ISO/FDIS 3630-8
(Main)Dentistry — Endodontic instruments — Part 8: Accuracy of electronic apex locator
Dentistry — Endodontic instruments — Part 8: Accuracy of electronic apex locator
This part of ISO 3630 specifies requirements and test methods for the accuracy of electronic apex locators that are used to determine the apical foramen (‘apex’ in this document) location during endodontic treatment. Integrated types of electronic apex locators are excluded from this standard.
Médecine bucco-dentaire ― Instruments d'endodontie — Partie 8: Précision du localisateur électronique d'apex
General Information
- Status
- Not Published
- Technical Committee
- ISO/TC 106/SC 4 - Dental instruments
- Drafting Committee
- ISO/TC 106/SC 4 - Dental instruments
- Current Stage
- 5000 - FDIS registered for formal approval
- Start Date
- 05-Dec-2025
- Completion Date
- 31-Oct-2025
Relations
- Effective Date
- 08-Jul-2023
Overview
ISO/FDIS 3630-8:2026 is an international standard that specifies the requirements and test methods for assessing the accuracy of electronic apex locators used in endodontic treatment. These devices are essential in dentistry for precisely determining the location of the apical foramen (apex) at the tip of a tooth root canal. Accurate apex measurement is critical to ensuring successful root canal therapy by avoiding over- or under-instrumentation. This standard excludes integrated types of electronic apex locators and focuses on standalone units.
The document guides manufacturers and dental professionals on consistent testing procedures to validate device precision, ensuring endodontic instruments meet a maximum allowable accuracy deviation of ±0.5 mm.
Key Topics
Scope and Applicability
Defines accuracy assessment methods specifically for electronic apex locators used during dental root canal procedures.Accuracy Definition
Accuracy is the closeness between the measured apex location by the device and the true apex location determined by a reference measuring system.Test Conditions and Environment
Standardized testing temperature (25 ± 5 °C) and use of a saline-based test liquid to simulate clinical conditions.Apparatus and Test Materials
- Root canal test blocks crafted from clear plastic with simulated canals and apex (e.g., polymethylmethacrylate)
- Class 1 endodontic files compliant with ISO 3630-1 and ISO 3630-5
- Video-based measuring devices or equivalent height gauges for precise measurement with at least 0.01 mm resolution
- Test liquids-aqueous sodium chloride 0.9% prepared with grade III water per ISO 3696
Test Procedures
Two main testing methods:- Video-based measurement: Visualizing file tip location against the test block apex for direct comparison
- Height gauge measurement: Setting and measuring the file tip position relative to the simulated apex with high precision
Sampling Requirements
Testing is performed on three randomly selected specimens to ensure consistent device performance.
Applications
ISO/FDIS 3630-8:2026 serves multiple key purposes in the field of endodontics:
Manufacturer Compliance
Enables device manufacturers to develop and validate electronic apex locators that meet international accuracy standards, ensuring quality and safety.Quality Control
Provides dental equipment suppliers and labs with a standardized approach to assess electronic apex locators before market release.Clinical Assurance
Supports dental practitioners in selecting apex locators that deliver reliable measurements, reducing clinical risks during root canal treatments.Research and Development
Establishes a benchmark for innovation in endodontic instrumentation, helping in the design of more precise and user-friendly apex locators.
Related Standards and References
- ISO 3630-1: Dentistry - Endodontic instruments - General requirements
- ISO 3630-5: Dentistry - Endodontic instruments - Shaping and cleaning instruments
- ISO 1942: Dentistry - Vocabulary
- ISO 3696: Water for analytical laboratory use - Specification and test methods
- ISO 13225: Geometrical product specifications - Height gauges design and metrological characteristics
- ISO 10993-1 & ISO 7405: Biological evaluation of medical devices in dentistry
- IEC 60601-1 & IEC 80601-2-60: Electrical safety standards for medical electrical equipment
These standards complement ISO/FDIS 3630-8 by covering terminology, instrument generalities, biological safety, and electrical compliance.
Keywords: electronic apex locator accuracy, endodontic instruments, root canal apex measurement, dental apex locator testing, ISO 3630-8, endodontic treatment standards, apex locator calibration, dental instrument quality control, root canal length determination, standard test methods dentistry
ISO/FDIS 3630-8 - Dentistry — Endodontic instruments — Part 8: Accuracy of electronic apex locator Released:15. 01. 2026
REDLINE ISO/FDIS 3630-8 - Dentistry — Endodontic instruments — Part 8: Accuracy of electronic apex locator Released:15. 01. 2026
Frequently Asked Questions
ISO/FDIS 3630-8 is a draft published by the International Organization for Standardization (ISO). Its full title is "Dentistry — Endodontic instruments — Part 8: Accuracy of electronic apex locator". This standard covers: This part of ISO 3630 specifies requirements and test methods for the accuracy of electronic apex locators that are used to determine the apical foramen (‘apex’ in this document) location during endodontic treatment. Integrated types of electronic apex locators are excluded from this standard.
This part of ISO 3630 specifies requirements and test methods for the accuracy of electronic apex locators that are used to determine the apical foramen (‘apex’ in this document) location during endodontic treatment. Integrated types of electronic apex locators are excluded from this standard.
ISO/FDIS 3630-8 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.
ISO/FDIS 3630-8 has the following relationships with other standards: It is inter standard links to ISO 11783-7:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO/FDIS 3630-8 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
International
Standard
ISO/TC 106/SC 4
Dentistry — Endodontic
Secretariat: DIN
instruments —
Voting begins on:
2026-01-29
Part 8:
Accuracy of electronic apex locator
Voting terminates on:
2026-03-26
Médecine bucco-dentaire ― Instruments d'endodontie —
Partie 8: Précision du localisateur électronique d'apex
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
FINAL DRAFT
International
Standard
ISO/TC 106/SC 4
Dentistry — Endodontic
Secretariat: DIN
instruments —
Voting begins on:
Part 8:
Accuracy of electronic apex locator
Voting terminates on:
Médecine bucco-dentaire ― Instruments d'endodontie —
Partie 8: Précision du localisateur électronique d'apex
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
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
5 Test methods . 2
5.1 Test conditions .2
5.2 Apparatus .2
5.3 Reagent .4
5.4 Procedure .4
5.4.1 Using the video-based measuring device .4
5.4.2 Using the height gauge .5
6 Sampling . 6
Bibliography . 7
iii
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 document 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. ISO shall not be held responsible for identifying any or all such patent rights.
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 between ISO and CEN (Vienna
Agreement.)
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.
iv
Introduction
An electronic apex locator is a device used to locate the apex of a root canal to facilitate an evaluation of root
canal length.
This document does not apply to requirements and test methods related to electrical components. Such
specifications are available through other standards such as IEC 60601-1 and IEC 80
...
Formatted: Left
Style Definition
Formatted: zzCover large
ISO/TC 106/SC 4/WG 9
Formatted: Left: 42.55 pt, Right: 42.55 pt, Section start:
New page, Header distance from edge: 36 pt, Footer
Secretariat: DIN
distance from edge: 36 pt
Date: 2025-10-312026-01-15
Dentistry — Endodontic instruments — —
Formatted: Cover Title_A2
Part 8:
Formatted
...
Accuracy of electronic apex locator
Médecine bucco-dentaire -― Instruments d'endodontie – — Formatted
...
Partie 8: Précision de mesure de localisateursdu localisateur électronique d'apex Formatted: Font: French (France)
Formatted: Cover Title_B, Adjust space between Latin and
Asian text, Adjust space between Asian text and numbers
Formatted
...
FDIS stage
TTTTTThhhhhhiiiiiissssss dr dr dr dr dr draaaaaafffffftttttt i i i i i issssss susususususubbbbbbmmmmmmiiiiiitttttttttttteeeeeed d d d d d ttttttoooooo aaaaaa ppppppaaaaaarrrrrraaaaaallellellellellellel l l l l l vvvvvvooooootttttteeeeee i i i i i innnnnn IIIIIISSSSSSOOOOOO,,,,,, CCCCCCEEEEEEN.N.N.N.N.N.
Formatted: Left
Formatted: HeaderCentered
Formatted: Font: Bold
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
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
Formatted: German (Germany)
Formatted: FooterPageRomanNumber
ii
Formatted: HeaderCentered, Left
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
5 Test methods . 2
5.1 Test conditions . 2
5.2 Apparatus . 2
5.3 Reagent . 4
5.4 Procedure . 4
6 Sampling . 7
Bibliography . 8
Formatted: Font: 10 pt
Formatted: Font: 10 pt
Formatted: FooterCentered, Left, Space Before: 0 pt, Tab
stops: Not at 487.6 pt
Formatted: Font: 11 pt
Formatted: FooterPageRomanNumber, Left, Space After: 0
pt, Tab stops: Not at 487.6 pt
iii
Formatted: HeaderCentered
Formatted: Font: Bold
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 document 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. ISO shall not be held responsible for identifying any or all such patent rights.
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 between ISO and CEN (Vienna
Agreement.)
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.
Formatted: FooterPageRomanNumber
iv
Formatted: HeaderCentered, Left
Introduction
An electronic apex locator is a device used to locate the apex of a root canal to facilitate an evaluation of root
canal length.
This document does not apply to requirements and test methods related to electrical components. Such
specifications are available through other standards such as IEC 60601-1 and IEC 80601-2-60.
This document does not apply to specific qualitative and quantitative test methods for demonstrating freedom
from unacceptable biological hazard. For the assessment of possible biological hazards, ISO 10993-1 and ISO
7405 can be used.
Formatted: Font: 10 pt
Formatted: Font: 10 pt
Formatted: FooterCentered, Left, Space Before: 0 pt, Tab
stops: Not at 487.6 pt
Formatted: Font: 11 pt
Formatted: FooterPageRomanNumber, Left, Space After: 0
pt, Tab stops: Not at 487.6 pt
v
Final Draft International Standard ISO/FDIS 3630-8:2025(en)
Formatted: Left
Formatted: Font color: Auto
Dentistry — Endodontic instruments —
Formatted: Font: Font color: Auto, (Asian) Japanese
Part 8:
Formatted: Main Title 2
Accuracy of electronic apex locator
Formatted: Font: Font color: Auto, (Asian) Japanese
1 Scope
Formatted: Font: Font color: Auto, (Asian) Japanese
Formatted: Adjust space between Latin and Asian text,
This document specifies requirements and test methods for measuring the accuracy of electronic apex locators
Adjust space between Asian text and numbers
that are used to determine the apex location during endodontic treatment.
2 Normative references
Formatted: Default Paragraph Font
The following documents are referred to in the text in such a way that some or all their content constitutes
Formatted
...
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.
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO 1942, Dentistry — Vocabulary
Formatted: Default Paragraph Font
ISO 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO 3630-5, Dentistry — Endodontic instruments — Part 5: Shaping and cleaning instruments
Formatted: Default Paragraph Font
ISO 3696, Water for analytical laboratory use — Specification and test methods
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
ISO 13225, Geometrical product specifications (GPS) — Dimensional measuring equipment; Height gauges —
Design and metrological characteristics
Formatted: Default Paragraph Font
Formatted: Default Paragraph Font
3 Terms and definitions
Formatted: Default Paragraph Font
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
Fo
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...