DIN EN ISO 22674-2016 Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674 2016) German version EN ISO 22674 2016《牙科 固定和可移动复位的金属材料和器具(ISO 2.pdf

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1、September 2016 English price group 19No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.060.10!%$g“2560168www.din.d

2、eDIN EN ISO 22674Dentistry Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016);English version EN ISO 22674:2016,English translation of DIN EN ISO 22674:2016-09Zahnheilkunde Metallische Werkstoffe fr festsitzenden und herausnehmbaren Zahnersatz und Applikationen (

3、ISO 22674:2016);Englische Fassung EN ISO 22674:2016,Englische bersetzung von DIN EN ISO 22674:2016-09Mdecine buccodentaire Matriaux mtalliques pour les restaurations fixes et amovibles et les appareillages (ISO 22674:2016);Version anglaise EN ISO 22674:2016,Traduction anglaise de DIN EN ISO 22674:20

4、16-09SupersedesDIN EN ISO 22674:200702www.beuth.deDocument comprises 46 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.09.16 DIN EN ISO 22674:2016-09 2 A comma is used as the decimal marker. National foreword This document (EN

5、 ISO 22674:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Wo

6、rking Committees NA 014-00-17-01 AK Metallische Werkstoffe and NA 014-00-17 AA Metalle. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 5832-2 DIN EN ISO 5832-2 ISO 5832-3 DIN E

7、N ISO 5832-3 ISO 6344-1 DIN ISO 6344-1 ISO 6892-1 DIN EN ISO 6892-1 ISO 9513 DIN EN ISO 9513 ISO 9693-1 DIN EN ISO 9693-1 ISO 10271 DIN EN ISO 10271 ISO 15223-1 DIN EN ISO 15223-1 Amendments This standard differs from DIN EN ISO 22674:2007-02 as follows: a) for the determination of the corrosion res

8、istance, reference is now made to the current International Standard ISO 10271:2011; b) for the determination of the tarnish resistance, a second test has been added and reference has been made to ISO 10271:2011; c) the designation “free of has been clarified in the clauses specifying the requiremen

9、ts for composition ” and labelling; d) lead has been added as a hazardous element; e) the elasticity measurement has been revised. In addition to the calculation of the elastic modulus using an extensometer, the flexure method in three- or four-point bending mode and the acoustic resonance method ha

10、ve been included as alternative methods; f) an informative Annex A dealing with the tensile testing of a non-cast Type 0 metallic material that is intended for use in a thickness between 0,1 mm and 0,5 mm has been added; g) a normative Annex B covering the calculation of uncertainty for elasticity m

11、easurement has been added; h) an informative Annex C for the measurement of the Poisson ratio has been added. DIN EN ISO 22674:2016-09 3 Previous editions DIN 13912: 1974-12, 1982-03, 1996-06 DIN 13906: 1975-08, 1982-02 DIN 13906-1: 1990-07 DIN 13906-2: 1988-03 DIN 13912-2: 1989-06, 1990-09 DIN EN 2

12、8891: 1991-09 DIN EN 26871: 1994-11 DIN EN ISO 1562: 1995-04, 2004-08 DIN EN ISO 8891: 1995-05, 2000-11 DIN EN ISO 6871-1: 1996-12 DIN EN ISO 6871-1 Corrigendum 1: 2000-03 DIN EN ISO 6871-2: 1996-12 DIN EN ISO 16744: 2004-05 DIN EN ISO 22674: 2007-02 National Annex NA (informative) Bibliography DIN

13、EN ISO 1942, Dentistry Vocabulary DIN EN ISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titanium DIN EN ISO 5832-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy DIN EN ISO 6892-1, Metallic materials Tensile testing Part 1: Metho

14、d of test at room temperature DIN EN ISO 9513, Metallic materials Calibration of extensometer systems used in uniaxial testing DIN EN ISO 9693-1, Dentistry Compatibility testing Part 1: Metal-ceramic systems DIN EN ISO 10271, Dentistry Corrosion test methods for metallic materials DIN EN ISO 15223-1

15、, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General rules DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test D

16、IN EN ISO 22674:2016-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22674 February 2016 ICS 11.060.10 Supersedes EN ISO 22674:2006English Version Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016) Mdecin

17、e bucco-dentaire - Matriaux mtalliques pour les restaurations fixes et amovibles et les appareillages (ISO 22674:2016) Zahnheilkunde - Metallische Werkstoffe fr festsitzenden und herausnehmbaren Zahnersatz und Applikationen (ISO 22674:2016) This European Standard was approved by CEN on 24 October 20

18、15. 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 concerning such national standards may be obtained

19、on application to the CEN-CENELEC 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 responsibility of a CEN member into its own language and notified to the CEN-CEN

20、ELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Ita

21、ly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Ave

22、nue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22674:2016 EForeword .5Introduction .61 Scope .72 Normative references 73 Terms and definitions .74 Classification 95 Requirements .105.1 Chemi

23、cal composition .105.1.1 Reported composition 105.1.2 Permitted deviation from the reported composition for elements .105.2 Hazardous elements 105.2.1 Hazardous elements 105.2.2 Limits for the hazardous elements cadmium and beryllium 105.2.3 Limit for lead 105.2.4 Nickel 115.3 Biocompatibility .115.

24、4 Mechanical properties .115.4.1 General.115.4.2 Proof stress of 0,2 % non-proportional extension 125.4.3 Elongation after fracture 125.5 Elastic modulus .135.5.1 Precision of measurement method .135.5.2 Determination of compliance with the requirements for Type 5 materials135.5.3 Mean value .145.6

25、Density 145.7 Corrosion resistance for material integrity .145.8 Tarnish resistance .145.9 Solidus and liquidus temperatures (alloy) or melting point (commercially pure metal) .145.10 Thermal expansion coefficient .145.11 Information, instructions and marking 156 Sampling .157 Preparation of test sp

26、ecimens .157.1 General 157.2 Heat treatment .157.2.1 General conditions 157.2.2 Metallic materials for which a heat treatment is recommended in the manufacturers instructions for use .157.2.3 Metallic material for metal-ceramic restorations .157.2.4 Metallic materials for which no heat-treatment is

27、recommended in the manufacturers instructions for use .157.3 Proof stress of 0,2 % non-proportional extension and the elongation after fracture: Metallic materials for which production of conventional specimens is possible .167.4 Type 0 metallic materials for which the production of conventional spe

28、cimens is not possible .177.5 Elastic moduli 177.5.1 General.177.5.2 Tensile strain method .177.5.3 Flexure method (three or four point bending) .177.5.4 Acoustic resonance method 187.6 Density measurement 19Contents Page2EN ISO 22674:2016 (E)DIN EN ISO 22674:2016-09 European foreword .47.9 Linear t

29、hermal expansion 198 Test methods 198.1 Information, instructions and marking 198.2 Chemical composition . 208.3 Mechanical testing 208.3.1 Apparatus 208.3.2 Test procedure 208.4 Proof stress of 0,2 % non-proportional extension 218.4.1 Calculation 218.4.2 Mean value .218.5 Percentage elongation afte

30、r fracture 218.5.1 Calculation 218.5.2 Mean value .218.6 Elastic modulus measurement . 218.6.1 Tensile strain method .218.6.2 Flexure method in three- or four-point bending mode .228.6.3 Acoustic resonance method 248.7 Calculation of elasticity parameters from acoustic measurement 258.7.1 General. 2

31、58.7.2 Elastic modulus 268.7.3 Shear modulus 268.7.4 Poisson ratio .278.8 Density 278.8.1 Preparation of test specimens . 278.8.2 Reagents .278.8.3 Apparatus 278.8.4 Procedure 278.9 Corrosion resistance by the static immersion procedure of ISO 10271:2011 278.9.1 Preparation of test specimens . 278.9

32、.2 Reagents .278.9.3 Apparatus 278.9.4 Test solution288.9.5 Test procedure 288.9.6 Analysis . 288.9.7 Treatment of data .288.10 Sulfide tarnish test (cyclic immersion) . 288.11 Sulfide tarnish test (static immersion) . 288.12 Solidus and liquidus temperatures (dental casting alloys) or melting point

33、 (commercially pure metals) . 288.12.1 Cooling curve method.288.12.2 Thermal analysis method 298.13 Linear thermal expansion 309 Information and instructions for use 309.1 Information . 309.2 Processing instructions 3110 Marking and labelling 3110.1 Marking 3110.2 Labelling of the package 31Annex A

34、(informative) Tensile testing of a non-cast Type 0 metallic material that is intended for use in a thickness between 0,1 mm and 0,5 mm .33Annex B (normative) Calculation of uncertainty for elasticity measurement .36Annex C (informative) Measurement of Poisson ratio 40Bibliography .423EN ISO 22674:20

35、16 (E)DIN EN ISO 22674:2016-09 7.7 Corrosion resistance . 197.8 Tarnish resistance and colour . 19European foreword This document (EN ISO 22674:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of whi

36、ch 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 August 2016, and conflicting national standards shall be withdrawn at the latest by August 2016. This document supersedes EN ISO

37、22674:2006. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards

38、organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembo

39、urg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22674:2016 has been approved by CEN as EN ISO 22674:2016 without any modification. 4EN ISO 22674:2016 (E)DIN EN ISO 22674:2016

40、-09 ForewordISO (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. Each member body interested in a subject for which

41、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 International Electrotechnical Commission (IEC) on all matt

42、ers of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This doc

43、ument was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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 s

44、uch patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and do

45、es not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary inform

46、ationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials.This second edition cancels and replaces the first edition (ISO 22674:2006), which has been technically revised with the following changes: Corrosion resistance measurement was refer

47、red to the recent standard ISO 10271:2011. A second tarnish test was included, referring to provisions in ISO 10271:2011. Clarification of the term “free of“ was added to the requirements of composition and labelling; Lead was added as a hazardous element. Measurement of elasticity was revised. Besi

48、de the method of calculation of elastic modulus using an extensometer, other alternative methods were added, namely, the flexure method in three- and four-point bending and the acoustic resonance method. Informative Annex A was added, dealing with tensile testing of non-cast Type 0 metallic material

49、s intended for use in a thickness between 0,1 and 0,5 mm. Normative Annex B was added, giving information on calculation of uncertainty for elastic measurement. Informative Annex C was added, giving information for measurement of Poisson ratio.5EN ISO 22674:2016 (E)DIN EN ISO 22674:2016-09 IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard