EN ISO 8325:2023/A1:2026
(Amendment)Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/Amd 1:2026)
General Information
- Abstract
- Status
- Published
- Publication Date
- 19-May-2026
- Technical Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 20-May-2026
- Completion Date
- 20-May-2026
Overview
EN ISO 8325:2023/A1:2026, titled Dentistry - Test methods for rotary instruments - Amendment 1, is an international amendment developed jointly by ISO and CEN, focusing on the test methods for dental rotary instruments. This standard amendment introduces updated terminology, refined definitions, and clarified requirements for dimensional measurement and strength testing of rotary dental instruments. Compliance with EN ISO 8325:2023/A1 is essential for manufacturers, testing laboratories, and regulatory authorities engaged in the production, assessment, and regulation of dental rotary tools.
Key Topics
This amendment affects several central areas for rotary instrument conformance in dentistry:
- Updated Terminology and Definitions: Incorporates newer references, notably ISO 1797, ISO 1942, and ISO 21850-1, to provide clearer, more harmonized definitions within the field.
- Shank Dimension Measurement:
- Specifies methods for determining shank diameter and length.
- Addresses the inclusion of markings for color coding as part of the fitting length, when relevant.
- Neck Strength Test Procedures:
- Details precise instructions for calculating the neck strength of rotary instruments.
- Introduces more explicit guidance on stopping criteria during force application and maximum allowed test forces.
- Test Force Limitations:
- Sets a maximum test force of 60 N to avoid applying clinically unrealistic levels during laboratory tests, ensuring greater safety and clinical relevance.
Applications
Adoption and implementation of EN ISO 8325:2023/A1:2026 provide the dental instruments industry, regulatory agencies, and testing laboratories with several key benefits:
- Quality Assurance: Ensures that dental rotary instruments such as burs and files meet updated international criteria for strength and dimensional properties.
- Patient and Practitioner Safety: By refining test force limits and measurement protocols, the amendment helps minimize breakage and performance failures during dental procedures.
- Regulatory Compliance: Offers manufacturers a harmonized reference for compliance with both ISO and CEN frameworks, often referenced in national regulations.
- Product Development: Supports instrument designers in developing dental tools that meet current materials and manufacturing trends, aligning with the latest clinical recommendations.
Related Standards
For complete assessment and testing of dental rotary instruments, reference may also be made to the following standards:
- ISO 1797: Dentistry - Shanks for rotary and oscillating instruments.
- ISO 1942: Dentistry - Vocabulary, providing standardized dental terms.
- ISO 21850-1: Dentistry - Rotary instruments - Part 1: General requirements.
- ISO 7711: Dentistry - Diamond rotary instruments, offering detailed requirements specifically for diamond instruments.
EN ISO 8325:2023/A1:2026 aligns closely with these related standards, ensuring consistency across the dental instruments sector and strengthening the foundations for quality, safety, and regulatory harmonization.
Adhering to EN ISO 8325:2023/A1:2026 ensures reliable, reproducible test results and supports the high standard of care expected within modern dental practice. For manufacturers, laboratories, and regulators seeking to meet the most up-to-date international criteria on rotary dental instruments, this amendment is a critical reference.
Relations
- Consolidated By
ISO 8325:2023/Amd 1:2026 - Dentistry — Test methods for rotary instruments — Amendment 1 - Effective Date
- 12-Feb-2026
- Effective Date
- 04-Oct-2023
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Frequently Asked Questions
EN ISO 8325:2023/A1:2026 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/Amd 1:2026)". This standard covers: Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/Amd 1:2026)
Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/Amd 1:2026)
EN ISO 8325:2023/A1:2026 is classified under the following ICS (International Classification for Standards) categories: 11.060.20 - Dental equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 8325:2023/A1:2026 has the following relationships with other standards: It is inter standard links to ISO 8325:2023/Amd 1:2026, EN ISO 8325:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 8325:2023/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-julij-2026
Zobozdravstvo - Preskusne metode za vrtilne instrumente - Dopolnilo A1 (ISO
8325:2023/Amd 1:2026)
Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/Amd
1:2026)
Zahnheilkunde - Prüfverfahren für rotierende Instrumente - Änderung 1 (ISO
8325:2023/Amd 1:2026)
Médecine bucco-dentaire - Méthodes d'essai pour instruments rotatifs - Amendement 1
(ISO 8325:2023/Amd 1:2026)
Ta slovenski standard je istoveten z: EN ISO 8325:2023/A1:2026
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 8325:2023/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2026
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Test methods for rotary instruments -
Amendment 1 (ISO 8325:2023/Amd 1:2026)
Médecine bucco-dentaire - Méthodes d'essai pour Zahnheilkunde - Prüfverfahren für rotierende
instruments rotatifs - Amendement 1 (ISO Instrumente - Änderung 1 (ISO 8325:2023/Amd
8325:2023/Amd 1:2026) 1:2026)
This amendment A1 modifies the European Standard EN ISO 8325:2023; it was approved by CEN on 25 April 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 CEN
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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8325:2023/A1:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 8325:2023/A1:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This Amendment to the European Standard EN ISO 8325:2023 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by November 2026,
and conflicting national standards shall be withdrawn at the latest by November 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8325:2023/Amd 1:2026 has been approved by CEN as EN ISO 8325:2023/A1:2026
without any modification.
International
Standard
ISO 8325
Third edition
Dentistry — Test methods for rotary
2023-03
instruments
AMENDMENT 1
AMENDMENT 1
2026-05
Médecine bucco-dentaire — Méthodes d'essai pour instruments
rotatifs
AMENDEMENT 1
Reference number
ISO 8325:2023/Amd.1:2026(en) © ISO 2026
ISO 8325:2023/Amd.1:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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or ISO’s member body in the country of the requester.
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