SIST EN IEC 60645-6:2022/A1:2026
(Amendment)Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022/AMD1:2026)
General Information
- Abstract
- Status
- Published
- Public Enquiry End Date
- 28-Feb-2026
- Publication Date
- 23-Sep-2026
- Technical Committee
- I11 - Imaginarni 11
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 22-Sep-2026
- Due Date
- 27-Nov-2026
- Completion Date
- 24-Sep-2026
Overview
SIST EN IEC 60645-6:2022/A1:2026 is an international amendment developed by the Slovenian Institute for Standardization (SIST) to update the requirements for instruments measuring otoacoustic emissions (OAE) in audiometric equipment. This amendment aligns references from earlier versions to the latest normative standards and ensures the continued accuracy and reliability of OAE measurement instruments. These instruments play a vital role in the assessment of cochlear (inner ear) function, particularly in newborn hearing screening and clinical audiology.
The amendment replaces references to the now-withdrawn IEC 60645-3 with IEC 60645-7:2025, clarifies specifications, and enhances editorial precision. While no technical requirements are changed, the document solidifies the foundations for future interoperability, device conformity, and consistent test methodologies in electroacoustic audiometry.
Key Topics
- Update of Normative References
- Replaces references from IEC 60645-3:2020 to IEC 60645-7:2025 for requirements related to test signals of short duration and auditory evoked potentials.
- Editorial Enhancements
- Clarifies acceptance limits for distortion product otoacoustic emission (DPOAE) stimulus levels as two-sided (±) values.
- Updates terminology and reference notes for acoustic measurements such as peak-to-peak equivalent sound pressure level (peSPL).
- Specification Clarification
- Specifies that the characteristics of stimuli used for transient-evoked otoacoustic emissions (TEOAE) must be manufacturer-defined according to IEC 60645-7:2025.
- Aligns general requirements and stimulus types with the latest editions of IEC 60645-1 and IEC 60645-7.
- Conformity and Stability
- Ensures the standard’s stability by aligning technical references with current editions, supported by the relevant IEC Technical Committee and Working Groups.
Applications
SIST EN IEC 60645-6:2022/A1:2026 is essential for organizations involved in the design, manufacture, calibration, and clinical application of audiometric equipment for measuring otoacoustic emissions. Key practical uses include:
- Newborn and Infant Hearing Screening
- OAE instruments are widely used for early detection of hearing impairment, enabling timely intervention and support.
- Diagnostic Audiology
- OAE testing assists clinicians in diagnosing cochlear health in both pediatric and adult populations.
- Device Manufacturing and Calibration
- Manufacturers rely on up-to-date standards for compliance, ensuring their products meet international accuracy and safety requirements.
- Equipment Maintenance and Quality Control
- Calibration labs and healthcare enterprises refer to these requirements to maintain traceable and reliable OAE measurements in routine checks.
By maintaining updated references and clarity in specifications, this amended standard facilitates interoperability, regulatory compliance, and higher confidence in clinical assessment outcomes.
Related Standards
Professionals and organizations applying SIST EN IEC 60645-6:2022/A1:2026 should also consider the following relevant standards for comprehensive conformity in audiometric equipment:
- 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 (supersedes IEC 60645-3 in providing normative content for short-duration test signals)
- ISO/IEC Directives, Part 1 & Part 2 - Guidelines for drafting, structure, and development of international standards
- Relevant calibration and testing protocols within medical device regulatory frameworks
SIST EN IEC 60645-6:2022/A1:2026 enhances audiometric device reliability, helping ensure accurate otoacoustic emissions measurement and effective hearing health outcomes. Organizations are encouraged to integrate this amendment to maintain compliance with international best practices in electroacoustic audiometry.
Relations
- Effective Date
- 01-Sep-2026
- Effective Date
- 21-Oct-2025
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Frequently Asked Questions
SIST EN IEC 60645-6:2022/A1:2026 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022/AMD1:2026)". This standard covers: Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022/AMD1:2026)
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions (IEC 60645-6:2022/AMD1:2026)
SIST 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.
SIST EN IEC 60645-6:2022/A1:2026 has the following relationships with other standards: It is inter standard links to SIST EN IEC 60645-7:2025, SIST EN IEC 60645-6:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST 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.
SIST 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)
...