EN ISO 5832-3-2012 3750 Implants for surgery - Metallic materials - Part 3 Wrought titanium 6-aluminium 4-vanadium alloy《外科植入物 金属材料 第3部分 6-铝4-钒合金变形钛》.pdf

1、BRITISH STANDARDBS 7252-3:1997ISO 5832-3:1996Metallic materials for surgical implants Part 3: Specification for wrought titanium 6-aluminium 4-vanadium alloyICS 11.040.40BS EN ISO 5832-3:2012Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloyCopyright Europe

2、an Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS 7252-3:1997This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the

3、authority of the Standards Board and comes into effect on 15 May 1997 BSI 01-1999First published April 1990Second edition May 1997The following BSI references relate to the work on this standard:Committee reference CH/18Draft for comment 95/560364 DCISBN 0 580 26644 3Committees responsible for this

4、British StandardThe preparation of this British Standard was entrusted to Technical Committee CH/18, Surgical implant materials, upon which the following bodies were represented:Association of British Health-Care IndustriesBritish Industrial Ceramic Manufacturers AssociationBritish Iron and Steel Pr

5、oducers AssociationBritish Medical AssociationBritish Orthopaedic AssociationBritish Surgical Trades AssociationDepartment of HealthNational Physical LaboratoryRoyal College of Surgeons of EnglandRoyal Veterinary CollegeScottish OfficeSurgical Dressings Manufacturers AssociationThe following bodies

6、were also represented in the drafting of the standard, through subcommittees and panels:British Dental AssociationBritish Investment Casting Trade AssociationConfederation of British ForgersInstitute of Sterile Services of EnglandAmendments issued since publicationAmd. No. Date CommentsBS EN ISO 583

7、2-3:2012ISBN 978 0 580 76457 8Amendments/corrigenda issued since publicationDate Comments31 August 2012 This corrigendum renumbers BS 7252-3:1997 (ISO 5832-3:1996) as BS EN ISO 5832-3:2012This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was

8、published under the authority of the Standards Board and comes into effect on 15 May 1997 The British Standards Institution 2012. Published by BSI Standards Limited 2012First published April 1990 Second edition May 1997National forewordThis British Standard is the UK implementation of EN ISO 5832-3:

9、2012. It is identical to ISO 5832-3:1996. It supersedes BS 7252-3:1997 (ISO 5832-3:1996), which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/1, Materials for surgical implants.A list of organizations re

10、presented on the subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Copyri

11、ght European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5832-3 May 2012 ICS 11.040.40 English Version Implants for surgery - Metallic m

12、aterials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:1996) Implants chirurgicaux - Produits base de mtaux - Partie 3: Alliage forger base de titane, daluminium 6 et de vanadium 4 (ISO 5832-3:1996) Chirurgische Implantate - Metallische Werkstoffe - Teil 3: Titan 6-Aluminium 4-

13、Vanadium Knetlegierungen (ISO 5832-3:1996) This European Standard was approved by CEN on 28 April 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

14、 Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by tr

15、anslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Fin

16、land, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EURO

17、PISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5832-3:2012: ECopyright European Committee for Standardization Provided by IHS under license w

18、ith CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN ISO 5832-3:2012 (E) 3 Foreword The text of ISO 5832-3:1996 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been

19、taken over as EN ISO 5832-3:2012 by Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2012, and conflictin

20、g national standards shall be withdrawn at the latest by November 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to t

21、he CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvi

22、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5832-3:1996 has been approved by CEN as a EN ISO 5832-3:2012 without any modification. BS EN ISO 5832-3:2

23、012ii The British Standards Institution 2012EN ISO 5832-3:2012Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Copyright European Committee for Standardization Provided by IHS und

24、er license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-blankCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS 7252-3:1997ii BSI 01

25、-1999ContentsPageForeword iiiIntroduction 11 Scope 12 Normative references 13 Chemical composition 14 Microstructure 15 Mechanical properties 16 Test Methods 2Table 1 Chemical composition 1Table 2 Mechanical properties of wrought titanium 6-aluminium 4-vanadium alloy in annealed condition 2Table 3 T

26、est methods 2BS EN ISO 5832-3:2012v The British Standards Institution 2012viISO 5832-3:1996Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS 7252-3:1997 BSI 01-1999 iiiForewordI

27、SO (the International Organization for Standardization) is a worldwide federation of national standards bodies (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 c

28、ommittee has been established has the right to be represented on that committee. International organizations, 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 electr

29、otechnical standardization.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 the member bodies casting a vote.International Standard ISO 5832-3 was prepared

30、by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.This third edition cancels and replaces the second edition (ISO 5832-3:1990), which has been technically revised.ISO 5832 consists of the following parts, under the general title Implants for surgery Metallic mater

31、ials: 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 alloy; Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy; Part 7: Forgeabl

32、e and cold-formedcobalt-chromium-nickel-molybdenum-iron alloy; Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy; Part 9: Wrought high nitrogen stainless steel; Part 10: Wrought titanium 5-aluminium 2,5-iron alloy; Part 11: Wrought titanium 6-aluminium 7-niobium alloy; Part 12: W

33、rought cobalt-chromium-molybdenum alloy.BS 7252-3:1997 BSI 01-1999 iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technic

34、al 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely wi

35、th the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.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 t

36、he member bodies casting a vote.International Standard ISO 5832-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.This third edition cancels and replaces the second edition (ISO 5832-3:1990), which has been technically revised.ISO 5832 consists of t

37、he 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 al

38、loy;Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy;Part 7: Forgeable and cold-formedcobalt-chromium-nickel-molybdenum-iron alloy; Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy; Part 9: Wrought high nitrogen stainless steel; Part 10: Wrought titanium 5-aluminium 2,5-i

39、ron alloy; Part 11: Wrought titanium 6-aluminium 7-niobium alloy; Part 12: Wrought cobalt-chromium-molybdenum alloy.BS EN ISO 5832-3:2012vi The British Standards Institution 2012ISO 5832-3:1996Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo rep

40、roduction or networking permitted without license from IHS-,-,-BS 7252-3:1997 BSI 01-1999 1IntroductionNo 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 t

41、his part of ISO 5832 has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications.1 ScopeThis part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known astitanium 6-alumi

42、nium 4-vanadium alloy(Ti 6-Al 4-V alloy) for use in the manufacture of surgical implants.NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.2 Normative referencesThe follow

43、ing standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 5832. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 5832 are encouraged to inv

44、estigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.ISO 6892:1984, Metallic materials Tensile testing. ISO 7438:1985, Metallic materials Bend test. ETTC2)Publication 2, 19

45、79, Microstructural standards for a + b titanium alloy bars3).3 Chemical compositionThe heat/ingot analysis of a representative sample of the alloy when determined in accordance with clause 6 shall comply with the chemical composition specified in Table 1.NOTE 2 Ingot analysis may be used for determ

46、ining all chemical requirements except hydrogen.The analysis of hydrogen shall be carried out after the final heat treatment and final surface treatment.Requirements for the major and minor elemental constituents for titanium 6-aluminium 4-vanadium alloy are listed in Table 1.Table 1 Chemical compos

47、ition4 MicrostructureThe microstructure, when examined as indicated in Table 3, shall be alpha + beta globular, and shall correspond to photomicrographs A1 to A9 in ETTC Publication 2 for annealed material.5 Mechanical properties5.1 TensileThe tensile properties of the alloy, when tested in accordan

48、ce with clause 6, shall comply with the values specified in Table 2.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 comply only if both additional test pieces meet the specified requirements.NOTE 3 However, the manufacturer may 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.5.2 BendingTitaniu