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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 12163:2000 The
2、European Standard EN ISO 12163:2000 has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dental baseplate/modelling wax Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This
3、 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 November 2000 BSI 11-2000 ISBN 0 580 36115 2 BS EN ISO 12163:2000 Amendments issued since publication A
4、md. No.DateComments National foreword This British Standard is the official English language version of EN ISO 12163:2000. It is identical with ISO 12163:1999. The UK participation in its preparation was entrusted to Technical Committee CH/51, Prosthodontic materials, which has the responsibility to
5、: 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 them in the UK. A list of organ
6、izations 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 corresponding European publications.
7、The British Standards which implement international or European publications referred to in this document 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 Catalogue. A Br
8、itish 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 comprises a fr
9、ont cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iii, a blank page, pages 1 to 9, the annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issue
10、d. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12163 August 2000 ICS 11.060.10 English version Dental baseplate/modelling wax (ISO 12163:1999) Cires dentaires modeler (ISO 12163:19
11、99)Dentale Basisplatten- und Modellierwachse (ISO 12163:1999) This European Standard was approved by CEN on 9 June 2000. 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 withou
12、t 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 official versions (English, French, German). A version in any other language mad
13、e 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, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland,
14、 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 Secretariat: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation
15、in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 12163:2000 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard from Technical Committee ISO/TC 106 “Denti
16、stry“ 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 shall be given the status of a national standard, either by publication of an id
17、entical text or by endorsement, at the latest by February 2001, and conflicting national standards shall be withdrawn at the latest by February 2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europea
18、n 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 notice The text of the International Standard ISO 12163:1999 has been approved b
19、y CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI A Reference number ISO 12163:1
20、999(E) INTERNATIONAL STANDARD ISO 12163 First edition 1999-05-01 Dental baseplate/modelling wax Cires dentaires modeler EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Foreword ISO (the International Organization for Sta
21、ndardization) 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 committee has been established has the righ
22、t 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 electrotechnical standardization. International
23、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 for voting. Publication as an International Standard requires approval by at least 75 % of the member bodi
24、es casting a vote. International Standard ISO 12163 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Introduction Thi
25、s International Standard does not specify the requirements for safety from biological or toxicological hazards. It is however recommended that reference be made to ISO 7405 and ISO 10993-1 for assessing possible biological or toxicological hazards. EN ISO 12163:2000 Licensed Copy: sheffieldun sheffi
26、eldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Dental baseplate/modelling wax 1 Scope This International Standard specifies the classification of,
27、 and requirements for, dental baseplate/modelling wax consisting of natural and synthetic waxes used principally in the construction of dentures, together with the test methods to be employed to determine compliance with those requirements. 2 Normative references The following normative documents co
28、ntain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to
29、 investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 1302, Tech
30、nical drawings Method of indicating surface texture. ISO 1942-2, Dental vocabulary Part 2: Dental materials. ISO 3336:1993, Dentistry Synthetic resin teeth. ISO 4824:1993, Dentistry Ceramic denture teeth. ISO 6873:1998, Dental gypsum products. 3 Classification Dental baseplate/modelling waxes are cl
31、assified according to the flow characteristics that represent their hardness, as follows: Type 1: Soft Type 2: Hard Type 3: Extra-hard 4 Requirements 4.1 Appearance The sheet wax shall be uniform in colour and thickness, of smooth texture and free of foreign materials. Use visual inspection (6.1) to
32、 determine compliance with this requirement. EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 4.2 Colour The colour of the wax shall be as stated by the manufacturer. Use visual inspection to determine compliance with this
33、 requirement (6.1). 4.3 Behaviour on softening When heated, the wax shall soften without crumbling or becoming flaky, and shall cohere readily and not laminate when formed into a working mass (6.1). 4.4 Behaviour on trimming The wax shall be trimmed easily and cleanly with a sharp instrument at (23,
34、0 2,0) oC without tearing, chipping or flaking (6.1). 4.5 Appearance after flaming The wax shall have a smooth glossy surface after sufficient flame heating to melt the wax superficially (6.1). 4.6 Residue The wax shall not leave a residue on ceramic or plastic teeth when tested as described in 6.2.
35、1. 4.7 Behaviour of colouring material The colouring material shall neither separate from the wax nor impregnate the gypsum mould when tested as described in 6.2.1. 4.8 Flow behaviour The samples of wax, when tested in accordance with 6.2.2, shall have flow properties complying with the requirements
36、 in Table 1. Table 1 Flow at certain temperatures Temperature Type 1 Type 2 Type 3 C Minimum (%) Maximum (%) Minimum (%) Maximum (%) Minimum (%) Maximum (%) (23,0 0,1) 1,0 0,6 0,2 (37,0 0,1) 5,0 90,0 10,0 1,2 (45,0 0,1) 50,0 90,0 5,0 50,0 EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na,
37、 Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 4.9 Adhesion on storage Self-adhesion during storage of the wax shall be such that when tested as described in 6.2.3, there shall be no evidence of damage to wax surfaces that have been in contact with each other or with the paper. Wh
38、ere separating paper is used, the wax and paper surfaces shall separate cleanly and readily. 5 Sampling The method of procurement and the amount of wax needed for testing shall be the subject of agreement between the interested parties. The material procured shall be from a single production batch.
39、6 Test methods 6.1 Visual inspection Use visual inspection in determining compliance with requirements specified in 4.1, 4.2, 4.3, 4.4 and 4.5. 6.2 Physical tests 6.2.1 Residue and colouring material 6.2.1.1 Apparatus 6.2.1.1.1 Metal former, of design illustrated in Figure 1, which incorporates a tr
40、ough 5 mm wide and at least 1,5 mm deep for use in mounting the teeth. 6.2.1.1.2 Normal dental laboratory apparatus for denture flasking and processing, as shown in Figure 1. 6.2.1.2 Procedure Place a strip of the test wax in the trough of the metal former. Mount three anterior synthetic polymer tee
41、th conforming to ISO 3336 and three ceramic teeth conforming to ISO 4824 into the wax as shown in Figure 1 a). Invest the metal former and mounted teeth in a denture flask using dental plaster or dental stone, or both, conforming to ISO 6873 see Figure 1b). Let the flask remain undisturbed for betwe
42、en 2 h and 3 h after pouring the plaster or stone in contact with the wax. Then immerse the flask in a water bath at (50 2) oC for 10 min, remove and open immediately. Strip out the metal block and the bulk of the wax, and flush the flask with a continuous stream of boiling water for (60 5) s. 6.2.1
43、.3 Evaluation When examined in accordance with 6.1, all exposed teeth and gypsum surfaces shall be free from wax residue. 6.2.2 Flow 6.2.2.1 Apparatus 6.2.2.1.1 Micrometer screw gauge, accurate to 0,005 mm or better. 6.2.2.1.2 Flow-testing instrument (see Figure 2),consisting of the following compon
44、ents: a) metallic cylinder (weight) (A); b) shaft having a low thermal conductivity (B); c) brass plate (C); d) measuring dial gauge (D), accurate to 0,005 mm or better; e) lock-nut screw (E). EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrol
45、led Copy, (c) BSI 4 Dimensions in millimetres a) b) Figure 1 Apparatus for test for residue and colouring material EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 5 Key AWeight BShaft CBrass plate DGauge ELock-nut screw Fig
46、ure 2 Flow-testing instrument EN ISO 12163:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 06:42:15 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 6 The total mass of the components A, B and C shall be such as to provide an axial compressive force of (19,6 0,1) N (equivalent to a mass of (2
47、000 10) g under standard gravity. The cylinder (A) shall be separated a minimum distance of 76 mm from the brass plate (C) by the shaft (B). This shaft shall be of hard rubber or a similarly poor thermal conductor, to reduce loss of heat from the specimen. The diameter of the brass plate (C) shall b
48、e not less than 50 mm, and the thickness not greater than 6,5 mm. 6.2.2.1.3 Mould (see Figure 3), consisting of a flat stainless steel plate, 6 mm thick, with parallel top and bottom surfaces. The plate shall have four holes, 10 mm in diameter, with the axes of the holes perpendicular to the surface
49、 of the plate. The sides of the holes shall have a smooth finish. 6.2.2.1.4 Metal pouring pan (see Figure 4) or similar porcelain pan with handle. 6.2.2.1.5 Controlled-temperature water bath, consisting of a sufficiently large container equipped with a temperature control device that maintains a specific water temperature accurate to 0,1 C and a stirring device that agitates the water continuously. 6.2.2.2 Preparation of test specimens Break a sufficient quantity of wax into pieces and place in the pan. Place the p