EN ISO 10477-2018 Dentistry - Polymer-based crown and veneering materials.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry Polymer-based crown and veneering materials (ISO 10477:2018)BS EN ISO 10477:2018National forewordThis British Standard is the UK implementation of EN ISO 10477:2018. It supersedes BS EN ISO 10477:2004, which i

2、s withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/2, Prosthodontic materials.A list of organizations represented on this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 all the necessary provisions of a

3、contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 90225 3ICS 11.060.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the

4、 authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 10477:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10477July 2018ICS 11.060.10 Supersedes EN ISO 10477:2004EUROPEAN COMMITT

5、EE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 10477:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDentistry - Poly

6、mer-based crown and veneering materials (ISO 10477:2018)Mdecine bucco-dentaire - Produits base de polymres pour couronnes et facettes (ISO 10477:2018)Zahnheilkunde - Kronen- und Verblendkunststoffe (ISO 10477:2018)This European Standard was approved by CEN on 13 May 2018.CEN members are bound to com

7、ply 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-CENELE

8、C 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 sa

9、me 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,

10、 Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 10477:2018 (E)European forewordThis document (EN ISO 10477:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collabor

11、ation 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 2019, and conflicting national standards shall

12、be withdrawn at the latest by January 2019.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 ISO 10477:2004.According to the

13、 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, Hu

14、ngary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 10477:2018 has been approved by CEN as EN ISO 10477:2018 witho

15、ut any modification.iiBS EN ISO 10477:2018ISO 10477:2018Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 25.1 General . 25.2 Depth of cure 35.2.1 General 35.2.2 Depth of cure, Type 2, Class 2 materials 35.3 Surface finish 35.4 Fl

16、exural strength . 35.5 Bond strength. 45.5.1 Special bonding system without macromechanical retention . 45.5.2 Values higher than 5 MPa . 45.6 Water sorption 45.7 Solubility 45.8 Shade consistency 45.9 Colour stability 45.10 Biocompatibility 46 Sampling 46.1 For all tests . 46.2 For test of shade co

17、nsistency 56.3 For test of colour stability . 57 Measurement and test methods . 57.1 General . 57.1.1 Test conditions. 57.1.2 Water 57.1.3 Preparation of test specimens 57.2 Visual inspection . 57.3 Depth of cure 57.3.1 Apparatus . 57.3.2 Materials . 67.3.3 Procedure . 67.3.4 Expression of results 6

18、7.4 Surface finish 67.5 Flexural strength . 77.5.1 Apparatus . 77.5.2 Materials . 87.5.3 Preparation of test specimens 87.5.4 Procedure . 97.5.5 Expression of results 97.6 Bond strength 107.6.1 Apparatus 107.6.2 Materials 117.6.3 Preparation of test specimens . 117.6.4 Procedure 127.6.5 Expression o

19、f results .127.7 Water sorption and solubility . 127.7.1 Apparatus 127.7.2 Materials 13 ISO 2018 All rights reserved iiiContents PageBS EN ISO 10477:2018ISO 10477:20187.7.3 Preparation of test specimen . 137.7.4 Procedure 147.7.5 Expression of results .147.8 Shade consistency and colour stability .

20、157.8.1 General. 157.8.2 Apparatus 157.8.3 Materials 167.8.4 Preparation of test specimens . 167.8.5 Procedure 167.8.6 Colour comparison 167.8.7 Expression of results for shade consistency .177.8.8 Expression of results for colour stability .178 Packaging and labelling .178.1 Packaging 178.2 Labelli

21、ng 178.2.1 General. 178.2.2 Labelling of outer pack 178.2.3 Labelling of containers 189 Instructions for use 18iv ISO 2018 All rights reservedBS EN ISO 10477:2018ISO 10477:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO

22、 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, gover

23、nmental 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 maintena

24、nce 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).Attentio

25、n 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 an

26、d/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 voluntary nature of standards, the meaning of ISO specific terms and

27、expressions related to conformity assessment, as well as information about ISOs adherence to 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 Technical Committee ISO/TC 106, Denti

28、stry, Subcommittee SC 2, Prosthodontic materials.This third edition cancels and replaces the second edition (ISO 10477:2004), which has been technically revised.The main changes compared to the previous edition are as follows: the limitation to anterior crowns has been deleted; the limitation to met

29、al substructure has been deleted; the test for ambient light testing has been deleted. ISO 2018 All rights reserved vBS EN ISO 10477:2018ISO 10477:2018IntroductionSpecific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazards are not included in thi

30、s document, but it is recommended that, for the assessment of possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.vi ISO 2018 All rights reservedBS EN ISO 10477:2018Dentistry Polymer-based crown and veneering materials 1 ScopeThis document classifies polymer-based crown

31、 and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. I

32、t also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of th

33、eir content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Specificat

34、ion and test methodsISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 7491, Dental materials Determination of colour stabilityISO 8601, Data elements and interchange formats Information int

35、erchange Representation of dates and timesISO 22674, Dentistry Metallic materials for fixed and removable restorations and appliances3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological datab

36、ases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.1polymer-based crown and veneering materialcomposition of powders and liquids or pastes that may contain monomers,

37、 inorganic and/or polymeric fillers and that, when polymerized, is suitable for use as permanent dental veneers or crownsNote 1 to entry: Polymerization is effected by mixing initiator(s) and activator(s) (“self-curing” materials) and/or by external energy activation by heat (“heat-curing” materials

38、), photoactivated materials, by visible light (“light-curing” materials) and/or by UV radiation.Note 2 to entry: The polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns may or may not be attached to a substructure.INTERNATIONAL STANDARD ISO 10477:2018 IS

39、O 2018 All rights reserved 1BS EN ISO 10477:2018ISO 10477:20183.2dentine resinpigmented and slightly translucent polymer-based crown and veneering material (3.1) that simulates the natural appearance of dentine3.3enamel resintranslucent and slightly pigmented polymer-based crown and veneering materi

40、al (3.1) that is packed in a layer over the dentine resin and that simulates the natural appearance of enamel3.4cervical resinintensely pigmented and slightly translucent polymer-based crown and veneering material (3.1) with a colour that simulates the natural appearance of dentine of the cervical r

41、egion of the tooth3.5opaque resinintensely pigmented polymer-based crown and veneering material applied in thin layers for masking the underlying material4 ClassificationThe polymer-based crown and veneering materials described in this document shall be classified according to their activation syste

42、m for polymerization. Type 1: polymer-based crown and veneering materials whose setting is effected by mixing initiator(s) and activator(s) (“self-curing” materials); Type 2: polymer-based crown and veneering materials whose setting is effected by the application of energy from an external source (“

43、external-energy-activated” materials), such as heat and/or radiation (visible or UV range); Class 1: polymer-based crown and veneering materials that do not contain a photo-polymerization initiator; Class 2: polymer-based crown and veneering materials that contain a photo-polymerization initiator; T

44、ype 3: polymer-based crown and veneering materials whose setting is effected by mixing initiator(s) and activator(s) and also by the application of energy from an external source (“dual-cure” materials).5 Requirements5.1 GeneralThe tests required for a crown and veneering material depend on the clas

45、sification according to Type and Class.See Table 1 for the necessity of the specific tests described in 5.2 to 5.9.2 ISO 2018 All rights reservedBS EN ISO 10477:2018ISO 10477:2018Table 1 Test protocolSubclause Property Type 1 Type 2 Type 3Class 1 Class 25.2 Depth of cure +a5.3 Surface finish +a+a+a+

46、a5.4 Flexural strength +a+a+a+a5.5 Bond strength + + + +5.6 to 5.9 Water sorption, solubility, shade consistency, colour stability+ + + +carry out test; do not test.aIf the material is opaque resin, do not test.5.2 Depth of cure5.2.1 GeneralTesting shall be carried out in accordance with 7.3.5.2.2 D

47、epth of cure, Type 2, Class 2 materialsFor Type 2, Class 2 polymer-based crown and veneering materials, the hardness of the bottom surface shall be not less than 70 % of that of the top surface (see Table 2).For Type 1, Type 2, Class 1 and Type 3 materials, no requirement is specified.5.3 Surface fi

48、nishA test specimen polished in accordance with 7.4 shall have a glossy surface.Testing shall be carried out in accordance with 7.4.5.4 Flexural strengthThe flexural strength shall be at least 50 MPa (see Table 2). This requirement is not applicable to opaque resins.Testing shall be carried out in a

49、ccordance with 7.5.Table 2 Physical and chemical requirementsSubclause Property Requirement5.2 Depth of cure Hardness of bottom surface 70 % of top surface5.4 Flexural strength 50 MPa5.5.1 Bond strength 5 MPa5.5.2 80 % of the value claimed5.6 Water sorption 40 g/mm35.7 Solubility 7,5 g/mm3 ISO 2018 All rights reserved 3BS EN ISO 10477:2018ISO 10477:20185.5 Bond strength5.5.1 Special bonding system without macromechanical retentionIf the manufacturer recommends a special bonding system without macrom