EN IEC 60645-6:2022/FprA1:2026
(Amendment)Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions
General Information
- Abstract
- Status
- Not Published
- Publication Date
- 17-Sep-2026
- Technical Committee
- CLC/SR 29 - Electroacoustics
- Current Stage
- 5060 - Voting results sent to TC, SR - Formal Approval
- Start Date
- 17-Jul-2026
- Completion Date
- 17-Jul-2026
Overview
EN IEC 60645-6:2022/FprA1:2026 Amendment 1 is an important update to the international standard governing electroacoustic audiometric equipment, specifically instruments for measuring otoacoustic emissions (OAE). Developed by the International Electrotechnical Commission (IEC) Technical Committee 29 (Electroacoustics) and adopted by CLC, this amendment ensures that references and terminology stay updated according to the latest industry developments.
This amendment primarily addresses the need to replace outdated references with the current IEC 60645-7:2025 standard. It clarifies specifications without introducing new technical requirements, supporting greater consistency and reliability in the latest audiometric equipment.
Key Topics
- Reference Update: The amendment replaces all references to the withdrawn IEC 60645-3:2020 with IEC 60645-7:2025, aligning the standard with current normative documents relevant to test signals and auditory evoked potential measurements.
- Editorial Clarification: Updates include clearer language around two-sided (±) acceptance limits for Distortion Product Otoacoustic Emissions (DPOAE) stimulus levels, promoting more robust interpretation across devices and end-users.
- Scope of Change: No technical or performance requirements for OAE instrumentation are modified. All changes are editorial or related to normative references, ensuring ongoing compatibility and compliance with the latest audiometric best practices.
Applications
EN IEC 60645-6:2022/FprA1:2026 is directly relevant for:
- Manufacturers of Audiometric Instruments: Guarantees that current and future OAE-measuring devices conform to the latest internationally recognized standards. This helps support market access and regulatory compliance for new products in global markets.
- Clinical Audiologists and Hearing Care Professionals: Offers assurance that the instrumentation used for detecting otoacoustic emissions meets the most current specifications, supporting accuracy in hearing assessment and diagnosis.
- Testing and Calibration Laboratories: Facilitates standardized testing procedures by referencing up-to-date criteria for acoustic stimulus systems and signal characteristics according to the latest IEC publications.
- Regulators and Notified Bodies: Enables authorities to reference the most current and harmonized international standards during equipment approval and quality assessment, streamlining conformity assessment processes.
By implementing the latest reference and editorial updates, stakeholders ensure devices for measuring otoacoustic emissions-crucial in newborn hearing screening and general audiology-are manufactured, tested, and used according to the highest standards of reliability and safety.
Related Standards
For comprehensive compliance and best practices, organizations should be aware of these associated standards:
- IEC 60645-1:2017 - Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry, specifying general requirements for audiometric instruments.
- IEC 60645-7:2025 - Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials, now the primary reference for short-duration test signals and auditory evoked measurements.
- EN IEC 60645-6:2022 - The core standard for instruments measuring otoacoustic emissions, providing foundational technical specifications.
Practical Value
- Ensures Consistency: By referencing the latest IEC standard, this amendment helps manufacturers and professionals use harmonized requirements worldwide.
- Supports Device Compliance: Equipment built to this standard remains up-to-date with regulatory and clinical expectations.
- Improves Clarity: Editorial updates reduce misinterpretations, promoting accurate and reproducible measurement of otoacoustic emissions.
- Facilitates International Trade: Harmonized standards lower technical barriers, enabling broader acceptance of audiometric equipment across markets.
For anyone involved in producing, testing, using, or approving audiometric OAE instruments, implementing EN IEC 60645-6:2022/FprA1:2026 is essential for staying compliant and ensuring quality in hearing health assessment.
Relations
- Effective Date
- 21-Oct-2025
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Frequently Asked Questions
EN IEC 60645-6:2022/FprA1:2026 is a draft 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/FprA1:2026 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/FprA1:2026 has the following relationships with other standards: It is inter standard links to 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/FprA1:2026 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/FprA1:2026 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
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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