ISO 8325:2023/FDAmd 1
(Amendment)Dentistry — Test methods for rotary instruments — Amendment 1
Dentistry — Test methods for rotary instruments — Amendment 1
Médecine bucco-dentaire — Méthodes d'essai pour instruments rotatifs — Amendement 1
General Information
- Status
- Not Published
- Technical Committee
- ISO/TC 106/SC 4 - Dental instruments
- Drafting Committee
- ISO/TC 106/SC 4/WG 1 - Rotary instruments
- Current Stage
- 5000 - FDIS registered for formal approval
- Start Date
- 04-Dec-2025
- Completion Date
- 23-Oct-2025
Relations
- Effective Date
- 28-Oct-2023
- Effective Date
- 23-Sep-2023
Overview
ISO 8325:2023/FDAmd 1 is an important amendment to the international standard governing test methods for rotary instruments used in dentistry. Published under the joint technical collaboration of ISO/TC 106 (Dentistry) and CEN/TC 55, this amendment updates specific definitions, measurement procedures, and test force calculations to enhance the safety, reliability, and consistency of dental rotary instruments.
This amendment reflects the latest consensus on best practices for verifying the mechanical properties of rotary dental tools, focusing on shank dimensions, load testing, and neck strength calculations. By aligning with related standards such as ISO 1797 and ISO 7711-1, it ensures international harmonization in the evaluation of dental instruments.
Key Topics
Updated Definitions and Terminology
The document references essential terms from ISO 1797, ISO 1942, ISO 21850-1, with clarifications specific to rotary instruments to guarantee precision in testing language and requirements.Measurement of Shank Dimensions
- Shank diameter is determined per ISO 1797 guidelines.
- Shank length is measured from the end point to the beginning of the neck or working part.
- Markings (e.g., color coding incisions) on shanks are considered part of the shank if they do not exceed the original shank diameter.
- Enlargements such as markings or working heads are excluded from fitting length, ensuring accurate dimension assessment.
Load Application and Run-Out Measurement
A standardized load of 2 Newtons (N) is applied for 5 seconds during testing to evaluate instrument durability. If the instrument remains intact, run-out (rotational imbalance) is measured again to confirm operational consistency.Neck Strength Test Force Calculations
The test force formula accounts for the shape, material, and geometry of the instrument:
[ F = k \times \frac{D^3}{L} ]- F = applied test force (N)
- k = constant derived from material and shape (e.g., 81.8 N/mm for diamond instruments)
- D = minimum neck diameter (mm)
- L = length from tip to minimum neck diameter (mm)
Importantly, the maximum applied force is capped at 60 N, reflecting clinical relevance by preventing unrealistically high forces not encountered in practice.
Incorporation of Related Standards
The amendment adds reference to ISO 7711-1 (Diamond rotary instruments), deepening technical consistency in instrument requirements.
Applications
Dental Instrument Manufacturers
Use ISO 8325:2023/FDAmd 1 to validate rotary instrument designs, verifying mechanical integrity and compliance for safer clinical use.Dental Laboratories and Quality Control
Implement standardized procedures for dimensional measurement and mechanical testing, assuring precision and quality across production batches.Regulatory Bodies and Certification Agencies
Utilize detailed testing protocols in conformity assessments and audits for market approval and ongoing safety monitoring.Dental Professionals and Technicians
Benefit from improved reliability of rotary dental instruments through adherence to internationally harmonized testing standards, reducing risk during clinical procedures.
Related Standards
- ISO 1797 – Dentistry - Standard definitions and dimensions for rotary instruments, fundamental for shank and fitting length measurements.
- ISO 1942 – Dentistry - Vocabulary, clarifying terminology used in dental equipment and test methods.
- ISO 21850-1 – Dentistry - Supplementary terms related to dental instruments.
- ISO 7711-1 – Dentistry - Diamond rotary instruments - General requirements, closely related for application of material-specific constants in test force calculations.
By incorporating ISO 8325:2023/FDAmd 1, stakeholders ensure that dental rotary instruments meet rigorous international safety and performance criteria. This amendment improves test accuracy while respecting clinically relevant mechanical limits, supporting global harmonization in dental instrument testing and quality assurance.
ISO 8325:2023/FDAmd 1 - Dentistry — Test methods for rotary instruments — Amendment 1 Released:13. 01. 2026
REDLINE ISO 8325:2023/FDAmd 1 - Dentistry — Test methods for rotary instruments — Amendment 1 Released:13. 01. 2026
ISO 8325:2023/FDAmd 1 - Médecine bucco-dentaire — Méthodes d'essai pour instruments rotatifs — Amendement 1 Released:23. 01. 2026
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Frequently Asked Questions
ISO 8325:2023/FDAmd 1 is a draft published by the International Organization for Standardization (ISO). Its full title is "Dentistry — Test methods for rotary instruments — Amendment 1". This standard covers: Dentistry — Test methods for rotary instruments — Amendment 1
Dentistry — Test methods for rotary instruments — Amendment 1
ISO 8325:2023/FDAmd 1 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.
ISO 8325:2023/FDAmd 1 has the following relationships with other standards: It is inter standard links to ISO 24395:2023, ISO 8325:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 8325:2023/FDAmd 1 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)
FINAL DRAFT
Amendment
ISO 8325:2023/
FDAM 1
ISO/TC 106/SC 4
Dentistry — Test methods for rotary
Secretariat: DIN
instruments
Voting begins on:
2026-01-27
AMENDMENT 1
Voting terminates on:
Médecine bucco-dentaire — Méthodes d'essai pour instruments
2026-03-24
rotatifs
AMENDEMENT 1
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO 8325:2023/FDAM 1:2026(en) © ISO 2026
FINAL DRAFT
ISO 8325:2023/FDAM 1:2026(en)
Amendment
ISO 8325:2023/
FDAM 1
ISO/TC 106/SC 4
Dentistry — Test methods for rotary
Secretariat: DIN
instruments
Voting begins on:
AMENDMENT 1
Voting terminates on:
Médecine bucco-dentaire — Méthodes d'essai pour instruments
rotatifs
AMENDEMENT 1
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 8325:2023/FDAM 1:2026(en) © ISO 2026
ii
ISO 8325:2023/FDAM 1:2026(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
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
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 types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. IS
...
ISO 8325:2023/DAMFDAmd 1:2025(en)
ISO /TC 106/SC 4/WG 1
Secretariat: DIN
Date: 2025-11-282026-01-13
Dentistry — Test methods for rotary instruments
AMENDMENT 1
Médecine bucco-dentaire — Méthodes d'essai pour instruments rotatifs
AMENDEMENT 1
FDIS stage
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ISO 8325:2023/DAMD FDAmd 1:2025 (E(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2025 2026 – All rights reserved
ii
ISO 8325:2023/DAMFDAmd 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
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely 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 types of
ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directiveswww.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents.www.iso.org/patents. ISO shall not be held responsible for identifying any or all such
patent rights.
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constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreem
...
PROJET FINAL
Amendement
ISO 8325:2023/
FDAM 1
ISO/TC 106/SC 4
Médecine bucco-dentaire —
Secrétariat: DIN
Méthodes d'essai pour instruments
Début de vote:
rotatifs
2026-01-27
AMENDEMENT 1
Vote clos le:
2026-03-24
Dentistry — Test methods for rotary instruments
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
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Numéro de référence
ISO 8325:2023/FDAM 1:2026(fr) © ISO 2026
PROJET FINAL
ISO 8325:2023/FDAM 1:2026(fr)
Amendement
ISO 8325:2023/
FDAM 1
ISO/TC 106/SC 4
Médecine bucco-dentaire —
Secrétariat: DIN
Méthodes d'essai pour instruments
Début de vote:
rotatifs
2026-01-27
AMENDEMENT 1
Vote clos le:
2026-03-24
Dentistry — Test methods for rotary instruments
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
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Publié en Suisse Numéro de référence
ISO 8325:2023/FDAM 1:2026(fr) © ISO 2026
ii
ISO 8325:2023/FDAM 1:2026(fr)
Avant-propos
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