DIN EN ISO 12836-2015 Dentistry - Digitizing devices for CAD CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836 2015) German version EN I.pdf

1、November 2015 English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.060.01; 35.240.80!%G“2365727

2、www.din.deDIN EN ISO 12836Dentistry Digitizing devices for CAD/CAM systems for indirect dental restorations Test methods for assessing accuracy (ISO 12836:2015);English version EN ISO 12836:2015,English translation of DIN EN ISO 12836:2015-11Zahnheilkunde Digitalisierungsgerte fr CAD/CAM-Systeme fr

3、indirekte dentale Restaurationen Prfverfahren zur Beurteilung der Genauigkeit (ISO 12836:2015);Englische Fassung EN ISO 12836:2015,Englische bersetzung von DIN EN ISO 12836:2015-11Mdecine bucco-dentaire Dispositifs de numrisation des systmes de CFAO pour restaurations dentaires Mthodes dessai pour l

4、valuation de lexactitude (ISO 12836:2015);Version anglaise EN ISO 12836:2015,Traduction anglaise de DIN EN ISO 12836:2015-11SupersedesDIN EN ISO 12836:2013-01www.beuth.deDocument comprises 25 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered a

5、uthoritative.11.15 DIN EN ISO 12836:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 12836:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: CNN, Canada) in collaboration with Working Committee CEN/TC 55 “Dentistry” (Secretari

6、at: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-06 AA CAD/CAM-Systeme. The DIN Standards corresponding to the International Standards referred to in this document are as follows

7、: ISO 1942 DIN EN ISO 1942 ISO 5725-1 DIN ISO 5725-1 Amendments This standard differs from DIN EN ISO 12836:2013-01 as follows: a) the scope of the standard has been limited to extraoral devices in that it no longer includes hand-held digitizing devices (e.g. intraoral scanners); b) terms 3.1, 3.8,

8、3.16 and 3.17 have been defined more clearly. Previous editions DIN EN ISO 12836: 2013-01 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions

9、 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12836 July 2015 ICS 11.060.01 Supersedes EN ISO 12836:2012English Version Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2015) Mdecine bucco-dentaire - Disp

10、ositifs de numrisation des systmes de CFAO pour restaurations dentaires - Mthodes dessai pour lvaluation de lexactitude (ISO 12836:2015) Zahnheilkunde - Digitalisierungsgerte fr CAD/CAM- Systeme fr indirekte dentale Restaurationen - Prfverfahren zur Beurteilung der Genauigkeit (ISO 12836:2015) This

11、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 co

12、ncerning 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

13、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

14、, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMI

15、TEE FR 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 worldwide for CEN national Members. Ref. No. EN ISO 12836:2015 EForeword . .Introduction 1 Scope .2 Normative references 3 Terms and definitions .

16、4 Requirements 4.1 General .4.2 Accuracy 5 Test methods .5.1 General .5.2 Test conditions 5.3 Accuracy 5.3.1 Repeatability .5.3.2 Reproducibility 5.3.3 Trueness 6 Test report .Annex A (normative) Inlay-cavity die .Annex B (normative) Crown-and-bridge preparation die 15Annex C (normative) Sphere Bibl

17、iography .Contents PageEN ISO 12836:2015 (E) 23455588899999999112023.DIN EN ISO 12836:2015-11 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 i

18、s 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 possibil

19、ity 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 or

20、ganizations 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, Luxembour

21、g, 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. EN ISO 12836:2015 (E) 3DIN EN ISO 12836:2015-

22、11 IntroductionThe 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

23、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 inc

24、ludes 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 oc

25、clusion, 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 algo

26、rithm) are available to calculate a standard deviation of discrepancies between the points of the point cloud or STL surface and the physical objects 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 surfa

27、ce 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 sp

28、ecimen, 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, “truenes

29、s” 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

30、“accuracy” is used to refer to both trueness and precision.EN ISO 12836:2015 (E) 4DIN EN ISO 12836:2015-11 1 ScopeThis 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 i

31、ndirect 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 digitiza

32、tion by radiographic (X-ray) methods or by magnetic resonance imaging (MRI) methods.2 Normative referencesThe 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 und

33、ated references, the latest edition of the referenced document (including any amendments) applies.ISO 554, Standard atmospheres for conditioning and/or testing SpecificationsISO 1942, Dentistry VocabularyISO 3290-2, Rolling bearings Balls Part 2: Ceramic ballsISO 5725-1, Accuracy (trueness and preci

34、sion) of measurement methods and results Part 1: General principles and definitionsISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM)3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 5

35、725-1, ISO Guide 99, and the following apply.3.1accuracymeasurement closeness of agreement between a result of a measurement and a true value of the measurandNote 1 to entry: Accuracy is a qualitative concept. See 3.8 and 3.17 for quantification of its two constituent components: precision and truen

36、ess.SOURCE: ISO 5725-1:1994, 3.6, modified3.2calibrationset 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 corr

37、esponding values realized by standardsEN ISO 12836:2015 (E) 5DIN EN ISO 12836:2015-11 3.3digitizing devicedental surface data acquisition devicedevice for computer-aided design and manufacturing of custom-made indirect dental restorations used to record the topographical characteristics of teeth and

38、 surrounding tissues, implant connecting components, dental impressions, dental moulds, or stone models by analogue or digital methodsNote 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 act

39、ually 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

40、 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.3.4errormeasurement result of a measurement

41、 minus a true value of the measurandNote 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”.3.5indirect dental restorationany kind of restoration ma

42、nufactured extraorally which replaces intra-oral hard and/or soft tissuesEXAMPLE 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

43、excluded.3.6measurandparticular quantity subject to measurement3.7measurement procedureset of operations which are specifically used in the performance of particular measurements according to a given techniqueNote 1 to entry: In a quality system, a measurement procedure is recorded as a working inst

44、ructions document and should be described in sufficient detail to enable an operator to carry out a measurement without additional information.3.8precisioncloseness of agreement between independent results of measurement obtained under stipulated conditionsNote 1 to entry: Precision is a qualitative

45、 concept. The operational definition that applies in this International Standard is the standard deviation described in 5.3.2.EN ISO 12836:2015 (E) 6DIN EN ISO 12836:2015-11 SOURCE: ISO 5725-1:1994, 3.12, modified3.9random errorresult of a measurement minus the mean that would result from an infinit

46、e number of measurements of the same measurand carried out under repeatable conditionsNote 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.

47、3.10relative errortrueness divided by a true value of the measurand3.11repeatabilityresults of measurements closeness of the agreement between the results of successive measurements of the same measurand carried out under the same conditions of measurementNote 1 to entry: Repeatability is a qualitat

48、ive 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.3.12repeatability conditionsconditions where independent results of measure

49、ments 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 calibrationSOURCE: ISO 5725-1:1994, 3.14, modified3.13reproducibilityresults of measurementscloseness of the agreement between the results of measurements of the same measurand carried out under changed conditions of measurementNote 1 to entry: The changed conditions may in