EN ISO 10477-2004 en Dentistry - Polymer-based crown and bridge materials《牙科学 高聚物基的牙冠和齿桥材料》.pdf

1、BRITISH STANDARD BS EN ISO 10477:2004 Dentistry Polymer-based crown and bridge materials The European Standard EN ISO 10477:2004 has the status of a British Standard ICS 11.060.10 BS EN ISO 10477:2004 This British Standard was published under the authority of the Standards Policy and Strategy Commit

2、tee on 13 October 2004 BSI 13 October 2004 ISBN 0 580 44589 5 National foreword This British Standard is the official English language version of EN ISO 10477:2004. It is identical with ISO 10477:2004. It supersedes BS EN ISO 10477:1996 which is withdrawn. The UK participation in its preparation was

3、 entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/2, Prosthodontic materials, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement intern

4、ational or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purpo

5、rt to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee

6、 any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO f

7、oreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 21 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM

8、 EN ISO 10477 October 2004 ICS 11.060.10 Supersedes EN ISO 10477:1996 English version Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004) Art dentaire - Produits base de polymres pour couronnes et ponts (ISO 10477:2004) Zahnheilkunde - Kronen- und Brckenkunststoffe (ISO 10477:2004)

9、 This European Standard was approved by CEN on 10 September 2004. 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

10、references concerning such national standards may be obtained on application to the Central Secretariat 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 memb

11、er into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lith

12、uania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All

13、 rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10477:2004: E I NESO 01:7742004 (E) 2 Foreword This document (EN ISO 10477:2004) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee

14、 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 April 2005, and conflicting national standards shall be withdrawn at the latest by

15、April 2005. This document supersedes EN ISO 10477:1996. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germa

16、ny, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10477:2004 has been approved by CEN as EN ISO 10477:2004 without any modifi

17、cations. ENISO10477:2004 Reference number ISO 10477:2004(E) OSI 4002INTERNATIONAL STANDARD ISO 10477 Second edition 2004-10-01 Dentistry Polymer-based crown and bridge materials Art dentaire Produits base de polymres pour couronnes et ponts ENISO10477:2004IS:77401 O4002(E) DPlcsid Fremia ihTs PDF fi

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22、 cirypothg fofice saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mail coirypthgiso.o gr We bwww.is.o gro Pulbisdehi n Switlrez dnaii ISO 4002 Allr ithgsr esedevrENISO10477:2004IS:77401 O4002(E) I SO 4002 All irthgs ersedevr iiiContents Page Foreword iv Introductio

23、n v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Classification. 2 5 Requirements 2 5.1 Biocompatibility 2 5.2 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials . 2 5.3 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials 3

24、 5.4 Surface finish 3 5.5 Flexural strength . 3 5.6 Bond strength 4 5.7 Water sorption. 4 5.8 Solubility 4 5.9 Shade consistency 4 5.10 Colour stability 4 6 Sampling 4 6.1 For all tests 4 6.2 For test of shade consistency . 4 6.3 For test of colour stability 5 7 Test methods. 5 7.1 General. 5 7.2 Vi

25、sual inspection. 5 7.3 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials . 5 7.4 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials 7 7.5 Surface finish 7 7.6 Flexural strength . 8 7.7 Bond strength 11 7.8 Water sorption and solubility 13 7.9

26、 Shade consistency and colour stability . 16 8 Packaging and labelling . 17 8.2 Labelling. 18 9 Manufacturers instructions and information for the user 19 9.1 Instructions for use. 19 9.2 Shade guide. 20 Bibliography . 21 ENISO10477:2004IS:77401 O4002(E) iv I SO 4002 All irthgs ersedevrForeword ISO

27、(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 comm

28、ittee 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 electrote

29、chnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the memb

30、er bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 identifyi

31、ng any or all such patent rights. ISO 10477 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This second edition cancels and replaces the first edition (ISO 10477:1992), which has been technically revised. It also incorporates the amendment ISO 1

32、0477:1992/Amd.1:1998. The following changes were made: a) addition of a bonding test; b) addition of a table for the test protocol and two tables of results. ENISO10477:2004IS:77401 O4002(E) I SO 4002 All irthgs ersedevr vIntroduction Specific qualitative and quantitative requirements for freedom fr

33、om biological hazards are not included in this International Standard. Assessment of possible biological hazards is covered in ISO 10993-1 and ISO 7405. ENISO10477:2004blank ENISO10477:2004INTENRATIONAL TSANDADR IS:77401 O4002(E)I SO 4002 All irthgs ersedevr 1Dentistry Polymer-based crown and bridge

34、 materials 1 Scope This International Standard classifies polymer-based dental crown and bridge materials and specifies their requirements. It also specifies the test methods to be used to determine compliance with these requirements. This International Standard is applicable to polymer-based dental

35、 crown and bridge materials for laboratory- fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion to the metal substructure without macrome

36、chanical retention such as beads or wires. This International Standard is not applicable to polymer-based materials that are used to make crowns, veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas of posterior teeth. 2 Normative referenc

37、es The following referenced documents are indispensable for the application 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 1562, Dentistry Casting gold alloys ISO 36

38、96:1987, Water for analytical laboratory use Specification and test methods ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method ISO 7491, Dental materials Determination of colour stability ISO

39、8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 8891, Dental casting alloys with noble metal content of at least 25 % but less than 75 % 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1

40、 polymer-based crown and bridge material composition of powders and liquids or pastes that may contain monomers, inorganic and/or polymeric fillers and that, when polymerized, is suitable for its intended use as permanent dental facings or anterior crowns NOTE Polymerization is effected by mixing in

41、itiator(s) and activator(s) (“self-curing” materials) and/or by external energy activation by heat (“heat-curing” materials), photoactivated materials, by visible light (“light-curing” materials) and/or by UV radiation. ENISO10477:2004IS:77401 O4002(E) 2 I SO 4002 All irthgs ersedevr3.2 dentine resi

42、n pigmented and slightly translucent polymer-based crown and bridge material that simulates the natural appearance of dentine 3.3 enamel resin translucent and slightly pigmented polymer-based crown and bridge material that is packed in a layer over the dentine resin and that simulates the natural ap

43、pearance of enamel 3.4 cervical resin intensely pigmented and slightly translucent polymer-based crown and bridge material with a colour that simulates the natural appearance of dentine of the cervical region of the tooth 3.5 opaque resin intensely pigmented polymer-based crown and bridge material f

44、or masking the underlying metal substructure 4 Classification The polymer-based crown and bridge materials described in this International Standard shall be classified according to their activation system for polymerization. Type 1 polymer-based crown and bridge materials whose setting is effected b

45、y mixing initiator(s) and activator(s) (“self-curing” materials); Type 2 polymer-based crown and bridge materials whose setting is effected by the application of energy from an external source (“external-energy-activated” materials), such as heat and/or light or UV radiation; Class 1 polymer-based c

46、rown and bridge materials that do not contain a light or UV-sensitive initiator; Class 2 polymer-based crown and bridge materials that contain a light or UV-sensitive initiator; Type 3 polymer-based crown and bridge materials whose setting is effected by mixing initiator(s) and activator(s) and also

47、 by the application of energy from an external source (“dual-cure” materials). 5 Requirements 5.1 Biocompatibility See the Introduction for guidance on biocompatibility. 5.2 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials The polymer-based crown and bridge mate

48、rials Type 2, Class 2 shall remain physically homogeneous when exposed to ambient light (see Table 1). Testing shall be carried out in accordance with 7.3. NOTE For Type 1, Type 2, Class 1 and Type 3 materials, no requirement is specified. ENISO10477:2004IS:77401 O4002(E) I SO 4002 All irthgs ersede

49、vr 3Table 1 Test protocol Type 2 Subclause Property Type 1 Class 1 Class 2 Type 3 5.2 Sensitivity to ambient light + 5.3 Depth of cure + a 5.4, 5.5 Surface finish, flexural strength + a+ a+ a+ a5.6 Bond strength + + + + 5.7 to 5.10 Water sorption, solubility, shade consistency, colour stability + a+ a+ a+ a+ carry out test; do not test. aIf the material is opaque resin, do not test. 5.3 Dept