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)

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)

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)

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 .
...