ASTM F67-2013 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250 UNS R50400 UNS R50550 UNS R50700)《外科植入物应用非合金钛(UNS R50250 UNS R50400 UNS R5.pdf

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1、Designation: F67 13Standard Specification forUnalloyed Titanium, for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700)1This standard is issued under the fixed designation F67; the number immediately following the designation indicates the year of originaladoption or, in t

2、he case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for fo

3、ur grades of unalloyed tita-nium strip, sheet, plate, bar, billet, forging, and wire used forthe manufacture of surgical implants.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; there

4、fore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:2B265 Specification for Titanium and Titanium Alloy Strip,Sheet, and PlateB348 Specification for Titanium and Titan

5、ium Alloy Barsand BilletsB381 Specification for Titanium and Titanium Alloy Forg-ingsE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE290 Test Methods for Bend Testing of Material for Duct

6、il-ityE1409 Test Method for Determination of Oxygen and Nitro-gen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE1447 Test Method for Determination of Hydrogen in Tita-nium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1941 Test Method for De

7、termination of Carbon in Refrac-tory and Reactive Metals and TheirAlloys by CombustionAnalysisE2371 Test Method for Analysis of Titanium and TitaniumAlloys by Direct Current Plasma and Inductively CoupledPlasma Atomic Emission Spectrometry (Performance-Based Test Methodology)E2626 Guide for Spectrom

8、etric Analysis of Reactive andRefractory MetalsF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneIEEE/ASTM SI 10 American National Standard for MetricPractice2.2 Aerospace Material Specification:3AMS 2249 Chemica

9、l Check Analysis Limits, Titanium andTitanium AlloysAMS 2380 Approval and Control of Premium Quality Tita-nium AlloysAMS 2631 Ultrasonic Inspection Titanium Alloy Bar, Billetand Plate2.3 ISO Standards:ISO 5832-2 Implants for SurgeryMetallic MaterialsUnalloyed Titanium4ISO 6892 Metallic MaterialsTens

10、ile Testing at AmbientTemperature4ISO 9001 Quality Management Systems43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.3.1.2 cold work, nany mechanica

11、l deformation processperformed below the recrystallization temperature which re-sults in strain hardening of the material.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallu

12、rgical Materials.Current edition approved June 1, 2013. Published August 2013. Originallyapproved in 1966. Last previous edition approved in 2006 as F67 06. DOI:10.1520/F0067-13.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org.

13、For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwau

14、kee, WI 53203.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.3 hot work, nany mechanical deformation processperformed above the recrystallization temperature.3.1.4

15、alpha case, noxygen, nitrogen or carbon-enriched,alpha-stabilized surface which results from elevated tempera-ture exposure.4. Product Classification4.1 Product classifications are consistent with SpecificationsB265, B348, and B381.4.1.1 StripAny product 0.188 in. (4.76 mm) and under inthickness and

16、 less than 24 in. (610 mm) wide.4.1.2 SheetAny product 0.188 in. (4.76 mm) and under inthickness and 24 in. (610 mm) or more in width.4.1.3 PlateAny product 0.188 in. (4.76 mm) thick andover and 10 in. (254 mm) wide and over, with widths greaterthan five times thickness. Plate up to 4 in. (102 mm),

17、thickinclusive is covered by this specification.4.1.4 BarRounds, flats, or other shapes from 0.188 in.(4.76 mm) to 4 in. (102 mm) in diameter or thickness. (Othersizes and shapes by special order.)4.1.5 Forging barBar as described in 4.1.4 used in theproduction of forgings. This product may be furni

18、shed in thehot worked condition.4.1.6 BilletA solid semi-finished section hot rolled orforged from an ingot, with a cross sectional area greater than 16in.2(10 322 mm2) whose width is less than 5 times itsthickness.4.1.7 ForgingAny product of work on metal formed to adesired shape by impact or press

19、ure in hammers, forgingmachines, upset presses, or related forming equipment.4.1.8 WireRounds, flats or other shapes less than 0.188 in.(4.76 mm) in diameter or thickness.4.1.9 OtherOther forms and shapes, including tubing,may be provided by agreement between purchaser and sup-plier.5. Ordering Info

20、rmation5.1 Inquiries and orders for material under this specificationshall include the following information:5.1.1 Quantity (weight or number of pieces),5.1.2 Grade (1, 2, 3, or 4),5.1.3 ASTM designation and date of issue,5.1.3.1 Units to be certified SI or inch-pound,5.1.4 Form (sheet, strip, plate

21、, bar, billet, forging, wire, orother forms),5.1.5 Condition (see 6.1),5.1.6 Mechanical properties (if applicable, for specialconditions),5.1.7 Finish (see 6.2),5.1.8 Applicable dimensions and tolerances including size,thickness, width, and length (exact, random, multiples) ordrawing number,5.1.9 Sp

22、ecial tests (if any), and5.1.10 Other requirements.6. Manufacture6.1 ConditionMaterial shall be furnished in the hot-worked, cold-worked, forged, annealed, or stress-relieved con-dition.6.2 FinishThe mill product may be furnished as descaledor pickled, abrasive blasted, chemically milled, ground,mac

23、hined, peeled, polished, or as specified by the purchaser.On billets, bars, plates, and forgings, it is permissible toremove minor surface imperfections by spot grinding if suchgrinding does not reduce the dimension below the minimumpermitted by the dimensional tolerance ordered.7. Chemical Composit

24、ion7.1 The heat analysis shall conform to the chemical com-position of Table 1. Ingot analysis may be used for reporting allchemical requirements, except hydrogen. Samples for hydro-gen shall be taken from the finished mill product. Supplier shallnot ship material with chemistry outside the requirem

25、entsspecified in Table 1 for the applicable grade.7.1.1 Requirements for the major and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements.Analysis for elements not listed in Table 1 isnot required to verify compliance with this specification.TABLE 1 Chemica

26、l RequirementsElementCompositionA, % (mass/mass)Grade 1 Grade 2 Grade 3 Grade 4UNS R50250 UNS R50400 UNS R50550 UNS R50700Nitrogen, max 0.03 0.03 0.05 0.05Carbon, max 0.08 0.08 0.08 0.08Hydrogen, maxB0.015 0.015 0.015 0.015Iron, max 0.20 0.30 0.30 0.50Oxygen, max 0.18 0.25 0.35 0.40Titanium balance

27、balance balance balanceAForgings are designated Grade F-1, F-2, F-3, or F-4 respectively. Forging compositions are as specified in Table 1.BMaximum hydrogen content for billet is 0.0100 wt%.TABLE 2 Product Analysis TolerancesAElementLimit or Maximum ofSpecified Range %,(mass/mass)Tolerance Under the

28、Minimum or Over theMaximum LimitBNitrogen up to 0.05 0.02Carbon 0.10 0.02Hydrogen up to 0.015 0.0020Iron up to 0.25 0.10Iron over 0.25 0.15Oxygen up to 0.20 0.02Oxygen over 0.20 0.03ARefer to AMS 2249.BUnder minimum limit not applicable for elements where only a maximumpercentage is indicated.F67132

29、7.2 Product Analysis7.2.1 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations in themeasurement of chemical content between laboratories. Theproduct analysis tolerances shall conform to the producttolerances in Table 2.7.2.2 The product analysis

30、is either for the purpose ofverifying the composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.7.2.3 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analysis. Product analyse

31、s outside the tolerance limitsallowed in Table 2 are cause for rejection of the product. Areferee analysis may be used if agreed upon by supplier andpurchaser.7.2.4 For referee purposes, use Test Methods E2371,E2626, E1409, E1447, E1941 or other analytical methodsagreed upon between the purchaser an

32、d supplier.7.3 Samples for chemical analysis shall be representative ofthe material being tested. The utmost care must be used insampling titanium for chemical analysis because of its affinityfor elements such as oxygen, nitrogen, and hydrogen. Incutting samples for analysis, therefore, the operatio

33、n should becarried out insofar as possible in a dust-free atmosphere.Cutting tools should be clean and sharp. Samples for analysisshould be stored in suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shallconform to the mechanical property requirements

34、in Table 3,Table 4 and Table 5. Grades may be ordered in the cold workedcondition to higher minimum tensile strength but a minimum10 % elongation in 4D or 2 in. (50 mm) must be met except forwire. See footnotes in Table 5. Alternate properties may beagreed upon between the purchaser and supplier.8.2

35、 Specimens for tension tests shall be prepared and testedin accordance with Test Methods E8/E8M. Tensile propertiesshall be determined using a strain rate of 0.003 to 0.007in/in/min (mm/mm/min) through yield and then the crossheadspeed may be increased so as to produce fracture in approxi-mately one

36、 additional minute. Tensile tests results for whichany specimen fractures outside the gage length shall beconsidered valid, if both the elongation and reduction of areameet the minimum requirements specified. Refer to sections7.11.4 and 7.12.5 of Test Methods E8/E8M. If either theelongation or reduc

37、tion of area is less than the minimumrequirement, invalidate the specimen and retest. Retest onespecimen for each specimen that did not meet the minimumrequirements.8.2.1 Bar, Forging Bar, Shapes, and WireTest accordingto Test Methods E8/E8M. Should any test specimen not meetthe specified requiremen

38、ts, test two additional test piecesrepresentative of the same lot, in the same manner, for eachfailed test specimen. The lot will be considered in complianceonly if all additional test pieces meet the specified requirements8.2.2 Tension testing of wire shall be conducted in accor-dance with Test Met

39、hods E8/E8M Tension testing shall beconducted using the appropriate gauge length, shown in Table5, for the size wire being tested. For wire sizes 0.0625 in.(1.59 mm) (4D gauge length) a strain rate of 0.003 to 0.007in./in. (mm/mm)/min through the specified yield strength shallbe used and then the cr

40、osshead speed shall be increased so asto produce fracture in approximately one additional minute.For wire diameters less than 0.0625 in. (1.59 mm) a crossheadspeed of 0.5 to 1.0 in./min (12.7 to 25.4 mm/min) shall be used.Once yielding has begun, the crosshead speed may be in-creased to a maximum of

41、 3.0 in./min (76.2 mm/min).8.2.3 Sheet, Strip, and PlateTest according to Test Meth-ods E8/E8M. Tests in the transverse direction need be madeonly on product from which a specimen not less than 8.0 in.(200 mm) in length for sheet and 2.50 in. (64 mm) in length forplate can be taken. Should any of th

42、ese test specimens not meetthe specified requirements, test two additional test piecesrepresentative of the same lot, in the same manner, for eachfailed test specimen. The lot will be considered in complianceonly if all additional test pieces meet the specified require-ments.8.3 For sheet and strip,

43、 perform at least one bend testaccording to Test Methods E290 from each lot in both thelongitudinal and transverse directions. Tests in the transversedirection need be made only on product from which a specimennot less than 8.0 in. (200 mm) in length for sheet and 2.50 in.(64 mm) in length for plate

44、 can be taken. The bend testspecimen shall withstand being bent cold through an angle of105 without fracture on the outside of the bent portion. Thebend shall be made around a mandrel which has a diameterequal to that shown in Table 4 for the applicable grade.9. Units of Measure9.1 SelectionThis spe

45、cification requires that the purchaserselects the units (SI or inch-pound) to be used for productcertification. In the absence of a stated selection of units on thepurchase order (PO), this selection may be expressed by thepurchaser in several alternate forms listed in order of prece-dence.TABLE 3 M

46、echanical Requirements: Annealed-Bar, Billet,Forgings, and Other FormsAGradeTensile Strength,minYield Strength,0.2 % Offset,minElongationBin 4D,min, %Reductionof Area,min, %Cksi MPa ksi MPa1 35 240 25 170 24 302 50 345 40 275 20 303 65 450 55 380 18 304 80 550 70 483 15 25AThese properties apply to

47、forgings having a maximum cross section area notgreater than 3 in.2(1935 mm2). Mechanical properties of forgings having greatercross sections shall be negotiated between the manufacturer and the purchaser.BElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W)shall be meas

48、ured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmust be reported with the test results. The method for determining elongation ofmaterial under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.Alternatively, a gauge length corresponding to ISO 6892 may be used whenagreed

49、upon between supplier and purchaser. (5.65 times the square root of So,where So is the original cross sectional area.)CReduction of area not required for tubing.F671339.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.2 In the absence of historic precedence, if the units usedto define the product on the purchasers PO, specification, andengineering drawing are consistent, these units shall be used bythe supplier for product certification9.1.3 If t