SIST EN ISO 23450:2021
(Main)Dentistry - Intraoral camera (ISO 23450:2021)
Dentistry - Intraoral camera (ISO 23450:2021)
This document specifies requirements and test methods for intraoral cameras used in dentistry on the patient for pictorial representation of the oral cavity 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/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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23450:2021
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
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
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.
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SIST EN ISO 23450:2021
EN ISO 23450:2021 (E)
Contents Page
European foreword . 3
2
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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.
3
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SIST EN ISO 23450:2021
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SIST EN ISO 23450:2021
INTERNATIONAL ISO
STANDARD 23450
First edition
2021-03
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)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 23450:2021
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 2021 – All rights reserved iii
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SIST EN ISO 23450:2021
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
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SIST EN ISO 23450:2021
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 2021 – All rights reserved v
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SIST EN ISO 23450:2021
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
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SIST EN ISO 23450:2021
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 2021 – All rights reserved 1
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SIST EN ISO 23450:2021
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 .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
intraoral camera
optical handpiece for use in the oral cavity of the patient to assist with diagnosis and facilitate patient
information and treatment
3.2
patient side of intraoral camera
intraoral camera (3.1) part which is designed to be introduced into the oral cavity
Note 1 to entry: See Figure 1.
3.3
resolving power
ability to distinguish between points or lines of an object which are close together in an image
Note 1 to entry: The resolving power is defined as the line frequency in line pairs per millimetre (lp/mm), which
is still resolved with a contrast transfer function of 20 %.
Note 2 to entry: A high resolving power means that the resolved distance is small.
Note 3 to entry: Unless otherwise specified, this term relates to distances perpendicular to the optical axis.
3.4
contrast transfer function
CTF
measurement describing the resolving power (3.3) by the number of equidistant black and white lines
per millimetre which can still be resolved with a certain contrast (in per cent)
EXAMPLE 5 lp/mm = 5 line pairs per millimetre.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 23450:2021
ISO 23450:2021(E)
Key
1 head (patient side of intraoral camera)
2 operation part (operator side of intraoral camera)
3 hand-held part (operator side of intraoral camera)
4 viewing window (patient side of intraoral camera)
5 illumination part (patient side of intraoral camera)
6 interface (operator side of intraoral camera)
Figure 1 — Part designation of intraoral camera
3.5
dynamic range
ratio between the smallest and largest detectable light energy
Note 1 to entry: The dynamic range can be defined as a pure ratio (1:n) or in decibels [10 lg(n)].
Note 2 to entry: In a camera sensor, it is typically around 1:20 000. Since its signal is quantized during digital
processing, however, the bit depth is the limiting factor. For example, a dynamic range of just 1:255 is achieved
with 8 bits.
Note 3 to entry: The optics are another limiting factor.
3.6
signal-to-noise ratio
fluctuation overlaying the signal in proportion to the signal average value
Note 1 to entry: Standard deviation is noise.
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SIST EN ISO 23450:2021
ISO 23450:2021(E)
3.7
vignetting
measure for the relative illumination in the field of view
3.8
distortion
deviation from the true image due to an optical system whereby the lateral magnification in the field of
view varies with the distance from the optical axis
Note 1 to entry: The distortion is defined as a percentage of the image height.
3.9
angular field of view
angle under which an object appears at a given diagonal expansion and distance
Note 1 to entry: See Formula (2) in 5.7.1 for the angular field of view.
3.10
working distance
distance between the object and the outside of the light entrance window of the intraoral camera (3.1)
Note 1 to entry: See Figure 2.
Key
1 intraoral camera normal axis
2 distal window surface of intraoral camera
3 angular field of view (angular aperture)
4 central axis of field of view
5 direction of view (angle of the central axis)
6 field of view
7 working distance
Figure 2 — Optical definitions
3.11
direction of view
location of the centre of the object field relative to the normal axis of the intraoral camera (3.1)
expressed as the angle (in degrees) between the normal axis of the intraoral camera and the central
axis of the field of view
3.12
depth of field
range in which an object remains sharp, i.e. the range of distances in which the demand of the resolving
power (3.3) is fulfilled without refocusing
4 © ISO 2021 – All rights reserved
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SIST EN ISO 23450:2021
ISO 23450:2021(E)
3.13
image resolution
fineness of the image rasterization, i.e. the number of pixels of the entire transmission chain actually
used for image transmission
3.14
latency
time delay of the data acquisition (sensor image) until the same data is displayed on the camera interface
3.15
fixed-focus
lenses or systems with a fixed distance setting
3.16
autofocus
lenses or systems with at least one active element for focusing
Note 1 to entry: Autofocusing can be activated manually or automatically.
3.17
focusing time
time from the start of the action to final focusing
3.18
pixel error
pixel in the image that is displayed incorrectly, constantly black or white
4 Classification
Intraoral cameras are classified according to their optical setup as follows:
a) fixed-focus cameras;
b) variable focus cameras
— manual
— autofocus.
5 Requirements
5.1 General
An intraoral camera is an electromedical device and shall be designed and manufactured so that its
application jeopardizes neither the clinical condition and safety of the patient nor the health and safety
of the operator or any third party.
The patient side of the intraoral camera is designed to be introduced into the oral cavity where all parts
of the dental handpiece within 80 mm to the tip shall be considered as an applied part in accordance
with IEC 60601-1.
For general requirements for the basic safety of intraoral cameras IEC 60601-1 and IEC 80601-2-60
shall apply.
© ISO 2021 – All rights reserved 5
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SIST EN ISO 23450:2021
ISO 23450:2021(E)
5.2 Biocompatibility
Biological evaluation of intraoral cameras shall be made in accordance with ISO 10993-1 and applies to:
— the patient side of the intraoral camera and other parts of the intraoral camera which are expected
to have direct or indirect contact with the patient body;
— the hygienic protective sleeves, if recommended or required by the manufacturer.
5.3 Usability
Usability evaluation and testing for intraoral cameras shall be carried out in accordance with
IEC 62366-1.
All operating elements shall be arranged and designed so as to avoid accidental operation.
Symbols for operating elements, if appropriate, shall conform with ISO 9687 and ISO 15223-1.
5.4 Reprocessing
The manufacturer shall provide information on reprocessing for the intraoral camera in accordance
with ISO 17664.
5.5 Protection from hazardous radiation
The illumination shall conform with the requirements for protection from hazardous radiation in
IEC 62471.
5.6 Image quality
5.6.1 Resolving power
The resolving power of variable focus cameras shall be specified in the technical description.
Testing shall be carried out for the variable focus camera at a working distance of 10 mm (l ) and for
2
fixed-focus cameras at a working distance specified by the manufacturer.
A resolving power of at least 20 lp/mm (CTF) at a working distance of 10 mm shall be reached.
For fixed-focus cameras with a working distance other than 10 mm, the minimum resolving power shall
be calculated according
...
SLOVENSKI STANDARD
oSIST prEN ISO 23450:2020
01-maj-2020
Zobozdravstvo - Intraoralna kamera (ISO/DIS 23450:2020)
Dentistry - Intraoral camera (ISO/DIS 23450:2020)
Zahnheilkunde - Intraoralkamera (ISO/DIS 23450:2020)
Médecine bucco-dentaire (ISO/DIS 23450:2020)
Ta slovenski standard je istoveten z: prEN ISO 23450
ICS:
11.060.20 Zobotehnična oprema Dental equipment
oSIST prEN ISO 23450:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 23450:2020
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oSIST prEN ISO 23450:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23450
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-03-13 2020-06-05
Dentistry — Intraoral camera
Médecine bucco-dentaire — Camera intraorale
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23450:2020(E)
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. ISO 2020
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oSIST prEN ISO 23450:2020
ISO/DIS 23450:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 23450:2020
ISO/DIS 23450:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 6
5 Requirements . 6
5.1 General . 6
5.2 Biocompatibility . 6
5.3 Usability . 6
5.4 Reprocessing . 6
5.5 Protection from hazardous radiation . 6
5.6 Image quality . 7
5.6.1 Resolving power . 7
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 . 8
5.7.1 Angular field of view. 8
5.7.2 Direction of view . 9
5.7.3 Working range of the camera . 9
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 .10
5.8.6 Compression artefact formation .10
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 .11
7.1.3 Vignetting .11
7.1.4 Distortion .12
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 .15
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 23450:2020
ISO/DIS 23450:2020(E)
10 Marking .15
10.1 General .15
10.2 Intraoral camera .15
11 Labelling .16
Annex A (informative) Examples of compression artefacts .17
Annex B (informative) Line pairs conversion table .18
iv © ISO 2020 – All rights reserved
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oSIST prEN ISO 23450:2020
ISO/DIS 23450:2020(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 4, Dental
instruments.
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.
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Introduction
In the field of dentistry, intraoral cameras have been used in the oral cavity of the patient for many
years. The intraoral camera provides the dentist 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
recognised 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,
wherever by stating the respective clause numbers of IEC 60601-1 and IEC 80601-2-60.
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oSIST prEN ISO 23450:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 23450:2020(E)
Dentistry — Intraoral camera
1 Scope
This document specifies requirements and test methods for intraoral cameras used in dentistry on the
patient for pictorial representation of the oral cavity 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/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, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to
chemical disinfectants
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance + Amendment 1:2012
IEC 62471, Photobiological safety of lamps and lamp systems
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IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
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:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
intraoral camera
optical handpiece for use in the oral cavity of the patient to assist with diagnosis and facilitate patient
information
3.2
patient side of intraoral camera
intraoral camera part which is designed to be introduced into the oral cavity where all parts of the
dental handpiece within 80 mm to the tip shall be considered as an applied part according to IEC 60601-1
Note 1 to entry: See Figure 1.
[SOURCE: IEC 80601-2-60:2012,201.3.208 PATIENT SIDE OF DENTAL HANDPIECE]
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oSIST prEN ISO 23450:2020
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Key
1 head (patient side of intraoral camera)
2 operation part (operator side of intraoral camera)
3 handheld part (operator side of intraoral camera)
4 viewing window (patient side of intraoral camera)
5 illumination part (patient side of intraoral camera)
6 interface (operator side of intraoral camera)
Figure 1 — Part designation of intraoral camera
3.3
operator side of intraoral camera
part of the intraoral camera which is designed to be handheld by the operator in normal use
3.4
resolving power
ability to distinguish between points or lines of an object which are close together in an image
Note 1 to entry: The resolving power is defined as the line frequency in line pairs pe
...
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