SVENSK STANDARD SS-EN ISO 22674:2016

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1 SVENSK STANDARD SS-EN ISO 22674:2016 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 2 Språk/Language: engelska/english ICS: Tandvård Metaller för fast- och avtagbar protetik och dess tillämpning (ISO 22674:2016) Dentistry Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)

2 Standarder får världen att fungera SIS (Swedish Standards Institute) är en fristående ideell förening med medlemmar från både privat och offentlig sektor. Vi är en del av det europeiska och globala nätverk som utarbetar internationella standarder. Standarder är dokumenterad kunskap utvecklad av framstående aktörer inom industri, näringsliv och samhälle och befrämjar handel över gränser, bidrar till att processer och produkter blir säkrare samt effektiviserar din verksamhet. Delta och påverka Som medlem i SIS har du möjlighet att påverka framtida standarder inom ditt område på nationell, europeisk och global nivå. Du får samtidigt tillgång till tidig information om utvecklingen inom din bransch. Ta del av det färdiga arbetet Vi erbjuder våra kunder allt som rör standarder och deras tillämpning. Hos oss kan du köpa alla publikationer du behöver allt från enskilda standarder, tekniska rapporter och standardpaket till handböcker och onlinetjänster. Genom vår webbtjänst e-nav får du tillgång till ett lättnavigerat bibliotek där alla standarder som är aktuella för ditt företag finns tillgängliga. Standarder och handböcker är källor till kunskap. Vi säljer dem. Utveckla din kompetens och lyckas bättre i ditt arbete Hos SIS kan du gå öppna eller företagsinterna utbildningar kring innehåll och tillämpning av standarder. Genom vår närhet till den internationella utvecklingen och ISO får du rätt kunskap i rätt tid, direkt från källan. Med vår kunskap om standarders möjligheter hjälper vi våra kunder att skapa verklig nytta och lönsamhet i sina verksamheter. Vill du veta mer om SIS eller hur standarder kan effektivisera din verksamhet är du välkommen in på eller ta kontakt med oss på tel Standards make the world go round SIS (Swedish Standards Institute) is an independent non-profit organisation with members from both the private and public sectors. We are part of the European and global network that draws up international standards. Standards consist of documented knowledge developed by prominent actors within the industry, business world and society. They promote cross-border trade, they help to make processes and products safer and they streamline your organisation. Take part and have influence As a member of SIS you will have the possibility to participate in standardization activities on national, European and global level. The membership in SIS will give you the opportunity to influence future standards and gain access to early stage information about developments within your field. Get to know the finished work We offer our customers everything in connection with standards and their application. You can purchase all the publications you need from us - everything from individual standards, technical reports and standard packages through to manuals and online services. Our web service e-nav gives you access to an easy-to-navigate library where all standards that are relevant to your company are available. Standards and manuals are sources of knowledge. We sell them. Increase understanding and improve perception With SIS you can undergo either shared or in-house training in the content and application of standards. Thanks to our proximity to international development and ISO you receive the right knowledge at the right time, direct from the source. With our knowledge about the potential of standards, we assist our customers in creating tangible benefit and profitability in their organisations. If you want to know more about SIS, or how standards can streamline your organisation, please visit or contact us on phone +46 (0)

3 Europastandarden EN ISO 22674:2016 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 22674:2016. Denna standard ersätter SS-EN ISO 22674:2006, utgåva 1. The European Standard EN ISO 22674:2016 has the status of a Swedish Standard. This document contains the official English version of EN ISO 22674:2016. This standard supersedes the Swedish Standard SS-EN ISO 22674:2006, edition 1. Copyright / Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som återfinns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. You will find the licence in the end of this document. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), telephone Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. Denna standard är framtagen av kommittén för Tandvård, SIS / TK 327. Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på - där hittar du mer information.

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5 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO February 2016 ICS Supersedes EN ISO 22674:2006 English Version Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016) Médecine bucco-dentaire - Matériaux métalliques pour les restaurations fixes et amovibles et les appareillages (ISO 22674:2016) Zahnheilkunde - Metallische Werkstoffe für festsitzenden und herausnehmbaren Zahnersatz und Applikationen (ISO 22674:2016) This European Standard was approved by CEN on 24 October 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 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-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 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 COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 E

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7 SS-EN ISO 22674:2016 (E) Contents Page European foreword... Introduction...vi 1 Scope Normative references Terms and definitions Classification Requirements Chemical composition Reported composition Permitted deviation from the reported composition for elements Hazardous elements Hazardous elements Limits for the hazardous elements cadmium and beryllium Limit for lead Nickel Biocompatibility Mechanical properties General Proof stress of 0,2 % non-proportional extension Elongation after fracture Elastic modulus Precision of measurement method Determination of compliance with the requirements for Type 5 materials Mean value Density Corrosion resistance for material integrity Tarnish resistance Solidus and liquidus temperatures (alloy) or melting point (commercially pure metal) Thermal expansion coefficient Information, instructions and marking Sampling Preparation of test specimens General Heat treatment General conditions Metallic materials for which a heat treatment is recommended in the manufacturer s instructions for use Metallic material for metal-ceramic restorations Metallic materials for which no heat-treatment is recommended in the manufacturer s instructions for use Proof stress of 0,2 % non-proportional extension and the elongation after fracture: Metallic materials for which production of conventional specimens is possible Type 0 metallic materials for which the production of conventional specimens is not possible Elastic moduli General Tensile strain method Flexure method (three or four point bending) Acoustic resonance method Density measurement Corrosion resistance Tarnish resistance and colour...13 iii

8 SS-EN ISO 22674:2016 (E) 7.9 Linear thermal expansion Test methods Information, instructions and marking Chemical composition Mechanical testing Apparatus Test procedure Proof stress of 0,2 % non-proportional extension Calculation Mean value Percentage elongation after fracture Calculation Mean value Elastic modulus measurement Tensile strain method Flexure method in three- or four-point bending mode Acoustic resonance method Calculation of elasticity parameters from acoustic measurement General Elastic modulus Shear modulus Poisson ratio Density Preparation of test specimens Reagents Apparatus Procedure Corrosion resistance by the static immersion procedure of ISO 10271: Preparation of test specimens Reagents Apparatus Test solution Test procedure Analysis Treatment of data Sulfide tarnish test (cyclic immersion) Sulfide tarnish test (static immersion) Solidus and liquidus temperatures (dental casting alloys) or melting point (commercially pure metals) Cooling curve method Thermal analysis method Linear thermal expansion Information and instructions for use Information Processing instructions Marking and labelling Marking Labelling of the package...25 Annex 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...27 Annex B (normative) Calculation of uncertainty for elasticity measurement...30 Annex C (informative) Measurement of Poisson ratio...34 Bibliography...36 iv

9 SS-EN ISO 22674:2016 (E) European 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 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 by August 2016, and conflicting national standards shall be withdrawn at the latest by August 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 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 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, Luxembourg, 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.

10 SS-EN ISO 22674:2016 (E) Introduction 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 has to be made to ISO and ISO Requirements for the performance of metals and alloys used for the metallic component of a metalceramic restoration contained in this International Standard supersede such requirements formerly contained in ISO The requirements for the performance of ceramic material and the metalceramic bond in metal-ceramic restorative systems continue to be specified in ISO Requirements for the proof stress and minimum elongation after fracture for Type 0 metallic materials are not included in this International 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

11 SS-EN ISO 22674:2016 (E) Dentistry Metallic materials for fixed and removable restorations and appliances 1 Scope This International Standard classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either with 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 third 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 references The following documents, in whole or in part, 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 Vocabulary ISO 3696, Water for analytical laboratory use Specification and test methods ISO , Implants for surgery Metallic materials Part 2: Unalloyed titanium ISO ), Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy ISO , Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO ), Metallic materials Tensile testing Part 1: Method of test at room temperature ISO 9513, Metallic materials Calibration of extensometer systems used in uniaxial testing ISO , Dentistry Compatibility testing Part 1: Metal-ceramic systems ISO 10271:2011, Dentistry Corrosion test methods for metallic materials ISO :2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions of ISO 1942 and the following apply. 3.1 base metal any metallic element with the exception of noble metals (i. e. gold and metals of the platinum group) and silver 1) To be published. 2) To be published. 1