EN IEC 60645-6:2022/A1:2026
(Amendment)Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
General Information
- Abstract
- Status
- Published
- Publication Date
- 17-Sep-2026
- Technical Committee
- CLC/SR 29 - Electroacoustics
- Current Stage
- 6060 - Document made available - Publishing
- Start Date
- 18-Sep-2026
- Due Date
- 31-Mar-2026
- Completion Date
- 18-Sep-2026
Overview
EN IEC 60645-6:2022/A1:2026 is an amendment to the international standard for electroacoustic audiometric equipment, specifically focusing on instruments for the measurement of otoacoustic emissions (OAE). Published by the European Committee for Electrotechnical Standardization (CLC), this amendment updates normative references and editorial content to ensure continued alignment with current technology and standardization practices in the field of audiological diagnostics.
Otoacoustic emission measurement is critical in both clinical and research audiology, as it provides objective assessment of cochlear (inner ear) function. Instruments covered by this standard are widely used for hearing screening, diagnostics, and auditory research.
Key Topics
- Updated Normative References: The amendment replaces references to the now-withdrawn IEC 60645-3:2020 with new sections in IEC 60645-7:2025, ensuring practitioners use the most up-to-date methods for short-duration test signals.
- Editorial Clarifications:
- Specifies that the acceptance limits for stimulus levels of Distortion Product Otoacoustic Emissions (DPOAE) primary tones should be given as ±1.5 dB.
- Clarifies the use of short-duration signals (for Transient Evoked Otoacoustic Emissions or TEOAE) and refers to updated figures and definitions from IEC 60645-7:2025.
- General Specification Alignment: Requirements for the acoustic stimulus system are harmonized with IEC 60645-1:2017 and relevant portions of IEC 60645-7:2025, supporting equipment interoperability and consistency in audiometric assessments.
- No Technical Changes: The amendment introduces no fundamental technical alterations, focusing only on updated references and clarifications.
Applications
Instruments compliant with EN IEC 60645-6:2022/A1:2026 are utilized in a wide range of environments:
- Newborn Hearing Screening: Rapid, non-invasive assessment of infants' hearing through otaocoustic emissions is a common protocol in hospitals and clinics worldwide.
- Pediatric and Adult Audiology: Objective measurements aid audiologists in diagnosing hearing impairment without requiring patient participation.
- Research Facilities: OAE measurements serve as valuable data in studies of cochlear mechanics and auditory pathway development.
- Hearing Aid Fitting and Monitoring: OAE instruments are used to monitor cochlear function over time, informing device programming and patient management.
Key practical benefits of standard compliance include:
- Consistency: Uniform procedures and acceptance criteria facilitate reliable cross-facility comparisons.
- Regulatory Acceptance: Demonstrating compliance with internationally recognized standards is often required for device certification and market access.
- Patient Safety and Reliability: Clear guidelines ensure accurate, reproducible test results and robust device performance.
Related Standards
For a comprehensive understanding and implementation, consider these associated standards:
- IEC 60645-1:2017 - Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
- IEC 60645-7:2025 - Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials (now referenced by this amendment)
- Previous Versions: IEC 60645-6:2022 (original), IEC 60645-3:2020 (withdrawn, replaced by -7:2025)
Summary
Adopting EN IEC 60645-6:2022/A1:2026 ensures that otoacoustic emission measurement instruments align with the latest normative and editorial best practices. This update supports continued excellence in clinical audiology, hearing screening, and auditory research, promoting consistent, high-quality patient care and technological innovation in the field of electroacoustics.
Relations
- Effective Date
- 01-Sep-2026
- Effective Date
- 21-Oct-2025
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Frequently Asked Questions
EN IEC 60645-6:2022/A1:2026 is a amendment published by CLC. Its full title is "Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions". This standard covers: Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
EN IEC 60645-6:2022/A1:2026 is classified under the following ICS (International Classification for Standards) categories: 17.140.50 - Electroacoustics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN IEC 60645-6:2022/A1:2026 has the following relationships with other standards: It is inter standard links to EN IEC 60645-7:2025, EN IEC 60645-6:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN IEC 60645-6:2022/A1:2026 is associated with the following European legislation: EU Directives/Regulations: 2014/35/EU; Standardization Mandates: M/511. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN IEC 60645-6:2022/A1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2026
Elektroakustika - Avdiometrična oprema - 6. del: Instrumenti za merjenje
ušesnoakustičnih emisij - Dopolnilo A1 (IEC 60645-6:2022/AMD1:2026)
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of
otoacoustic emissions (IEC 60645-6:2022/AMD1:2026)
Akustik - Audiometer - Teil 6: Geräte zur Messung von otoakustischen Emissionen (IEC
60645-6:2022/AMD1:2026)
Électroacoustique - Appareils audiométriques - Partie 6: Instruments pour la mesure des
émissions otoacoustiques (IEC 60645-6:2022/AMD1:2026)
Ta slovenski standard je istoveten z: EN IEC 60645-6:2022/A1:2026
ICS:
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60645-6:2022/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM September 2026
ICS 17.140.50
English Version
Electroacoustics - Audiometric equipment - Part 6: Instruments
for the measurement of otoacoustic emissions
(IEC 60645-6:2022/AMD1:2026)
Électroacoustique - Appareils audiométriques - Partie 6: Akustik - Audiometer - Teil 6: Geräte zur Messung von
Instruments pour la mesure des émissions otoacoustiques otoakustischen Emissionen
(IEC 60645-6:2022/AMD1:2026) (IEC 60645-6:2022/AMD1:2026)
This amendment A1 modifies the European Standard EN IEC 60645-6:2022; it was approved by CENELEC on 2026-09-11. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60645-6:2022/A1:2026 E
European foreword
The text of document 29/1240/FDIS, future edition 2 of IEC 60645-6/AMD1, prepared by TC 29
"Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2027-09-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2029-09-30
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CENELEC by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60645-6:2022/AMD1:2026 was approved by CENELEC as
a European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Replace IEC 60645-3:2020 with:
Publication Year Title EN/HD Year
IEC 60645-7 2025 Electroacoustics - Audiometric equipment - EN IEC 60645-7 2025
Part 7: Instruments for the measurement of
auditory evoked potentials
IEC 60645-6 ®
Edition 2.0 2026-08
INTERNATIONAL
STANDARD
AMENDMENT 1
Electroacoustics - Audiometric equipment -
Part 6: Instruments for the measurement of otoacoustic emissions
ICS 17.140.50 ISBN 978-2-8327-1428-7
IEC 60645-6:2022-03/AMD1:2026-08(en)
IEC 60645-6:2022/AMD1:2026 © IEC 2026
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Electroacoustics -
Audiometric equipment -
Part 6: Instruments for the measurement of otoacoustic emissions
AMENDMENT 1
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees)
...