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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 11245:2000 The
2、European Standard EN ISO 11245:2000 has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dental restorations Phosphate-bonded refractory die materials Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006,
3、Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 September 2000 BSI 09-2000 ISBN 0 580 36053 9 BS EN ISO 11245:2000 Amend
4、ments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 11245:2000. It is identical with ISO 11245:1999. The UK participation in its preparation was entrusted to Technical Committee CH/51, Prosthodontic materials,
5、 which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate
6、 them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corre
7、sponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalo
8、gue. A British Standard does not 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 compr
9、ises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 11 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na,
10、 Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11245 June 2000 ICS 11.060.10 English version Dental restorations - Phosphate-bonded refractory die materials (ISO 11245:1999) Restaurations dentaires - Produits pour modles rfrac
11、taires liant phosphate (ISO 11245:1999) Dentale Restaurationen - Phosphatgebundene hitzebestndige Modellstumpfwerkstoffe (ISO 11245:1999) This European Standard was approved by CEN on 19 May 2000. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condition
12、s 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 Central Secretariat or to any CEN member. This European Standard exists in three offi
13、cial 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria,
14、Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretar
15、iat: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11245:2000 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The t
16、ext of the International Standard from Technical Committee ISO/TC 106 “Dentistry“ of the International Organization for Standardization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard shal
17、l be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2000, and conflicting national standards shall be withdrawn at the latest by December 2000. According to the CEN/CENELEC Internal Regulations, the national standards
18、organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement noti
19、ce The text of the International Standard ISO 11245:2000 has been approved by CEN as a European Standard without any modification. EN ISO 11245:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI A Reference number ISO 11245:1999(E) INTERNA
20、TIONAL STANDARD ISO 11245 First edition 1999-03-01 Dental restorations Phosphate-bonded refractory die materials Restaurations dentaires Produits pour modles rfractaires liant phosphate EN ISO 11245:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Cop
21、y, (c) BSI ii Contents 1 Scope1 2 Terms and definitions .1 3 Requirements.1 4 Sampling, test conditions and mixing.2 5 Test methods3 6 Instructions 7 7 Marking.7 Annex A (normative) Linear setting expansion9 Bibliography11 EN ISO 11245:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:2
22、7:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Foreword ISO (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. Ea
23、ch 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 collaborates closely with the Internatio
24、nal Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies fo
25、r voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 11245 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. Annex A forms a normative part of this In
26、ternational Standard. EN ISO 11245:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Introduction During preparation of this International Standard for phosphate-bonded refractory die material, consideration was made to address issues
27、regarding the linear setting expansion requirement. The importance of the setting expansion measurement relative to the performance of a phosphate-bonded refractory die material is recognized. However, measurement of the linear setting expansion with existing apparatus, method and techniques may pro
28、vide results with a high degree of variation. It is therefore recommended that the test remain in this International Standard as a normative annex until suitable means are available to achieve consistent results in the measurement of linear setting expansion. EN ISO 11245:2000 Licensed Copy: sheffie
29、ldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Dental restorations Phosphate-bonded refractory die materials 1 Scope This International Standard is applicable to phosphate bonded refractory die materials used in the production of dental restorations by a sinte
30、ring technique. It specifies requirements for the essential physical properties of the refractory die material and the test methods to be used to determine these properties. It also includes a requirement for adequate instructions to accompany each package. 2 Terms and definitions For the purposes o
31、f this International Standard, the following terms and definitions apply. 2.1 refractory die material powder mixture of a refractory filler system and a binding system specially designed so that when mixed with a liquid it forms a hardened die suitable for the production of dental ceramic restoratio
32、ns using the sintering technique NOTE The refractory filler system usually consists of refractory oxides such as silica. The binding system usually consists mainly of an acidic phosphate such as ammonium dihydrogenphosphate together with a basic oxide such as magnesium oxide. When the mixture is mix
33、ed with a suitable liquid it forms a paste that hardens at room temperature to form a refractory die. The suitable liquid may be the special liquid (2.2), the special liquid diluted with water, or it can be water alone. 2.2 special liquid liquid made available by the manufacturer or supplier for mix
34、ing with the powder mixture NOTE The special liquid usually consists mainly of a suspension of colloidal silica particles in water. 3 Requirements 3.1 Quality The powder (2.1) shall be uniform and free from foreign matter and lumps when examined visually. If a special liquid (2.2) is required, it sh
35、all be free of sediment. 3.2 Fluidity The diameter of the base of the set mass shall be at least 70 mm. Test in accordance with 5.1. 3.3 Setting time The setting time shall not differ by more than 30 % from the time stated by the manufacturer. If the manufacturer gives a range of setting time, then
36、the setting time shall not differ from the midpoint of this range by more than 30 %. Test in accordance with 5.2 and report in accordance with 6 h). EN ISO 11245:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3.4 Compressive strength
37、 The compressive strength of the set refractory die material shall be not less than 13 MPa. Test in accordance with 5.3 and report in accordance with 6 j). 3.5 Linear setting expansion For the reasons stated in Introduction, the linear setting expansion requirement shall be as specified in clause A.
38、1 of annex A. 3.6 Linear thermal dimensional change The linear dimensional change after firing (degassing) and the linear thermal expansion shall not differ by more than 15 % from the values stated by the manufacturer. If the manufacturer gives a range of linear thermal change after firing and a ran
39、ge of linear thermal expansion, then the values shall not differ from the midpoint of these ranges by more than 15 %. Test in accordance with 5.5 and report according to 6 k). 4 Sampling, test conditions and mixing 4.1 Sampling The date when material is tested shall not be later than the expiry date
40、 see 7.1 f) stated on the package. Sufficient retail packages of the material of one batch shall be obtained to provide at least 3 kg of material. Any packages that are not sealed shall be discarded. When the powder is supplied in bulk, it shall be thoroughly blended and stored in a moisture-proof c
41、ontainer. If a special liquid is recommended by the manufacturer 6 d), an adequate supply shall be obtained. 4.2 Test conditions All test specimen preparation shall be carried out in an environment at (23 1) C and (50 10) % relative humidity. All specimens should remain in this environment until the
42、y are ready to be tested. Testing according to 5.1, 5.2, 5.3, 5.4 and 5.5 shall be carried out at (23 1) C and (50 10) % relative humidity. All other testing of the die material shall be carried out in a room shielded from obvious draughts and at (23 2) C and (50 10) % relative humidity. All test eq
43、uipment shall be clean, dry and at test temperature. Before testing begins, material shall be held for at least 16 h at the test conditions of temperature and humidity. 4.3 Mixing 4.3.1 Apparatus 4.3.1.1 Clean apparatus for mechanical mixing in vacuum as recommended by the manufacturer and used excl
44、usively for phosphate-bonded materials. 4.3.1.2 Timing device, such as a stopwatch. 4.3.2 Test procedure Measure, to within 1 %, the required mass of powder and the required volume of liquid in the mixture ratio given by the manufacturer 6 c). If the manufacturer specifies a range of concentrations
45、or volumes for the liquid, use the mean concentration or volume. Pour the liquid into the mixing bowl and sift the powder into the liquid within 10 s, minimizing entrapment of air. Begin timing from the moment the powder and liquid first make contact. Hand spatulate for (15 1) s. Mechanically mix fo
46、r the time specified by the manufacturer and then transfer the mix to the test moulds or form within 15 s. EN ISO 11245:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:27:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 5 Test methods 5.1 Fluidity 5.1.1 Apparatus 5.1.1.1 Clean dry cyli
47、ndrical mould having a length of (50 1) mm and an inside diameter of (35 1) mm, constructed from a corrosion-resistant, non-absorbent material. 5.1.1.2 Mould-release agent such as dry silicone spray. 5.1.1.3 Flat, square glass plate, of dimensions at least 150 mm by 150 mm. 5.1.1.4 Dental vibrator o
48、perating on 50 Hz or 60 Hz power supply. 5.1.1.5 Scale graduated in millimetres to measure the major and minor diameters of the slumped mix. 5.1.2 Test procedure Coat the inside surface of the mould with mould-release agent. Mix the material as described in 4.3 using 200 g of powder. Start the timin
49、g device when the powder and the liquid first make contact. Centre the mould base on the glass plate and place it on the dental vibrator platform. Pour the mix into the mould until it is slightly overfilled. After filling, vibrate for 5 s. Level the mix flush with the top of the mould. At (120 2) s from the start of mixing, lift the mould vertically from the plate at a rate of approximately 10 mm/s, allowing the mix to slump on the plate. As soon as the material has set, measure the largest and the smallest diameters o
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