prEN ISO 18374

Dentistry - Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis - Data generation, data annotation and data processing (ISO/DIS 18374:2024)

This document applies to software for 2D x ray image analysis in dental medicine, the basis of which is the application of artificial intelligence (AI).
The scope of applicability of this document includes
a) Software-as-a-Medical Device (SaMD)
b) Software-in-a-Medical Device (SiMD) and
c) Software to improve the efficiency of healthcare applications.
This document applies to AI applications that learn statically and continuously/incrementally.

Zahnmedizin - Künstliche Intelligenz (KI) und erweiterte Intelligenz (AuI) für die Analyse von 2D-Röntgenbildern - Datengenerierung, Datenkommentierung und Datenverarbeitung (ISO/DIS 18374:2024)

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/DIS 18374:2024)

Zobozdravstvo - Analiza 2D rentgenskih posnetkov na podlagi umetne inteligence (AI) in razširjene inteligence (AuI) - Ustvarjanje podatkov, anotacija podatkov in obdelava podatkov (ISO/DIS 18374:2024)

General Information

• Status: Not Published
• Publication Date: 19-Jan-2026
• 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: 4060 - Closure of enquiry - Enquiry
• Start Date: 19-Sep-2024
• Due Date: 06-Dec-2024
• Completion Date: 19-Sep-2024
• Ref Project: oSIST prEN ISO 18374:2024 - Dentistry - Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis - Data generation, data annotation and data processing (ISO/DIS 18374:2024)

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2024
Zobozdravstvo - Analiza 2D rentgenskih posnetkov na podlagi umetne inteligence
(AI) in razširjene inteligence (AuI) - Ustvarjanje podatkov, anotacija podatkov in
obdelava podatkov (ISO/DIS 18374:2024)
Dentistry - Artificial intelligence (AI) and augmented intelligence (AuI) based 2D
radiograph analysis - Data generation, data annotation and data processing (ISO/DIS
18374:2024)
Zahnmedizin - Künstliche Intelligenz (KI) und erweiterte Intelligenz (AuI) für die Analyse
von 2D-Röntgenbildern - Datengenerierung, Datenkommentierung und
Datenverarbeitung (ISO/DIS 18374:2024)
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/DIS 18374:2024)
Ta slovenski standard je istoveten z: prEN ISO 18374
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.

DRAFT
International
Standard
ISO/DIS 18374
ISO/TC 106
Dentistry — Artificial intelligence
Secretariat: SCC
(AI) and augmented intelligence
Voting begins on:
(AuI) based 2D radiograph analysis
2024-06-27
— Data generation, data annotation
Voting terminates on:
and data processing
2024-09-19
ICS: 35.240.80; 11.060.01
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 18374:2024(en)
DRAFT
ISO/DIS 18374:2024(en)
International
Standard
ISO/DIS 18374
ISO/TC 106
Dentistry — Artificial intelligence
Secretariat: SCC
(AI) and augmented intelligence
Voting begins on:
(AuI) based 2D radiograph analysis
— Data generation, data annotation
Voting terminates on:
and data processing
ICS: 35.240.80; 11.060.01
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 2024
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 18374:2024(en)
ii
ISO/DIS 18374:2024(en)
Contents  Page
Introduction .iv
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  Symbols and abbreviated terms. 4
5  General . 4
6  Requirements . 5
6.1 Data .5
6.1.1 Quantity, scope and handling of data .5
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 .6
6.1.7 Data protection control .6
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 . 7
7.1 General .7
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 .8
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) .9
7.3.1 Annotation strategy .9
7.3.2 Annotation procedure .9
7.3.3 Competence .10
7.4 Data pre-processing .10
7.4.1 Risks of data processing .11
8  Test report .11
9  Electronic instructions for use .11
Bibliography .12

iii
ISO/DIS 18374:2024(en)
Introduction
Artificial intelligence (AI) and Augmented intelligence (AuI) systems have gained growing prominence
in the field of dentistry, enhancing both clinical decision support (CDS) and administrative operations
and improving the acces
...