EN ISO 8325:2023/FprA1

Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/FDAM 1:2026)

Zahnheilkunde - Prüfverfahren für rotierende Instrumente - Änderung 1 (ISO 8325:2023/FDAM 1:2026)

Médecine bucco-dentaire - Méthodes d'essai pour instruments rotatifs - Amendement 1 (ISO 8325:2023/FDAM 1:2026)

Zobozdravstvo - Preskusne metode za vrtilne instrumente - Dopolnilo A1 (ISO 8325:2023/FDAM 1:2026)

General Information

• Status: Not Published
• Publication Date: 24-Jun-2026
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Start Date: 25-Apr-2026
• Completion Date: 25-Apr-2026
• Ref Project: SIST EN ISO 8325:2023/kFprA1:2026 - Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/FDAM 1:2026)

Relations

• Consolidated By: ISO 8325:2023/Amd 1 - Dentistry — Test methods for rotary instruments — Amendment 1
• Effective Date: 12-Feb-2026
• Amends: EN ISO 8325:2023 - Dentistry - Test methods for rotary instruments (ISO 8325:2023)
• Effective Date: 04-Oct-2023

Overview

EN ISO 8325:2023/FprA1, titled Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/FDAM 1:2026), is an important amendment to the established standard for testing dental rotary instruments. Jointly developed by ISO Technical Committee ISO/TC 106/SC 4 and CEN, this amendment updates and clarifies test methods for rotary instruments used in dental procedures, ensuring precision and safety in clinical practice.

This standard is crucial for stakeholders involved in the design, manufacturing, and testing of dental rotary instruments. Its guidelines support consistent quality, enhance patient safety, and streamline compliance for dental product manufacturers.

Key Topics

• Updated Terminology and Definitions
  The amendment incorporates updated terminology, referencing recent ISO standards (ISO 1797, ISO 1942, ISO 21850-1) to ensure consistency and clarity in describing dental instrument features.

• Measurement of Shank Dimensions
  New guidance details how to measure shank diameter and length, including the role of color-coded markings and how these affect shank measurement. This provides clarity for manufacturers to guarantee their products conform to international dimensional requirements.

• Test Methods for Rotary Instrument Strength
  The amendment refines procedures for testing neck strength and run-out, specifying that:

  • The shank diameter is determined in accordance with ISO 1797.
  • The load in certain tests (Section 5.11.3.1) should be 2 N for 5 seconds, and run-out is to be measured if the instrument does not break.
  • Calculation of the neck strength test force (Section 5.11.4) is clearly defined, with maximum force limits set at 60 N, ensuring alignment with practical clinical use.

• Reference to Instrument-Specific Standards
  Where applicable, the amendment refers to related instrument-specific standards (such as ISO 7711 for diamond instruments) for the determination of constants (k-factors) used in test force calculations.

Applications

EN ISO 8325:2023/FprA1 is widely applicable across the dental industry, particularly for:

• Dental instrument manufacturers looking to validate the quality and safety of rotary devices.
• Testing laboratories needing clear and harmonized procedures for instrument assessment.
• Regulatory compliance by ensuring instruments meet consistent European and international requirements before market release.
• Quality assurance teams seeking standardized approaches to verify product dimensions and mechanical properties.
• Procurement specialists who need assurance that supplied instruments comply with rigorous international standards.

Use of this amendment enhances patient safety, ensures product reliability, and supports regulatory approval across markets in Europe and globally.

Related Standards

Several related standards are referenced and complement EN ISO 8325:2023/FprA1:

• ISO 1797: Dentistry - Shanks for rotary and oscillating instruments
• ISO 1942: Dentistry - Vocabulary
• ISO 21850-1: Dentistry - Rotary instruments - General requirements
• ISO 7711: Dental rotary instruments - Diamond instruments

Adherence to EN ISO 8325:2023/FprA1 alongside these standards ensures that dental rotary instruments are designed, manufactured, and tested according to the latest international best practices.

By following the updated recommendations in this amendment, the dental sector can ensure higher safety, harmonized quality, and consistent performance of rotary instruments used in professional practice.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8325:2023/oprA1:2025
01-junij-2025
Zobozdravstvo - Preskusne metode za vrtilne instrumente - Dopolnilo A1 (ISO
8325:2023/Amd 1:2025)
Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/Amd
1:2025)
Zahnheilkunde - Prüfverfahren für rotierende Instrumente - ÄNDERUNG 1 (ISO
8325:2023/Amd 1:2025)
Médecine bucco-dentaire - Méthodes d'essai pour instruments rotatifs - Amendement 1
(ISO 8325:2023/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 8325:2023/prA1:2025
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
SIST EN ISO 8325:2023/oprA1:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 8325:2023/oprA1:2025

SIST EN ISO 8325:2023/oprA1:2025
DRAFT
Amendment
ISO 8325:2023/
DAM 1
ISO/TC 106/SC 4
Dentistry — Test methods for rotary
Secretariat: DIN
instruments
Voting begins on:
AMENDMENT 1
2025-04-10
Médecine bucco-dentaire — Méthodes d'essai pour instruments Voting terminates on:
rotatifs 2025-07-03
AMENDEMENT 1
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 8325:2023/DAM 1:2025(en)
SIST EN ISO 8325:2023/oprA1:2025
DRAFT
ISO 8325:2023/DAM 1:2025(en)
Amendment
ISO 8325:2023/
DAM 1
ISO/TC 106/SC 4
Dentistry — Test methods for rotary
Secretariat: DIN
instruments
Voting begins on:
AMENDMENT 1
Médecine bucco-dentaire — Méthodes d'essai pour instruments Voting terminates on:
rotatifs
AMENDEMENT 1
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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RIGHTS OF WHICH THEY ARE AWARE AND TO
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Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO 8325:2023/DAM 1:2025(en)
ii
SIST EN ISO 8325:2023/oprA1:2025
ISO 8325:2023/DAM 1:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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has been established has the right to be represented on that committee. International organizations,
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different type
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