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1、BRITISH STANDARD BS EN ISO 9333:2006 Dentistry Brazing materials The European Standard EN ISO 9333:2006 has the status of a British Standard ICS 11.060.10 ? Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN
2、 ISO 9333:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2006 BSI 2006 ISBN 0 580 49735 6 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 9333:2006. It supersedes BS EN 293
3、33:1992 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/2, Prosthodontic materials. A list of organizations represented on CH/106/2 can be obtained on request to its secretary. This publication does not purpor
4、t to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London
5、South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9333 July 2006 ICS 11.060.10Supersedes EN 29333:1991 English Version Dentistry - Brazing materials (ISO 9333:2006) Art dentaire - Produits pour brasage (ISO
6、9333:2006)Zahnheilkunde - Hartlote (ISO 9333:2006) This European Standard was approved by CEN on 14 July 2006. 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 alte
7、ration. 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 made by trans
8、lation 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, H
9、ungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Ce
10、ntre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9333:2006: E Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrol
11、led Copy, (c) BSI Foreword This document (EN ISO 9333:2006) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration 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 standar
12、d, either by publication of an identical text or by endorsement, at the latest by January 2007, and conflicting national standards shall be withdrawn at the latest by January 2007. This document supersedes EN 29333:1991. According to the CEN/CENELEC Internal Regulations, the national standards organ
13、izations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slo
14、vakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 9333:2006 has been approved by CEN as EN ISO 9333:2006 without any modifications. EN ISO 9333:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:
15、00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 9333 Second edition 2006-07-15 Reference number ISO 9333:2006(E) Dentistry Brazing materials Art dentaire Produits pour brasage EN ISO 9333:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:
16、14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national stand
17、ards 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 right to be represented on that committee. International orga
18、nizations, 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 Standards are drafted in accordance with the rules given
19、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 member bodies for voting. Publication as an International Standard requires approval by at least 75
20、% 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 identifying any or all such patent rights. ISO 9333 was prepared by Technical Committee ISO/TC 106, Denti
21、stry, Subcommittee SC 2, Prosthodontic materials. This second edition cancels and replaces the first edition (ISO 9333:1990), subclauses 4.1 and 4.4 of which have been technically revised: a)in 4.1 by the introduction of upper limits for cadmium, beryllium and lead; b)in 4.4 by a reduction in the me
22、chanical strength of a brazed joint; c)further, the requirement for flow temperature has been cancelled. EN ISO 9333:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank U
23、niversity, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Dentistry Brazing materials 1Scope This International Standard specifies requirements and test methods for brazing materials suitable for use in metallic restorations. 2Normative references The
24、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 1942, Dentistry Vocabulary ISO 6344-1, Coated abr
25、asives Grain size analysis Part 1: Grain size distribution test ISO 7405, Dentistry Preclinical evaluation of biocompatibility of medical devices used in dentistry Test methods for dental materials ISO 10271:2001, Dental metallic materials Corrosion test methods ISO 10993-1, Biological evaluation of
26、 medical devices Part 1: Evaluation and testing 3Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 brazing material alloy suitable for use as a filler material in operations in which dental alloy parts are joined by braz
27、ing to form dental appliances and restorations 3.2 noble metal gold, platinum, palladium, ruthenium, iridium, osmium and rhodium 3.3 base metal all metallic elements with the exception of noble metals and silver EN ISO 9333:2006 Licensed Copy: London South Bank University, London South Bank Universi
28、ty, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 4Requirements 4.1Chemical composition 4.1.1Reported composition For all elements that are present in excess of (mass fraction), the percentage by mass of each of the constituent elements shall be declared by the manufacturer and sh
29、all be reported as instructed in 8 c) to a precision of (mass fraction). Any element that is present in a concentration in excess of (mass fraction), but not in excess of (mass fraction), shall be identified as instructed in 8 c) either by name or symbol. 4.1.2Permitted deviation from the reported c
30、omposition For silver-based or noble-metal-based brazing materials the percentage of each of the constituents shall not deviate by more than (mass fraction) from the values stated in the manufacturers or distributors instructions for use see 8 c). For base-metal-based brazing materials, all elements
31、 present with more than (mass fraction) shall not deviate from the value stated in the manufacturers or distributors instructions for use by more than (mass fraction). Those present in excess of (mass fraction) but not in excess of (mass fraction) shall not deviate from the value stated in the manuf
32、acturers or distributors instructions for use by more than (mass fraction) see 8 c). 4.1.3Hazardous elements 4.1.3.1Recognised hazardous elements For the purposes of this document the elements nickel, cadmium, beryllium and lead are designated to be hazardous elements. 4.1.3.2Permitted limits for ha
33、zardous elements The brazing material shall not contain more than (mass fraction) of cadmium or beryllium or lead. If the brazing material contains more than (mass fraction) of nickel, the percentage shall not exceed the amount indicated on the package see 9.2 e) or insert see 8 d). 4.2Biocompatibil
34、ity Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard but it is recommended that, in assessing possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405. 4.3Corrosion resistance A comparison o
35、f the surface of the tested specimens with that of the untested specimens shall not reveal any visible evidence that a chemical reaction has occurred. Testing shall be carried out in accordance with 7.3. 1,0 % 0,1 %0,1 % 1,0 % 0,5 % 20 % 2 % 1 %20 % 1 % 0,02 % 0,1 % EN ISO 9333:2006 Licensed Copy: L
36、ondon South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 4.4Mechanical strength (tensile strength) of brazed joint The tensile strength shall exceed . If the proof strength of either one or both of the metallic materials to be joined
37、 by the brazing material is below , the tensile strength shall exceed the lower of the two. Testing shall be carried out in accordance with 7.4. 4.5Melting range The solidus temperature and the liquidus temperature of the brazing material shall be within of the values given in the manufacturers inst
38、ructions see 8 e). Testing shall be carried out in accordance with 7.5. 5Sampling The amount of test material shall be sufficient to prepare the specimens required in 6.2 and 6.3, including provision for a second set for tensile testing. 6Preparation of test specimens 6.1General The test specimens c
39、onsist of the recommended metallic materials joined with the brazing material according to the manufacturers instructions. Prepare the test specimens by the “lost wax process” of investment casting. Methods other than casting may be recommended by the manufacturer for the metallic material to be tes
40、ted with brazing materials. Use such a method, if recommended by the manufacturer. Follow the manufacturers instructions relating to the processing of the metallic material(s) and the brazing material including necessary aids, casting and brazing equipment as given in 8 f) and 8 g). 6.2Specimens for
41、 corrosion testing Prepare four pieces of dimensions approximately and clean the surfaces. Cut the samples in half . Use two halves of the pieces for brazing. If two different metallic materials are to be brazed, use one of each for the two halves. Set the gap between the cut pieces at . Use the rec
42、ommended flux and follow the manufacturers instructions on brazing. Following brazing remove at least from all surfaces of the samples using standard metallographic procedures ending with wet silicon carbide paper of grade P 1200 in accordance with ISO 6344-1. Use the same grinding paper solely for
43、the preparation of specimens of the same composition. 6.3Specimens for tensile testing Prepare a set of six specimens of the metallic material(s) to be brazed, which comply with either Figure 1 or Figure 2. Replace specimens that have visible shrinkage, defects or porosities. Cut the specimens of th
44、e set at right angles to its long axis at the midpoint of the gauge length using a fine saw. Remove rough edges. Grind the cut surface smooth, plane and perpendicular to the axis of the test specimen. Support the two halves of the specimens and align them in an investment or a rigid jig. If two diff
45、erent metallic materials are to be brazed, use one of each for the two halves. Set the gap between the cut pieces at . Use the recommended flux and follow the manufacturers instructions on brazing. After brazing, ensure that the diameter of each tensile specimen is within the tolerances given in Fig
46、ure 1 or Figure 2, and does not show visual evidence of radial run-out when rotated. 250 MPa0,2 % 250 MPa 20 C 10 mm10 mm1 mm (5 mm10 mm1 mm) (0,20,1) mm 0,1 mm (0,20,1) mm EN ISO 9333:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006,
47、 Uncontrolled Copy, (c) BSI 4 If the proof strength of non-proportional elongation of the dental metallic material for which the brazing material is recommended is less than , prepare an additional set of six specimens of the metallic material to be brazed to determine its proof strength. 7Testing 7
48、.1Visual inspection 7.1.1Specimens Without the aid of magnification, inspect the surface of specimens to be tested for visible defects. Replace any test specimens that have defects. 7.1.2Information and instructions, packaging and labelling Visually inspect to check that the requirements specified i
49、n Clauses 8 and 9 have been met. Dimensions in millimetres Figure 1 Test specimen with conical shoulders Dimensions in millimetres Figure 2 Test specimen with radial shoulders 250 MPa 0,2 % EN ISO 9333:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 03:58:14 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 5 7.2Chemical composition Determine the composition using analytical procedures with sensitivities appropriate to t