SVENSK STANDARD SS-EN ISO 13356:2015

Transkript

1 SVENSK STANDARD SS-EN ISO 13356:2015 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 2 Språk/Language: engelska/english ICS: ; Kirurgiska implantat Keramiska material Yttriumoxidstabiliserad tetragonal zirkoniumoxid (ISO 13356:2015) Implants for surgery Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

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 13356:2015 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 13356:2015. Denna standard ersätter SS-EN ISO 13356:2013, utgåva 1. The European Standard EN ISO 13356:2015 has the status of a Swedish Standard. This document contains the official English version of EN ISO 13356:2015. This standard supersedes the Swedish Standard SS-EN ISO 13356:2013, 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 September 2015 ICS Supersedes EN ISO 13356:2013 English Version Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015) Implants chirurgicaux - Produits céramiques à base de zircone tétragonal stabilisée à l'yttrium (Y-TZP) (ISO 13356:2015) Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkonium (Y-TZP) (ISO 13356:2015) This European Standard was approved by CEN on 22 August 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 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13356:2015 E

6 Contents Page European foreword... Introduction...v 1 Scope Normative references Physical and chemical properties Test category General Category Category Test methods General Bulk density Chemical composition Microstructure Principle Test report Amount of monoclinic phase Biaxial flexural strength Principle Apparatus Preparation of test specimens Procedure Calculation of results Test report Four-point bending strength Weibull modulus Young s modulus Hardness Cyclic fatigue Principle Apparatus Sample size and preparation of test specimens Procedure and sample requirement Test Report Radioactivity Principle Apparatus Sample preparation Isotope identification - Energy calibration Quantitative analysis Expression of results Test report Accelerated aging test General Procedure Evaluation of accelerated aging outcome...12 Bibliography...13 iii

7 European foreword This document (EN ISO 13356:2015) 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 March 2016, and conflicting national standards shall be withdrawn at the latest by March 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. This document supersedes EN ISO 13356:2013. 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 13356:2015 has been approved by CEN as EN ISO 13356:2015 without any modification. iv

8 Introduction No known surgical implant material has ever been found to cause absolutely no adverse reactions in the human body. However, long-term clinical experience regarding the use of the material referred to in this International Standard has shown that an acceptable level of biological response can be expected if the material will be used in appropriate applications. v

9 Implants for surgery Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP) 1 Scope This International Standard specifies the requirements and corresponding test methods for a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants. 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 , Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth ISO 3611, Geometrical product specifications (GPS) Dimensional measuring equipment: Micrometers for external measurements Design and metrological characteristics ISO , Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration of the force-measuring system ISO , Fine ceramics (advanced ceramics, advanced technical ceramics) Microstructural characterization Part 1: Determination of grain size and size distribution ISO 14704, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for flexural strength of monolithic ceramics at room temperature ISO 14705, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for hardness of monolithic ceramics at room temperature ISO 17561, Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for elastic moduli of monolithic ceramics at room temperature by sonic resonance ISO 18754, Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of density and apparent porosity ISO 20501, Fine ceramics (advanced ceramics, advanced technical ceramics) Weibull statistics for strength data ISO 22214, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for cyclic bending fatigue of monolithic ceramics at room temperature EN 623 2, Advanced technical ceramics Monolithic ceramics General and textural properties Part 2: Determination of density and porosity EN 843 2, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 2: Determination of Young s modulus, shear modulus and Poisson s ratio EN 843 4, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 4: Vickers, Knoop and Rockwell superficial hardness EN 843 5, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 5: Statistical analysis 1

10 ASTM C1161, Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature ASTM C1198, Standard Test Method for Dynamic Young s Modulus, Shear Modulus, and Poisson s Ratio for Advanced Ceramics by Sonic Resonance ASTM C1239, Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics ASTM C1259, Standard Test method for Dynamic Young s Modulus. Shear Modulus, and Poisson s Ratio for Advanced Ceramics by Impulse Excitation of Vibration ASTM C1327, Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics ASTM C1331, Standard Test Method for Measuring Ultrasonic Velocity in Advanced Ceramics with Broadband Pulse-Echo Cross-Correlation Method ASTM E112, Standard Test Method for Determining Average Grain Size 3 Physical and chemical properties The physical and chemical properties, when tested as specified in Clause 4, shall comply with the values specified in Table Test category General The required tests are divided into two categories Category 1 The following test shall be performed for periodical production control: a) bulk density; b) chemical composition; c) microstructure; d) strength (including Weibull modulus); e) accelerated aging (monoclinic fraction) Category 2 The manufacturer shall define the general materials specification. In addition to all tests in 3.1.2, the following tests shall be performed to demonstrate compliance with the material specification: a) hardness; b) Young s modulus; c) fatigue strength; d) accelerated aging (strength); e) quantity of monoclinic phase; f) radioactivity. 2

11 Table 1 Limits for material properties Property Unit Test category Requirement Reference Subclause Bulk density g/cm3 1 6,00 ISO EN Chemical composition 4.3 ZrO 2 +HfO 2 +Y 2 O 3 a 99,0 Y 2 O 3 > 4,5 to 6,0 HfO 2 % mass fraction 1 5 Al 2 O 3 0,5 Other oxides 0,5 Microstructure 4.4 Grain size μm 1 Intercept distance 0,4 ISO Standard deviation < 0,2 ASTM E112 Amount of monoclinic phase % molar fraction 2 20 See Strength: alternative of 1) or 2) 1a) Biaxial flexurea ASTM C ISO b) Weibull modulus 1 8 EN ASTM C1239 MPa 2a) 4-point bendinga b) Weibull modulus 1 8 Young s modulus GPa Hardness GPa 2 11,8 Cyclic fatigue limit stress at 106 cycles ISO EN ASTM C1161 ISO EN ASTM C 1239 ISO EN ASTM C1198 ASTM C1259 ASTM C1331 ISO EN ASTM C1327 MPa ISO Radioactivityb Bq/kg Accelerated aging 4.12 NOTE The number of fractional digits given for each limit value in this table indicates the appropriate number of fractional digits which should be given for the respective measured values. a Measured on a minimum of 10 test specimens. b The radioactivity, defined as the sum of the mass activity of U 238, Ra 226, Th 232, and determined by gamma spectroscopy on the ready-to-use powder should be equal or less than 200 Bq/kg. This value will be reviewed at the next revision of this International Standard and will be based upon the radioactivity data from implant ceramic manufacturers. All naturally occurring gamma emitters are to be analysed