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1、BRITISH STANDARD BS EN ISO 10477:1996 Incorporating Amendment No. 1 to BS 7651:1993 (renumbers the BS as BS EN ISO 10477:1996) and incorporating Amendment No. 1 and Corrigendum No. 1 to BS EN ISO 10477:1996 Dentistry Polymer-based crown and bridge materials The European Standard EN ISO 10477:1996, w
2、ith the incorporation of amendment A1:2000, has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10477:1996 This B
3、ritish Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 April 1993 BSI 03-2001 The following BSI references relate to the work on this standard: Committee reference H
4、CC/51 Draft for comment 93/500576 DC ISBN 0 580 21722 1 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/51, upon which the following bodies were represented: Assoc
5、iation of Dental Hospitals of the United Kingdom British Ceramic Research Ltd. British Dental Association British Dental Trade Association British Institute of Surgical Technologists British Society for Restorative Dentistry British Society for the Study of Orthodontics British Society for the Study
6、 of Prosthetic Dentistry British Society of Periodontology Dental Laboratories Association Limited Dental Materials Panel Department of Health Gypsum Products Development Association Institute of Physics Ministry of Defence Orthodontic Technicians Association Plastics and Rubber Institute Royal Soci
7、ety of Medicine Society of University Dental Instructors Amendments issued since publication Amd. No.DateComments 9230September 1996 11032January 2001 13104 Corr. No. 1 March 2001Correction to front cover Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:24:12 GMT+00:00 2006, Uncontrolled Co
8、py, (c) BSI BS EN ISO 10477:1996 BSI 03-2001 i Contents Page Committees responsibleInside front cover National forewordii Foreword2 1Scope3 2Normative references3 3Definitions3 4Classification3 5Requirements3 6Sampling4 7Test methods4 8Manufacturers instructions and shade guide11 9Packaging12 10Mark
9、ing12 Annex ZA (normative) Normative references to international publications with their relevant European publications13 Figure 1 Preliminary mould for preparation of test specimens6 Figure 2 Split mould for preparation of test specimens for the flexural test, made from stainless steel7 Figure 3 Ap
10、paratus for testing shear bond strength10 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10477:1996 ii BSI 03-2001 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy C
11、ommittee and is identical with ISO 10477:1992 Dentistry Polymer-based crown and bridge materials, including amendment A1:1998, prepared by Technical Committee 106, Dentistry, of the International Organization for Standardization (ISO). In 1996 the European Committee for Standardization (CEN) accepte
12、d ISO 10477:1992 as European Standard EN ISO 10477:1996. As a consequence of implementing the European Standard this British Standard is renumbered as BS EN ISO 10477:1996 and any reference to BS 7651:1993 should be read as a reference to BS EN ISO 10477:1996. The introduction to ISO 10477:1992 read
13、s as follows: “Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this International Standard but it is recommended that, in assessing possible biological or toxicological hazards, reference should be made to ISO/TR 7405:1984, Biological evalua
14、tion of dental materials, or any more recent edition. Although this International Standard does not require manufacturers to declare details of the composition, attention is drawn to the fact that some national or international authorities require details to be provided to them.” In the UK it is com
15、mon practice to assess the biological hazards of dental materials using BS 5828:1989 Methods for biological assessment of dental materials. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Cat
16、alogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. The Technical Committee has reviewed the provisions of ISO 6507-2:1983, to which normative reference is made in the text, and has decided that
17、they are acceptable for use in conjunction with this standard. A related British Standard to ISO 6507-2:1983 is BS 5600-4.6:1987 Power metallurgical materials and products Part 4: Methods of testing and chemical analysis of hard metals Section 4.6: Vickers hardness test. A British Standard does not
18、purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside fro
19、nt cover, pages i and ii, the EN ISO title page, pages 2 to 13 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDA
20、RD NORME EUROPENNE EUROPISCHE NORM EN ISO 10477 March 1996 + A1 May 2000 ICS 11.060.10 Descriptors: Dentistry, dental materials, resins, classification, specifications, tests, determination, stability, colour English version Dentistry Polymer based crown and bridge materials (includes amendment A1:2
21、000) (ISO 10477:1992 + A1:1998) Art dentaire Produits base de polymre pour couronnes et ponts (inclut lamendement A1:2000) (ISO 10477:1992 + A1:1998) Zahnheilkunde Kronen- und Brckenkunststoffe (enthlt nderung A1:2000) (ISO 10477:1992 + A1:1998) This European Standard was approved by CEN on 1996-01-
22、28. Amendment A1 was approved by CEN on 2000-04-17. 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 con
23、cerning 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 member into its ow
24、n 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerlan
25、d and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN ISO 10477:1996 + A1:2000 E Licensed Copy: sheffieldun sheffieldun
26、, na, Thu Nov 16 07:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10477:1996 BSI 03-2001 2 Foreword The text of the International Standard from Technical Committee ISO/TC 106, Dentistry, of the International Organization for Standardization (ISO) has been taken over as a European Standard
27、by the 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 September 1996, and conflicting national standards shall b
28、e withdrawn at the latest by September 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembo
29、urg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Foreword to amendment A1 The text of this amendment EN 10477:1996/A1:2000 to the EN 10477:1996 from Technical Committee ISO/TC 106, Dentistry, of the International Organization for Standardization (ISO) has been taken ov
30、er as an amendment to the European Standard by Technical Committee CEN/TC 55, Dentistry, the Secretariat of which is held by DIN. This amendment to the European Standard EN ISO 10477:1996 shall be given the status of a national standard, either by publication of an identical text or by endorsement,
31、at the latest by November 2000, and conflicting national standards shall be withdrawn at the latest by November 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cz
32、ech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:24:12 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10477:1996
33、 BSI 03-2001 3 1 Scope This International Standard covers polymer-based crown and bridge materials for laboratory-fabricated permanent facings or anterior crowns which may or may not be attached to a metal substructure. It excludes polymer-based materials which are used by the dentist to make crowns
34、 or veneers, or for repairs at the operatory. Nor does it cover the application of those materials for stress-bearing areas of posterior teeth. This International Standard applies to polymer-based crown and bridge materials for which the manufacturer claims adhesion to the metal sub-frame without ma
35、cromechanical retention, such as beads or wires. It does not apply to denture base polymer and its adhesion to metal alloys, or to ceramic and its bonding to alloys. This International Standard classifies polymer-based crown and bridge materials and specifies the requirements: it also specifies the
36、test methods to be used to determine compliance with these requirements. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All s
37、tandards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
38、ISO 1562:1993, Dental casting gold alloys. ISO 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 6507-2:1983, Metallic materials Hardness test Vickers test Part 2: HV 0,2 to less than HV 5. ISO 7491:1985, Dental materials Determination of colour stability of dental p
39、olymeric materials. ISO 8601:1988, Data elements and interchange formats Information interchange Representation of dates and times. ISO 8891:1993, Dental casting alloys with noble metal content of 25 % up to but not including 75 %. 3 Definitions For the purposes of this International Standard, the f
40、ollowing definitions apply. 3.1 polymer-based crown and bridge material composition of powders and liquids or pastes which may contain monomer, polymeric and/or inorganic fillers the crown and bridge materials polymerize by heat, chemical activation or photoactivation to be suitable for the intended
41、 use as permanent facings or anterior crowns 3.2 dentine resin pigmented and slightly translucent polymer-based crown and bridge material with a colour suitable to imitate the natural colour of dentine 3.3 enamel resin translucent and slightly pigmented polymer-based crown and bridge material suitab
42、le to imitate the natural colour of the tooth enamel packed in a layer over the dentine resin 3.4 cervical resin intensely pigmented and slightly translucent polymer-based crown and bridge material with a colour suitable to imitate the natural dentine colours of the cervical part of the tooth 3.5 op
43、aque resin intensely pigmented polymer-based crown and bridge material suitable to mask the underlying metal substructure 4 Classification The materials described in this International Standard are classified according to their activation system: 5 Requirements 5.1 Components When a component is sup
44、plied in the form of a powder, it shall be free of extraneous matter. When a component is supplied in the form of a liquid, it shall be free of deposits and/or sediment. The viscosity of the liquid shall not increase, and the liquid shall not discolour. When a component is supplied in the form of a
45、paste, it shall be free of extraneous matter. Type 1heat-activated material; Type 2chemically activated (self-curing) material; Type 3photoactivated- (light and/or UV radiation-activated) material. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:24:12 GMT+00:00 2006, Uncontrolled Copy, (c)
46、 BSI EN ISO 10477:1996 4 BSI 03-2001 Testing shall be carried out in accordance with 7.2 and 7.3. 5.2 Polymerized crown and bridge material 5.2.1 Biocompatibility See the introduction for guidance on biocompatibility. 5.2.2 Depth of cure For types 1 and 2, no requirement is specified. For type 3, th
47、e hardness of the bottom surface shall not be less than 70 % of that of the top surface (i.e. the surface towards the radiation) for 1 mm thick specimens of cervical resins and for 2 mm thick specimens of dentine resins and enamel resins. Testing shall be carried out in accordance with 7.4. 5.2.3 Su
48、rface finish A test specimen polished in accordance with 7.5 shall have a highly polished surface. Testing shall be carried out in accordance with 7.2 and 7.5. 5.2.4 Flexural strength The flexural strength, B, in megapascals, shall be at least 50 MPa, and shall be not lower than the value N = (flexu
49、ral modulus? 0,0025) + 40 MPa. Testing shall be carried out in accordance with 7.6. 5.2.5 Water absorption The water absorption of the polymer-based crown and bridge material shall not exceed 32?g/mm3. Testing shall be carried out in accordance with 7.7. 5.2.6 Solubility The solubility of the polymer-based crown and bridge material shall not exceed 5?g/mm3. Testing shall be carried out in accordance with 7.7. 5.2.7 Colour and translucency The colour and translucency of the polymer-based crown
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