1、Designation: F2066 18Standard 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 revi
2、sion, 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 titan
3、ium-15 molybde-num alloy to be used in the manufacture of surgical implants(1).21.2 The SI units in this standard are the primary units. Thevalues stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. Thevalues stated in each system may not be exa
4、ct equivalents;therefore, each system shall be used independently of eachother. Combining values from the two systems may result innon-conformance with the standard.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established
5、 in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:3E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Pra
6、ctice for Using Significant Digits 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
7、 for Determination of Oxygen 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
8、 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)F67 Specification for Unalloyed Titanium, for Surgical Im-pl
9、ant Applications (UNS R50250, 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 Insertion into Bon
10、eF1408 Practice for Subcutaneous Screening Test 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
11、Ultrasonic Inspection Titanium and TitaniumAlloy 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 Requirements1This specification is under the jurisdi
12、ction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Feb. 15, 2018. Published March 2015. Originallyapproved in 2001. Last previous edition approved in 2013 as F2066 131. DO
13、I:10.1520/F206618.2The 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 serviceastm.org. For Annual Book of ASTMStandards volume information, refer to th
14、e 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 Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org
15、.*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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization est
16、ablished in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.12.4 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Qual-ity C
17、ontrol Program63. 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 rapidlyquenched, for example, by water quenching or pres
18、surizedhelium gas, from a temperature below the beta transus ofapproximately 750C 1382F.3.1.2 alpha + beta annealed + aged, nthe condition of thematerial that is obtained by reheating the alpha + beta annealedmaterial to a time-temperature combination below the betatransus to increase the strength o
19、f 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, from atemperature above the beta transus of approximate
20、ly 750C1382F.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 4.76 mm 0.1875 in. inthickness and under 610 mm 24 in. wide.4.2 SheetAny product under 4.76 mm 0.1875 in. inthickness and
21、610 mm 24 in. or more in width.4.3 PlateAny product 4.76 mm 0.1875 in. thick andover and 254 mm 10 in. wide and over, with a width greaterthan five times the thickness. Any plate up to 101.60 mm 4in., thick inclusive, is covered by this specification.4.4 BarRounds, flats, or other shapes from 4.76 m
22、m0.1875 in. to 101.60 mm 4 in. 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 other shapes less than 4.76 mm316 in. in diameter or thick
23、ness.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 Quantity,5.1.2 Applicable ASTM designation and date of
24、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, thickness,width, length, or drawing number,5.1.8 Special
25、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-binations of these operations, or as specified by the pu
26、rchaser.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 AnnealedMaterial shall be furnished in the betaannealed conditio
27、n. 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 Annealed + AgedMaterial shall befurnished in the alpha + beta
28、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 taken from the finished mill product, and thesupplier shal
29、l 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 in Table 1 isnot required to verify compliance with this
30、 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 material that is outside the limitsspecified in Table 1. The
31、product analysis tolerances shallconform to the product tolerances in Table 2.6Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.TABLE 1 Chemical RequirementsElement Composition, %, (Mass/Mass)Nitrogen, max 0.05Carbon, max 0.10Hydrogen,
32、max 0.015Iron, max 0.10Oxygen, max 0.20Molybdenum 14.00-16.00TitaniumAbalanceAApproximately equal to the difference between 100 % and the sum percentage ofthe other specified elements. The percentage titanium content by difference is notrequired to be reported.F2066 1827.2.2 The product analysis is
33、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 o
34、utside 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, E539, E1409,E1447, E1941, and E2371 or other analytical methods agreedupon between the purchas
35、er and the 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 oper
36、ation 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 requireme
37、nts in Table 3 orTable 4.8.2 Specimens for tension tests shall be machined 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 the specified yield and thenthe crosshead speed shall be increased so
38、as to produce fracturein approximately 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 i
39、nTable 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 Methods E8/E8M. Perform at least one tension testfrom each lot in the longitudinal direction. Should any testspecimen not meet the specified requirements, tes
40、t two addi-tional test pieces representative of the same lot, in the samemanner, for each failed test specimen. 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 leng
41、th shall be considered acceptable if boththe elongation and the reduction of area meet the minimumrequirements specified. Refer to sections 7.11.4 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 o
42、ne specimen for each specimen that did not meetthe minimum requirements.8.4.3 Sheet, Strip, and PlateTest according to Test Meth-ods E8/E8M. Perform at least one tension test from each lot inthe longitudinal direction. Perform at least one bend test fromeach lot in both the longitudinal and transver
43、se directions.Testsin the transverse direction need be made only on product fromwhich a specimen not less than 200 mm (8.0 in.) in length forsheet, and 64 mm (2.50 in.) in length for plate can be taken.Should any of these test pieces not meet the specifiedrequirements, test two additional test piece
44、s representative ofthe same lot, in the same manner, for each failed test specimen.The lot shall be considered in compliance only if all additionaltest pieces meet the specified requirements.9. Dimensions, Mass, and Permissible Variations9.1 Units of Measure:9.1.1 SelectionThis specification require
45、s 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 thepurchase order, this selection may be expressed by the pur-chaser in several alternate forms listed in order of precedence.TABLE 2 Product Analysis Toler
46、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.TABLE 3 Mechanical Proper
47、tiesBar and WireConditionAUltimateTensile Strength,min, MPa psiYield Strength(0.2 % Offset),min, MPa psiElongationBin50 mm 2 in.4D or 4W,min, %Reduction ofArea, min, %Beta Annealed 690 100 000 483 70 000 20 60Alpha + Beta AnnealedC,D900 130 500 800 116 000 10 25Alpha + Beta Annealed + Aged 1150 166
48、750 1050 152 250 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 1.6 mm 0.063 in. or greater in diameter (D) or width (W) shall be measured using a gauge length of 50 mm 2 in.
49、or 4D or 4W. The gauge lengthmust be reported with the test results. The method for determining elongation of material under 1.6 mm 0.063 in. in diameter or thickness may be negotiated.Alternatively,a gauge 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 b
