SIST EN ISO 8325:2023

Dentistry - Test methods for rotary instruments (ISO 8325:2023)

This document specifies general test methods for rotary instruments used in dentistry. These test methods are used for measuring the dimensional characteristics, neck strength and surface roughness of rotary instruments, such as burs, cutters, polishers, grinding instruments and rotary instruments used for oral surgery such as drills and countersinks.
Specific tests are specified in the respective instrument standards, if available.
This document does not specify test methods for materials used for rotary instruments.
NOTE       For materials used for rotary instruments, see ISO 21850-1 and respective instrument standards.
This document is not applicable to endodontic instruments. For endodontic instruments, see ISO 3630-1.

Zahnheilkunde - Prüfverfahren für rotierende Instrumente (ISO 8325:2023)

Dieses Dokument legt allgemeine Prüfverfahren für rotierende Instrumente fest, die in der Zahnheilkunde verwendet werden. Diese Prüfverfahren werden zur Messung der maßlichen Eigenschaften, der Halsfestigkeit und der Oberflächenrauheit von rotierenden Instrumenten wie Bohrern, Fräsern, Polierern, Diamantinstrumenten, Schleifinstrumenten und rotierenden Instrumenten für die Oralchirurgie wie Bohrern und Senkern angewendet.
Spezifische Prüfungen sind in den jeweiligen Instrumentnormen angegeben, sofern vorhanden.
Das vorliegende Dokument legt keine Prüfverfahren für Werkstoffe fest, die für rotierende Instrumente verwendet werden.
ANMERKUNG   Für bei rotierenden Instrumenten verwendete Werkstoffe, siehe ISO 21850 1 und die entsprechenden Instrumentnormen.
Dieses Dokument ist nicht auf endodontische Instrumente anwendbar. Für endodontische Instrumente wird auf ISO 3630 1 verwiesen.

Médecine bucco-dentaire - Méthodes d'essai pour instruments rotatifs (ISO 8325:2023)

Le présent document définit des méthodes d’essai générales pour les instruments rotatifs utilisés en médecine bucco-dentaire. Ces méthodes d’essai sont utilisées pour mesurer les caractéristiques dimensionnelles, la résistance du col et la rugosité de surface des instruments rotatifs comme les fraises, les fraises techniques, les polissoirs, les instruments de meulage, et des instruments rotatifs utilisés pour la chirurgie buccale comme les forets et les fraises coniques.
Des essais spécifiques sont définis dans les normes relatives aux instruments concernés si celles-ci sont disponibles.
Le présent document ne définit pas de méthodes d’essai pour les matériaux utilisés pour les instruments rotatifs.
NOTE            En ce qui concerne les matériaux utilisés pour les instruments rotatifs, voir l’ISO 21850‑1 et les normes relatives aux instruments concernés.
Le présent document ne s’applique pas aux instruments d’endodontie. Pour les instruments d’endodontie, voir l’ISO 3630‑1.

Zobozdravstvo - Preskusne metode za vrtilne instrumente (ISO 8325:2023)

Ta dokument določa splošne preskusne metode za rotacijske instrumente, ki se uporabljajo v zobozdravstvu. Te preskusne metode se uporabljajo za merjenje dimenzijskih značilnosti, moči vratu in hrapavost površine rotacijskih instrumentov, kot so svedri, rezalniki, peskalniki, brusilni instrumenti in rotacijski instrumenti, ki se uporabljajo pri operacijah ustne votline, kot so svedri in grezilniki.
Posebni preskusi so določeni v ustreznih standardih za instrumente, če so na voljo.
Ta dokument ne določa preskusnih metod za materiale, ki se uporabljajo za rotacijske instrumente.
OPOMBA:       Za materiale, ki se uporabljajo za rotacijske instrumente, glej standard ISO 21850-1 in standarde za ustrezen instrument.
Ta dokument se ne uporablja za endodontske instrumente. Za endodontske instrumente glej standard ISO 3630-1.

General Information

• Status: Published
• Public Enquiry End Date: 27-Apr-2022
• Publication Date: 13-Apr-2023
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Apr-2023
• Due Date: 11-Jun-2023
• Completion Date: 14-Apr-2023
• Ref Project: EN ISO 8325:2023 - Dentistry - Test methods for rotary instruments (ISO 8325:2023)

Relations

• Replaces: SIST EN ISO 8325:2005 - Dentistry - Test methods for rotary instruments (ISO 8325:2004)
• Effective Date: 01-May-2023
• Amended By: SIST EN ISO 8325:2023/oprA1:2025 - Dentistry - Test methods for rotary instruments - Amendment 1 (ISO 8325:2023/Amd 1:2025)
• Effective Date: 04-Oct-2023

Overview

EN ISO 8325:2023 - Dentistry: Test methods for rotary instruments is the updated international / European test-method standard for rotary dental instruments (ISO 8325:2023) published under CEN/ISO. It specifies harmonized procedures to measure dimensional characteristics, neck strength, surface roughness and rotational performance of rotary tools used in dentistry - for example burs, cutters, polishers, grinding instruments and surgical rotary tools (drills, countersinks). The standard does not cover material test methods or endodontic instruments (see ISO 21850‑1 and ISO 3630‑1).

Key topics and technical requirements

• Scope and applicability
  • General test methods for most dental rotary instruments, excluding endodontic files.
• Measurement conditions
  • Ambient conditions and calibration requirements for reproducible dimensional and surface measurements.
• Dimensional measurements
  • Procedures for measuring the shape and diameter of the working part, neck diameter, shank and mandrel dimensions, working-part length and overall length, and angle of taper.
  • Defined locations for measurement points and evaluation approaches to ensure consistent results.
• Rotational accuracy (run‑out)
  • Apparatus description and measurement points for run-out of the working part to quantify concentricity and balance.
• Neck strength testing
  • Specified test apparatus, applied test forces and a technically derived formula for calculating neck‑strength loads (Formula updated in 2023 edition).
  • Annex A provides the deduction/derivation of the neck‑strength formula.
• Surface roughness
  • Profile method references and guidance for assessing surface texture consistent with GPS standards.
• Reporting
  • Required content for test reports to support conformity assessment and traceability.

Practical applications

• Ensure consistent, comparable test results across manufacturers and test laboratories.
• Quality control for production batches of dental burs, rotary polishers, surgical drills, and other rotary instruments.
• Input to design validation and risk assessment for new rotary instrument products.
• Evidence for regulatory compliance, procurement specifications and supplier acceptance testing.

Who uses this standard

• Dental device manufacturers and product engineers
• Quality assurance and metrology laboratories
• Notified bodies and conformity assessment organizations
• Procurement and clinical device managers
• Standards committees and test method developers

Related standards

• ISO 21850‑1 (materials for dental instruments - stainless steel)
• ISO 3630‑1 (endodontic instruments - separate test methods)
• ISO 1797 (shanks), ISO 13295 (mandrels), ISO 3274 / ISO 21920‑3 (surface texture/profile methods)

EN ISO 8325:2023 is essential for anyone involved in the testing, manufacture or regulatory oversight of dental rotary instruments who needs harmonized, repeatable test methods for dimensional, mechanical and surface characteristics.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2023
Nadomešča:
SIST EN ISO 8325:2005
Zobozdravstvo - Preskusne metode za vrtilne instrumente (ISO 8325:2023)
Dentistry - Test methods for rotary instruments (ISO 8325:2023)
Zahnheilkunde - Prüfverfahren für rotierende Instrumente (ISO 8325:2023)
Médecine bucco-dentaire - Méthodes d'essai pour instruments rotatifs (ISO 8325:2023)
Ta slovenski standard je istoveten z: EN ISO 8325:2023
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
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2023
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 8325:2004
English Version
Dentistry - Test methods for rotary instruments (ISO
8325:2023)
Médecine bucco-dentaire - Méthodes d'essai pour Zahnheilkunde - Prüfverfahren für rotierende
instruments rotatifs (ISO 8325:2023) Instrumente (ISO 8325:2023)
This European Standard was approved by CEN on 1 March 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard 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 CEN
member.
This European Standard 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8325:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8325:2023) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2023, and conflicting national standards
shall be withdrawn at the latest by September 2023.
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.
This document supersedes EN ISO 8325:2004.
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 has been approved by CEN as EN ISO 8325:2023 without any modification.

INTERNATIONAL ISO
STANDARD 8325
Third edition
2023-03
Dentistry — Test methods for rotary
instruments
Médecine bucco-dentaire — Méthodes d'essai pour instruments
rotatifs
Reference number
ISO 8325:2023(E)
ISO 8325:2023(E)
© ISO 2023
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 8325:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Measurement and test methods .2
4.1 General . 2
4.2 Ambient conditions. 2
4.3 Measurements . 2
5 Measurement of single characteristics . 2
5.1 Measuring instrument . 2
5.2 Shape of the working part . 2
5.3 Diameter of the working part . 2
5.3.1 Location of measurement points . 2
5.3.2 Procedure . 3
5.3.3 Evaluation of test results . 3
5.4 Neck diameter . 3
5.4.1 Location of measurement points . 3
5.4.2 Procedure . 3
5.5 Dimensions of shanks . 3
5.5.1 Shank diameter . . 3
5.5.2 Shank length. 4
5.6 Dimensions of mandrels. 4
5.7 Length of working part . 4
5.7.1 Location of measurement points . 4
5.7.2 Procedure . 4
5.8 Overall length . 4
5.8.1 Location of measurement points . 4
5.8.2 Procedure . 4
5.9 Angle of taper of working part . 4
5.9.1 Location of measurement points . 4
5.9.2 Procedure . 4
5.10 Run-out of the working part . 5
5.10.1 Apparatus . 5
5.10.2 Location of measurement points . 6
5.10.3 Procedure . 6
5.11 Neck strength test . 6
5.11.1 Apparatus . 6
5.11.2 Test force . 7
5.11.3 Procedure . 7
5.11.4 Calculation of test force for neck strength . 7
5.11.5 E valuation . . 8
5.12 Surface roughness . 8
6 Test report . 8
Annex A (informative) Deduction of the neck strength formula . 9
iii
ISO 8325:2023(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
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.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 Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 8325:2004), which has been technically
revised.
The main changes compared to the previous edition are as follows:
a) some definitions have been added such as for rotary instruments;
b) list of suitable measuring instruments have been deleted from 4.3;
c) tolerances for the measuring instruments have been clarified in 5.1;
d) the formula for neck strength test has been replaced in 5.11 by a technically based Formula in
5.11.4;
e) Annex A has been added for the deduction of Formula (3).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 8325:2023(E)
Introduction
To check the conformity of dental rotary instruments against rel
...