EN ISO 18374:2025

Dentistry - Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis - Data generation, data annotation and data processing (ISO 18374:2025)

This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.

Zahnmedizin - Künstliche Intelligenz (KI) und erweiterte Intelligenz (AuI) für die Analyse von 2D-Röntgenbildern - Datengenerierung, Datenkommentierung und Datenverarbeitung (ISO 18374:2025)

Dieses Dokument legt Anforderungen an die Entwicklung und Dokumentation der Ziele, Beschränkungen, Ziel-Endanwender und Ziel-Patientenpopulationen für künstliche Intelligenz (KI) und erweiterte Intelligenz (AuI) fähige 2D-Röntgenbildanalyse für zahnmedizinische Anwendungen fest. Sie umreißt die Anforderungen an geeignete Trainingsdaten, Validierungsdaten, Prüfdaten und notwendige Annotationen für die Software, um sicherzustellen, dass KI/AuI-Anwendungen ihre beabsichtigten Ziele erreichen. Es beschränkt sich auf diese Aspekte. Dieses Dokument befasst sich nicht mit den spezifischen Implementierungsdetails; es konzentriert sich zudem auf statische (d. h. nicht-dynamische) KI/AuI.

Médecine bucco-dentaire - Analyse des radiographies bidimensionnelles basée sur l’intelligence artificielle (IA) et l’intelligence augmentée (IAu) - Génération, annotation et traitement des données (ISO 18374:2025)

Le présent document définit les exigences en matière d’élaboration et de documentation des objectifs, des limites, des utilisateurs finaux cibles et de la population patiente cible qui s’appliquent aux logiciels d’analyse de radiographies bidimensionnelles basés sur l’intelligence artificielle (IA) et l’intelligence augmentée (IAu), destinés à des applications de médecine bucco-dentaire. Il précise les exigences relatives à l’utilisation des données d’entraînement, de validation et d’essai et à l’annotation des données, qui sont nécessaires pour s’assurer que le logiciel réponde aux objectifs prévus tout en se conformant de façon appropriée à ces aspects. Le présent document ne couvre pas les détails de la mise en œuvre et se concentre sur l’IA/IAu statique (c’est-à-dire non dynamique).

Zobozdravstvo - Analiza 2D rentgenskih posnetkov na podlagi umetne inteligence (AI) in razširjene inteligence (AuI) - Ustvarjanje podatkov, anotacija podatkov in obdelava podatkov (ISO 18374:2025)

Ta dokument določa zahteve za razvoj in dokumentiranje ciljev, omejitev, ciljnih končnih uporabnikov in ciljne populacije pacientov za programsko opremo za analizo 2D rentgenskih posnetkov na podlagi umetne inteligence (AI) in razširjene inteligence (AuI), ki se uporablja v zobozdravstvu. Opisuje zahteve za ustrezne učne podatke, validacijske podatke, preskusne podatke in opombe za programsko opremo, s čimer se zagotovi doseganje predvidenih ciljev, ter je omejen na vidike. Ta dokument ne zajema specifičnih podrobnosti izvedbe in se osredotoča na statično (tj. nedinamično) umetno oziroma razširjeno inteligenco.

General Information

• Status: Published
• Publication Date: 06-May-2025
• ICS: 11.060.01 - Dentistry in general
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 07-May-2025
• Due Date: 07-Apr-2026
• Completion Date: 07-May-2025
• Ref Project: SIST EN ISO 18374:2025 - Dentistry - Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis - Data generation, data annotation and data processing (ISO 18374:2025)

Overview

EN ISO 18374:2025 - "Dentistry - Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis - Data generation, data annotation and data processing" - defines requirements for developing and documenting goals, limitations, target end users and target patient populations for AI/AuI software that analyses 2D dental radiographs. The standard focuses on static (non‑dynamic) AI/AuI and sets out expectations for appropriate training, validation and test datasets and for consistent data annotation and processing. It does not prescribe implementation-level algorithms or software architecture.

Key topics and requirements

• Scope and purpose: Clear definition of intended use, clinical goals, target users and patient populations.
• Dataset requirements: Guidance on quantity, scope and handling of training, validation and test data to support model claims.
• Data quality control: Procedures and criteria to ensure image quality, consistency and suitability for model development.
• Bias analysis factors: Identification and documentation of factors that may introduce bias (e.g., demographic or acquisition differences).
• Annotation (labelling):
  • Annotation strategy and procedures
  • Competency requirements for annotators and reviewers
  • Reproducibility and inter‑annotator agreement
• Data pre‑ and post‑processing: Recommended controls and documentation for image preprocessing steps and output handling, plus assessment of associated risks.
• Data protection and privacy: Requirements for protecting patient data and demonstrating appropriate controls.
• Test method and reporting: Defined test data criteria, inclusion/exclusion rules, validation processes and required contents of test reports and electronic instructions for use.

Applications and who should use it

EN ISO 18374:2025 is directly relevant to:

• Dental AI/AuI developers building diagnostic or decision‑support tools for 2D radiograph analysis.
• Medical device manufacturers producing imaging software for dentistry.
• Clinical researchers and data scientists preparing datasets or performing validation studies.
• Regulators and conformity assessment bodies assessing claims and evidence for dental AI products.
• Dental clinics and health IT teams procuring or integrating AI tools and evaluating vendor documentation.

Practical use cases include clinical decision support, automated image triage, measurement/annotation tools, and quality control of radiographic imaging workflows.

Related standards (applicable)

This standard complements broader medical device, data protection and AI governance frameworks - for example, standards and regulations addressing medical device quality management, clinical evaluation and data privacy - and should be used alongside applicable national/regional regulatory requirements.

Keywords: EN ISO 18374:2025, dentistry, AI, AuI, 2D radiograph analysis, data annotation, data processing, training data, validation data, bias analysis, data protection.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2025
Zobozdravstvo - Analiza 2D rentgenskih posnetkov na podlagi umetne inteligence
(AI) in razširjene inteligence (AuI) - Ustvarjanje podatkov, anotacija podatkov in
obdelava podatkov (ISO 18374:2025)
Dentistry - Artificial intelligence (AI) and augmented intelligence (AuI) based 2D
radiograph analysis - Data generation, data annotation and data processing (ISO
18374:2025)
Zahnmedizin - Künstliche Intelligenz (KI) und erweiterte Intelligenz (AuI) für die Analyse
von 2D-Röntgenbildern - Datengenerierung, Datenkommentierung und
Datenverarbeitung (ISO 18374:2025)
Médecine bucco-dentaire - Analyse des radiographies bidimensionnelles basée sur
l’intelligence artificielle (IA) et l’intelligence augmentée (IAu) - Génération, annotation et
traitement des données (ISO 18374:2025)
Ta slovenski standard je istoveten z: EN ISO 18374:2025
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 18374
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2025
EUROPÄISCHE NORM
ICS 11.060.01; 35.240.80
English Version
Dentistry - Artificial intelligence (AI) and augmented
intelligence (AuI) based 2D radiograph analysis - Data
generation, data annotation and data processing (ISO
18374:2025)
Médecine bucco-dentaire - Analyse des radiographies Zahnmedizin - Künstliche Intelligenz (KI) und
bidimensionnelles basée sur l'intelligence artificielle erweiterte Intelligenz (AuI) für die Analyse von 2D-
(IA) et l'intelligence augmentée (IAu) - Génération, Röntgenbildern - Datengenerierung,
annotation et traitement des données (ISO Datenkommentierung und Datenverarbeitung (ISO
18374:2025) 18374:2025)
This European Standard was approved by CEN on 2 May 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18374:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18374:2025) 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 November 2025, and conflicting national standards
shall be withdrawn at the latest by November 2025.
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.
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 18374:2025 has been approved by CEN as EN ISO 18374:2025 without any modification.

International
Standard
ISO 18374
First edition
Dentistry — Artificial intelligence
2025-04
(AI) and augmented intelligence
(AuI) based 2D radiograph analysis
— Data generation, data annotation
and data processing
Médecine bucco-dentaire — Analyse des radiographies
bidimensionnelles basée sur l’intelligence artificielle (IA) et
l’intelligence augmentée (IAu) — Génération, annotation et
traitement des données
Reference number
ISO 18374:2025(en) © ISO 2025
ISO 18374:2025(en)
© ISO 2025
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 18374:2025(en)
Contents  Page
Foreword .iv
Introduction .v
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
3.1 Artificial intelligence (AI) and its components .1
3.2 Machine learning techniques .2
3.3 Data processing and privacy .2
3.4 Data annotation and labelling .3
3.5 Dataset management .3
3.6 Assessment and evaluation .4
4  Abbreviated terms . 4
5  General . 4
6  Requirements . 4
6.1 Data .4
6.1.1 Quantity, scope and handling of data .4
6.1.2 Quality control .5
6.1.3 Factors for the bias analysis .5
6.1.4 Input (training, testing and validation) data .5
6.1.5 Data validation .5
6.1.6 Data protection .5
6.1.7 Data protection control .5
6.2 Data annotation (labelling) .6
6.2.1 Annotation strategy .6
6.2.2 Annotation procedure .6
6.2.3 Competence .6
6.3 Data pre-processing .6
6.3.1 Pre-processing the data .6
6.3.2 Risks of data processing .6
6.4 Data post-processing .6
7  Test method . 6
7.1 General .6
7.2 Data .7
7.2.1 Quantity and scope .7
7.2.2 Inclusion and exclusion criteria .7
7.2.3 Quality control .7
7.2.4 Factors for the bias analysis .7
7.2.5 Input data .8
7.2.6 Data validation .8
7.2.7 Data protection .9
7.2.8 Data protection control .9
7.3 Data annotation (labelling) .10
7.3.1 Annotation strategy .10
7.3.2 Annotation procedure .10
7.3.3 Competence .10
7.4 Data pre-processing .11
7.4.1 General .11
7.4.2 Risks of data processing .11
8  Test report .11
9  Electronic instructions for use .12
Bibliography .13

iii
ISO 18374:2025(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
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, 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).
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 18374:2025(en)
Introduction
Artificial intelligence (AI) and augmented intelligence (AuI) systems have gained growing prominence
in the field of dentistry. These systems enhance both clinical decision support (CDS) and administrative
operations and improve the accessibility, quality and efficiency of dental care. These systems are designed
to guide clinical decisions related to disease prevention, management and surgical interventions, so specific
consideration is needed to differentiate between normal, pre-pathologic and pathologic radiographic
findings and manage them appropriately. Regulation plays an important role in ensuring the safety of
patients and users as well as in commercialisation and market acceptance.
AI and AuI systems regularly involve supervised and unsupervised machine learning (ML) and, specifically,
deep learning, and can be used for computer vision. Machine learning involves training computing systems
to look for patterns in data to build models. Deep learning utilizes the neural networks of computing systems
to discover and analyse complicated patterns in large “big data” databases. Computer vision can involve the
use of deep learning to recognize patterns in images or videos.
One focus of current efforts around AI and AuI in dentistry is dental radiograph analysis, in particular, the
analysis of 2-D dental radiographs like panoramic, bitewing or periapical or cephalometric radiographs. For
these use cases, AI and AuI provide diagnostic support, but also facilitate documentation (reporting) and
communication. The focus on 2-D radiograph analysis is due to the following:
— in dentistry, operators produce a high volume of radiographic images;
— the accuracy of dental practitioners when interpreting these images is limited (e.g. the sensitivity for the
[14]
detection of early caries lesion on radiographic images is <50 %) , high inter- and intra- practitioner
variability with human operators (e.g. influence of the circumstances of the day, resources available at
[15]
one location) ;
— a systematic and comprehensive diagnosis and documentation of the diagnosis results is time-consuming.
AI- and AuI-based software applications regularly detect non-pathological and pathological structures
on radiographic images (e.g. teeth, anatomical structures, restorations, caries lesions). The functionality,
performance specifications and safety of AI- and AuI-based medical software applications, including those
for 2D radiographic image analysis in dentistry, are significantly influenced by the underlying data. Data
generation, annotation and pre-processing raise technological, methodical and ethical questions. They
also raise questions about data protection, safety and the law. There is a need for appropriate mechanisms
that ensure the performance, compatibility, safety and efficacy of AI- and AuI-based medical software
applications. Domain-specific aspects and particularities of dental data, in particular radiographs, and
clinical requirements to analyse these data are expected to be taken into account when regulating AI- and
AuI-applications. For example:
— there are usually several images of the same patient in one data set, these images can stem from the same
time point (cross-sectional) or different time points (longitudinal);
— there is severe clustering of pathologies and statistical units;
— there is a range of levels on which data can be analysed and results be reported, like image, tooth, site or
pixel level.
This document adopts recommendations by the Focus Group on Artificial Intelligence for Health of the
International Telecommunication Union and World Health Organization towards regulating data generation,
annotation and processing around AI- and AuI-based medical applications.

v
International Standard ISO 18374:2025(en)
Dentistry — Artificial intelligence (AI) and augmented
intelligence (AuI) based 2D radiograph analysis — Data
generation, data annotation and data processing
1  Scope
This document defines the requirements for developing and documenting the goals, limitations, target end
users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled
2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate
training data, validation data, test data and annotation for the software to ensure that it achieves its
intended goals, and is restricted to the aspects. This document does not cover the specific implementation
details, and focuses on static (i.e. non-dynamic) AI/AuI.
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 1942, Dentistry — Vocabulary
ISO 27799, Health informatics — Information security management in health using ISO/IEC 27002
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1  Artificial intelligence (AI) and its components
3.1.1
artificial intelligence
AI
branch of computer science devoted to developing data processing systems that perform functions normally
associated with human intelligence, such as reasoning, learning, and self-improvement
[SOURCE: ISO/IEC/IEEE 24765:2017, 3.234]
3.1.2
augmented intelligence
AuI
capability to acquire, process, create and apply knowledge, held in the form of a model, to conduct
one or more given tasks that require the inclusion of human decision-making

ISO 18374:2025(en)
3.1.3
clinical decision support
CDS
type of service that assists healthcare providers and patients in making collaborative medical decisions,
which typically requires input of patient-specific clinical variables and provide patient-specific
recommendations
[SOU
...