DIN ISO 5832-5-2008 Implants for surgery - Metallic materials - Part 5 Wrought cobalt-chromium-tungsten-nickel alloy (ISO 5832-5 2005) English version of DIN ISO 5832-5 2008-04《外科植.pdf

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1、April 2008DEUTSCHE 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!$NL“1434129www.

2、din.deDDIN ISO 5832-5Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy(ISO 5832-5:2005)English version of DIN ISO 5832-5:2008-04Chirurgische Implantate Metallische Werkstoffe Teil 5: Kobalt-Chrom-Wolfram-Nickel-Schmiedelegierung (ISO 5832-5:2005)Englische

3、Fassung DIN ISO 5832-5:2008-04SupersedesDIN ISO 5832-5:2001-04www.beuth.deDocument comprises 7 pagesDIN ISO 5832-5:2008-04 2 National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials”. The responsible German body involved

4、 in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee NA 027-02-06 AA Implantat-werkstoffe. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 643 DIN E

5、N ISO 643 ISO 6892 DIN EN ISO 6892 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-molybdenum casting al

6、loy 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 nitrogen stainle

7、ss steel Part 11: Wrought titanium 6-aluminium 7-niobium alloy Part 12: Wrought cobalt-chromium-molybdenum alloy Amendments This standard differs from DIN ISO 5832-5:2001-04 as follows: a) Clause 2 “Normative references” has been corrected. b) c) In Table 2, thick inclusions are now specified. d) In

8、 Table 3, the percentage elongation value has been corrected to 30. Previous editions DIN ISO 5832-5: 2001-04 Table 1 has been extended to include sulfur and phosphorus. The values have been adapted. National Annex NA (informative) Bibliography DIN EN ISO 643, Steels Micrographic determination of th

9、e apparent grain size DIN EN ISO 6892, Metallic materials Tensile testing Method of testing at ambient temperature 3 DIN ISO 5832-5:2008-04 Introduction No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. However, long-term clinical ex

10、perience 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, if the material is used in appropriate applications. 4 DIN ISO 5832-5:2008-04 Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tu

11、ngsten-nickel alloy 1 Scope This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought cobalt-chromium-tungsten-nickel alloy for use in the manufacture of surgical implants. NOTE The tensile properties of a sample obtained from a finished product made of this

12、 alloy might not necessarily comply with those specified in this part of ISO 5832. 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

13、 referenced document (including any amendments) applies. ISO 643, Steels Micrographic determination of the apparent grain size ISO 4967:1998, Steel Determination of content of nonmetallic inclusions Micrographic method using standard diagrams ISO 6892, Metallic materials Tensile testing at ambient t

14、emperature 3 Chemical composition The analysis of a representative sample of the alloy when determined as specified in Clause 6 shall comply with the chemical composition specified in Table 1. Table 1 Chemical composition Element Compositional limits mass fraction % Chromium 19 to 21 Tungsten 14 16

15、Nickel 9 to 11 Iron u 3 Carbon u 0,15 Silicon u 1 Manganese u 2 Sulfur 0,03 Phosphorus 0,04 Cobalt Balance 5 DIN ISO 5832-5:2008-04 4 Microstructure 4.1 Grain size index Samples shall be prepared and etched for examination by any recognized technique. The grain size measured in accordance with ISO 6

16、43 shall be 5 or finer. NOTE ISO 643 is given as a reference even though the material dealt with in this part of ISO 5832 is not iron-based. 4.2 Inclusion content A longitudinal sample suitably polished shall be examined in accordance with ISO 4967, Method A, and shall not exhibit inclusions in exce

17、ss of those specified in Table 2. Table 2 Inclusion content limits Type of inclusion Inclusion content: thin aA Sulfides 1 B Aluminates 3 C Silicates 1 D Oxides (globular) 3 aThick inclusions are allowed until 0,5. 5 Tensile properties The tensile properties of the alloy, determined as specified in

18、Clause 6, shall be in accordance with the requirements of Table 3. The level of mechanical properties for material in other than the annealed condition shall be specified in the purchase order. Table 3 Tensile properties Condition Tensile strength MPa 0,2 % offset proof stress MPa Percentage elongat

19、ion % Annealed W 860 W 310 W 30 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 4. Representative test pieces for the determination of tensile properties shall be prepared in accordance with ISO 6892. 6

20、 DIN ISO 5832-5:2008-04 Table 4 Test methods Requirement Relevant clause or subclause Test methods Chemical composition Clause 3 Recognized analytical procedures (ISO methods where these exist) Tensile properties Clause 5 ISO 6892 Grain size 4.1 ISO 643 Inclusion content 4.2 ISO 4967 7 DIN ISO 5832-5:2008-04