1、April 2009DEUTSCHE NORM English price group 5No part of this standard 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!$Vyz
2、“1518687www.din.deDDIN ISO 5832-12Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy(ISO 5832-12:2007)English version of DIN ISO 5832-12:2009-04Chirurgische Implantate Metallische Werkstoffe Teil 12: Kobalt-Chrom-Molybdn-Schmiedelegierung (ISO 5832-12:2007)Engl
3、ische Fassung DIN ISO 5832-12:2009-04SupersedesDIN ISO 5832-12:2000-08www.beuth.deDocument comprises 6 pagesDIN ISO 5832-12:2009-04 National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials”. The responsible German body i
4、nvolved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee NA 027-02-06 AA Implantatwerkstoffe. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 643
5、 DIN EN ISO 643 ISO 6892 E DIN EN ISO 6892 DIN ISO 5832 consists of the following parts, under the general title Implants for surgery Metallic materials: Part 1: Wrought stainless steel Part 2: Unalloyed titanium Part 3: Wrought titanium 6-aluminium 4-vanadium alloy Part 4: Cobalt-chromium-molybdenu
6、m casting alloy Part 5: Wrought cobalt-chromium-tungsten-nickel alloy Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy Part 9: Wrought high nitr
7、ogen stainless steel Part 11: Wrought titanium 6-aluminium 7-niobium alloy Part 12: Wrought cobalt-chromium-molybdenum alloy Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy Amendments This standard differs from DIN ISO 5832-12:2000-08 as follows: a) NOTE 2 relating to carbide d
8、istribution has been added to the scope. b) In Table 1, a distinction is now made between low carbon and high carbon. c) Further requirements have been included in clause 5. d) Table 2 “Mechanical properties” has been updated. Previous editions DIN ISO 5832-12: 2000-08 2DIN ISO 5832-12:2009-04 Natio
9、nal Annex NA (informative) Bibliography DIN EN ISO 643, Steels Micrographic determination of the apparent grain size E DIN EN ISO 6892, Metallic materials Tensile testing Method of testing at ambient temperature 3DIN ISO 5832-12:2009-04 This page is intentionally blank 41 Scope This part of ISO 5832
10、 covers the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified
11、 in this part of ISO 5832. NOTE 2 The high carbon content of this alloy produces a structure containing a significant carbide distribution. This can be adjusted either in the production of the bar or in subsequent thermomechanical processing to produce the final device. Carbide distribution in the f
12、inal device is not included as part of this document. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includi
13、ng any amendments) applies. ISO 643, Steels Micrographic determination of the apparent grain size ISO 6892, Metallic materials Tensile testing at ambient temperature 3 Chemical composition The heat analysis of a representative sample of the alloy when determined in accordance with Clause 6 shall com
14、ply with the chemical composition specified in Table 1. Introduction No known surgical implant 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 tha
15、t an acceptable level of biological response can be expected when the material is used in appropriate applications. Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy DIN ISO 5832-12:2009-04 5Table 1 Chemical composition Mass fraction % Element Alloy 1 Low carb
16、on Alloy 2 High carbon Chromium 26,0 to 30,0 26,0 to 30,0 Molybdenum 5,0 to 7,0 5,0 to 7,0 Iron 0,75 max. 0,75 max. Manganese 1,0 max. 1,0 max. Silicon 1,0 max. 1,0 max. Carbon 0,14 max. 0,15 to 0,35 Nickel 1,0 max. 1,0 max. Nitrogen 0,25 max. 0,25 max. Cobalt Balance Balance 4 Microstructure The mi
17、crostructure of the alloy shall be uniform. The grain size, determined in accordance with Clause 6, shall not be coarser than grain size No 5. 5 Mechanical properties The tensile properties of the alloy, when tested in accordance with Clause 6, shall comply with the values specified in Table 2. If a
18、ny of the test pieces break outside the gauge length or fail to meet the specified requirements, two further test pieces representative of the same batch shall be tested in the same manner. The alloy shall be deemed to comply only when both additional test pieces meet the specified requirements. Tab
19、le 2 Mechanical properties Tensile strength Proof stress Percentage elongation Rm,minRp0,2minAminCondition MPa MPa % Annealed 897 517 20 Hot worked 1 000 700 12 Warm worked 1 192 827 12 6 Test methods The test methods to be used in determining compliance with the requirements of this part of ISO 5832 shall be those given in Table 3. Table 3 Test Methods Parameter Relevant clause Test method Chemical composition 3 Recognised analytical procedures (ISO methods, where these exist) Grain size 4 ISO 643 Mechanical properties 5 ISO 6892 DIN ISO 5832-12:2009-04 6
