DIN ISO 5832-14-2009 Implants for surgery - Metallic materials - Part 14 Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy (ISO 5832-14 2007)《外科植入物 金属材料 第14部分 锻造钛15 钼5 锆.pdf

1、December 2009DEUTSCHE NORM English price group 6No 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; 77.120.50!$

2、+b“1560863www.din.deDDIN ISO 5832-14Implants for surgery Metallic materials Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminiumalloy (ISO 5832-14:2007)English version of DIN ISO 5832-14:2009-12Chirurgische Implantate Metallische Werkstoffe Teil 14: Titan Molybdn-15 Zirkonium-5 Aluminium-

3、3 Knetlegierung (ISO 5832-14:2007)Englische Fassung DIN ISO 5832-14:2009-12www.beuth.deDocument comprises pages8DIN ISO 5832-14:2009-12 Contents Page National foreword . 3 National Annex NA (informative) Bibliography 4 Introduction . 5 1 Scope . 6 2 Normative references 6 3 Chemical composition. 6 4

4、 Microstructure 7 5 Mechanical properties . 7 6 Test methods 7 Bibliography 8 2DIN ISO 5832-14:2009-12 National foreword This standard has been prepared by Technical Committee ISO/TC 150 “Implants for surgery”, Subcommittee SC 1 “Materials” (Secretariat: DIN, Germany). The responsible German body in

5、volved 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 text of ISO 5832-14:2007 has been adopted in this standard without any modifications. DIN ISO 5832 consists of

6、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 alloy Part 5: Wrought cobalt-chromium-tungsten-nickel allo

7、y 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 stainless steel Part 11: Wrought titanium 6-aluminium 7-niobium

8、 alloy Part 12: Wrought cobalt-chromium-molybdenum alloy Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 643 DIN EN ISO 643 ISO 6892 E DIN EN ISO 6892-1 3DIN ISO 5832

9、-14:2009-12 National Annex NA (informative) Bibliography DIN EN ISO 643, Steels Micrographic determination of the apparent grain size E DIN EN ISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperature 4DIN ISO 5832-14:2009-12 Introduction No known surgical implant mat

10、erial 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 appropr

11、iate applications. 5Implants for surgery Metallic materials Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy 1 Scope This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for u

12、se in the manufacture of surgical implants. This part of ISO 5832 applies to materials in bar form up to a maximum diameter of 100 mm. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832. 2 Normative

13、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 (including any amendments) applies. ISO 643, Steels Micrographic determina

14、tion of the apparent grain size ISO 6892, Metallic materials Tensile testing at ambient temperature 3 Chemical composition The heat analysis when determined as specified in Clause 6 shall comply with the chemical composition specified in Table 1. Ingot analysis may be used for reporting all chemical

15、 requirements except hydrogen, which shall be determined after the last heat treatment and pickling procedure. Table 1 Chemical composition Element Compositional limits Percent mass fraction Molybdenum 14,0 to 16,0 Zirconium 4,5 to 5,5 Aluminium 2,5 to 3,5 Iron 0,30 max. Oxygen 0,20 max.Carbon 0,08

16、max.Nitrogen 0,05 max. Hydrogen 0,02 max.Titanium Balance DIN ISO 5832-14:2009-12 64 Microstructure The microscopic structure of the alloy in the solution annealed condition shall be uniform and fully recrystallized single-phase beta microstructure. The grain size, determined as specified in Clause

17、6, shall be no coarser than grain size No. 4. at a magnification of 100 , and no alpha case or other foreign phases shall be visible. 5 Mechanical properties The tensile properties of the alloy, determined as specified in Clause 6, shall be in accordance with the requirements of Table 2. Should any

18、of the test pieces not meet 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 if both additional test pieces meet the specified requirements. If a test piece fails outside the gauge limits, th

19、e test is invalid and a retest shall be performed. If any of the retests fails to meet the appropriate requirements, the product represented shall be deemed not to comply with this part of ISO 5832. However, the manufacturer may, if desired, subject the material to heat treatment again and resubmit

20、it for testing in accordance with this part of ISO 5832. Table 2 Mechanical properties of bars Condition Tensile strength Rm,minMPa Proof stress Rp0,2minMPa Elongation Amin% Solution annealed a900 800 12 aMaximum diameter = 100 mm. 6 Test methods The test methods to be used in determining compliance

21、 with the requirements of 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 the provisions of ISO 6892. Table 3 Test methods Parameter Relevant clause Test method Chemical composition 3 Recognized analytical procedures Grain size 4 ISO 643 Tensile properties 5 ISO 6892 DIN ISO 5832-14:2009-12 7Bibliography 1 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing DIN ISO 5832-14:2009-12 8