EN ISO 12836-2015 en Dentistry - Digitizing devices for CAD CAM systems for indirect dental restorations - Test methods for assessing accuracy《牙科 间接牙科修复的计算机辅助设计 制造的数字化设备 评估精确度的测试方法.pdf

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1、BSI Standards PublicationBS EN ISO 12836:2015Dentistry Digitizing devicesfor CAD/CAM systems forindirect dental restorations Test methods for assessingaccuracyBS EN ISO 12836:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 12836:2015. It supersedes BS E

2、N ISO 12836:2012 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/106, Dentistry.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisi

3、ons of a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 89577 7 ICS 11.060.01 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was publishe

4、d under the authority of the Standards Policy and Strategy Committee on 31 July 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12836 July 2015 ICS 11.060.01 Supersedes EN ISO 12836:2012English Version Dentistry

5、- Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2015) Mdecine bucco-dentaire - Dispositifs de numrisation des systmes de CFAO pour restaurations dentaires - Mthodes dessai pour lvaluation de lexactitude (ISO 12836:2015) Zahnh

6、eilkunde - Digitalisierungsgerte fr CAD/CAM-Systeme fr indirekte dentale Restaurationen - Prfverfahren zur Beurteilung der Genauigkeit (ISO 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

7、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 Standa

8、rd 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 natio

9、nal 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, Slov

10、akia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any mean

11、s reserved worldwide for CEN national Members. Ref. No. EN ISO 12836:2015 EBS EN ISO 12836:2015EN ISO 12836:2015 (E) 3 European foreword This document (EN ISO 12836:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” incollaboration with Technical Committee CEN/TC 55 “Dentistry” th

12、e secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by January 2016, and conflicting national standards shall be withdrawn atthe latest by January 2016. Attention is

13、 drawn to the possibility that some of the elements of this document may be the subject of patentrights. 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

14、national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Li

15、thuania, 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. BS EN ISO 12836:2015ISO 1283

16、6:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 44.1 General . 44.2 Accuracy 45 Test methods . 55.1 General . 55.2 Test conditions 55.3 Accuracy 55.3.1 Repeatability . 55.3.2 Reproducibility 55.3.3 Trueness 56 Test report . 5Annex A (nor

17、mative) Inlay-cavity die 7Annex B (normative) Crown-and-bridge preparation die 11Annex C (normative) Sphere 16Bibliography .19 ISO 2015 All rights reserved iiiContents PageBS EN ISO 12836:2015ISO 12836:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation

18、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. I

19、nternational 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

20、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

21、 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 docum

22、ent 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

23、expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 9,

24、 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 reservedBS EN ISO 12836:2015ISO 12836:2015(E)IntroductionThe application of dental computer-aided design and manufacturing (CAD/CAM) sy

25、stems 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 ther

26、eof 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

27、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, besid

28、es 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

29、 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 surface and visualize discrepancies, resulting in a qualitative assessment.The following three spe

30、cimens (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 dist

31、ance 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 th

32、e 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. ISO 2015 All rights reserved vBS

33、EN ISO 12836:2015ISO 12836:2015(E)BS EN ISO 12836:2015Dentistry Digitizing devices for CAD/CAM systems for indirect dental restorations Test methods for assessing accuracy1 ScopeThis International Standard specifies test methods for the assessment of the accuracy of digitizing devices for computer-a

34、ided 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 sc

35、anning devices.These test methods are not applicable to digitization 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 applicatio

36、n. 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 SpecificationsISO 1942, Dentistry VocabularyISO 3290-2, Rolling bearings Bal

37、ls Part 2: Ceramic ballsISO 5725-1, Accuracy (trueness and precision) 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 t

38、his document, the terms and definitions given in ISO 1942, ISO 5725-1, 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 quant

39、ification of its two constituent components: precision and trueness.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 repres

40、ented by a material measure or a reference material and the corresponding values realized by standardsINTERNATIONAL STANDARD ISO 12836:2015(E) ISO 2015 All rights reserved 1BS EN ISO 12836:2015ISO 12836:2015(E)3.3digitizing devicedental surface data acquisition devicedevice for computer-aided design

41、 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 methodsNote 1 to entry: These systems consist of

42、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 m

43、athematically 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 extractio

44、n method of a surface from the raw data points, and the matching of point clouds.3.4errormeasurement result of a measurement 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

45、2 to entry: In many instances, the trueness is called “total error”.3.5indirect dental restorationany kind of restoration manufactured extraorally which replaces intra-oral hard and/or soft tissuesEXAMPLE Crowns, bridges, inlays, implant superstructures, prostheses, provisional restorations.Note 1 t

46、o entry: Epitheses that involve the oral cavity are included; devices for short-term use, for example, surgical guides, are excluded.3.6measurandparticular quantity subject to measurement3.7measurement procedureset of operations which are specifically used in the performance of particular measuremen

47、ts according to a given techniqueNote 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.3.8precisioncloseness of agreemen

48、t between independent results of measurement obtained under stipulated conditionsNote 1 to entry: Precision is a qualitative concept. The operational definition that applies in this International Standard is the standard deviation described in 5.3.2.2 ISO 2015 All rights reservedBS EN ISO 12836:2015

49、ISO 12836:2015(E)SOURCE: ISO 5725-1:1994, 3.12, modified3.9random errorresult of a measurement minus the mean that would result from an infinite 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.3.10relative errortrueness divided by a true value of the measurand3.11repeatabilit