EN ISO 12836:2015

SLOVENSKI STANDARD
01-oktober-2015
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SIST EN ISO 12836:2012
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Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test
methods for assessing accuracy (ISO 12836:2015)
Zahnheilkunde - Digitalisierungsgeräte für CAD/CAM-Systeme für indirekte dentale
Restaurationen - Prüfverfahren zur Beurteilung der Genauigkeit (ISO 12836:2015)
Médecine bucco-dentaire - Dispositifs de numérisation des systèmes de CFAO pour
restaurations dentaires - Méthodes d'essai pour l'évaluation de l'exactitude (ISO
12836:2015)
Ta slovenski standard je istoveten z: EN ISO 12836:2015
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.

EUROPEAN STANDARD
EN ISO 12836
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2015
ICS 11.060.01 Supersedes EN ISO 12836:2012
English Version
Dentistry - Digitizing devices for CAD/CAM systems for indirect
dental restorations - Test methods for assessing accuracy (ISO
12836:2015)
Médecine bucco-dentaire - Dispositifs de numérisation des Zahnheilkunde - Digitalisierungsgeräte für CAD/CAM-
systèmes de CFAO pour restaurations dentaires - Systeme für indirekte dentale Restaurationen -
Méthodes d'essai pour l'évaluation de l'exactitude (ISO Prüfverfahren zur Beurteilung der Genauigkeit (ISO
12836:2015) 12836:2015)
This European Standard was approved by CEN on 7 May 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12836:2015 E
worldwide for CEN national Members.

Contents Page
European foreword .3

European foreword
This document (EN ISO 12836:2015) 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 January 2016, and conflicting national standards shall be withdrawn at
the latest by January 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 12836:2012.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 12836:2015 has been approved by CEN as EN ISO 12836:2015 without any modification.

INTERNATIONAL ISO
STANDARD 12836
Second edition
2015-07-01
Dentistry — Digitizing devices for
CAD/CAM systems for indirect dental
restorations — Test methods for
assessing accuracy
Médecine bucco-dentaire — Dispositifs de numérisation des systèmes
de CFAO pour restaurations dentaires — Méthodes d’essai pour
l’évaluation de l’exactitude
Reference number
ISO 12836:2015(E)
©
ISO 2015
ISO 12836:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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.
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

ISO 12836:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 4
4.1 General . 4
4.2 Accuracy . 4
5 Test methods . 5
5.1 General . 5
5.2 Test conditions . 5
5.3 Accuracy . 5
5.3.1 Repeatability . 5
5.3.2 Reproducibility . 5
5.3.3 Trueness . 5
6 Test report . 5
Annex A (normative) Inlay-cavity die . 7
Annex B (normative) Crown-and-bridge preparation die .11
Annex C (normative) Sphere .16
Bibliography .19
ISO 12836:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 9, Dental
CAD/CAM systems.
This second edition cancels and replaces the first edition (ISO 12836:2012), of which it constitutes a
minor revision.
iv © ISO 2015 – All rights reserved

ISO 12836:2015(E)
Introduction
The application of dental computer-aided design and manufacturing (CAD/CAM) systems is increasing
throughout the world.
This International Standard specifies three test methods for assessing the accuracy of dental digitizing
devices used for CAD/CAM systems.
This International Standard is based on the premise that only the matched point cloud and the resulting
tessellation thereof conforming to the StereoLithography Interface Specification (also known as
Standard Tesselation Language or STL) be regarded as the product of scanning the physical object.
This International Standard includes the measurement of the image that is digitized from dental scanners
(lab-based optical scanners and lab-based mechanical contact scanners). Digitized images are not only
used for the fabrication of restorative products but also applied to teaching and research in dentistry, in
such areas as occlusion, tooth and gingival contour change measurements, and so forth.
It was felt that, besides the sphere, more physical objects are required, for example, a surface with an
inlay-shaped cavity with a sharp edge to simulate the edge of an inlay preparation. When no means (for
example, software algorithm) are available to calculate a standard deviation of discrepancies between
the points of the point cloud or STL surface and the physical object’s surface as a measure for accuracy,
some software is required to match the CAD STL format file of the physical object with the point cloud
or STL surface and visualize discrepancies, resulting in a qualitative assessment.
The following three specimens (two dental and one technical), which are specified in Annex A, Annex B,
and Annex C, can be used for assessing digitizing devices:
a) specimen shaped to simulate a cavity for an inlay;
b) multi-unit specimen, c
...