1、Designation: F 2066 08Standard 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 () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requirements for wrought tit
3、anium-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 standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2.
4、Referenced Documents2.1 ASTM Standards:3E8 Test Methods for Tension Testing of 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 forDu
5、ctilityE 1409 Test Method for Determination of Oxygen andNitrogen in Titanium and 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 fo
6、r Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma SpectrometryF67 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 Pract
7、ice for Assessment of Compatibility of Bioma-terials for Surgical Implants with 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 All
8、oys42.3 ISO Standards:5ISO 6892 Metallic Materials Tensile TestingISO 9001 Quality 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, nth
9、e condition of the material that isobtained if, following the final hot-working 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, n
10、the minimum temperature at whichthe alpha plus beta phase can transform to 100 % 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 w
11、idth.4.3 PlateAny product 0.1875 in. (4.76 mm) thick andover and 10 in. (254 mm) 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 on
12、Medical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2008. Published October 2008. Originallyapproved in 2001. Last previous edition approved in 2007 as F 2066 07.2The boldface numbers in parenth
13、eses refer to the list of references at the end ofthis standard.3For referenced ASTM 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 websi
14、te.4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, 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
15、), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.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.4.4 BarRounds, flats, or other shapes from 0.1875 in.(
16、4.76 mm) to 4 in. (101.60 mm) in diameter or thickness.(Other sizes and shapes by 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 i
17、nformation.5.1.1 Quantity,5.1.2 Applicable ASTM designation and date of issue,5.1.3 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,
18、thickness,width, length, or drawing number,5.1.8 Special tests, if any, and5.1.9 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
19、asspecified by the purchaser. On billets, bars, plates, and forg-ings, it is permissible to remove minor surface imperfectionsby grinding if the resultant area meets the dimensional andsurface finish requirements of this section.6.2 Condition:6.2.1 Beta AnnealedMaterial shall be furnished in thebeta
20、 annealed condition.6.2.2 Alpha + BetaMaterial may be furnished in theannealed, aged, coldworked, hot-rolled, or any combination ofthese conditions.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position of Table 1. Ingot analysis may be used for reporting allchemica
21、l 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 major and minor elementalconstituents are listed in Table 1. Also liste
22、d 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 analysis requirements but cover variations betweenlaboratories in the mea
23、surement 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 either for the purpose ofverifying the composition of a heat or manufa
24、cturing 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 outside the tolerance limitsallowed in Table 2 are cause for rejection
25、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 the supplier.7.3 Samples for chemical analysis are representative of them
26、aterial 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
27、 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 Table 3 orTable 4.8.2 Specimens for tension tests shall be machined and t
28、estedin 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 produce fracture inapproximately one additional minute.8.3 For sheet and s
29、trip, 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. Test conditions shall conform to Test Method E 290.8.4 Number of Tests
30、: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 the same lot, in theTABLE 1 Chemical RequirementsElement Composition, %,
31、 (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 TolerancesAElementTolerance Under the Minimum o
32、r 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.F2066082same manner, for each failed test piece. The lot shall beco
33、nsidered in compliance only if all additional test pieces meetthe specified requirements.8.4.2 Tensile test results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and the reduction of area meet the minimumrequirements specified. Refer to
34、 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 requirements.8.4.3 Sheet, Strip, and PlatePerform at least one tensiontest
35、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 less than 8.0in. (200 mm) in length for sheet, and 2.50 in. (64 mm) in l
36、engthfor 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 considered in complianceonly if all additional test pieces meet the specifi
37、ed require-ments.9. Special Requirements9.1 Microstructure:9.1.1 Beta AnnealedThe microstructure shall consist of afully recrystallized beta phase structure. Primary alpha andalpha prime (also known as martensitic alpha) are not permit-ted in the microstructure when viewed at 1003 magnification.The
38、grain size in the annealed condition shall be 5 or finer, inaccordance with Test Methods E112.9.1.2 Alpha + BetaThe microstructure shall be a finedispersion of the alpha and beta phases resulting from process-ing in the alpha plus beta field. There shall be no continuousalpha network at prior beta g
39、rain boundaries. There shall be nocoarse, elongated alpha platelets.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 permitted for products supplied with amachined, ground, or chemi
40、cally 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 specification. To determine conformance to these limits,an observ
41、ed 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 a certification that thematerial was tested in accordance with t
42、his 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 C1 or ISO 9001.13. Keywords13.1 metals (for surgical implants);
43、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. (50 mm)4D or 4W,min, %Reduction ofArea, min, %Beta annealed 100
44、000 (690) 70 000 (483) 20 60Alpha + BetaC,D130 500 (900) 116 000 (800) 10 25AMechanical properties 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 diameter (D) or width (W
45、) shall be measured using a gage length of 2 in. or 4D or 4W. The gage 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. Alternatively,a gage length corresponding to ISO 6892 may be use
46、d when agreed upon between supplier and purchaser. (5.65 times the square root of So, where So is the originalcross sectional area.) Gage length will be reported with the elongation value.CMechanical properties for the hot rolled condition may be established by agreement between the supplier and pur
47、chaser.DUp to 4.00-in. (101.60-mm) diameter or thickness.TABLE 4 Mechanical PropertiesSheet, Strip, and PlateABend Test Mandrel DiameterBConditionAUltimateTensile Strength,min, psi (MPa)Yield Strength(0.2 % Offset),min, psi (MPa)ElongationCin2in.(50 mm), min, %Under 0.070 in.(1.78 mm)in Thickness0.0
48、70 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 listed in this table may be established by agreement between the supplier and purchaser.BT equals the thickness of the bend test specimen. Bend tests a
49、re not applicable to material over 0.1875 in. (4.76 mm) in thickness. The limits listed apply to tests takenboth longitudinally and transversely to the 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 gage length of 2 in. or 4D or 4W. The gage 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. Alternatively,a gage length corresponding to ISO 6892 may be used when agre
