SIST EN ISO 23450:2021

Dentistry - Intraoral camera (ISO 23450:2021)

This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking.
This document is not applicable to:
a)   powered polymerization activators for polymerization of dental materials;
b)   exclusively extraoral camera equipment to prepare overviews or to record treatments;
c)   dental microscopes for minimally invasive treatments;
d)   medical endoscopes;
e)   camera handpieces for tooth illumination (transillumination);
f)    CAD or CAM scanner handpieces;
g)   combinations of dental instruments with camera functions;
h)   cameras for endodontic purposes;
i)     devices for root canal inspection (endoscopic microcameras);
j)     cameras for tool navigation;
k)   cameras for determination of tooth colour.

Zahnheilkunde - Intraoralkamera (ISO/DIS 23450:2020)

Dieses Dokument legt Anforderungen und Prüfverfahren für Intraoralkameras fest, die in der Zahnheilkunde am Patienten zur bildlichen Darstellung in der Mundhöhle eingesetzt werden, um die Diagnose zu unterstützen und die Aufklärung des Patienten zu erleichtern. Es legt Anforderungen, Prüfverfahren, Gebrauchsanweisung und Kennzeichnung fest.
Dieses Dokument ist nicht anwendbar auf:
a) Lichtpolymerisationsgeräte zur Polymerisation von Dentalwerkstoffen;
b) ausschließlich extraorale Kameraausrüstung zur Erstellung von Übersichtsaufnahmen oder zur Dokumentation von Behandlungen;
c) Dentalmikroskope für minimalinvasive Behandlungen;
d) medizinische Endoskope;
e) Kamerahandstücke für die Zahndurchleuchtung (Transillumination);
f) CAD- oder CAM-Scannerhandstücke;
g) Kombinationen von Dentalinstrumenten mit Kamerafunktionen;
h) Kameras für endodontische Zwecke;
i) Geräte zur Inspektion des Wurzelkanals (endoskopische Mikrokameras);
j) Kameras für die Instrumentennavigation;
k) Kameras zur Bestimmung der Zahnfarbe.

Médecine bucco-dentaire - Caméra intrabuccale (ISO 23450:2021)

Le présent document spécifie les exigences et les méthodes d'essai relatives aux caméras intrabuccales utilisées en médecine bucco-dentaire, pour la représentation graphique des cavités buccales des patients, afin de faciliter le diagnostic et la communication avec le patient. Il spécifie les exigences, les méthodes d'essai, ainsi que les instructions d'utilisation et de marquage.
Le présent document n'est pas applicable aux:
a)    activateurs électriques de polymérisation des matériaux dentaires;
b)    matériels photographiques exclusivement extrabuccaux servant à préparer des vues d'ensemble ou à consigner des traitements;
c)    microscopes dentaires pour les traitements minimalement invasifs;
d)    endoscopes médicaux;
e)    pièces à main à caméra pour l'éclairage des dents (transillumination);
f)    pièces à main à scanner CFAO;
g)    combinaisons d'instruments dentaires à fonctions caméra;
h)    caméras à fonctions endodontiques;
i)     dispositifs d'inspection du canal radiculaire (microcaméras endoscopiques);
j)     caméras pour la navigation d'outils;
k)    caméras pour la détermination de la teinte dentaire.

Zobozdravstvo - Intraoralna kamera (ISO 23450:2021)

General Information

• Status: Published
• Public Enquiry End Date: 19-May-2020
• Publication Date: 03-Jun-2021
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 12-May-2021
• Due Date: 17-Jul-2021
• Completion Date: 04-Jun-2021
• Ref Project: EN ISO 23450:2021 - Dentistry - Intraoral camera (ISO 23450:2021)

Overview

EN ISO 23450:2021 (ISO 23450:2021) specifies requirements and test methods for intraoral cameras used in dentistry to produce pictorial representations of the oral cavity for diagnosis and patient information. Published by CEN/ISO in 2021, the standard covers technical requirements, test procedures, instructions for use, marking and labelling for intraoral camera devices intended for clinical use.

This standard applies to intraoral camera medical devices only and is not applicable to items such as powered polymerization activators, exclusively extraoral cameras, dental microscopes, medical endoscopes, transillumination handpieces, CAD/CAM scanner handpieces, endodontic/root-canal microcameras, tool-navigation cameras or tooth-colour determination cameras.

Key Topics and Requirements

EN ISO 23450:2021 defines measurable technical and safety characteristics including:

• Image quality: resolving power, dynamic range, illumination, vignetting and distortion, with test methods for visual performance and artefact assessment.
• Optical characteristics: angular field of view, direction of view, working range and depth of field.
• Performance characteristics: image resolution, latency, autofocus behaviour, signal-to-noise ratio (SNR), pixel error rates, compression artefacts and frame rate.
• Safety and usability: biocompatibility, usability, reprocessing (cleaning/sterilization), protection from hazardous radiation and ergonomic considerations.
• Documentation: requirements for instructions for use, maintenance information, marking and labelling, and a formal test report format.
• Test methods: detailed measurement procedures for image quality, optics and performance metrics, including sampling guidance and annex examples (e.g., compression artefacts).

Applications and Practical Value

EN ISO 23450:2021 provides a technical benchmark for reliable dental imaging and supports:

• Improved diagnostic imaging and consistent image quality in dental clinics.
• Clear product specifications for manufacturers developing or validating intraoral cameras.
• Objective performance testing by independent laboratories and regulatory bodies.
• Informed procurement decisions for dental practices and hospital departments seeking compliant intraoral camera systems.
• Better patient communication and documentation through standardized image outputs.

Keywords: EN ISO 23450:2021, intraoral camera, dentistry standard, dental imaging, image quality, test methods, medical device.

Who Would Use This Standard

• Dental device manufacturers and R&D teams
• Test laboratories and conformity assessment bodies
• Regulatory authorities and notified bodies in Europe
• Dental clinics and procurement managers
• Quality and compliance engineers in dental technology

Related Standards

• IEC 60601-1 (medical electrical safety) - referenced for safety considerations.
• ISO/TC 106 and CEN/TC 55 are the relevant technical committees responsible for the document.

This standard ensures intraoral cameras meet defined performance, safety and usability expectations, creating a common basis for product development, testing and clinical use.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2021
Zobozdravstvo - Intraoralna kamera (ISO 23450:2021)
Dentistry - Intraoral camera (ISO 23450:2021)
Zahnheilkunde - Intraoralkamera (ISO/DIS 23450:2020)
Médecine bucco-dentaire - Caméra intrabuccale (ISO 23450:2021)
Ta slovenski standard je istoveten z: EN ISO 23450:2021
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23450
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Intraoral camera (ISO 23450:2021)
Médecine bucco-dentaire - Caméra intrabuccale (ISO Zahnheilkunde - Intraoralkamera (ISO 23450:2021)
23450:2021)
This European Standard was approved by CEN on 16 March 2021.

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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23450:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23450:2021) 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 October 2021, and conflicting national standards shall
be withdrawn at the latest by October 2021.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 23450:2021 has been approved by CEN as EN ISO 23450:2021 without any modification.

INTERNATIONAL ISO
STANDARD 23450
First edition
2021-03
Dentistry — Intraoral camera
Médecine bucco-dentaire — Caméra intrabuccale
Reference number
ISO 23450:2021(E)
©
ISO 2021
ISO 23450:2021(E)
© ISO 2021
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 2021 – All rights reserved

ISO 23450:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 5
5 Requirements . 5
5.1 General . 5
5.2 Biocompatibility . 6
5.3 Usability . 6
5.4 Reprocessing . 6
5.5 Protection from hazardous radiation . 6
5.6 Image quality . 6
5.6.1 Resolving power . 6
5.6.2 Dynamic range . 7
5.6.3 Illumination . 7
5.6.4 Vignetting . 7
5.6.5 Distortion . 7
5.7 Optical characteristics . 7
5.7.1 Angular field of view. 7
5.7.2 Direction of view . 8
5.7.3 Working range of the camera . 8
5.7.4 Depth of field . 9
5.8 Performance characteristics. 9
5.8.1 Image resolution . 9
5.8.2 Latency . 9
5.8.3 Autofocus . 9
5.8.4 Signal-to-noise ratio . 9
5.8.5 Pixel error . 9
5.8.6 Compression artefact formation . 9
5.8.7 Frame rate.10
5.9 Test report .10
6 Sampling .10
7 Measurement and test methods .10
7.1 Image quality .10
7.1.1 General.10
7.1.2 Resolving power and visual compression artefacts .10
7.1.3 Vignetting .11
7.1.4 Distortion .11
7.2 Optical characteristics .12
7.2.1 Angular field of view.12
7.2.2 Working range of the intraoral camera .12
7.2.3 Depth of field .12
7.3 Performance characteristics.13
7.3.1 Latency .13
7.3.2 Autofocus .14
7.3.3 Signal-to-noise ratio .14
7.3.4 Pixel error .14
8 Instructions for use, information on maintenance and servicing .14
9 Technical description .14
ISO 23450:2021(E)
10 Marking .15
10.1 General .15
10.2 Intraoral camera .15
11 Labelling .15
Annex A (informative) Examples of compression artefacts .17
Annex B (informative) Line pairs conversion table .18
iv © ISO 2021 – All rights reserved

ISO 23450:2021(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
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 04,
Dental instruments, 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.
ISO 23450:2021(E)
Introduction
In the field of dentistry, intraoral cameras have been used in the oral cavity of patients for many years.
The intraoral camera provides dentists with an aid which is able to significantly improve communication
with the patient, facilitate documentation and raise the diagnostics to another qualitative level.
Technological advancement enables the continuous development of new and improved intraoral
cameras, the handling of which is becoming easier and the possible applications of which are becoming
more extensive.
These intraoral cameras are produced by the dental industry as high-quality medical devices under
recognized quality management systems.
In order to maintain this high level of quality, this document describes the applicable technical product
features.
This document refers to IEC 60601-1, the basic standard on safety of medical electrical equipment, by
stating the respective clause numbers of IEC 60601-1 and IEC 80601-2-60.
vi © ISO 2021 – All rights reserved

INTERNATIONAL STANDARD ISO 23450:2021(E)
Dentistry — Intraoral camera
1 Scope
This document specifies requirements and test methods for intraoral cameras used in dentistry on
patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient
information. It specifies requirements, test methods, instructions for use and marking.
This document is not applicable to:
a) powered polymerization activators for polymerization of dental materials;
b) exclusively extraoral camera equipment to prepare overviews or to record treatments;
c) dental microscopes for minimally invasive treatments;
d) medical endoscopes;
e) camera handpieces for tooth illumination (transillumination);
f) CAD or CAM scanner handpieces;
g) combinations of dental instruments with camera functions;
h) cameras for endodontic purposes;
i) devices for root canal inspection (endoscopic microcameras);
j) cameras for tool navigation;
k) cameras for determination of tooth colour.
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 9687, Dentistry — Graphical symbols for dental equipment
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 17664, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
ISO 23450:2021(E)
IEC 62471, Photobiological safety of lamps and lamp systems
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for the basic safety
and essential performance of dental equipment
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .o
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