DIN ISO 5832-11-2015 Implants for surgery - Metallic materials - Part 11 Wrought titanium 6-aluminium 7-niobium alloy (ISO 5832-11 2014)《外科植入物 金属材料 第11部分 锻制6钛 7铝 铌合金(ISO 5832-11-20.pdf

1、December 2015 English price group 5No 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; 77.120.99!%I“2385691w

2、ww.din.deDIN ISO 5832-11Implants for surgery Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium alloy (ISO 5832-11:2014),English translation of DIN ISO 5832-11:2015-12Chirurgische Implantate Metallische Werkstoffe Teil 11: Titan Aluminium-6 Niob-7 Knetlegierung (ISO 5832-11:2014),Eng

3、lische bersetzung von DIN ISO 5832-11:2015-12Implants chirurgicaux Produits base de mtaux Partie 11: Alliage forger base de titane, daluminium 6 et de niobium 7 (ISO 5832-11:2014),Traduction anglaise de DIN ISO 5832-11:2015-12SupersedesDIN ISO 5832-11:2001-04www.beuth.deDocument comprises 6 pagesDTr

4、anslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.15 A comma is used as the decimal marker. Contents PageNational foreword 3Introduction .41 Scope . 52 Normative references 53 Chemical composition . 54 Microstructure 65 Mechanical pro

5、perties 66 Test methods . 6DIN ISO 5832-11:2015-12 2National Anne x NA (informative) B ibliography 3National foreword This document (ISO 5832-11:2014) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials” (Secretariat: DIN, Germany). The responsibl

6、e German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-06 AA Implantatwerkstoffe. Attention is drawn to the possibility that some of the elements of this document may be the subjec

7、t of patent rights. DIN shall not be held responsible for identifying any or all such patent rights. The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 6892-1 DIN EN ISO 6892-1 Amendments This standard differs from DIN ISO 5832-11:2001-04 as

8、follows: a) normative references have been updated; b) the reference to publication ETTC 2 Microstructural standards for alpha and beta titanium alloy bars, which is no longer available, has been replaced by reference to ISO 20160:2006; c) the standard has been editorially revised. Previous editions

9、 DIN ISO 5832-11:2001-04 National Annex NA (informative) Bibliography DIN EN ISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperature DIN ISO 5832-11:2015-12 3 IntroductionNo known surgical implant material has ever been shown to be completely free of adverse reactio

10、ns in the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO 5832 has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications.Implants for surgery Metallic materials Part 1

11、1: Wrought titanium 6-aluminium 7-niobium alloyDIN ISO 5832-11:2015-12 4 1 ScopeThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical i

12、mplants.NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with those specified in this part of ISO 5832.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are in

13、dispensable 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 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 20160:2006, Imp

14、lants for surgery Metallic materials Classification of microstructures for alpha+beta titanium alloy bars3 Chemical compositionThe heat analysis shall conform to the requirements as to the chemical composition prescribed in Table 1. Ingot analysis can be used for reporting all chemical requirements

15、except hydrogen, which shall be determined after the heat treatment and pickling procedure.Table 1ElementCompositional limits % (m/m)Aluminium 5,5 to 6,5Niobium 6,5 to 7,5Tantalum 0,50 max.Iron 0,25 max.Oxygen 0,20 max.Carbon 0,08 max.Nitrogen 0,05 max.Hydrogen 0,009 max.Titanium BalanceDIN ISO 5832

16、11:2015-12 5 4 MicrostructureThe microstructure, when examined as indicated in Table 3, shall be alpha + beta, and shall correspond to ISO 20160:2006, micrograph A 1 to micrograph A 9, for annealed material.5 Mechanical propertiesThe tensile properties of the alloy, determined as specified in Claus

17、e 6, shall be in accordance with the requirements of Table 2.Table 2 Mechanical properties of alloy in annealed conditionForm of alloyTensile strength min. MPaProof stress of non-proportional elongation min. MPaPercentage elonga-tion min. %Reduction of area min. %Bara900 800 10 25aMaximum diameter o

18、r thickness = 100 mm.Should any of the pieces not meet the specified requirements or should they break outside the gauge limits, two further test pieces representative of the same batch shall be tested in the same manner. The alloy shall be deemed to comply only if both additional test pieces meet t

19、he specified requirements.If any of the retests fail to meet the appropriate requirements, the product represented shall be deemed not to comply with this part of ISO 5832.6 Test methodsThe test methods to be used in determining compliance with the requirements of this part of ISO 5832 shall be thos

20、e given in Table 3.Representative test pieces for the determination of mechanical properties shall be prepared in accordance with the provisions of ISO 6892-1.Table 3 Test methodsRequirement Relevant clause Test methodsChemical composition 3 Recognized analytical procedures (International Standards where these exist)Microstructure 4 ISO 20160Mechanical properties Tensile strength Proof stress of non-proportional elongation Percentage elongation Reduction of area5ISO 6892-1ISO 6892-1ISO 6892-1ISO 6892-1DIN ISO 5832-11:2015-12 6