FprEN ISO 3630-8
(Main)Dentistry - Endodontic instruments - Part 8: Accuracy of electronic apex locator (ISO/FDIS 3630-8:2026)
Dentistry - Endodontic instruments - Part 8: Accuracy of electronic apex locator (ISO/FDIS 3630-8:2026)
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.
Zahnheilkunde - Endodontische Instrumente - Teil 8: Genauigkeit des elektronischen Apex-Locators (ISO/FDIS 3630-8:2026)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 8: Précision du localisateur électronique d'apex (ISO/FDIS 3630-8:2026)
Zobozdravstvo - Endodontski instrumenti - 8. del: Točnost elektronskega iskalnika vrha (ISO/FDIS 3630-8:2026)
General Information
- Status
- Not Published
- Publication Date
- 28-Jun-2026
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 5020 - Submission to Vote - Formal Approval
- Start Date
- 29-Jan-2026
- Due Date
- 12-Nov-2025
- Completion Date
- 29-Jan-2026
Overview
The prEN ISO 3630-8:2025 standard, titled Dentistry - Endodontic instruments - Part 8: Accuracy of electronic apex locator, is a critical document developed by CEN in collaboration with ISO. It defines the requirements and test methods to evaluate the accuracy of electronic apex locators used during endodontic treatments. These devices determine the precise location of the apical foramen (the apex) within a root canal, which is essential for effective root canal therapy.
This part of ISO 3630 specifically addresses the measurement precision of standalone electronic apex locators and excludes integrated types. It aims to ensure dental professionals achieve consistent and clinically reliable measurements for improved patient outcomes.
Key Topics
Scope and Purpose
Focuses on the accuracy of electronic apex locators in identifying the apical foramen location during root canal procedures.Defined Accuracy Requirements
The apex locator must measure the apex within ±0.5 mm of the true position, ensuring high precision aligned with clinical needs.Test Methods and Conditions
Testing involves using a root canal test block made of clear plastic (e.g., polymethylmethacrylate) simulating a canal with a 2% taper and a 0.2 mm apex aperture. Measurements are performed at controlled room temperature (25 ± 5 °C). Devices are tested using a video-based measuring system with an accuracy of at least 0.01 mm.Test Apparatus and Setup
Includes a test jig or tank filled with a 0.9% NaCl saline test liquid, a lip hook as electrode contact, and a file holder attached to an endodontic file compliant with ISO 3630-1 & 3630-5 standards.Sampling and Validation
The standard advises testing three samples from different lots to ensure reproducibility and reliability of device accuracy.Terminology and Definitions
Clear definitions of terms such as electronic apex locator, probe cord, lip hook, file holder, and apex (apical foramen) are provided to unify understanding.
Applications
Electronic apex locators compliant with ISO 3630-8:2025 are primarily used in dental clinics and endodontic practices to:
- Precisely determine the length of root canals for effective cleaning and shaping.
- Minimize risks of over- or under-instrumentation by providing accurate apex positioning.
- Support clinicians in achieving higher success rates in root canal therapy.
- Improve patient safety and comfort by reducing unnecessary radiation exposure compared to traditional radiographic methods.
- Facilitate standardization in manufacturing and quality control of endodontic electronic devices.
This standard is essential for manufacturers of standalone electronic apex locators aiming to demonstrate device accuracy and gain regulatory approvals. It also aids dental professionals in selecting reliable instruments backed by international benchmarks.
Related Standards
- ISO 3630 Series: Other parts cover general requirements (Part 1), and shaping and cleaning instruments (Part 5).
- IEC 60601-1: Standards addressing electrical safety of medical devices, complementing this standard’s focus on functional accuracy.
- ISO 80601-2-60: Particular requirements for electrical equipment used in dental patient monitoring.
- ISO 7405: Guidelines on evaluating biocompatibility of dental medical devices.
- ISO 10993-1: Biological evaluation and risk management of medical devices, important for assessing safety aspects beyond accuracy.
Implementing prEN ISO 3630-8:2025 promotes conformity with international best practices, enhancing clinical efficacy and promoting user confidence in modern endodontic equipment.
Keywords: electronic apex locator, endodontic instruments, root canal apex, apex location accuracy, dental standards, ISO 3630-8, endodontic treatment, apex measurement, dental device testing, endodontic precision
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Frequently Asked Questions
FprEN ISO 3630-8 is a draft published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Endodontic instruments - Part 8: Accuracy of electronic apex locator (ISO/FDIS 3630-8:2026)". 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.
FprEN ISO 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.
FprEN ISO 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)
SLOVENSKI STANDARD
oSIST prEN ISO 3630-8:2025
01-junij-2025
Zobozdravstvo - Endodontski instrumenti - 8. del: Točnost elektronskega iskalnika
vrha (ISO/DIS 3630-8:2025)
Dentistry - Endodontic instruments - Part 8: Accuracy of electronic apex locator (ISO/DIS
3630-8:2025)
Zahnheilkunde - Endodontische Instrumente - Teil 8: Genauigkeit des elektronischen
Apex-Locators (ISO/DIS 3630-8:2025)
Médecine bucco-dentaire - Instruments d'endodontie - Partie 8: Précision du localisateur
électronique d'apex (ISO/DIS 3630-8:2025)
Ta slovenski standard je istoveten z: prEN ISO 3630-8
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 3630-8:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 3630-8:2025
oSIST prEN ISO 3630-8:2025
DRAFT
International
Standard
ISO/DIS 3630-8
ISO/TC 106/SC 4
Dentistry — Endodontic
Secretariat: DIN
instruments —
Voting begins on:
Part 8: 2025-04-18
Accuracy of electronic apex locator
Voting terminates on:
2025-07-11
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 3630-8:2025(en)
oSIST prEN ISO 3630-8:2025
DRAFT
ISO/DIS 3630-8:2025(en)
International
Standard
ISO/DIS 3630-8
ISO/TC 106/SC 4
Dentistry — Endodontic
Secretariat: DIN
instruments —
Voting begins on:
Part 8:
Accuracy of electronic apex locator
Voting terminates on:
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 2025
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 3630-8:2025(en)
ii
oSIST prEN ISO 3630-8:2025
ISO/DIS 3630-8:2025(en)
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 Procedures .4
6 Sampling . 5
Annex A (informative) Definition of Apex . 6
Bibliography . 7
iii
oSIST prEN ISO 3630-8:2025
ISO/DIS 3630-8:2025(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/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
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