EN ISO 22674-2016 en Dentistry - Metallic materials for fixed and removable restorations and appliances《牙科 固定或可移动的修复体和设备所需的金属材料(ISO 22674 2016)》.pdf

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1、BSI Standards PublicationBS EN ISO 22674:2016Dentistry Metallic materialsfor fixed and removablerestorations and appliances(ISO 22674:2016)BS EN ISO 22674:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO22674:2016. It supersedes BS EN ISO 22674:2006 whic

2、h is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a

3、contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 78981 6ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the a

4、uthority of theStandards Policy and Strategy Committee on 31 March 2016.Amendments issued since publicationDate Text affectedEUROPEAN 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

5、 and removable restorations and appliances (ISO 22674:2016) Mdecine 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

6、:2016) This European Standard was approved by CEN on 24 October 2015. 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 bibliographi

7、cal references concerning such national standards may be obtained 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

8、 of a CEN member into its own language and notified to the CEN-CENELEC 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

9、Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, 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

10、 EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue 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 EBS EN ISO 22674:2016EN ISO 22674:2016 (E) 3 European foreword Thi

11、s 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 which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an

12、 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 22674:2006. Attention is drawn to the possibility that some of the elements of this document may be the subject of pate

13、nt 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 organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cro

14、atia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

15、the United Kingdom. Endorsement notice The text of ISO 22674:2016 has been approved by CEN as EN ISO 22674:2016 without any modification. BS EN ISO 22674:2016ISO 22674:2016(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 35 Requirements 45.1

16、Chemical composition 45.1.1 Reported composition . 45.1.2 Permitted deviation from the reported composition for elements 45.2 Hazardous elements . 45.2.1 Hazardous elements . 45.2.2 Limits for the hazardous elements cadmium and beryllium . 45.2.3 Limit for lead . 45.2.4 Nickel . 55.3 Biocompatibilit

17、y 55.4 Mechanical properties 55.4.1 General 55.4.2 Proof stress of 0,2 % non-proportional extension . 65.4.3 Elongation after fracture . 65.5 Elastic modulus 75.5.1 Precision of measurement method 75.5.2 Determination of compliance with the requirements for Type 5 materials. 75.5.3 Mean value 85.6 D

18、ensity . 85.7 Corrosion resistance for material integrity 85.8 Tarnish resistance 85.9 Solidus and liquidus temperatures (alloy) or melting point (commercially pure metal) 85.10 Thermal expansion coefficient 85.11 Information, instructions and marking . 96 Sampling 97 Preparation of test specimens 9

19、7.1 General . 97.2 Heat treatment 97.2.1 General conditions . 97.2.2 Metallic materials for which a heat treatment is recommended in the manufacturers instructions for use 97.2.3 Metallic material for metal-ceramic restorations 97.2.4 Metallic materials for which no heat-treatment is recommended in

20、the manufacturers instructions for use 97.3 Proof stress of 0,2 % non-proportional extension and the elongation after fracture: Metallic materials for which production of conventional specimens is possible .107.4 Type 0 metallic materials for which the production of conventional specimens is not pos

21、sible . 117.5 Elastic moduli 117.5.1 General. 117.5.2 Tensile strain method .117.5.3 Flexure method (three or four point bending) .117.5.4 Acoustic resonance method 127.6 Density measurement 137.7 Corrosion resistance . 137.8 Tarnish resistance and colour . 13 ISO 2016 All rights reserved iiiContent

22、s PageBS EN ISO 22674:2016ISO 22674:2016(E)7.9 Linear thermal expansion 138 Test methods 138.1 Information, instructions and marking 138.2 Chemical composition . 148.3 Mechanical testing 148.3.1 Apparatus 148.3.2 Test procedure 148.4 Proof stress of 0,2 % non-proportional extension 158.4.1 Calculati

23、on 158.4.2 Mean value . 158.5 Percentage elongation after fracture 158.5.1 Calculation 158.5.2 Mean value . 158.6 Elastic modulus measurement . 158.6.1 Tensile strain method .158.6.2 Flexure method in three- or four-point bending mode .168.6.3 Acoustic resonance method 188.7 Calculation of elasticit

24、y parameters from acoustic measurement 198.7.1 General. 198.7.2 Elastic modulus 208.7.3 Shear modulus 208.7.4 Poisson ratio . 218.8 Density 218.8.1 Preparation of test specimens . 218.8.2 Reagents . 218.8.3 Apparatus 218.8.4 Procedure 218.9 Corrosion resistance by the static immersion procedure of I

25、SO 10271:2011 218.9.1 Preparation of test specimens . 218.9.2 Reagents . 218.9.3 Apparatus 218.9.4 Test solution228.9.5 Test procedure 228.9.6 Analysis . 228.9.7 Treatment of data .228.10 Sulfide tarnish test (cyclic immersion) . 228.11 Sulfide tarnish test (static immersion) . 228.12 Solidus and li

26、quidus temperatures (dental casting alloys) or melting point (commercially pure metals) . 228.12.1 Cooling curve method.228.12.2 Thermal analysis method 238.13 Linear thermal expansion 249 Information and instructions for use 249.1 Information . 249.2 Processing instructions 2510 Marking and labelli

27、ng 2510.1 Marking 2510.2 Labelling of the package 25Annex A (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 .27Annex B (normative) Calculation of uncertainty for elasticity measurement .30Annex C (informative) Mea

28、surement of Poisson ratio 34Bibliography .36iv ISO 2016 All rights reservedBS EN ISO 22674:2016ISO 22674:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards i

29、s 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 organizations, governmental and non-governmental, in liaison with ISO, also take par

30、t in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters 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 particul

31、ar the different approval criteria needed for the different types of ISO documents should be noted. This document 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

32、document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such 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.is

33、o.org/patents).Any trade name used in this document is information given for the convenience of users and does 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 WT

34、O principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe 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

35、), which has been technically revised with the following changes: Corrosion resistance measurement was referred 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 c

36、omposition and labelling; Lead was added as a hazardous element. Measurement of elasticity was revised. Beside 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 resona

37、nce method. Informative Annex A was added, dealing with tensile testing of non-cast Type 0 metallic materials 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,

38、giving information for measurement of Poisson ratio. ISO 2016 All rights reserved vBS EN ISO 22674:2016ISO 22674:2016(E)IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that, in as

39、sessing possible biological hazards, reference has to be made to ISO 10993-1 and ISO 7405.Requirements for the performance of metals and alloys used for the metallic component of a metal-ceramic restoration contained in this International Standard supersede such requirements formerly contained in IS

40、O 9693. The requirements for the performance of ceramic material and the metal-ceramic bond in metal-ceramic restorative systems continue to be specified in ISO 9693-1.Requirements for the proof stress and minimum elongation after fracture for Type 0 metallic materials are not included in this Inter

41、national Standard, but it is recommended to adopt the test procedure given in Annex A when measuring these properties. Requirements will be included in a revision of this International Standard when information becomes available to Technical Committee ISO/TC 106/SC 2.vi ISO 2016 All rights reservedB

42、S EN ISO 22674:2016Dentistry Metallic materials for fixed and removable restorations and appliances1 ScopeThis International Standard classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either wit

43、h or without a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials, including products delivered for sale to a t

44、hird party.This International Standard does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).2 Normative referencesThe following documents, in whole or in par

45、t, are normatively referenced in this document and are indispensable for its application. 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 VocabularyISO 3696, Water for a

46、nalytical laboratory use Specification and test methodsISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titaniumISO 5832-31), Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloyISO 6344-1, Coated abrasives Grain size analysis Part 1: Gra

47、in size distribution testISO 6892-12), Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 9513, Metallic materials Calibration of extensometer systems used in uniaxial testingISO 9693-1, Dentistry Compatibility testing Part 1: Metal-ceramic systemsISO 10271:2011, Dentis

48、try Corrosion test methods for metallic materialsISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the terms and definitions of ISO 1942 and t

49、he following apply.3.1base metalany metallic element with the exception of noble metals (i. e. gold and metals of the platinum group) and silver1) To be published.2) To be published.INTERNATIONAL STANDARD ISO 22674:2016(E) ISO 2016 All rights reserved 1BS EN ISO 22674:2016ISO 22674:2016(E)3.2noble metalgold and metals of the platinum groupSOURCE: ISO 1942:2009, 2.1873.3hazardous elementelement that is known for its potential to produce an adverse biological effectNote 1 to entry: The presence of such an element (a