DIN ISO 5832-4-2015 Implants for surgery - Metallic materials - Part 4 Cobalt-chromium-molybdenum casting alloy (ISO 5832-4 2014)《外科植入物 金属材料 第4部分 钴铬钼铸造合金(ISO 5832-4-2014)》.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“2385690w

2、ww.din.deDIN ISO 5832-4Implants for surgery Metallic materials Part 4: Cobalt-chromium-molybdenum casting alloy (ISO 5832-4:2014),English translation of DIN ISO 5832-4:2015-12Chirurgische Implantate Metallische Werkstoffe Teil 4: Kobalt-Chrom-Molybdn-Gusslegierung (ISO 5832-4:2014),Englische bersetz

3、ung von DIN ISO 5832-4:2015-12Implants chirurgicaux Produits base de mtaux Partie 4: Alliage couler base de cobalt, de chrome, et de molybdne (ISO 5832-4:2014),Traduction anglaise de DIN ISO 5832-4:2015-12SupersedesDIN ISO 5832-4:2000-08www.beuth.deDocument comprises 6 pagesDTranslation by DIN-Sprac

4、hendienst.In case of doubt, the German-language original shall be considered authoritative.11.15 A comma is used as the decimal marker. Contents PageNational f oreword .3Introduction 41 Scope . 52 Normative references 53 Chemical composition . 54 Mechanical properties 65 Test methods .6DIN ISO 5832-

5、4:2015-12 2National Annex NA (informative) B ibliograp h y .3National foreword This document (ISO 5832-4:2014) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials” (Secretariat: DIN, Germany). The responsible German body involved in its preparatio

6、n was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-06 AA Implantatwerkstoffe. The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 6892-1 DIN EN ISO 6892-1 Atte

7、ntion is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN shall not be held responsible for identifying any or all such patent rights. Amendments This standard differs from DIN ISO 5832-4:2000-08 as follows: a) normative references have bee

8、n updated; b) the standard has been editorially revised. Previous editions DIN ISO 5832-4: 2000-08 National Annex NA (informative) Bibliography DIN EN ISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperature DIN ISO 5832-4:2015-12 3 IntroductionNo known surgical impl

9、ant material has ever been shown to cause absolutely no adverse reactions 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

10、appropriate applications.DIN ISO 5832-4:2015-12 4Implants for surgery Metallic materials Part 4: Cobalt-chromium-molybdenum casting alloy1 ScopeThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting alloy for use in the manufact

11、ure of surgical implants.NOTE The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with the specifications given in this part of ISO 5832.2 Normative referencesThe following documents, in whole or in part, are normatively referenced i

12、n 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 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temp

13、erature3 Chemical compositionThe heat analysis of a representative sample of the alloy when determined in accordance with Clause 5 shall comply with the chemical composition specified in Table 1.Requirements for the major and minor elemental constituents for cobalt-chromium-molybdenum casting alloy

14、are listed in Table 1.Table 1 Chemical compositionElementCompositional limits % (m/m)Chromium 26,5 to 30,0Molybdenum 4,5 to 7,0Nickel 1,0 max.Iron 1,0 max.Carbon 0,35 max.Manganese 1,0 max.Silicon 1,0 max.Cobalt BalanceDIN ISO 5832-4:2015-12 5 4 Mechanical propertiesThe tensile properties of the all

15、oy, when tested in accordance with Clause 5, shall comply with the specified values in Table 2.Table 2 Mechanical propertiesTensile strength Rmmin. MPaProof stress of non-proportional elongation Rp0,2min. MPaPercentage elongation after frac-tureaA min.665 450 8aGauge length = 5,65 Somm or 50 mm, whe

16、re Sois the original cross-sectional area, in square millimetres.Should any of the test 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

17、 comply only if both additional test pieces meet the specified requirements.However, the manufacturer can re-heat treat the material and resubmit it for testing in accordance with this part of ISO 5832. In this case, all parts should be heat-treated in the same fashion.5 Test methodsThe test methods

18、 used in determining compliance with this part of ISO 5832 shall be those given in Table 3.Representative test pieces for the determination of mechanical properties shall be prepared in accordance with ISO 6892-1.Table 3 Test methodsParameter Relevant clause Test methodChemical composition 3 Recognized analytical procedures (International Standards where these exist)Mechanical properties Tensile strength Proof stress of non-proportional elongation Percentage elongation4ISO 6892-1ISO 6892-1ISO 6892-1DIN ISO 5832-4:2015-12 6