ASTM F67-2006 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250 UNS R50400 UNS R50550 UNS R50700)《外科植入用非合金钛(UNS R50250、UNS R50400、UNS R505.pdf

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1、Designation: F 67 06Standard Specification forUnalloyed Titanium, for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700)1This standard is issued under the fixed designation F 67; the number immediately following the designation indicates the year of originaladoption or, in

2、 the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements

3、 for four 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 inch-pound units are to be regardedas the standard. The SI equivalents in parentheses are forinformation only.2. Referenced Documents2.1 A

4、STM Standards:2B 265 Specification for Titanium and Titanium Alloy Strip,Sheet, and PlateB 348 Specification for Titanium and Titanium Alloy Barsand BilletsB 381 Specification for Titanium and Titanium Alloy Forg-ingsE8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Sig

5、nificant Digits in Test Data toDetermine Conformance with SpecificationsE 290 Test Methods for Bend Testing of Material forDuctilityE 1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE 1447 Test Method for Determination of Hydro

6、gen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity/Infrared Detection MethodE 2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma SpectrometryF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Resp

7、ect to Effect ofMaterials on Muscle and Bone2.2 Aerospace Material Specification:AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys32.3 ISO Standards:ISO 5832-2 Implants for SurgeryMetallic MaterialsUnalloyed Titanium4ISO 6892 Metallic MaterialsTensile Testing at AmbientTemperature

8、4ISO 9001 Quality Management Systems42.4 American Society for Quality (ASQ) Standard:C1 Specifications of General Requirements for a QualityProgram43. Terminology3.1 Definition of Term Specific to This Standard:3.1.1 lot, nthe total number of mill products producedfrom the same melt heat under the s

9、ame conditions at essen-tially the same time.4. Product Classification4.1 Product classifications are consistent with SpecificationsB 265, B 348, and B 381.4.1.1 StripAny product 0.1875 in. (4.76 mm) and under inthickness and less than 24 in. (610 mm) in width.4.1.2 SheetAny product 0.1875 in. (4.76

10、 mm) and underin thickness and 24 in. (610 mm) or more in width.4.1.3 PlateAny product 0.1875 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. (101.60 mm), thickinclusive is covered by this specification.4.1.4 BarRounds, f

11、lats, or other shapes from 0.1875 in.(4.76 mm) to 4 in. (101.60 mm) in diameter or thickness.(Other sizes and shapes by special order.)4.1.5 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 t

12、imes itsthickness.4.1.6 ForgingAny product of work on metal formed to adesired shape by impact or pressure in hammers, forgingmachines, upset presses, or related forming equipment.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is

13、the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved June 1, 2006. Published June 2006. Originallyapproved in 1966. Last previous edition approved in 2000 as F 67 00.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Cu

14、stomer Service at serviceastm.org. 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 (

15、ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.7 WireRounds, flats or other shapes less than 0.1875in. (4.76 mm)

16、in diameter or thickness.4.1.8 OtherOther forms and shapes, including tubing,may be provided by agreement between purchaser and sup-plier.5. Ordering Information5.1 Inquiries and orders for material under this specificationshall include the following information:5.1.1 Quantity (weight or number of p

17、ieces),5.1.2 Grade (1, 2, 3, or 4),5.1.3 ASTM designation,5.1.4 Form (sheet, strip, plate, bar, billet, forging, wire, orother forms),5.1.5 Condition (see 6.1),5.1.6 Mechanical properties (if applicable, for special con-ditions),5.1.7 Finish (see 6.2),5.1.8 Applicable dimensions and tolerances inclu

18、ding size,thickness, width, and length (exact, random, multiples) ordrawing number,5.1.9 Special tests, 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 FinishUnalloyed titanium mat

19、erial shall be free ofinjurious external and internal imperfections of a nature thatwill interfere with the purpose for which it is intended. The millproduct may be furnished as descaled or pickled, abrasiveblasted, chemically milled, ground, machined, peeled, pol-ished, or as specified by the purch

20、aser. On billets, bars, plates,and forgings, it is permissible to remove minor surfaceimperfections by spot grinding if such grinding does not reducethe dimension below the minimum permitted by the dimen-sional tolerance ordered.7. Chemical Composition7.1 The heat analysis shall conform to the chemi

21、cal 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 requirementsspecified in Table 1 for the applicable grade.7

22、.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.7.2 Product AnalysisProduct analysis tolerances do notbroaden the

23、 specified heat analysis requirements but covervariations between laboratories in the measurement of chemi-cal content. The product analysis tolerances shall conform tothe product tolerances in Table 2.7.2.1 The product analysis is either for the purpose ofverifying the composition of a heat or manu

24、facturing lot or todetermine variations in the composition within the heat.7.2.2 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analysis.7.3 Referee AnalysisIf the results of the purchasersproduct analysis are outside the li

25、mits allowed in Table 2, theseTABLE 1 Chemical 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 0.50Oxy

26、gen, max 0.18 0.25 0.35 0.40Titanium balance 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 ofSpe

27、cified Range %,(mass/mass)Tolerance Under theMinimum 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

28、 only a maximumpercentage is indicated.TABLE 3 Mechanical 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 30

29、4 80 550 70 483 15 25AThese properties apply to 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 g

30、reater in diameter (D)orwidth(W) shall be measured 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 cor

31、responding to ISO 6892 may be used whenagreed 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.F67062results may be subject to a referee analysis. For refereepurposes, use Test Methods E 2

32、371, E 1409, and E 1447 orother analytical methods. Refereeing will be used, if the needfor refereeing, the test lab to perform the referee testing, andthe referee test method are agreed upon between the supplierand the purchaser.7.4 Samples for chemical analysis shall be representative ofthe materi

33、al 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 operation should becarried out insofar as possible in a dust-free atmosphere.Cutting tool

34、s should be clean and sharp. Samples for analysisshould be stored in suitable containers.8. Mechanical Requirements8.1 Bar, billet, and forging shall conform to the mechanicalproperty requirements prescribed in Table 3. Sheet, strip, andplate shall conform to the mechanical property requirementspres

35、cribed in Table 4. Wire products shall conform to themechanical property requirements prescribed in Table 5.Grades may be ordered in the cold-worked condition to higherminimum tensile strength but a minimum 10 % elongation in4D or 2 in. (50 mm) must be met except for wire. See footnotesin Table 5.8.

36、2 For sheet and strip, the bend test specimen shall with-stand being bent cold through an angle of 105 without fractureon the outside of the bent portion. The bend shall be made ona diameter equal to that shown in Table 4 for the applicablegrade.TABLE 4 Mechanical Requirements: Annealed-Sheet, Strip

37、, and PlateGradeTensile Strength,Amin Yield Strength,A(0.2 % Offset)ElongationBin 2 in. or 50mm, min,%Bend TestMandrel DiameterCksi MPamin max Under 0.070in. (1.8 mm)in Thickness0.070 to0.187 in. (1.8to 4.75 mm)in Thicknessksi MPa ksi MPa1 35 240 25 170 45 310 24 3T 4T2 50 345 40 275 65 450 20 4T 5T

38、3 65 450 55 380 80 550 18 4T 5T4 80 550 70 483 95 655 15 5T 6TAMinimum and maximum limits apply to tests taken both longitudinal and transverse to the direction of rolling. Mechanical properties for conditions other than annealedor plate thickness over 1 in. (25 mm) may be established by agreement b

39、etween the manufacturer and the purchaser.BElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length mustbe reported with the test results. The method for determining elongation of material under 0.

40、063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternatively,a gauge length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the originalcross sectional area.)CT equals the thickness of the bend test s

41、pecimen; refer to Test Methods E 290. Bend tests are not applicable to material over 0.1875 in. (4.75 mm) in thickness.TABLE 5 Mechanical Requirements: Annealed WireADiameter, in. (mm) GradeUltimate TensileStrength, min,ksi (MPa)Yield Strength,(0.2% offset) min,ksi (MPa)ElongationBmin, %Reduction in

42、 Area,min, %$0.125 1 35 (240) 25 (170) 24 30($3.18) 2 50 (345) 40 (275) 20 303 65 (450) 55 (380) 18 304 80 (550) 70 (483) 15 250.125 to 0.062 inclusive 1 35 (240) 25 (170) 15 . . .(3.18 to 1.58 inclusive) 2 50 (345) 40 (275) 12 . . .3 65 (450) 55 (380) 10 . . .4 80 (550) 70 (483) 8 . . .0.062 to 0.0

43、20 inclusive 1 35 (240) . . . 12 . . .(1.58 to 0.51 inclusive) 2 50 (345) . . . 10 . . .3 65 (450) . . . 8 . . .4 80 (550) . . . 6 . . .0.020 to 0.005 inclusive 1 35 (240) . . . 10 . . .(0.51 to 0.13 inclusive) 2 50 (345) . . . 8 . . .3 65 (450) . . . 6 . . .4 80 (550) . . . 4 . . .AMechanical prope

44、rties for cold worked condition shall be established by agreement between the supplier and the purchaser.BElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length mustbe reported with the test resu

45、lts. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated, or a 10 in. gaugelength may be used. Alternatively, a gauge length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square

46、root of So, where So is the original cross sectional area.)TABLE 6 Round Wire Size TolerancesDiameter,in. (mm)Size Variation,in. (mm)Out-of-Round,Ain. (mm)0.3125 to 0.125 inclusive 60.002 (0.051) 0.002 (0.051)(7.94 to 3.18 inclusive)0.125 to 0.030 inclusive 60.001 (0.025) 0.001 (0.025)(3.18 to 0.76

47、inclusive)0.030 to 0.010 inclusive 60.0008 (0.020) 0.0008 (0.020)(0.76 to 0.25 inclusive)0.010 to 0.005 inclusive 60.0005 (0.013) 0.0005 (0.013)(0.25 to 0.13 inclusive)AOut-of-Round is the difference between the maximum and minimum diametersof the wire measured at the same cross section.F670638.3 Te

48、nsion testing shall be performed in accordance withTest Methods E8. Tensile properties shall be determined usinga strain rate of 0.003 to 0.007 in./in. (mm/mm)/min through thespecified yield strength, and then the crosshead speed shall beincreased so as to produce fracture in approximately oneadditi

49、onal minute.8.3.1 Tension testing of wire shall be conducted in accor-dance with Test Methods E8. Tension testing shall be con-ducted using the appropriate gauge length, shown in Table 5,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 crosshead 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./