1、Designation: F 2066 07Standard Specification forWrought Titanium-15 Molybdenum Alloy for Surgical ImplantApplications (UNS R58150)1This standard is issued under the fixed designation F 2066; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re
2、vision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for wrought ti
3、tanium-15 molybde-num alloy to be used in the manufacture of surgical implants(1).21.2 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 ASTM Standards:3E8 Test Methods for Tension Testing of
4、Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE 290 Test Methods for Bend Testing of Material forDuctilityE 1409 Test Method for Determination of Oxygen andNitrogen in Titanium a
5、nd Titanium Alloys by the Inert GasFusion TechniqueE 1447 Test Method for Determination of Hydrogen 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 Spectrometr
6、yF67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with
7、 Respect to Effect ofMaterials on Muscle and BoneF 1408 Practice for Subcutaneous Screening Test for Im-plant Materials2.2 Aerospace Material Specification:AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys42.3 ISO Standards:5ISO 6892 Metallic Materials Tensile TestingISO 9001 Qual
8、ity Management Systems2.4 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Qual-ity Program63. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta annealed, nthe condition of the material that isobtained if, following the final hot-working
9、 or cold-workingoperation, the mill product is rapidly quenched, for example,by water quenching or pressurized helium gas quench, from atemperature above the beta transus of approximately 1382F(750C).3.1.2 beta transus, nthe minimum temperature at whichthe alpha plus beta phase can transform to 100
10、% beta phase.4. Product Classification4.1 StripAny product under 0.1875 in. (4.76 mm) inthickness and under 24 in. (610 mm) wide.4.2 SheetAny product under 0.1875 in. (4.76 mm) inthickness and 24 in. (610 mm) or more in width.4.3 PlateAny product 0.1875 in. (4.76 mm) thick andover and 10 in. (254 mm
11、) wide and over, with widths greaterthan five times the thickness. Any plate up to 4 in. (101.60mm), thick inclusive, is covered by this specification.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofS
12、ubcommittee F04.12 on Metallurgical Materials.Current edition approved April 1, 2007. Published June 2007. Originallyapproved in 2001. Last previous edition approved in 2001 as F 2066 01.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For referenced A
13、STM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Wa
14、rrendale, PA 15096-0001, http:/www.sae.org.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.6Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1*A Summary of C
15、hanges 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.4.4 BarRounds, flats, 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
16、 special order.)4.5 WireRounds, flats, or other shapes less than316 in.(4.76 mm) in diameter or thickness.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecification the following information.5.1.1 Quantity,5.1.2 Applicable ASTM designation and date of issue,5.1
17、.3 Form (strip, sheet, plate, bar, or wire),5.1.4 Condition (see Section 3 and 6.1),5.1.5 Mechanical properties (if applicable for special con-ditions),5.1.6 Finish (see 6.2),5.1.7 Applicable dimensions including size, thickness,width, length, or drawing number,5.1.8 Special tests, if any, and5.1.9
18、Special requirements.6. Materials and Manufacture6.1 FinishThe mill product may be furnished to theimplant manufacturer as descaled or pickled, abrasive-blasted,chemically milled, ground, machined, peeled, polished, or asspecified by the purchaser. On billets, bars, plates, and forg-ings, it is perm
19、issible to remove minor surface imperfectionsby grinding if the resultant area meets the dimensional andsurface finish requirements of this section.6.2 ConditionMaterial shall be furnished in the betaannealed condition.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-p
20、osition 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, and thesupplier shall not ship material with chemistry outside therequirements specified in Table 1.7.1.1 Requirements for the
21、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 Analysis:7.2.1 Product analysis tolerances do not broaden the speci-fied heat an
22、alysis requirements but cover variations betweenlaboratories in the measurement of chemical content. Themanufacturer shall not ship material that is outside the limitsspecified in Table 1. The product analysis tolerances shallconform to the product tolerances in Table 2.7.2.2 The product analysis is
23、 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 analyses
24、outside the tolerance limitsallowed in Table 2 are cause for rejection of the product. Areferee analysis may be used if agreed upon by the supplier andpurchaser.7.2.4 For referee purposes, use Test Methods, E 1409,E 1447, and E 2371 or other analytical methods agreed uponbetween the purchaser and th
25、e supplier.7.3 Samples for chemical analysis are representative of thematerial 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 sho
26、uld 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 in Ta
27、ble 3 orTable 4.8.2 Specimens for tension tests shall be machined and testedin accordance with Test Methods E8. Tensile properties shallbe determined using a strain rate of 0.003 to 0.007 in./in./min(mm/mm/min) through the specified yield and then the cross-head speed shall be increased so as to pro
28、duce fracture inapproximately one additional minute.8.3 For sheet and strip, the bend test specimen shall with-stand being bent cold through an angle of 105 without fracturein the outside surface of the bend portion. The bend shall bemade over a mandrel with a diameter equal to that shown inTable 4.
29、 Test conditions shall conform to Test Method E 290.8.4 Number of Tests:8.4.1 Bar, Forging Bar, Shapes, and WirePerform at leastone tension test from each lot in the longitudinal direction.Should this test result not meet the specified requirements, testtwo additional test pieces representative of t
30、he same lot, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.8.4.2 Tensile test results for which any specimen fracturesoutside the gauge length shall be considered acceptable, if bothTABLE 1 Ch
31、emical RequirementsElement Composition, %, (Mass/Mass)Nitrogen, max 0.05Carbon, max 0.10Hydrogen, max 0.015Iron, max 0.10Oxygen, max 0.20Molybdenum 14.00-16.00TitaniumAbalanceAThe percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 2 Product Analysis Toler
32、ancesAElementTolerance Under the Minimum or Over theMaximum LimitB, %, (Mass/Mass)Nitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Oxygen 0.02Molybdenum 0.25ARefer to AMS 2249.BUnder the minimum limit not applicable for elements in which only a maximumpercentage is indicated.F2066072the elongation an
33、d the reduction of area meet the minimumrequirements specified. Refer to sections 7.11.4 and 7.12.5 ofTest Methods E8. If either the elongation or reduction of areais less than the minimum requirement, discard the test andretest. Retest one specimen for each specimen that did not meetthe minimum req
34、uirements.8.4.3 Sheet, Strip, and PlatePerform at least one tensiontest from each lot in the longitudinal direction. Perform at leastone bend test from each lot in both the longitudinal andtransverse directions. Tests in the transverse direction need bemade only on product from which a specimen not
35、less than 8.0in. (200 mm) in length for sheet, and 2.50 in. (64 mm) in lengthfor plate can be taken. Should any of these test pieces not meetthe specified requirements, test two additional test piecesrepresentative of the same lot, in the same manner, for eachfailed test pieces. The lot shall be con
36、sidered in complianceonly if all additional test pieces meet the specified require-ments.9. Special Requirements9.1 The microstructure shall consist of a fully recrystallizedbeta phase structure. Primary alpha and alpha prime (alsoknown as martensitic alpha) are not permitted in the micro-structure
37、when viewed at 1003 magnification. The grain sizein the annealed condition shall be 5 or finer, in accordance withTest Methods E112.9.2 Determine the beta transus temperature for each heat bya suitable method and report on the material certification ifrequired by the purchaser.9.3 Alpha case is not
38、permitted for products supplied with amachined, ground, or chemically milled surface finish. Forother products, there will be no continuous layer of alpha casewhen examined at 1003 magnification.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this s
39、pecification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last right-hand digit used in expressing the specifi-cation limit, in accordance with the rounding method ofPractice E29.11. Certification11.1 The supplier shall provide
40、a certification that thematerial was tested in accordance with this specification andmet all requirements. A report of the test results shall befurnished to the purchaser at the time of shipment.12. Quality Program Requirements12.1 The supplier shall maintain a quality program such asdefined in ASQ
41、C1 or ISO 9001.13. Keywords13.1 metals (for surgical implants); orthopaedic medicaldevices; titanium alloys; titanium alloys (for surgical implants)TABLE 3 Mechanical PropertiesBar and WireConditionAUltimateTensile Strength,min, psi (MPa)Yield Strength(0.2 % Offset),min, psi (MPa)ElongationBin2 in.
42、(50 mm)4D or 4W,min, %Reduction ofArea, min, %Beta annealed 100 000 (690) 70 000 (483) 20 60AMechanical Pproperties for conditions other than those listed in this table may be established by agreement between the supplier and purchaser.BElongation of material 0.063 in. (1.6 mm) or greater in diamete
43、r (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 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternately, agauge length corresponding to I
44、SO 6892 may be used when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the original crosssectional area.) Gauge length will be reported with the elongation value.TABLE 4 Mechanical PropertiesSheet, Strip, and PlateABend Test Mandrel DiameterBConditionAUlt
45、imateTensile Strength,min, psi (MPa)Yield Strength(0.2 % Offset),min, psi (MPa)ElongationCin2in.(50 mm), min, %Under 0.070 in.(1.78 mm)in Thickness0.070 to 0.1875 in.(1.78 to 4.76 mm)in ThicknessBeta annealed 105 000 (724) 80 000 (552) 12 5T 6TAMechanical properties for conditions other than those l
46、isted in this table may be established by agreement between the supplier and purchaser.BT equals the thickness of the bend test specimen. Bend tests are not applicable to material over 0.1875 in. (4.76 mm) in thickness. The limits listed apply to tests takenboth longitudinally and transversely to th
47、e direction of rolling.CElongation 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 0.063 in. (1.6 mm) in
48、 diameter or thickness may be negotiated. Alternately, agauge 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 original crosssectional area.) Gauge length will be reported with the elongation value.F20660
49、73APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, mechanical, and metallurgical properties of wroughttitanium-15 molybdenum alloy to be used in the manufactureof surgical implants (1-4).X1.2 The microstructural requirements contained in thisspecification represent current general consensus with respectto optimization of mechanical properties for implant applica-tions.X1.3 The minimum mechanical properties specified ensurea baseline of strength and ductility for the highly stresseddevices for
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