EN ISO 5832-2-2012 en Implants for surgery - Metallic materials - Part 2 Unalloyed titanium《外科植入物 金属材料 第2部分 非合金钛》.pdf

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1、|BRITISH STANDARDBS EN ISO5832-2:2012ICS 11.040.40; 77.120.50NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWImplants for surgery Metallic materials Part 2: Unalloyed titaniumNational forewordThe UK participation in its preparation was entrusted by Technical Committee CH/150, I

2、mplants for surgery, to Subcommittee CH/150/1, Materials for surgical implants.A list of organizations represented on this 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 c

3、orrect application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 5832-2:2012This British Standard, having been prepared under the direction of the Health and En-vironment Sector Committee, was published under the authority of the Standards Committee and c

4、omes into effect on 15 December 1999 The British Standards In-stitution 2012. Published by BSI Standards Limited 2012Amendments/corrigenda issued since publicationDate Comments 30 September 2012ISBN 978 0 580 76456 1This British Standard is the UK implementation of EN ISO 5832-2:2012. It is identica

5、l to ISO 5832-2:1999. It supersedes withdrawn.BS ISO 5832-2:1999, which is This corrigendum renumbers BS ISO 5832-2:1999 as BS EN ISO 5832-2:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5832-2 May 2012 ICS 11.040.40 English Version Implants for surgery - Metallic materials - Part 2:

6、Unalloyed titanium (ISO 5832-2:1999) Implants chirurgicaux - Produits base de mtaux - Partie 2: Titane non alli (ISO 5832-2:1999) Chirurgische Implantate - Metallische Werkstoffe - Teil 2: Unlegiertes Titan (ISO 5832-2:1999) This European Standard was approved by CEN on 28 April 2012. CEN members ar

7、e 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. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to

8、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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Ce

9、ntre 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, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, No

10、rway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in

11、 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5832-2:2012: EForeword The text of ISO 5832-2:1999 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as

12、 EN ISO 5832-2:2012 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 conflicting national st

13、andards 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 the CEN/CENELE

14、C 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, Latvia, Lithuania,

15、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5832-2:1999 has been approved by CEN as a EN ISO 5832-2:2012 without any modification. BS EN ISO 5832-2:2012 EN ISO 58

16、32-2:2012 (E)ii AReference numberISO 5832-2:1999(E)INTERNATIONALSTANDARDISO5832-2First edition1999-07-15Implants for surgery Metallic materials Part 2:Unalloyed titaniumImplants chirurgicaux Produits base de mtaux Partie 2: Titane non alliForewordISO (the International Organization for Standardizati

17、on) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be repre

18、sented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards are dr

19、afted in accordance with the rules given in the ISO/IEC Directives, Part 3.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.

20、International Standard ISO 5832-2 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 5832-2:1993), which has been technically revised.ISO 5832 consists of the following parts, under the gen

21、eral title Implants for surgery Metallic materials:Part 1: Wrought stainless steelPart 2: Unalloyed titaniumPart 3: Wrought titanium 6-aluminium 4-vanadium alloyPart 4: Cobalt-chromium-molybdenum casting alloyPart 5: Wrought cobalt-chromium-tungsten-nickel alloyPart 6: Wrought cobalt-nickel-chromium

22、-molybdenum alloyPart 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloyPart 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloyPart 9: Wrought high nitrogen stainless steelPart 10: Wrought titanium 5-aluminium 2,5-iron alloyPart 11: Wrought titanium 6-aluminium 7

23、-niobium alloyPart 12: Wrought cobalt-chromium-molybdenum alloyBS EN ISO 5832-2:2012 ISO 5832-2:1999 (E)IntroductionNo known surgical implant material has ever been shown to cause absolutely no adverse reaction in the humanbody. However, long-term clinical experience of the use of the material refer

24、red to in this part of ISO 5832 hasshown that an acceptable level of biological response can be expected when the material is used in appropriateapplications.BS EN ISO 5832-2:2012 ISO 5832-2:1999 (E) INTERNATIONAL STANDARD 1Implants for surgery Metalic materials Part 2:Unalloyed titanium1 ScopeThis

25、part of ISO 5832 specifies the characteristics of, and corresponding test methods for, unalloyed titanium foruse in the manufacture of surgical implants.Provision is made for six grades of titanium based on tensile strength (see Table 2).NOTE The mechanical properties of a sample obtained from a fin

26、ished product made of this metal may not necessarilycomply with those specified in this part of ISO 5832.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis International Standard. For dated references, subseq

27、uent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreements based on this International Standard are encouraged toinvestigate the possibility of applying the most recent editions of the normative documents indicated below. Forundated references, the lat

28、est edition of the normative document referred to applies. Members of ISO and IECmaintain registers of currently valid International Standards.ISO 6892:1998, Metallic materials Tensile testing at ambient temperature.ISO 7438:1995, Metallic materials Bend test.ASTM E 112:1988, Standard Test Methods f

29、or Determining Average Grain Size.3 Chemical compositionThe heat analysis when determined as specified in clause 6 shall conform to the requirements as to chemicalcomposition specified in Table 1. Ingot analysis may be used for reporting all chemical requirements excepthydrogen, which shall be deter

30、mined after the last heat treatment and pickling procedure.4 MicrostructureThe microscopic structure of the titanium in the annealed condition shall be uniform. The grain size, determined asspecified in clause 6, shall be no coarser than grain size No. 5.At a magnification of 1003, no inclusions or

31、foreign phases shall be visible.BS EN ISO 5832-2:2012 ISO 5832-2:1999 (E) 25 Mechanical properties5.1 Tensile propertiesThe tensile properties of the titanium, determined as specified in clause 6, shall be in accordance with therequirements of Table 2.Should any of the test pieces not meet the speci

32、fied requirements, two further test pieces representative of thesame batch shall be tested in the same manner. The titanium shall be deemed to comply only if both additional testpieces meet the specified requirements. If a test piece fails outside the gauge limits, the test is invalid and a retestsh

33、all be performed.If any of the retests fails to meet the appropriate requirements, the product represented shall be deemed not tocomply with this part of ISO 5832. However, the manufacturer may, if desired, re-heat-treat the material andresubmit it for testing in accordance with the requirements of

34、this part of ISO 5832.5.2 Bending propertiesTitanium sheet and strip, when tested as specified in clause 6, shall not show any cracking on the outside surface ofthe test piece.Table 1 Chemical compositionElement Maximum compositional limitspercent mass fractionGrade 1 ELI Grade 1 Grade 2 Grade 3 Gra

35、des 4A and 4BNitrogen 0,012 0,03 0,03 0,05 0,05Carbon 0,03 0,10 0,10 0,10 0,10Hydrogen 0,012 5 a0,012 5 a0,012 5 a0,012 5 a0,012 5 aIron 0,10 0,20 0,30 0,30 0,50Oxygen 0,10 0,18 0,25 0,35 0,40Titanium Balance Balance Balance Balance BalanceaExcept for billets, for which the maximum hydrogen content

36、shall be 0,010 0 % (mass fraction) and for flat products forwhich the maximum hydrogen content shall be 0,015 % (mass fraction).BS EN ISO 5832-2:2012 ISO 5832-2:1999 (E)3Table 2 Mechanical propertiesGrade ConditionTensile stength aProof stress ofnon-proportionalelongationPercentageelongation bMandre

37、l diameter for bend testfor sheet and strip cmin. min. min. mmMPa MPa % wheret 2 mmwhere2 mm t 5 mm1 ELI Annealed 200 140 30 3 t 4 t1 Annealed 240 170 24 3 t 4 t2 Annealed 345 275 20 4 t 5 t3 Annealed 450 380 18 4 t 5 t4A Annealed 550 483 15 5 t 6 t4B Cold-worked 680 520 10 6 t 6 taTensile, yield an

38、d bending requirements of sheet shall apply to material taken both parallel and perpendicular to the directionof rolling.b Gauge length = 5,65 S0or 50 mm, where S0is the original cross-sectional area, in square millimetres.ct = thickness of the sheet or strip.6 Test methodsThe test methods to be use

39、d in determining compliance with the requirements of this part of ISO 5832 shall bethose given in Table 3.Representative test pieces for the determination of mechanical properties shall be prepared in accordance with theprovisions of ISO 6892.Table 3 Methods of testRequirement Relevant clause Method

40、 of testChemical composition 3 Recognized analytical proceduresGrain size 4 ASTM E 112Mechanical propertiesUltimate tensile strengthYield strengthElongationReduction of areaBend test5ISO 6892ISO 6892ISO 6892ISO 6892ISO 7438 Bend the sheet or strip throughan angle of at least 105 around amandrel of t

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