SIST EN ISO 12836:2015
(Main)Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2015)
Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2015)
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. The methods described in this International Standard require a digitizing device in
which the object is mounted relative to the optical or mechanical-contact system and therefore do not
apply to hand-held scanning devices.
These test methods are not applicable to digitization by radiographic (X-ray) methods or by magnetic
resonance imaging (MRI) methods.
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)
L'ISO 12836:2015 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. Les méthodes décrites dans l'ISO 12836:2015 requièrent un dispositif de numérisation dans lequel l'objet est installé par rapport au système optique ou à contact mécanique, et ne s'appliquent donc pas aux dispositifs de balayage manuels.
Ces méthodes d'essai ne s'appliquent pas à la numérisation par radiographie (rayons X) ou par imagerie par résonance magnétique (IRM).
Zobozdravstvo - Pripomočki za za uporabo sistemov CAD/CAM za posredne zobne preureditve - Preskusne metode za ugotavljanje točnosti (ISO 12836:2015)
Ta mednarodni standard določa preskusne metode za ugotavljanje točnosti digitalnih pripomočkov za računalniško podprte sisteme načrtovanja/proizvodnje (CAD/CAM) za posredne zobne preureditve. Metode, opisane v tem mednarodnem standardu, potrebujejo digitalni pripomoček, v katerem je predmet nameščen ustrezno glede na optični sistem ali sistem z mehanskim stikom, in se zato ne uporabljajo za ročne pripomočke za skeniranje.
Te preskusne metode se ne uporabljajo za digitalizacijo z radiografskimi (rentgenskimi) metodami ali metodami slikanja z magnetno resonanco (MRI).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 12836:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO 12836:2012
=RER]GUDYVWYR3ULSRPRþNL]D]DXSRUDERVLVWHPRY&$'&$0]DSRVUHGQH]REQH
SUHXUHGLWYH3UHVNXVQHPHWRGH]DXJRWDYOMDQMHWRþQRVWL ,62
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
SIST EN ISO 12836:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 12836:2015
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SIST EN ISO 12836:2015
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.
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SIST EN ISO 12836:2015
EN ISO 12836:2015 (E)
Contents Page
European foreword .3
2
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SIST EN ISO 12836:2015
EN ISO 12836:2015 (E)
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.
3
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SIST EN ISO 12836:2015
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SIST EN ISO 12836:2015
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
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SIST EN ISO 12836:2015
ISO 12836:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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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
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SIST EN ISO 12836:2015
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
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SIST EN ISO 12836:2015
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.
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SIST EN ISO 12836:2015
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, consisting of two core dies for coverage by a full crown with a centre-to-centre
distance of 30 mm, being designed to simulate digitizing a four-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.
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SIST EN ISO 12836:2015
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SIST EN ISO 12836:2015
INTERNATIONAL STANDARD ISO 12836:2015(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. The methods described in this International Standard require a digitizing device in
which the object is mounted relative to the optical or mechanical-contact system and therefore do not
apply to hand-held scanning devices.
These test methods are not applicable to digitization by radiographic (X-ray) methods or by magnetic
resonance imaging (MRI) methods.
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, ISO Guide 99,
and the following apply.
3.1
accuracy
〈measurement〉 closeness of agreement between a result of a measurement and a true value of the measurand
Note 1 to entry: Accuracy is a qualitative concept. See 3.8 and 3.17 for quantification of its two constituent
components: precision and trueness.
[SOURCE: ISO 5725-1:1994, 3.6, modified]
3.2
calibration
set of operations that establish, under specified conditions, the relationship between values of quantities
indicated by a measuring instrument or measuring system or values represented by a material measure
or a reference material and the corresponding values realized by standards
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SIST EN ISO 12836:2015
ISO 12836:2015(E)
3.3
digitizing device
dental surface data acquisition device
device for computer-aided design and manufacturing of custom-made indirect dental restorations
used to record the topographical characteristics of teeth and surrounding tissues, implant connecting
components, dental impressions, dental moulds, or stone models by analogue or digital methods
Note 1 to entry: These systems consist of a scanning device, hardware and software.
Note 2 to entry: A surface digitization procedure starts with the generation of actually measured surface points
(or their conversion, for example, in STL format), which are the measured digitization data. In most digitizing
systems, the measured points are mathematically processed by operations such as:
— matching;
— filtering;
— weighing;
— selective removal;
— smoothing, etc.
This results in the processed digitization data (or surface data). These data depend very much on, for example, the
digitization protocol (for example, the number of passes), the extraction method of a surface from the raw data
points, and the matching of point clouds.
3.4
error
〈measurement〉 result of a measurement minus a true value of the measurand
Note 1 to entry: When it is necessary to distinguish “error” from “relative error”, the former is sometimes called
“absolute trueness”.
Note 2 to entry: In many instances, the trueness is called “total error”.
3.5
indirect dental restoration
any kind of restoration manufactured extraorally which replaces intra-oral hard and/or soft tissues
EXAMPLE Crowns, bridges, inlays, implant superstructures, prostheses, provisional restorations.
Note 1 to entry: Epitheses that involve the oral cavity are included; devices for short-term use, for example,
surgical guides, are excluded.
3.6
measurand
particular quantity subject to measurement
3.7
measurement procedure
set of operations which are specifically used in the performance of particular measurements according
to a given technique
Note 1 to entry: In a quality system, a measurement procedure is recorded as a working instructions document
and should be described in sufficient detail to enable an operator to carry out a measurement without
additional information.
3.8
precision
closeness of agreement between independent results of measurement obtained under stipulated conditions
Note 1 to entry: Precision is a qualitative concept. The operational definition that applies in this International
Standard is the standard deviation described in 5.3.2.
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SIST EN ISO 12836:2015
ISO 12836:2015(E)
[SOURCE: ISO 5725-1:1994, 3.12, modified]
3.9
random error
result of a measurement minus the mean that would result from an infinite number of measurements of
the same measurand carried out under repeatable conditions
Note 1 to entry: Random error is equal to trueness minus systematic error.
Note 2 to entry: In practice, random error may be estimated from 20 or more repeated measurements of a
measurand under specified conditions.
3.10
relative error
trueness divided by a true value of the measurand
3.11
repeatability
〈results of measurements〉 closeness of the agreement between the results of successive measurements
of the same measurand carried out under the same conditions of measurement
Note 1 to entry: Repeatability is a qualitative concept. Its quantitative counterpart is standard deviation of
repeatability or coefficient of variation of repeatability of the measurement results.
Note 2 to entry: Repeatability may depend on the value of the measurand.
3.12
repeatability conditions
conditions where independent results of measurements are obtained with the same measurement
procedure in the same laboratory by the same operator using the same equipment within short intervals
of time without new calibration
[SOURCE: ISO 5725-1:1994, 3.14, modified]
3.13
reproducibility
results of measurements
closeness of the agreement between the results of measurements of the same measurand carried out
under changed conditions of measurement
Note 1 to entry: The changed conditions may include principle of measurement, method of measurement, observer,
measuring instrument, reference standard, location, conditions of use, and time.
Note 2 to entry: The set of specified conditions is termed “reproducibility conditions”.
Note 3 to entry: Reproducibility is a qualitative concept. Its quantitative counterpart is standard deviation of
reproducibility or coefficient of variation of reproducibility of the measurement results.
Note 4 to entry: Reproducibility may depend on the value of the measurand.
3.14
reproducibility conditions
conditions where results of measurements are obtained on the same measurand under different
conditions in different laboratories
Note 1 to entry: The differences in conditions are intended to be specified.
[SOURCE: ISO 5725-1:1994, 3.18, modified]
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SIST EN ISO 12836:2015
ISO 12836:2015(E)
3.15
systematic error
mean that would result from an infinite number of measurements of the same measurand carried out
under repeatable conditions minus a true value of the measurand
Note 1 to entry: Systematic error is equal to error of measurement minus random error.
Note 2 to entry: Systematic error may be constant or proportional to the value of the measurand.
Note 3 to entry: In practice, systematic error is estimated from 20 or more repeated measurements of a measurand
under specified conditions.
3.16
true value
of a quantity
value consistent with the definition of a given particular quantity
Note 1 to entry: This is a value that would be obtained by a perfect measurement. True values are, by nature,
indeterminate.
Note 2 to entry: The indefinite article “a”, rather than the definite article “the”, is used in conjunction with “true
value” because there may be many values consistent with the definition of a given particular quantity.
Note 3 to entry: A reference data set obtained by the procedures of A.4.2 or B.4.2 is used as a true value in A.6.2 or
B.6.2. Dimensions described in C.4 are used as a true value in C.6.2.
Note 4 to entry: The magnitude of an angle or a dimension of a test object described in A.4.1 or B.4.1 obtained
by an independent method of measurement may be taken as a true value, provided that the object has been
manufactured in a process qualified and calibrated to the precision specified in A.4.1 or B.4.1.
3.17
trueness
closeness of agreement between the mean obtained from repeated measurements and a true value or a
conventional true value
Note 1 to entry: Trueness is a qualitative concept. The operational definition that applies for this International
Standard is given in 5.3.3.
[SOURCE: ISO 5725-1:1994, 3.7, modified]
4 Requirements
4.1 General
The manufacturer of the digitizing device shall provide product-specific information including
instructions for use.
The digitization device shall be driven by software recommended by the supplier or manufacturer for
digitization and rendering of the scanned physical object surface.
4.2 Accuracy
The manufacturer of the digitizing device shall provide product-specific information on the accuracy
(trueness and precision) of the digitizing device (e.g. a description of the tested object) in the
instructions for use.
In order to determine the quality of a digitizing device in terms of accuracy, repeatability, and
reproducibility, known physical objects shall be analysed for structures that are important for the
purpose of generating indirect dental restorations. The manufacturer of the digitizing device shall
report on the tests carried out, for example, in the instructions for use.
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SIST EN ISO 12836:2015
ISO 12836:2015(E)
From the assessment performed with the test specimens specified in Annex A, Annex B, or Annex C, the
manufacturer shall derive comprehensive documentation.
The test procedure used shall be reported.
EXAMPLE “Tested in accordance with ISO 12836:2012, Annex A, Inlay-shaped specimen.”
5 Test methods
5.1 General
Use at least two of the test methods described in Annex A, Annex B, and Annex C.
5.2 Test conditions
Testing shall be done under the following test conditions:
a) the change of temperature during the test shall remain within ±1 °C;
b) the ambient room temperature shall be (23 ± 2) °C in accordance with ISO 554;
c) the quality of the data set in terms of any missing or corrupted data shall be evaluated by the
operator; in cases of missing or corrupted data, the test shall be repeated.
5.3 Accuracy
5.3.1 Repeatability
Repeat the measurement 30 times without removing the test specimen from the digitizing device. Use
the test specimen and procedures specified in Annex A, Annex B, or Annex C as recommended in the
manufacturer’s instructions for use. Calculate the mean and standard deviation of the 30 measurements.
Record this value(s).
5.3.2 Reproducibility
Repeat the measurement 30 times, removing the test specimen from the digitizing device and replacing
it into the digitizing device. Use the test specimen and procedures specified in Annex A, Annex B, or
Annex C as recommended in the manufacturer’s instructions for use. Calculate the mean and standard
deviation of the 30 measurements. Record this value(s).
5.3.3 Trueness
Calculate the difference between the mean of the 30 repeatability measurements and a true value
obtained independently according to the respective annex. (See A.6.2, B.6.2, or C.6.2).
6 Test report
Prepare a written test report. The test report shall contain at least the following information:
a) a reference to this International Standard, i.e. ISO 12836:2015;
b) a reference to the annexes of this International Standard used for testing;
c) identification of the test specimen (i.e. inlay-shaped specimen, crown-shaped specimen, bridge-
shaped specimen, sphere specimen);
d) specimen surface preparation;
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SIST EN ISO 12836:2015
ISO 12836:2015(E)
e) test conditions, including the number of scanning views manually matched, if it is necessary
according to the measurement procedure as specified in the manufacturer’s instructions;
f) trueness;
g) mean and standard deviation for repeatability and reproducibility of measurement;
h) software and the version of the software used for assessment;
i) full identification and qualifications of the person who performed the test;
j) full documentation of the conditions used during reproducibility testing.
In addition, the following information shall be included for tests made in accordance with Annex C:
— number of measured points;
— histogram distribution of points;
— mean radius, R ;
mn
— minimum and maximum radius;
— radius deviation.
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SIST EN ISO 12836:2015
ISO 12836:2015(E)
Annex A
(normative)
Inlay-cavity die
A.1 General
This annex specifies the measurement of a die which simulates an inlay-cavity. This test procedure uses
a negative geometry.
A.2 Principle
An inlay-cavity die is first measured with a reference measurement system in order to produce a
reference data set (calibration of the measurement object).
Then, the digitizing device under investigation is used to capture the inlay-shaped physical object. The
resulting measurement data are compared to the reference data set.
A.3 Apparatus
A.3.1 Test specimen, in the form of an inlay-shaped physical object, as specified in Figure A.1. The
mater
...
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