harmonised standards in the field of the Low Voltage Directive
• Ref Project: EN IEC 60645-6:2022/FprA1:2026 - Amendment 1 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions

Relations

• Amends: SIST EN IEC 60645-6:2022 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022)
• Effective Date: 21-Oct-2025

Overview

SIST EN IEC 60645-6:2022/kFprA1:2026 is the first amendment to the international standard IEC 60645-6:2022, “Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions.” This amendment, prepared by SIST in alignment with IEC TC 29 (Electroacoustics), addresses references and editorial clarifications for manufacturers and users of audiometric equipment, specifically those measuring otoacoustic emissions (OAE).

Otoacoustic emissions (OAEs) are sound waves generated within the inner ear, used extensively in auditory health assessments and audiology. The standard ensures that equipment for measuring OAEs adheres to uniform and recognized performance criteria, promoting international harmonization and accuracy across clinical and research practices.

Key Topics

• Reference Updates: Amendment 1 replaces all references to the now withdrawn IEC 60645-3:2020 (test signals of short duration) with corresponding content and requirements now contained in IEC 60645-7:2025. This ensures continued compatibility and coherence across related standards for audiometric equipment.
• Normative Reference Adjustment: The standard now cites IEC 60645-7:2025 for requirements and specifications related to auditory evoked potential instruments, supporting the measurement of OAEs with accurate short-duration stimuli.
• Editorial Clarifications: The amendment refines the acceptance limits for stimulus levels used in Distortion Product Otoacoustic Emissions (DPOAE) measurements. The limit is explicitly stated as “±1.5 dB” for improved clarity and consistency in equipment calibration and reporting.
• No Technical Changes: Importantly, this amendment does not introduce substantive technical changes. Instead, it consolidates references and corrects editorial details, promoting ease of implementation and compliance for manufacturers and users.

Applications

The effective measurement of otoacoustic emissions is fundamental to:

• Newborn Hearing Screening: OAE measurement is a cornerstone in universal screening programs for early detection of hearing impairment in infants.
• Diagnostic Audiology: Clinicians utilize OAE instruments to diagnose sensorineural hearing loss, monitor cochlear function, and differentiate between sensory and neural hearing deficits.
• Hearing Aid Fitting and Monitoring: OAEs assist audiologists in fine-tuning and verifying the performance of hearing aids and cochlear implants.
• Research and Development: Standardized references allow for reproducibility and reliability in both clinical trials and basic auditory science research.

By updating normative references and clarifying acceptance criteria, the amendment ensures that audiometric instruments remain accurate, reliable, and harmonized with international best practices.

Related Standards

• IEC 60645-6:2022: The main standard for instruments measuring otoacoustic emissions, providing comprehensive specifications for performance and testing.
• IEC 60645-7:2025: Now a key normative reference, this standard details instruments for measuring auditory evoked potentials and encompasses requirements previously found in IEC 60645-3.
• IEC 60645-1:2017: Specifies basic requirements for audiometric equipment, relevant where OAE instruments also offer hearing threshold measurement capabilities.

Keywords: audiometric equipment, otoacoustic emissions, IEC 60645-6, IEC 60645-7, hearing screening, distortion product otoacoustic emissions, OAE standards, electroacoustics, auditory evoked potentials

This amendment is vital for professionals needing up-to-date references for OAE instrumentation, aligning testing and reporting with the latest international standards in audiology and electroacoustics.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60645-6:2022/oprA1:2026
01-februar-2026
Elektroakustika - Avdiometrična oprema - 6. del: Instrumenti za merjenje
ušesnoakustičnih emisij - Dopolnilo A1
Amendment 1 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the
measurement of otoacoustic emissions
Akustik - Audiometer - Teil 6: Geräte zur Messung von otoakustischen Emissionen
électroacoustique - équipements audiométriques - Partie 6: Instruments pour la mesure
des émissions otoacoustiques
Ta slovenski standard je istoveten z: EN IEC 60645-6:2022/prA1:2025
ICS:
17.140.50 Elektroakustika Electroacoustics
SIST EN IEC 60645-6:2022/oprA1:2026 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN IEC 60645-6:2022/oprA1:2026

SIST EN IEC 60645-6:2022/oprA1:2026

29/1224/CDV
COMMITTEE DRAFT FOR VOTE (CDV)

PROJECT NUMBER:
IEC 60645-6/AMD1 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-12-26 2026-03-20
SUPERSEDES DOCUMENTS:
29/1221/RR
IEC TC 29 : ELECTROACOUSTICS
SECRETARIAT: SECRETARY:
Denmark Ms Lise Aagesen
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):

ASPECTS CONCERNED:
SUBMITTED FOR CENELEC PARALLEL VOTING
NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Amendment 1 - Electroacoustics - Audiometric equipment - Part 6: Instruments for the
measurement of otoacoustic emissions

PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
At its meeting in September 2025, TC 29 took the following decision, doc. 29/1219/DL refers:
DECISION 6
TC 29 asks the secretariat to circulate a Review Report to initiate a fast-track amendment of IEC 60645-
6:2022 "Electroacoustics – Audiometric equipment – Part 6: Instruments for the measurement of otoacoustic
emissions" to replace the references to the withdrawn IEC 60645-3 by references to IEC 60645-7:2025
Part 7: Instruments for the measurement of auditory evoked
"Electroacoustics – Audiometric equipment –
potentials", allocated to WG 10 with Karan Narang, India, as project leader and with the following target
dates:
CDV: 2025-10-31
Publication: 2026-03-31.
this electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee
positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other
purpose without permission in writing from IEC.

SIST EN IEC 60645-6:2022/oprA1:2026
IEC CDV 60645-6/AMD1 © IEC 2025
1 INTERNATIONAL ELECTROTECHNICAL COMMISSION
2 ____________
4 ELECTROACOUSTICS –
5 AUDIOMETRIC EQUIPMENT –
7 Part 6: Instruments for the measurement of otoacoustic emissions
9 AMENDMENT 1
11 FOREWORD
12 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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