BS EN ISO 22112-2017 Dentistry Artificial teeth for dental prostheses《牙科学 牙修复术用假牙》.pdf

1、Dentistry - Artificial teeth for dental prostheses (ISO 22112:2017)BS EN ISO 22112:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 22112:2017. It is identical to ISO 22112:2017. It supersed

2、es BS EN ISO 22112:2006, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include al

3、l the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 92377 7ICS 11.060.10Compliance with a British Standard cannot confer immunity from legal obligations. This British

4、 Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 22112:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22112August 2017ICS 11.060.10 Supe

5、rsedes EN ISO 22112:2006EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 22112:2017: EAll rights of exploitation in any form and by any means reserved worldwide

6、for CEN national MembersDentistry - Artificial teeth for dental prostheses (ISO 22112:2017)Mdecine bucco-dentaire - Dents artificielles pour prothses dentaires (ISO 22112:2017)Zahnheilkunde - Knstliche Zhne fr Dentalprothesen (ISO 22112:2017)This European Standard was approved by CEN on 6 May 2017.C

7、EN 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 ap

8、plication 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 M

9、anagement 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, Lat

10、via, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 22112:2017 (E)European forewordThis document (EN ISO 22112:2017) has been prepared by Technical Committee ISO/TC

11、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 February 2018, and conflicti

12、ng national standards shall be withdrawn at the latest by February 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document supersedes EN IS

13、O 22112:2006.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

14、, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.2BS EN ISO 22112:2017ISO 22112:2017(E)Foreword v1 Scope .12 Normati

15、ve references 13 Terms and definitions .14 Classification 25 Requirements 25.1 General . 25.1.1 Biocompatibility . 25.1.2 Dimensions of teeth 25.1.3 Colour and blending of shades. 25.1.4 Surface finish . 25.1.5 Porosity and other defects . 35.2 Ceramic teeth 35.2.1 Radioactivity 35.2.2 Anchorage 35.

16、2.3 Resistance to thermal shock 35.3 Polymer teeth . 35.3.1 Bonding to denture base polymer 35.3.2 Resistance to blanching, distortion and crazing . 35.3.3 Colour stability 35.3.4 Dimensional stability . 36 Sampling 47 Measurement and test methods . 47.1 Visual inspection . 47.2 Dimensions of teeth

17、47.2.1 Reagents and/or materials . 47.2.2 Apparatus . 47.2.3 Procedure . 47.3 Comparison with shade guide . 57.3.1 Reagents and/or materials . 57.3.2 Apparatus . 57.4 Surface finish of ceramic teeth 57.4.1 Reagents and/or materials . 57.4.2 Apparatus . 67.4.3 Processing 67.4.4 Grinding . 67.5 Surfac

18、e finish of polymer teeth . 67.5.1 Reagents and/or materials . 67.5.2 Apparatus . 77.5.3 Processing 77.6 Porosity of ceramic teeth and other defects 77.6.1 Reagents and/or materials . 77.6.2 Apparatus . 77.6.3 Preparation of specimens 87.6.4 Procedure . 87.7 Porosity of polymer teeth and other defec

19、ts . 87.7.1 Reagents and/or materials . 87.7.2 Apparatus . 87.7.3 Procedure . 87.8 Radioactivity of ceramic teeth . 97.8.1 Reagents and/or materials . 97.8.2 Apparatus . 9 ISO 2017 All rights reserved iiiContents PageBS EN ISO 22112:2017ISO 22112:2017(E)7.8.3 Sample preparation 107.8.4 Counting proc

20、edure107.8.5 Assessment of results .107.9 Anchorage of ceramic teeth to denture base polymers 107.9.1 Reagents and/or materials 107.9.2 Apparatus 107.9.3 Procedure 107.10 Resistance of ceramic teeth to thermal shock . 107.10.1 Reagents and/or materials 107.10.2 Apparatus 107.10.3 Preparation of spec

21、imens . 117.10.4 Procedure 117.11 Bonding of polymer teeth to denture-base polymers 117.11.1 Reagents and/or materials 117.11.2 Apparatus 117.11.3 Procedure 127.12 Resistance to blanching, distortion and crazing of polymer teeth 137.12.1 Sampling. 137.12.2 Reagents and/or materials 147.12.3 Apparatu

22、s 147.12.4 Conditioning of test specimens 147.12.5 Procedure for exposure to monomer 147.12.6 Visual inspection .157.13 Colour stability of polymer teeth . 157.13.1 General. 157.13.2 Reagents and/or materials 157.13.3 Procedure 157.14 Dimensional stability of polymer teeth 157.14.1 Reagents and/or m

23、aterials 157.14.2 Apparatus 157.14.3 Procedure 158 Marking, labelling, and information to be supplied by the manufacturer 168.1 Marking and labelling 168.2 Information to be supplied by manufacturer 168.2.1 Mould chart . 168.2.2 Shade guide . 168.3 Manufacturers instructions for use 169 Packaging 16

24、Bibliography .17iv ISO 2017 All rights reservedBS EN ISO 22112:2017ISO 22112:2017(E)ForewordISO (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 throu

25、gh 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 collabora

26、tes 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 cr

27、iteria 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

28、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 nam

29、e used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to

30、 the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by ISO/TC 106 Dentistry, Subcommittee SC 2 Prosthodontic materials.This second edition cancels and replaces the first edition (ISO 2

31、2112:2005), which has been technically revised.The main changes compared to the previous edition are as follows: clarification of colour and blending requirement for multi-layered teeth (5.1.3); clarification of test procedure for surface finishing (7.5); for testing of radioactivity of ceramic teet

32、h: gamma spectroscopy system is added (7.8). ISO 2017 All rights reserved vBS EN ISO 22112:2017This page deliberately left blankDentistry - Artificial teeth for dental prostheses (ISO 22112:2017)1 ScopeThis document specifies the classification, requirements, and test methods for artificial teeth su

33、ch as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the ed

34、ition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 483, Plastics Small enclosures for conditioning and testing using aqueous solutions to maintain the humidity at a constant valueISO 1942, Dentistry VocabularyISO 3950, De

35、ntistry Designation system for teeth and areas of the oral cavityISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 6873:2013, Dentistry Gypsum productsISO 7491:2000, Dental materials Determination of colour stabilityISO 20795-1, Dentistry Base polymers Part 1:

36、Denture base polymers3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and ISO 20795-1 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:

37、/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1artificial teethmanufactured product designed to simulate and replace natural teeth3.2diatoric teethteeth designed to be retained by anchorage slots and/or holes3.3pin teethteeth designed to be retained by hea

38、ded pins3.4setset of six anterior teeth or eight posterior teeth, as received from the manufacturerINTERNATIONAL STANDARD ISO 22112:2017(E) ISO 2017 All rights reserved 1BS EN ISO 22112:2017ISO 22112:2017(E)3.5half-setthree teeth on one side of a set of anterior teeth or four teeth on one side of a

39、set of posterior teeth3.6mould chartchart representing the form, shape and dimensions of all individual teeth of a set4 ClassificationFor the purposes of this document, artificial teeth are classified into the following types: Type 1: anterior teeth; Type 2: posterior teeth.5 Requirements5.1 General

40、5.1.1 BiocompatibilitySpecific qualitative and quantitative requirements for freedom from biological hazard are not included in this document, but it is recommended that, in assessing possible biological or toxicological hazards, reference be made to ISO 10993-1 and ISO 7405.5.1.2 Dimensions of teet

41、hThe designation of the teeth shall be as given in ISO 3950.The dimensions of the teeth when examined in accordance with 7.2 shall not differ by more than 5 % for polymer teeth and 7 % for ceramic teeth from the values shown in the manufacturers mould chart.5.1.3 Colour and blending of shadesWhen te

42、sted in accordance with 7.3, sets of anterior and posterior teeth shall exhibit no perceptible colour difference compared with the manufacturers shade guide (8.2.2) or nominated shade guide. Multi-layered teeth shall show no line of demarcation between incisal and cervical portions on the facial asp

43、ects of the teeth.NOTE This requirement is not intended to disallow especially designed demarcations placed to simulate borders of restorations or enamel imperfections found in natural teeth.5.1.4 Surface finishWhen inspected visually in accordance with 7.1, the teeth as received (excluding retentio

44、n areas) shall have a smooth, lustrous, non-porous surface.When ceramic teeth are tested in accordance with 7.4, the processing shall not have impaired the original finish of the teeth, and the teeth shall be capable of being ground and polished.When polymer teeth are tested in accordance with 7.5,

45、the teeth shall be capable of being polished to restore the original finish.2 ISO 2017 All rights reservedBS EN ISO 22112:2017ISO 22112:2017(E)5.1.5 Porosity and other defectsCeramic teeth shall not show more than a total of 16 pores of diameter greater than 30 m on the four test surfaces when teste

46、d in accordance with 7.6. No more than six of those pores shall have diameters ranging from 40 m and 150 m. There shall be no pores of diameter greater than 150 m.Examine the ceramic teeth in accordance with 7.6.Polymer teeth shall exhibit no porosity or defect, such as rough trimming, rough finish

47、or visible impurities, on the coronal surfaces.Examine the polymer teeth in accordance with 7.7.5.2 Ceramic teeth5.2.1 RadioactivityWhen tested in accordance with 7.8, ceramic teeth shall have an activity concentration of no more than 1,0 Bqg-1of uranium-238.5.2.2 AnchorageAll ceramic diatoric teeth

48、, examined in accordance with 7.9, shall provide a means of positive retention and have holes all of which shall be open and unsealed.5.2.3 Resistance to thermal shockCeramic teeth shall, when tested in accordance with 7.10, show no signs of cracking.5.3 Polymer teeth5.3.1 Bonding to denture base po

49、lymerAll polymer teeth shall be capable of being bonded to heat-polymerizable denture-base materials which conform to ISO 20795-1. For five out of the six test specimens, the bond formed between the ridge lap portion of the teeth and the denture base polymer shall pass the test specified in 7.11.NOTE Additional information for another bonding test between polymer teeth and denture base polymer is given in ISO/TS 19736.5.3.2 Resistance to blanching, distortion and crazingWhen tested in accordance with 7.12, no teeth shall