prEN ISO 3630-1

• Abstract:

  This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

• Status: Not Published
• Publication Date: 21-Sep-2027
• ICS: 11.060.25 - Dental instruments
• Technical Committee: CEN/TC 55 - Dentistry
• Current Stage: 4060 - Closure of enquiry - Enquiry
• Start Date: 18-May-2026
• Completion Date: 18-May-2026
• Ref Project: oSIST prEN ISO 3630-1:2026 - Dentistry - Endodontic instruments - Part 1: General requirements (ISO/DIS 3630-1:2026)

• Revises: EN ISO 3630-1:2019 - Dentistry - Endodontic instruments - Part 1: General requirements (ISO 3630-1:2019)
• Effective Date: 04-Oct-2023

Overview

prEN ISO 3630-1:2026 – Dentistry - Endodontic instruments - Part 1: General requirements – is an international draft standard developed by ISO and CEN. It specifies essential requirements and test methods for endodontic instruments used in dental procedures, including but not limited to enlargers, compactors, accessory instruments, and tools for shaping and cleaning root canals. This part also covers a unified numeric coding system, general size designations, color-coding, packaging, and identification symbols, providing a standardized framework for manufacturers and dental professionals.

By setting out clear and harmonized requirements, prEN ISO 3630-1 supports the quality, safety, and effective use of endodontic instruments globally, fostering comparability and reliability in dental care products.

Key Topics

• Instrument Classification: Clarifies different classes of endodontic instruments, such as standard (uniform taper), taper, non-taper, non-uniform taper, and shape instruments.
• Terminology and Symbols: Defines terms (e.g., tip, shank, handle, taper) and prescribes standard symbols for communication and documentation.
• Size Designation and Color-Coding: Establishes numeric size coding and color-coding systems to aid in instrument identification and reduce clinical errors.
• Material and Dimensional Requirements: Sets out expectations for materials, overall dimensions, and construction to ensure reliability and safety.
• Mechanical Requirements: Outlines performance criteria, including resistance to fracture (twisting, angular deflection, and cyclic fatigue), stiffness, and handle or shank security.
• Test Methods: Details standardized measurement and testing procedures, such as visual inspections, dimensional checks, and mechanical testing, to verify compliance.
• Product Information: Specifies requirements for marking, labeling, packaging, and instructions for use to improve traceability and end-user safety.

Applications

prEN ISO 3630-1 is applicable to all manufacturers and suppliers of dental endodontic instruments as well as dental professionals and regulatory bodies. Its implementation supports:

• Product Development and Manufacturing: Ensures that endodontic instruments are produced to internationally recognized quality and safety benchmarks, aiding innovation while maintaining compliance.
• Market Access and Regulation: Provides a harmonized reference for regulatory approvals, facilitating trade and acceptance across different markets and national jurisdictions.
• Clinical Practice: Enhances the safety and efficacy of endodontic procedures by ensuring that instruments meet standardized criteria for performance, identification, and use.
• Procurement and Quality Assurance: Enables dental organizations and distributors to specify, assess, and purchase endodontic instruments with confidence.
• End-User Confidence: Dental professionals benefit from consistent color and size codings, reducing risk of procedural errors, and improving patient outcomes.

Related Standards

prEN ISO 3630-1 forms the foundational part of the larger ISO 3630 series for endodontic instruments. Related standards include:

• ISO 3630-2: Enlargers – Specific requirements and test methods for enlarging instruments.
• ISO 3630-3: Compactors – Standards for compacting instruments.
• ISO 3630-4: Auxiliary instruments – Focused on supplemental endodontic tools.
• ISO 3630-5: Shaping and cleaning instruments – Addresses design and testing for shaping and cleaning tools.
• ISO 3630-7: Ultrasonic inserts – Specifications for ultrasonic endodontic inserts.
• ISO 3630-8: Electronic apex locators – Test methods for devices measuring canal length electronically.
• ISO 6877: Endodontic obturating materials – Coordination of obturating point sizes with instrument standards.
• ISO 1797: Shanks for rotary and oscillating instruments.
• ISO 15223-1, ISO 17664-1, ISO 20417, ISO 1942, and ISO 13402: Cover additional aspects such as symbols, processing, labeling, and vocabulary relevant to dental and medical device manufacturers.

prEN ISO 3630-1:2026 is essential for the effective and safe design, assessment, and use of endodontic instruments in modern dentistry, aligning industry practices with global expectations.

SLOVENSKI STANDARD
01-april-2026
Zobozdravstvo - Endodontski instrumenti - 1. del: Splošne zahteve (ISO/DIS 3630-
1:2026)
Dentistry - Endodontic instruments - Part 1: General requirements (ISO/DIS 3630-
1:2026)
Zahnheilkunde - Endodontische Instrumente - Teil 1: Allgemeine Anforderungen
(ISO/DIS 3630-1:2026)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 1: Prescriptions générales
(ISO/DIS 3630-1:2026)
Ta slovenski standard je istoveten z: prEN ISO 3630-1
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 3630-1
ISO/TC 106/SC 4
Dentistry — Endodontic
Secretariat: DIN
instruments —
Voting begins on:
Part 1: 2026-02-23
General requirements
Voting terminates on:
2026-05-18
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 1: Exigences générales
ICS: 11.060.25
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 3630-1:2026(en)
DRAFT
ISO/DIS 3630-1:2026(en)
International
Standard
ISO/DIS 3630-1
ISO/TC 106/SC 4
Dentistry — Endodontic
Secretariat: DIN
instruments —
Voting begins on:
Part 1:
General requirements
Voting terminates on:
Médecine bucco-dentaire — Instruments d'endodontie —
Partie 1: Exigences générales
ICS: 11.060.25
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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 3630-1:2026(en)
ii
ISO/DIS 3630-1:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification and Symbols . 3
4.1 Classification .3
4.2 Symbols .3
5 Requirements . 4
5.1 General .4
5.2 Class 1: Standard instrument .4
5.2.1 Length .4
5.2.2 Size designation and diameters .4
5.2.3 Colour designation .5
5.2.4 Tip shape .5
5.3 Class 2: Taper instrument .5
5.3.1 Length .5
5.3.2 Tip shape .5
5.3.3 Size designation .6
5.3.4 Designation and diameters .6
5.3.5 Taper designation .6
5.3.6 Diameter colour identification .6
5.4 Class 3: Non-taper instrument .6
5.4.1 Length .6
5.4.2 Size designation and diameters .7
5.4.3 Colour designation .7
5.4.4 Tip .7
5.5 Class 4: Non-uniform taper instrument .7
5.5.1 Length .7
5.5.2 Size designation .7
5.5.3 Diameter designation and diameters .7
5.5.4 Diameter colour identification .8
5.5.5 Tip shape .8
5.6 Class 5: Shape instrument (Arc shape) .8
5.6.1 Length .8
5.6.2 Size designation and diameters .8
5.6.3 Colour designation .9
5.7 Material .9
5.8 Dimensions .9
5.8.1 General .9
5.8.2 Length .9
5.8.3 Handle and shank .9
5.9 Mechanical requirements .10
5.9.1 Resistance to fracture by twisting and angular deflection .10
5.9.2 Stiffness (Resistance to bending) .11
5.9.3 Handle and shank security .11
5.9.4 Resistance to fracture by cyclic fatigue .11
6 Sampling .11
7 Measurement and test methods .11
7.1 Visual inspection .11
7.2 Test conditions .11
7.3 Measurement of dimensions .11

iii
ISO/DIS 3630-1:2026(en)
7.3.1 Principle .11
7.3.2 Measuring device .11
7.3.3 Procedure . 12
7.3.4 Taper calculation . 12
7.4 Resistance to fracture by twisting and angular deflection . . 12
7.4.1 Principle . 12
7.4.2 Material. 12
7.4.3 Apparatus . 12
7.4.4 Procedure . 13
7.4.5 Expression of results .14
7.5 Stiffness (resistance to bending) .14
7.5.1 Principle .14
7.5.2 Material.14
7.5.3 Apparatus .14
7.5.4 Procedure .14
7.5.5 Expression of results . 15
7.6 Handle or shank security . 15
7.6.1 Principle . 15
7.6.2 Apparatus . 15
7.6.3 Preparation of test sample . 15
7.6.4 Procedure .16
7.7 Resistance to fracture by cyclic fatigue .16
7.7.1 Principle .16
7.7.2 Material.16
7.7.3 Apparatus .17
7.7.4 Preparation of test samples .19
7.7.5 Procedure .19
7.7.6 Results . 22
7.8 Resistance to processing/reprocessing . 22
7.8.1 Principle . 22
7.8.2 Procedures . 22
8 Product information .23
8.1 Marking (symbols) . 23
8.2 Labeling . . . 23
8.3 Packaging . 23
8.4 Instructions for use .24
Bibliography .25

iv
ISO/DIS 3630-1:2026(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).
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, Working group WG 9, Endodontic 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 fourth edition cancels and replaces the third edition (ISO 3630-1:2019), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— clarification of vocabulary and symbols to make it harmonize with the other parts of the 3630 standards.
A list of all parts in the ISO 3630 series can be found on the ISO website.
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.

v
ISO/DIS 3630-1:2026(en)
Introduction
This document specifies general requirements and test methods for endodontic instruments. Other parts of
the ISO 3630 series provide the specific requirements and test methods for specific endodontic instruments
(enlargers, compactors, auxiliary instruments, shaping and cleaning instruments, and ultrasonic inserts). It
also provides test methods for accuracy of electronic apex locators.
With the current use of nickel-titanium alloys for the manufacture of endodontic instruments, a need for
adequate expertise in their safe use is recommended. Cyclic fatigue and subsequent breakage of engine-
driven -titanium endodontic instruments remain an issue when practicing endodontic treatment. A test
method is provided to evaluate the fatigue resistance of such instruments using a custom-made device.
This document provides guidance and information for the proper use of these instruments.
The sizes of the endodontic obturating points (cones) specified in ISO 6877 Dentistry — Endodontic
obturating materials should coordinate with the corresponding sizes for the endodontic instruments which
are specified in all parts of the ISO 3630 series.

vi
DRAFT International Standard ISO/DIS 3630-1:2026(en)
Dentistry — Endodontic instruments —
Part 1:
General requirements
1 Scope
This document specifies general requirements and test methods for endodontic instruments used for
specific purposes, e.g., enlargers, compactors, auxiliary instruments, shaping and cleaning instruments, and
ultrasonic inserts. In addition, it covers general size designations, colour-coding,, identification symbols,
and product information including marking, labeling, packaging, and instructions for use.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 554, Standard atmospheres for conditioning and/or testing — Specifications
ISO 1797, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary
ISO 3630-2, Dentistry — Endodontic instruments — Part 2: Enlargers
ISO 3630-3, Dentistry — Endodontic instruments — Part 3: Compactors
ISO 3630-4, Dentistry — Endodontic instruments — Part 4: Auxiliary instruments
ISO 3630-5, Dentistry — Endodontic instruments — Part 5: Shaping and cleaning instruments
ISO 3630-7, Dentistry — Endodontic instruments — Part 7: Ultra sonic inserts
ISO 3630-8, Dentistry — Endodontic instruments — Part 8: Accuracy of electronic apex locators
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied — Part 1: General requirements
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 13402:2025, Surgical and dental hand instruments — Determination of resistance against autoclaving,
corrosion and thermal exposure

ISO/DIS 3630-1:2026(en)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. ISO
and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
endodontic instrument
dental device designed to explore, shape, clean and help obturate the root canal system
3.2
nominal size
general designation of an endodontic instrument (3.1) using the value of the extended diameters at the tip of
the working part (3.11) or working surface (3.12) in hundredths of a millimetre and for shape instrument, the
maximum diameter.
3.3
taper
variation of the outer diameter of the working part of an endodontic instrument, expressed in hundredths of
a millimetre per millimetre of length (3.10)
3.4
standard instrument
endodontic instrument (3.1) having a uniform taper of 0,02 mm per millimetre of length of the working part
(3.11) or working surface (3.12) throughout the range of available sizes
Note 1 to entry: The nominal sizes of Class 1 endodontic instruments are listed in Table 1.
Note 2 to entry: Some manufacturers may designate taper as a 2-digit number, e.g., ‘02’ or as a percentage, e.g., ‘2 %’.
3.5
non-standard instrument
endodontic instrument (3.1) which has either a tip diameter or shape, or both, other than that of an endodontic
standard instrument (3.4)
3.6
taper instrument
endodontic instrument (3.1) which the sizes are determined by the tip sizes and have uniform tapers of the
working part (3.11) or working surface (3.12) other than 0,02 mm per millimetre of length
3.7
non-taper instrument
endodontic instrument (3.1) having a cylindrical shape, i.e., zero taper, along the working part
3.8
non-uniform taper instrument
endodontic instrument (3.1) having more than one taper along the working part
3.9
shape instrument
endodontic instrument (3.1) having a contoured working part with continuously varying profile
3.10
tip
part of an endodontic instrument (3.1) which is intended as a tapered or rounded point or flat surface
3.11
working part
part of an endodontic instrument (3.1) which has a cutting surface

ISO/DIS 3630-1:2026(en)
3.12
working surface
part of an endodontic instrument (3.1) that contacts obturation material
Note 1 to entry: This definition is used in ISO 3630-3.
3.13
operative part
part of an endodontic instrument (3.1) from the tip to the handle or shank
3.14
shaft
part of an endodontic instrument (3.1) between the handle or shank and the working part (3.11) or working
surface (3.12)
3.15
handle
part of an endodontic instrument (3.1) which is held by the user’s fingers for manipulation of the instrument
in the root canal system
3.16
shank
part of a rotary, oscillating or reciprocating endodontic instrument (3.1) which is designed to fit into the
chuck of a dental handpiece
4 Classification and Symbols
4.1 Classification
For the purposes of this document, endodontic instruments are classified as follows:
Standard instrument
— Cl
...