DIN EN ISO 13356-2016 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356 2015) German version EN ISO 13356 2015《外科植入物 含有稳定氧化.pdf

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1、February 2016 English price group 11No 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 11.040.40!%LS*“2414807www.din.d

2、eDIN EN ISO 13356Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015);English version EN ISO 13356:2015,English translation of DIN EN ISO 13356:2016-02Chirurgische Implantate Keramische Werkstoffe aus yttriumstabilisiertem tetragonalem Zirkon

3、iumoxid (Y-TZP) (ISO 13356:2015);Englische Fassung EN ISO 13356:2015,Englische bersetzung von DIN EN ISO 13356:2016-02Implants chirurgicaux Produits cramiques base de zircone ttragonal stabilise lyttrium (Y-TZP) (ISO 13356:2015);Version anglaise EN ISO 13356:2015,Traduction anglaise de DIN EN ISO 13

4、356:2016-02SupersedesDIN EN ISO 13356:2013-08www.beuth.deDocument comprises 20 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.16DIN EN ISO 13356:2016-02 2 A comma is used as the decimal marker. National foreword This docume

5、nt (EN ISO 13356:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” 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 Committ

6、ee Dentistry), Working Committee NA 014-00-21 AA Dentalimplantate. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3310-1 DIN ISO 3310-1 ISO 3611 DIN EN ISO 3611 ISO 7500-1 DIN EN ISO 7500-1 Amendments This standard differs from DIN EN

7、ISO 13356:2013-08 as follows: a) the material tests have been subdivided into two categories: category 1: periodical production control, category 2: material specifications; b) the material properties hardness, Youngs modulus and Weibull modulus have been included; c) Figure 1 showing cuts for the c

8、ross sections of the biaxial disc and 4-point flexure bar has been dropped. Previous editions DIN EN ISO 13356: 2013-08 National Annex NA (informative) Bibliography DIN EN ISO 3611, Geometrical Product Specifications (GPS) Dimensional measuring equipment: Micrometers for external measurements Design

9、 and metrological characteristics DIN EN ISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibration of the force-measuring system DIN ISO 3310-1, Test sieves Technical requirements and testing Part 1: Test

10、 sieves of metal wire cloth EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13356 September 2015 ICS 11.040.40 Supersedes EN ISO 13356:2013English Version Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015) Implants chirurgicaux -

11、 Produits cramiques base de zircone ttragonal stabilise lyttrium (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 2015. CEN members are bound to c

12、omply 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-CENE

13、LEC 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

14、 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, Luxembo

15、urg, 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: Avenue Marnix 17, B-1000 Brussels

16、 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 EContents Page European foreword .3Introduction 51 Scope .62 Normative references 63 Physical and chemical properties . 73.1 Test category .73.1.1 General 73.1.2

17、Category 1 73.1.3 Category 2 74 Test methods . 94.1 General . 94.2 Bulk density . 94.3 Chemical composition 94.4 Microstructure 94.4.1 Principle 94.4.2 Test report 104.4.3 Amount of monoclinic phase 104.5 Biaxial flexural strength . 114.5.1 Principle . 114.5.2 Apparatus 114.5.3 Preparation of test s

18、pecimens . 114.5.4 Procedure 124.5.5 Calculation of results . 134.5.6 Test report 134.6 Four-point bending strength 134.7 Weibull modulus . 144.8 Youngs modulus . 144.9 Hardness 144.10 Cyclic fatigue 144.10.1 Principle . 144.10.2 Apparatus 144.10.3 Sample size and preparation of test specimens . 144

19、.10.4 Procedure and sample requirement 144.10.5 Test Report . 154.11 Radioactivity 154.11.1 Principle . 154.11.2 Apparatus 154.11.3 Sample preparation 164.11.4 Isotope identification - Energy calibration 164.11.5 Quantitative analysis .164.11.6 Expression of results .174.11.7 Test report 174.12 Acce

20、lerated aging test 174.12.1 General. 174.12.2 Procedure 174.12.3 Evaluation of accelerated aging outcome 17Bibliography .18Foreword .4EN ISO 13356:2015 (E) DIN EN ISO 13356:2016-022 European foreword This document (EN ISO 13356:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in

21、 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 standard

22、s shall be withdrawn at the latest by March 2016. 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 1335

23、6:2013. 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, Fra

24、nce, 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 IS

25、O 13356:2015 without any modification. EN ISO 13356:2015 (E)DIN EN ISO 13356:2016-023ForewordISO (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 thro

26、ugh 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 part in the work. ISO collabor

27、ates 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 particular the different approval c

28、riteria 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 document may be the subject

29、 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.iso.org/patents).Any trade na

30、me 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 WTO principles in the Technic

31、al Barriers to Trade (TBT) see the following URL: Foreword - Supplementary InformationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.This third edition cancels and replaces the second edition (ISO 13356:2008), which has been technically

32、revised.EN ISO 13356:2015 (E) DIN EN ISO 13356:2016-024 IntroductionNo 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 h

33、as shown that an acceptable level of biological response can be expected if the material will be used in appropriate applications.EN ISO 13356:2015 (E)DIN EN ISO 13356:2016-0251 ScopeThis International Standard specifies the requirements and corresponding test methods for a biocompatible and biostab

34、le 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 referencesThe following documents, in whole or in part, are normatively referenced in this document and are indis

35、pensable 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 3310-1, Test sieves Technical requirements and testing Part 1: Test sieves of metal wire clothISO 3611, Geo

36、metrical product specifications (GPS) Dimensional measuring equipment: Micrometers for external measurements Design and metrological characteristicsISO 7500-1, Metallic materials Verification of static uniaxial testing machines Part 1: Tension/compression testing machines Verification and calibratio

37、n of the force-measuring systemISO 13383-1, Fine ceramics (advanced ceramics, advanced technical ceramics) Microstructural characterization Part 1: Determination of grain size and size distributionISO 14704, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for flexural stre

38、ngth of monolithic ceramics at room temperatureISO 14705, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for hardness of monolithic ceramics at room temperatureISO 17561, Fine ceramics (advanced ceramics, advanced technical ceramics) - Test method for elastic moduli of mo

39、nolithic ceramics at room temperature by sonic resonanceISO 18754, Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of density and apparent porosityISO 20501, Fine ceramics (advanced ceramics, advanced technical ceramics) Weibull statistics for strength dataISO 22214, Fin

40、e ceramics (advanced ceramics, advanced technical ceramics) Test method for cyclic bending fatigue of monolithic ceramics at room temperatureEN 623-2, Advanced technical ceramics Monolithic ceramics General and textural properties Part 2: Determination of density and porosityEN 843-2, Advanced techn

41、ical ceramics Mechanical properties of monolithic ceramics at room temperature Part 2: Determination of Youngs modulus, shear modulus and Poissons ratioEN 843-4, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 4: Vickers, Knoop and Rockwell superfici

42、al hardnessEN 843-5, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 5: Statistical analysisEN ISO 13356:2015 (E) DIN EN ISO 13356:2016-026 ASTM C1161, Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient TemperatureASTM C1198,

43、Standard Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Sonic ResonanceASTM C1239, Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced CeramicsASTM C1259, Standard Test method for Dynam

44、ic Youngs Modulus. Shear Modulus, and Poissons Ratio for Advanced Ceramics by Impulse Excitation of VibrationASTM C1327, Standard Test Method for Vickers Indentation Hardness of Advanced CeramicsASTM C1331, Standard Test Method for Measuring Ultrasonic Velocity in Advanced Ceramics with Broadband Pu

45、lse-Echo Cross-Correlation MethodASTM E112, Standard Test Method for Determining Average Grain Size3 Physical and chemical propertiesThe physical and chemical properties, when tested as specified in Clause 4, shall comply with the values specified in Table 1.3.1 Test category3.1.1 GeneralThe require

46、d tests are divided into two categories.3.1.2 Category 1The 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).3.1.3 Category 2The manufacture

47、r 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) Youngs modulus;c) fatigue strength;d) accelerated aging (strength);e) quantity of monoclinic phase;f)

48、 radioactivity.EN ISO 13356:2015 (E)DIN EN ISO 13356:2016-027Table 1 Limits for material propertiesProperty UnitTest categoryRequirement Reference SubclauseBulk density g/cm31 6,00ISO 18754 EN 62324.2Chemical composition 4.3ZrO2+HfO2+Y2O3a% mass fraction1 99,0Y2O3 4,5 to 6,0HfO2 5Al2O3 0,5Other oxid

49、es 0,5Microstructure 4.4Grain size m 1Intercept distance 0,4Standard deviation HV 500 or HRC 40) in order to minimize damage or roughness caused by fracture of the test specimens. In order to accommodate slight departures from surface flatness of the test specimens, a (0,6 0,1) mm thick rubber plate with a Shore hardness of 60 5 shall be placed between the support ring and the test specimen on both surfaces.4.5.2.3 Micrometer, in accordance with ISO 3611, capable of meas