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1、BRITISH STANDARD BS EN ISO 16744:2003 Incorporating Corrigendum No.1 Dentistry Base metal materials for fixed dental restorations The European Standard EN ISO 16744:2003 has the status of a British Standard ICS 11.060.10 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00:00 200
2、6, Uncontrolled Copy, (c) BSI BS EN ISO 16744:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 23 December 2003 BSI 17 March 2004 ISBN 0 580 43153 3 National foreword This British Standard is the official English language version of EN IS
3、O 16744:2003. It is identical with ISO 16744:2003. The UK participation in its preparation was 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 obtai
4、ned on request to its secretary. Cross-references The British Standards which implement international 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 o
5、f the BSI Electronic Catalogue or of British Standards Online. This publication does not purport 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
6、 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. Summary of pages Thi
7、s document comprises 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 8, the Annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendment
8、s issued since publication Amd. No. DateComments 15060 Corrigendum No.1 17 March 2004Corrected EN ISO Foreword page and incorporation of Annex ZA page Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISC
9、HE NORM EN ISO 16744 December 2003 ICS 11.060.10 English version Dentistry - Base metal materials for fixed dental restorations (ISO 16744:2003) Art dentaire - Alliages dentaires en mtaux pour les restaurations fixes (ISO 16744:2003) Zahnheilkunde - Nichtedelmetall-Werkstoffe fr festsitzenden Zahner
10、satz (ISO 16744:2003) This European Standard was approved by CEN on 9 December 2003. 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 a
11、nd bibliographical references concerning such national standards may be obtained on application to the Management Centre 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 responsibil
12、ity of a CEN member into its own language and notified to the Management Centre 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, Hungary, Iceland, Ireland, Italy, Luxembourg, Ma
13、lta, Netherlands, Norway, Portugal, Slovakia, 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 2003 CENAll rights of exploitation in any form and
14、by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16744:2003 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI I NESO 61:4472003 (E) 2 CORRECTED 2004-03-03 Foreword This document (EN ISO 16744:2003) has been prepared
15、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 standard, either by publication of an identical text or by endorsement, at the latest
16、 by June 2004, and conflicting national standards shall be withdrawn at the latest by June 2004. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark
17、, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 16744:2003 has been approved by CEN as EN ISO 16744:2003 without any modifications.
18、NOTE Normative references to International Standards are listed in Annex ZA (normative). EN ISO 16744:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 16744 First edition 2003-12-15 Reference number ISO 16744:2
19、003(E) OSI 2003 Dentistry Base metal materials for fixed dental restorations Art dentaire Produits dentaires base mtallique pour les restaurations fixes EN ISO 16744:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO :44761(3002)E ii I
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25、d Copy, (c) BSI ISO 47613002:4)E( ISO 3002 r llAithgs reservde 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
26、 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with
27、 the International 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 2. The main task of technical committees is to prepare International Standards. Draft Intern
28、ational 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 bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may
29、be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 16744 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. EN ISO 16744:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17
30、10:08:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO :44761(3002)E iv ISO 3002 All rithgs reresvde Introduction Dental base metal materials are suitable for use in fabrication of fixed dental restorations. Specific qualitative and quantitative requirements for freedom from biological hazard are n
31、ot included in this International Standard but it is recommended that, in assessing possible biological hazards, reference be made to ISO 10993-1 and ISO 7405. For base metal materials that are also intended as the substructure of a metal-ceramic dental restorative system, ISO 9693 also applies. EN
32、ISO 16744:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ANRETNIITOTS LANDNADRAISO 47613002:4)E( ISO 3002 r llAithgs reservde 1 Dentistry Base metal materials for fixed dental restorations 1Scope This International Standard gives the c
33、lassification of, and specifies requirements and test methods for, metallic materials with a base metal as the main constituent. It applies to base metal materials suitable for use in the fabrication of fixed dental restorations. This International Standard is not applicable to base metal materials
34、intended for use in the fabrication of removable appliances, for which ISO 6871-1 and ISO 6871-2 apply. 2Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the l
35、atest edition of the referenced document (including any amendments) applies. ISO 3585, Borosilicate glass 3.3 Properties ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method ISO 6892, Metallic mater
36、ials Tensile testing at ambient temperature 3Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 alloy substance with metallic properties and composed of two or more elements, of which at least one is a metal 3.2 alloying element element added to o
37、r retained by a metal or alloy for the purpose of giving the resulting alloy particular properties 3.3 impurity element present but which is not intentionally added to or retained by a metal 3.4 base metal any metallic element with the exception of gold, silver, platinum, palladium, ruthenium, iridi
38、um, rhodium and osmium 3.5 base metal material base metal or an alloy with a base metal as main constituent EN ISO 16744:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO :44761(3002)E 2 ISO 3002 All rithgs reresvde 4Classification Fo
39、r the purposes of this International Standard, dental base metal materials are classified, according to their mechanical properties and the application for which they are recommended, as follows: Type 1: Low strength: for applications subject to very slight stress, e.g. inlays. Type 2: Medium streng
40、th: for applications subject to moderate stress, e.g. inlays, onlays and full crowns. Type 3: High strength: for applications subject to high stress, e.g. onlays and overlays, crowns, thin cast backings, pontics, and implant-retained suprastructures. Type 4: Extra high strength: for applications sub
41、ject to very high stress, e.g. veneered single crowns, long- span bridges or bridges with small cross-sections, bars, attachments, and implant-retained suprastructures. 5Requirements 5.1Chemical composition 5.1.1General All alloying elements which are present in more than mass fraction shall not dev
42、iate from the composition value stated on the package or label or insert 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 on the package or label or insert by more than mass fraction. 5.1.2Hazardous elemen
43、ts For the purpose of this International Standard, the elements nickel, cadmium and beryllium are defined to be hazardous elements. The alloy shall not contain more than mass fraction of cadmium and/or beryllium. If the alloy contains more than mass fraction of nickel, the percentage shall not excee
44、d the amount indicated on the package see 10.2 g) or label or insert see 9 b). 5.2Biocompatibility See the Introduction for guidance on biocompatibility. 5.3Mechanical properties The mechanical properties of the different types of dental base metal material shall comply with the requirements specifi
45、ed in Table 1. Table 1 Mechanical properties Type Proof strength of non-proportional elongation Percentage elongation after fracture 18018 218010 32406 44003 20 % 2 %1 % 20 % 1 % 0,02 % 0,1 % RP0,2 MPa% min.min. EN ISO 16744:2003 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:29 GMT+00
46、:00 2006, Uncontrolled Copy, (c) BSI ISO 47613002:4)E( ISO 3002 r llAithgs reservde 3 Testing shall be carried out in accordance with 7.1 and 8.3. 5.4Density The mass density shall not deviate by more than from the value stated by the manufacturer in the instructions see 9 h). 5.5Melting range The s
47、olidus and liquidus temperatures shall not deviate by more than from the values stated in the instructions see 9 i). 5.6Corrosion resistance The total amount of ions per surface area leached in seven days shall not exceed . Testing shall be carried out in accordance with 7.2 and 8.4. The corrosion r
48、esistance found by testing in accordance with 7.2 and 8.4 shall be classified according to Table 2. 6Sampling The sample shall be an adequate amount to prepare the specimens required in 7.1 and 7.2, including provision for a second set for tensile testing, and shall be from one lot. Further samples
49、and packaging materials shall be made available for inspection in accordance with 8.1. 7Preparation of test specimens 7.1Specimens for tensile testing For tensile testing in accordance with 8.3, prepare six specimens which conform to either Figure 1 or Figure 2. Test specimens shall be prepared in accordance with the manufacturers procedure for processing fixed dental restorations. Discard and replace specimens with visible defects.