BS EN ISO 13356-2015 Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)《外科植入物 稳定氧化钇的四方氧化锆(Y-TZP)基的陶瓷材料》.pdf

1、BSI Standards PublicationBS EN ISO 13356:2015Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)BS EN ISO 13356:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13356:2015. It supersedes BS EN ISO 13356:2013 wh

2、ich iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary prov

3、isions of a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 81541 6 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was publi

4、shed under the authority of the Standards Policy and Strategy Committee on 31 October 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13356 September 2015 ICS 11.040.40 Supersedes EN ISO 13356:2013English Version

5、 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015) Implants chirurgicaux - Produits cramiques base de zircone ttragonal stabilise lyttrium (Y-TZP) (ISO 13356:2015) Chirurgische Implantate - Keramische Werkstoffe aus yttriumstabilisiertem

6、 tetragonalem Zirkonium (Y-TZP) (ISO 13356:2015) This European Standard was approved by CEN on 22 August 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 alte

7、ration. 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 mad

8、e 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, Eston

9、ia, 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 STAND

10、ARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 EBS EN ISO 13356:2015EN I

11、SO 13356:2015 (E) 3 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 natio

12、nal 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 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent ri

13、ghts. 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 St

14、andard: 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,

15、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. BS EN ISO 13356:2015ISO 13356:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Physical and chemical pr

16、operties . 23.1 Test category . 23.1.1 General 23.1.2 Category 1 23.1.3 Category 2 24 Test methods . 44.1 General . 44.2 Bulk density . 44.3 Chemical composition 44.4 Microstructure 44.4.1 Principle 44.4.2 Test report . 54.4.3 Amount of monoclinic phase . 54.5 Biaxial flexural strength 64.5.1 Princi

17、ple 64.5.2 Apparatus . 64.5.3 Preparation of test specimens 64.5.4 Procedure . 74.5.5 Calculation of results 84.5.6 Test report . 84.6 Four-point bending strength . 84.7 Weibull modulus 94.8 Youngs modulus 94.9 Hardness . 94.10 Cyclic fatigue . 94.10.1 Principle 94.10.2 Apparatus . 94.10.3 Sample si

18、ze and preparation of test specimens 94.10.4 Procedure and sample requirement . 94.10.5 Test Report . 104.11 Radioactivity 104.11.1 Principle . 104.11.2 Apparatus 104.11.3 Sample preparation 114.11.4 Isotope identification - Energy calibration 114.11.5 Quantitative analysis .114.11.6 Expression of r

19、esults .124.11.7 Test report 124.12 Accelerated aging test 124.12.1 General. 124.12.2 Procedure 124.12.3 Evaluation of accelerated aging outcome 12Bibliography .13 ISO 2015 All rights reserved iiiContents PageBS EN ISO 13356:2015ISO 13356:2015(E)ForewordISO (the International Organization for Standa

20、rdization) 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 a technical committee has been established has the right t

21、o 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 matters of electrotechnical standardization.The procedures use

22、d 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 document was drafted in accordance with the editorial rules o

23、f 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 such patent rights. Details of any patent rights identified

24、 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 does not constitute an endorsement.For an explanation on the

25、 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 InformationThe committee responsible for this document is ISO/TC

26、 150, Implants for surgery, Subcommittee SC 1, Materials.This third edition cancels and replaces the second edition (ISO 13356:2008), which has been technically revised.iv ISO 2015 All rights reservedBS EN ISO 13356:2015ISO 13356:2015(E)IntroductionNo known surgical implant material has ever been fo

27、und 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 ap

28、plications. ISO 2015 All rights reserved vBS EN ISO 13356:2015BS EN ISO 13356:2015Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)1 ScopeThis International Standard specifies the requirements and corresponding test methods for a biocompatible and biostabl

29、e 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 indisp

30、ensable 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, Geom

31、etrical 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 calibration

32、 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 stren

33、gth 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 mon

34、olithic 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, Fine

35、 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 techni

36、cal 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 superficia

37、l hardnessEN 843-5, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 5: Statistical analysisINTERNATIONAL STANDARD ISO 13356:2015(E) ISO 2015 All rights reserved 1BS EN ISO 13356:2015ISO 13356:2015(E)ASTM C1161, Standard Test Method for Flexural Stren

38、gth of Advanced Ceramics at Ambient TemperatureASTM C1198, 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

39、Advanced CeramicsASTM C1259, Standard Test method for Dynamic 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

40、 Ultrasonic Velocity in Advanced Ceramics with Broadband Pulse-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 spe

41、cified in Table 1.3.1 Test category3.1.1 GeneralThe required 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

42、aging (monoclinic fraction).3.1.3 Category 2The 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) Youngs modulus;c) fatigue strength;d) acce

43、lerated aging (strength);e) quantity of monoclinic phase;f) radioactivity.2 ISO 2015 All rights reservedBS EN ISO 13356:2015ISO 13356:2015(E)Table 1 Limits for material propertiesProperty UnitTest categoryRequirement Reference SubclauseBulk density g/cm31 6,00ISO 18754 EN 62324.2Chemical composition

44、 4.3ZrO2+HfO2+Y2O3a% mass fraction1 99,0Y2O3 4,5 to 6,0HfO2 5Al2O3 0,5Other oxides 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 departure

45、s 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 measuring to an accuracy of 0,01 mm shall be used

46、.4.5.3 Preparation of test specimensPrepare billets or discs of the zirconia ceramic using the same methods as the production of final components for surgery, using the same precursor powder, pressing technique, pressure, and firing conditions.Test specimens (see Figure 1) shall be circular plates o

47、f diameter D = (36,0 1,0) mm, thickness t = (2,0 0,1) mm and shall be flat on the test face to less than 0,3 mm.The surface finish of the specimen shall be specified. For an as-fired surface, specify the green processing methods.At least 10 test specimens shall be prepared for determination of mean

48、strength.6 ISO 2015 All rights reservedBS EN ISO 13356:2015ISO 13356:2015(E)Key1 loading ring Dlloading ring mean (contact) diameter3 support ring Dssupport ring mean (contact) diameter2 paper disc D test specimen diameter4 rubber sheet F force applied at fractures5 specimen t test specimen thicknes

49、sFigure 1 Schematic diagram of the biaxial flexure testing device employing concentric loading and support rings4.5.4 Procedurea) Measure the diameter of the test specimen to an accuracy of 0,1 mm and the thickness to an accuracy of 0,01 mm, each in at least three random positions. Calculate the mean diameter and mean thickness.b) Place the rubber sheet on the support ring of the test jig. Place the test specimen on the rubber sheet, with the surface to be tested in contac