EN ISO 12836:2012
(Main)Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2012)
Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2012)
ISO 12836:2012 specifies test methods for the assessment of the accuracy of digitizing devices for computer-aided design/computer-aided manufacturing (CAD/CAM) systems for indirect dental restorations.
Zahnheilkunde - Digitalisierungsgeräte für CAD/CAM-Systeme für indirekte dentale Restaurationen - Prüfverfahren zur Beurteilung der Genauigkeit (ISO 12836:2012)
In dieser Internationalen Norm werden Prüfverfahren zur Beurteilung der Genauigkeit von Digitalisierungsgeräten für computergestützte Design-/computergestützte Herstellungs- (CAD/CAM) Systeme für indirekte dentale Restaurationen beschrieben.
Dieses Prüfverfahren gilt nicht für die Digitalisierung mit Hilfe von Röntgenverfahren und Kernspintomografie (MRI).
Médecine bucco-dentaire - Dispositifs de numérisation des systèmes de CFAO pour restaurations dentaires - Méthodes d'essai pour l'évaluation de l'exactitude (ISO 12836:2012)
L'ISO 12836:2012 spécifie les méthodes d'essai permettant d'évaluer l'exactitude des dispositifs de numérisation des systèmes de Conception Assistée par Ordinateur/Fabrication Assistée par Ordinateur (CFAO) pour la restauration dentaire indirecte.
Zobozdravstvo - Digitalne naprave za uporabo sistemov CAD/CAM za posredne zobne restavracije/obnovo - Preskusne metode za ugotavljanje točnosti (ISO 12836:2012)
Ta mednarodni standard opisuje preskusne metode za ugotavljanje točnosti in obnovljivosti digitalnih naprav za uporabo sistemov CAD/CAM za posredne zobne restavracije/obnovo. Učinkovitost digitalnih naprav za notranje in zunanje ustne površine za trdo in mehko tkivo ter komponente dentalnega implantantnega sistema in vseh modelov je treba določiti s točnostjo, ponovljivostjo in obnovljivostjo
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2012
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Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test
methods for assessing accuracy (ISO 12836:2012)
Zahnheilkunde - Digitalisierungsgeräte für CAD/CAM-Systeme für indirekte dentale
Restaurationen - Prüfverfahren zur Beurteilung der Genauigkeit (ISO 12836:2012)
Médecine bucco-dentaire - Dispositifs de numérisation des systèmes CAD/CAM pour
restorations dentaires indirectes - Méthodes d'essai pour l'exactitude d'évaluation (ISO
12836:2012)
Ta slovenski standard je istoveten z: EN ISO 12836:2012
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
September 2012
ICS 11.060.01
English Version
Dentistry - Digitizing devices for CAD/CAM systems for indirect
dental restorations - Test methods for assessing accuracy (ISO
12836:2012)
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
12836:2012) 12836:2012)
This European Standard was approved by CEN on 14 September 2012.
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.
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Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12836:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 12836:2012) has been prepared by Technical Committee ISO/TC 106 "Dentistry" in
collaboration with Technical Committee 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 March 2013, and conflicting national standards shall be withdrawn at
the latest by March 2013.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 12836:2012 has been approved by CEN as a EN ISO 12836:2012 without any modification.
INTERNATIONAL ISO
STANDARD 12836
First edition
2012-10-01
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 12836:2012(E)
©
ISO 2012
ISO 12836:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
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Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 12836:2012(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 . 4
5.1 General . 4
5.2 Test conditions . 4
5.3 Accuracy . 5
6 Test report . 5
Annex A (normative) Inlay-shaped specimen . 6
Annex B (normative) Crown- and bridge-shaped specimens .10
Annex C (normative) Sphere .14
Bibliography .17
ISO 12836:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 12836 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 9, Dental
CAD/CAM systems.
iv © ISO 2012 – All rights reserved
ISO 12836:2012(E)
Introduction
The application of dental 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
Standard Tesselation Language surface (STL surface) thereof 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 (intra-
oral 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 formatfile 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 Annexes A, B and C, can
be used for assessing digitizing devices:
a) inlay-shaped specimen in order to simulate inlay-shaped cavities;
b) multi-unit specimen, consisting of two full coverage dies with a centre-to-centre distance of 30 mm, being
designed to simulate digitizing a 4-unit-bridge;
c) a sphere, the measurement of which is limited to the hemisphere lying above the horizontal plane.
ISO 5725-1 uses two terms, “trueness” and “precision”, to describe the accuracy of a measurement method.
“Trueness” refers to the closeness of agreement between the arithmetic mean of a large number of test results
and the true or accepted value. “Precision” refers to the closeness of agreement between test results. The
general term “accuracy” is used to refer to both trueness and precision.
INTERNATIONAL STANDARD ISO 12836:2012(E)
Dentistry — Digitizing devices for CAD/CAM systems for indirect
dental restorations — Test methods for assessing accuracy
1 Scope
This International Standard specifies test methods for the assessment of the accuracy of digitizing devices for
computer-aided design/computer-aided manufacturing (CAD/CAM) systems for indirect dental restorations.
These test methods are not applicable to digitization by radiographic methods (X-ray) and by magnetic
resonance imaging methods (MRI).
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 554, Standard atmospheres for conditioning and/or testing — Specifications
ISO 1942, Dentistry — Vocabulary
ISO 3290-2, Rolling bearings — Balls — Part 2: Ceramic balls
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 5725-1 and ISO Guide 99
and the following apply.
3.1
accuracy
〈measurement〉 closeness of agreement between a result of a measure
...
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