General Information

Abstract

This document specifies the general requirements and test methods for steel and carbide rotary instruments used in dentistry, including designation, colour code and a quality control for these instruments.
It applies to all types of steel and carbide rotary instruments independent of type and shape.

Status
Not Published
Publication Date
17-Oct-2027
Technical Committee
CEN/TC 55 - Dentistry
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
10-Jun-2026
Completion Date
10-Jun-2026

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prEN ISO 3823:2026 - BARVE

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Overview

prEN ISO 3823:2026 - Dentistry - Rotary Instruments - Steel and Carbide Dental Burs is a draft international standard developed by CEN and ISO. It specifies the general requirements and test methods for steel and carbide rotary instruments used in dentistry, covering aspects such as material specifications, designation, colour coding, dimensional tolerances, and quality control. The standard applies to all types of steel and carbide dental burs, regardless of their type or shape, ensuring consistency and safety in dental instrument manufacturing and use.

Adhering to prEN ISO 3823 is essential for manufacturers, dental practitioners, and regulatory bodies to guarantee that dental rotary instruments meet high standards of quality, durability, and performance.

Key Topics

  • Material Requirements

    • Defines acceptable materials for shank and working parts (steel, stainless steel, tungsten carbide).
    • References relevant standards such as ISO 21850-1 and ISO 1797.
  • Designation and Colour Coding

    • Outlines the standardized designation system and optional colour coding for carbide finishing instruments.
    • Specifies colours for identifying fine (red), extra fine (yellow), and ultra fine (white) instruments.
  • Dimensional Tolerances

    • Sets strict tolerances for the overall length, shank dimensions, and nominal diameter of the working part.
    • Alignment with ISO 1797 and ISO 2157 ensures interchangeability and safety.
  • Quality Control and Testing

    • Describes tests for instrument strength, run-out, and resistance to processing/reprocessing.
    • Includes bending and breaking tests to verify durability.
    • Visual inspection protocols for corrosion or defects are defined.
  • Marking, Packaging, and Labelling

    • Requirements for product marking, labelling, and information on packaging to support traceability and regulatory compliance.
    • Unique Device Identification (UDI) provisions as required by country-specific regulations.

Applications

  • Dental Instrument Manufacturing

    • Provides manufacturers with a clear framework for producing reliable, high-quality steel and carbide dental burs.
    • Guides quality management and standardization of production processes.
  • Dental Practice and Clinical Use

    • Assures dentists and clinicians that instruments conform to rigorous safety and performance standards.
    • Reduces risks associated with substandard products, such as breakage or corrosion during procedures.
    • Standardized dimensions allow easy integration with dental handpieces and systems.
  • Regulatory Compliance

    • Supports legal and market requirements for dental products in Europe and globally.
    • Ensures that products are eligible for approval and market access by aligning with harmonized international standards.
  • Procurement and Supply Chain

    • Facilitates informed purchasing decisions by dental institutions and clinics through standardized product information and labelling.
    • Enhances interoperability and reduces supply chain confusion.

Related Standards

For comprehensive compliance, users should also refer to the following related ISO standards:

  • ISO 1797: Dentistry - Shanks for rotary and oscillating instruments
  • ISO 1942: Dentistry - Vocabulary
  • ISO 2157: Dentistry - Nominal diameters and designation code numbers for rotary instruments
  • ISO 8325: Dentistry - Test methods for rotary instruments
  • ISO 14457: Dentistry - Handpieces and motors
  • ISO 21850-1: Dentistry - Materials for dental instruments - Part 1: Stainless steel
  • ISO 17664-1: Processing of healthcare products - Information for the processing of medical devices

Practical Value

prEN ISO 3823:2026 enhances global harmonization of dental rotary instrument quality, improves patient safety, and supports seamless market accessibility. By following this standard, stakeholders ensure their dental products meet essential quality criteria, stand up to repeated processing, and deliver reliable performance in clinical practice.

Keywords: dentistry, rotary instruments, dental burs, steel burs, carbide burs, dental instrument standards, CEN, ISO, quality control, dental test methods, marking and packaging, dental device compliance.

Relations

Effective Date
29-May-2024
Effective Date
29-May-2024

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prEN ISO 3823:2026 - BARVE

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Frequently Asked Questions

prEN ISO 3823 is a draft published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Rotary instruments - Steel and carbide dental burs (ISO/DIS 3823:2026)". This standard covers: This document specifies the general requirements and test methods for steel and carbide rotary instruments used in dentistry, including designation, colour code and a quality control for these instruments. It applies to all types of steel and carbide rotary instruments independent of type and shape.

This document specifies the general requirements and test methods for steel and carbide rotary instruments used in dentistry, including designation, colour code and a quality control for these instruments. It applies to all types of steel and carbide rotary instruments independent of type and shape.

prEN ISO 3823 is classified under the following ICS (International Classification for Standards) categories: 11.060.25 - Dental instruments. The ICS classification helps identify the subject area and facilitates finding related standards.

prEN ISO 3823 has the following relationships with other standards: It is inter standard links to EN ISO 3823-2:2003, EN ISO 3823-1:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

prEN ISO 3823 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-maj-2026
Zobozdravstvo - Rotacijski instrumenti - Jekleni in karbidni zobni svedri (ISO/DIS
3823:2026)
Dentistry - Rotary instruments - Steel and carbide dental burs (ISO/DIS 3823:2026)
Zahnheilkunde - Rotierende Instrumente - Zahnärztliche Stahl- und Hartmetallbohrer
(ISO/DIS 3823:2026)
Médecine bucco-dentaire - Instruments rotatifs - Fraises dentaires en acier et en carbure
(ISO/DIS 3823:2026)
Ta slovenski standard je istoveten z: prEN ISO 3823
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 3823
ISO/TC 106/SC 4
Dentistry — Rotary instruments —
Secretariat: DIN
Steel and carbide dental burs
Voting begins on:
ICS: 11.060.25
2026-03-18
Voting terminates on:
2026-06-10
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/DIS 3823:2026(en)
DRAFT
ISO/DIS 3823:2026(en)
International
Standard
ISO/DIS 3823
ISO/TC 106/SC 4
Dentistry — Rotary instruments —
Secretariat: DIN
Steel and carbide dental burs
Voting begins on:
ICS: 11.060.25
Voting terminates on:
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 2026
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
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 3823:2026(en)
ii
ISO/DIS 3823:2026(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
4 Requirements . 3
4.1 Material .3
4.1.1 Shank .3
4.1.2 Working part .3
4.2 Designation, colour code . .3
4.2.1 Designation .3
4.3 Dimensions .4
4.3.1 Designated dimensions of overall length .4
4.3.2 Designated dimensions of the shank .4
4.3.3 Dimensions of working part . .4
4.4 Bending test to verify the instrument strength .5
4.4.1 General .5
4.4.2 Effect on run-out .5
4.4.3 Breaking test . .5
4.4.4 Limiting the test force .6
4.5 Resistance to processing and reprocessing .6
5 Measurement and test methods . 7
5.1 Sampling .7
5.2 Testing of the dimensions .7
5.3 Testing of the run-out .7
5.4 Testing of resistance to processing and reprocessing .7
5.4.1 Procedure .7
5.4.2 Equipment .7
5.4.3 Reagent .7
5.4.4 Preparation of the test piece . .7
5.4.5 Method . .8
5.5 Visual inspection and evaluation .8
6 Marking and packaging . 8
6.1 Marking .8
6.2 Packaging .8
6.3 Labelling on the package .8
6.4 Instructions for use .8
Bibliography . 9

iii
ISO/DIS 3823:2026(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).
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 of ISO 3823 cancels and replaces the second edition (ISO 3823-1:1997) and the second
edition (ISO 3823-2:2003) and the amendment 1 2008, which have been technically revised.
The main changes compared to the previous edition are as follows:
— Corrosion resistance was revised to become resistance to processing and reprocessing.
— Neck strength was revised and harmonized with ISO 7711 as breaking test.
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
DRAFT International Standard ISO/DIS 3823:2026(en)
Dentistry — Rotary instruments — Steel and carbide dental
burs
1 Scope
This document specifies the general requirements and test methods for steel and carbide burs used in
dentistry, including designa
...