BS ISO 5832-14-2009 Implants for surgery - Metallic materials - Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy《外科植入物 金属材料 锻造钛15-钼5-锆3-铝合金》.pdf

1、BS ISO5832-14:2007ICS 11.040.40NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDImplants for surgery Metallic materialsPart 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminiumalloyThis British Standard was published under theauthority of the StandardsPolic

2、y and StrategyCommittee on 31 January2009 BSI 2009ISBN 978 0 580 60919 0Amendments/corrigenda issued since publicationDate CommentsBS ISO 5832-14:2007National forewordThis British Standard is the UK implementation of ISO 5832-14:2007.The UK participation in its preparation was entrusted to Technical

3、Committee CH/150/1, Materials for surgical implants.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance wi

4、th a British Standard cannot confer immunityfrom legal obligations.BS ISO 5832-14:2007Reference numberISO 5832-14:2007(E)ISO 2007INTERNATIONAL STANDARD ISO5832-14First edition2007-10-15Implants for surgery Metallic materials Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy Impla

5、nts chirurgicaux Matriaux mtalliques Partie 14: Alliage corroy base de titane, de molybdne-15, de zirconium-5 et daluminium-3 BS ISO 5832-14:2007ISO 5832-14:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or vi

6、ewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability i

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8、 for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utili

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10、 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reservedBS ISO 5832-14:2007ISO 5832-14:2007(E) ISO 2007 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bo

11、dies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizatio

12、ns, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the

13、ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of th

14、e member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 5832-14 was prepared by Technical Committee ISO/TC 150, Implants

15、for surgery, Subcommittee SC 1, Materials. 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 ca

16、sting 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 nitrogen

17、 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 BS ISO 5832-14:2007ISO 5832-14:2007(E) iv ISO 2007 All rights reservedIntroduction No known surgical implant

18、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 appr

19、opriate applications. BS ISO 5832-14:2007INTERNATIONAL STANDARD ISO 5832-14:2007(E) ISO 2007 All rights reserved 1Implants 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 correspo

20、nding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for use 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 pro

21、duct made of this alloy can differ from 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

22、referenced document (including 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 when determined as specified in Clause 6 shall comply with the ch

23、emical composition specified in Table 1. Ingot analysis may be used for reporting all chemical 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

24、 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 max.Nitrogen 0,05 max. Hydrogen 0,02 max.Titanium Balance BS ISO 5832-14:2007ISO 5832-14:2007(E) 2 ISO 2007 All rights reserved4 Microstructure The microscopic structure of the alloy in the solution anneale

25、d condition shall be uniform and fully recrystallized single-phase beta microstructure. The grain size, determined as specified in Clause 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

26、tensile properties of the alloy, determined as specified in Clause 6, shall be in accordance with the requirements of Table 2. Should any 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 b

27、e deemed to comply only if both additional test pieces meet the specified requirements. If a test piece fails outside the gauge limits, the 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 t

28、o comply with this part of ISO 5832. However, the manufacturer may, if desired, subject the material to heat treatment again and resubmit 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 Elong

29、ation Amin% Solution annealed a900 800 12 aMaximum diameter = 100 mm. 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. Representative test pieces for the determination of mechanical properties shall b

30、e 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 BS ISO 5832-14:2007ISO 5832-14:2007(E) ISO 2007 All rights reserved 3Bibliog

31、raphy 1 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing BS ISO 5832-14:2007ISO 5832-14:2007(E) ICS 11.040.40 Price based on 3 pages ISO 2007 All rights reserved BS ISO 5832-14:2007This page has been intentionally left blank BS ISO5832-14:2007BSI GroupHeadquarters

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