1、Designation: F2066 131Standard Specification forWrought Titanium-15 Molybdenum Alloy for Surgical ImplantApplications (UNS R58150)1This standard is issued under the fixed designation F2066; the number immediately following the designation indicates the year oforiginal adoption or, in the case of rev
2、ision, 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.1NOTEThe designation was corrected editorially in December 2013.1. Scope*1.1 This specification covers the chem
3、ical, mechanical, andmetallurgical requirements for wrought titanium-15 molybde-num alloy to be used in the manufacture of surgical implants(1).21.2 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 equ
4、ivalents; therefore, eachsystem shall be used independently of each other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:3E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant D
5、igits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE290 Test Methods for Bend Testing of Material for Ductil-ityE539 Test Method forAnalysis ofTitaniumAlloys by X-RayFluorescence SpectrometryE1409 Test Method for Determination of Oxygen
6、and Nitro-gen in Titanium and Titanium Alloys by Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Tita-nium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and Thei
7、rAlloys by CombustionAnalysisE2371 Test Method for Analysis of Titanium and TitaniumAlloys by Direct Current Plasma and Inductively CoupledPlasma Atomic Emission Spectrometry (Performance-Based Test Methodology)F67 Specification for Unalloyed Titanium, for Surgical Im-plant Applications (UNS R50250,
8、 UNS R50400, UNSR50550, UNS R50700)F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1408 Practice for Subcutaneous Screening T
9、est for ImplantMaterialsIEEE/ASTM SI 10 American National Standard for Use ofthe International System of Units (SI): The Modern MetricSystem2.2 Aerospace Material Specifications:4AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium AlloysAMS 2631 Ultrasonic Inspection Titanium and TitaniumA
10、lloy Bar and BilletAMS 2380 Approval and Control of Premium Quality Tita-nium Alloys2.3 ISO Standards:5ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management Systems Requirements2.4 American Society for Quality Standard:ASQ C1 Specification of General Requiremen
11、ts for a Qual-ity Control Program61This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2013. Published November 2013. Origina
12、llyapproved in 2001. Last previous edition approved in 2011 as F2066 11. DOI:10.1520/F206613E01.2The boldface numbers in parentheses 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 ser
13、viceastm.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., Warrendale, PA 15096-0001, http:/www.sae.org.5Available from American National Standards Inst
14、itute (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.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Har
15、bor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 alpha + beta annealed, nthe condition of the mate-rial that is obtained if, following the final hot-working orcold-working operation, the mill product may be
16、 rapidlyquenched, for example, by water quenching or pressurizedhelium gas, from a temperature below the beta transus ofapproximately 1382F 750C.3.1.2 alpha + beta annealed + aged, nthe condition of thematerial that is obtained by reheating the alpha + beta annealedmaterial to a time-temperature com
17、bination below the betatransus to increase the strength of the alloy.3.1.3 beta annealed, nthe 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
18、, from atemperature above the beta transus of approximately 1382F750C.3.1.4 beta transus, nthe 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 S
19、heetAny 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 wide and over, with a width greaterthan five times the thickness. Any plate up to 4 in. 101.60mm, thick inclusive, is covered by this specif
20、ication.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 special order.)4.5 Forging BarBar as described in 4.4 used for produc-tion of forgings, may be furnished in the hot worked condition.4.6 WireRounds, flats, or o
21、ther shapes less than316 in.4.76 mm in diameter or thickness.4.7 OtherOther forms and shapes, including tubing, maybe provided by agreement between purchaser and supplier.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecification the following information.5.1.1
22、 Quantity,5.1.2 Applicable ASTM designation and date of issue,5.1.3 Form (strip, sheet, plate, bar, forging bar, wire, other),5.1.4 Condition (see Section 3 and 6.2),5.1.5 Mechanical properties (if applicable for specialconditions),5.1.6 Finish (see 6.1),5.1.7 Applicable dimensions including size, t
23、hickness,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, com-
24、binations of these operations, or as specified by the purchaser.On billets, bars, plates, and forgings, it is permissible toremove minor surface imperfections by grinding if the resultantarea meets the dimensional and surface finish requirements ofthis specification.6.2 Condition:6.2.1 Beta Annealed
25、Material shall be furnished in the betaannealed condition. Two classes of beta annealed sheet, strip,and plate are available. If no class is chosen, Class 1 productshall be provided.6.2.2 Alpha + Beta AnnealedMaterial shall be furnishedin the alpha + beta annealed condition.6.2.3 Alpha + Beta Anneal
26、ed + AgedMaterial shall befurnished in the alpha + beta annealed + aged condition.7. Chemical Requirements7.1 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 ta
27、ken 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 listed are importantresidual elements.Analysis for elements not listed
28、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 measurement of chemical content. Themanufacturer shall not ship mater
29、ial 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 manufacturing lot or todetermine variations in the composition within th
30、e 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 of the product. Areferee analysis may be used if agreed upon by th
31、e supplier andpurchaser.TABLE 1 Chemical 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 certif
32、ied.F2066 13127.2.4 For referee purposes, use Test Methods, E539, E1409,E1447, E1941, and E2371 or other analytical methods agreedupon between the purchaser and the supplier.7.3 Samples for chemical analysis are representative of thematerial being tested. The utmost care must be used insampling tita
33、nium 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 tools should be clean and sharp. Samples for analysisshould be st
34、ored 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 testedin accordance with Test Methods E8/E8M. Tensile propertiessha
35、ll be determined using a strain rate of 0.003 to 0.007in./in./min mm/mm/min through the specified yield and thenthe crosshead speed shall be increased so as to produce fracturein approximately one additional minute.8.3 For sheet and strip, the bend test specimen shall with-stand being bent cold thro
36、ugh 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 E290.8.4 Number of Tests:8.4.1 Bar, Forging Bar, Shapes, and WireTest accordingto Test Meth
37、ods E8/E8M. Perform at least one tension testfrom each lot in the longitudinal direction. Should any testspecimen not meet the specified requirements, test two addi-tional test pieces representative of the same lot, in the samemanner, for each failed test specimen. The lot shall beconsidered in comp
38、liance 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 boththe elongation and the reduction of area meet the minimumrequirements specified. Refer to sections 7.11.4
39、 and 7.12.5 ofTest Methods E8/E8M. If either the elongation or reduction ofarea is 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 PlateTest according to Test Meth-ods E8/E8M. Perfo
40、rm at least one tension test from each lot inthe longitudinal direction. Perform at least one bend test fromeach lot in both the longitudinal and transverse directions.Testsin the transverse direction need be made only on product fromwhich a specimen not less than 8.0 in. (200 mm) in length forsheet
41、, and 2.50 in. (64 mm) in length for plate can be taken.Should any of these test pieces not meet the specifiedrequirements, test two additional test pieces representative ofthe same lot, in the same manner, for each failed test specimen.The lot shall be considered in compliance only if all additiona
42、ltest pieces meet the specified requirements.9. Dimensions, Mass, and Permissible Variations9.1 Units of Measure:9.1.1 SelectionThis specification requires that the pur-chaser select the units (SI or inch-pound) to be used for productcertification. In the absence of a stated selection of units on th
43、epurchase order, this selection may be expressed by the pur-chaser in several alternate forms listed in order of precedence.9.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 In the a
44、bsence of historic precedence, if the unitsused to define the product on the purchasers PO, specification,and engineering drawing are consistent, these units shall beused by the supplier for product certification.9.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be a
45、greed upon between the purchaserand supplier.9.1.2 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsTABLE 2 Product Analysis TolerancesAElementTolerance Under the Minimum or Over theMaximum LimitB, %, (Mass/Mass)Nitrogen 0.02Carbon 0.02
46、Hydrogen 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.TABLE 3 Mechanical PropertiesBar and WireConditionAUltimateTensile Strength,min, psi MPaYield Strength(0.2 % Offset),min, psi MPaEl
47、ongationBin2 in. 50 mm4D or 4W,min, %Reduction ofArea, min, %Beta Annealed 100 000 690 70 000 483 20 60Alpha + Beta AnnealedC,D130 500 900 116 000 800 10 25Alpha + Beta Annealed + Aged 166 750 1150 152 250 1050 10 25AMechanical properties for conditions other than those listed in this table may be e
48、stablished by agreement between the supplier and 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 ma
49、terial under 0.063 in. 1.6 mm in diameter or thickness may be negotiated. Alternatively, agauge length corresponding to ISO 6892 may be used when agreed upon between the supplier and purchaser. (5.65 times the square root of So, where So is the originalcross sectional area.) The gauge length shall be reported with the elongation value.CMechanical properties for the hot rolled condition may be established by agreement between the supplier and purchaser.DUp to 4.00-in. 101.60-mm diameter or thic
