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 23450:2021)

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

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Standards Content (Sample)

SIST EN ISO 23450:2021
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
11.060.20 Zobotehnična oprema Dental equipment
SIST EN ISO 23450:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23450:2021

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SIST EN ISO 23450:2021

EN ISO 23450


April 2021
ICS 11.060.20
English Version

Dentistry - Intraoral camera (ISO 23450:2021)
Médecine bucco-dentaire - Caméra intrabuccale (ISO Zahnheilkunde - Intraoralkamera (ISO 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

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.



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.

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SIST EN ISO 23450:2021
EN ISO 23450:2021 (E)
Contents Page
European foreword . 3


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SIST EN ISO 23450:2021
EN ISO 23450:2021 (E)
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.


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SIST EN ISO 23450:2021

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SIST EN ISO 23450:2021
First edition
Dentistry — Intraoral camera
Médecine bucco-dentaire — Caméra intrabuccale
Reference number
ISO 23450:2021(E)
ISO 2021

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SIST EN ISO 23450:2021
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 fro

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