1、Designation: F1713 08 (Reapproved 2013)Standard Specification forWrought Titanium-13Niobium-13Zirconium Alloy for SurgicalImplant Applications (UNS R58130)1This standard is issued under the fixed designation F1713; the number immediately following the designation indicates the year oforiginal adopti
2、on or, in the case of revision, 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. Scope1.1 This specification covers the chemical, mechanical, andmetallurgical requi
3、rements for wrought titanium-13niobium-13zirconium alloy to be used in the manufacture of surgicalimplants (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 a
4、re not considered standard.2. 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 SpecificationsE1409 Test Method for Determination of Oxygen and Nitro-gen in Titanium and
5、 Titanium Alloys by the Inert GasFusion TechniqueE1447 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 TheirAlloys by Combu
6、stionAnalysisE2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma Spectrometry (With-drawn 2013)4F748 Practice for Selecting Generic BiologicalTest Methodsfor Materials and DevicesF1472 Specification for Wrought Titanium-6Aluminum-4VanadiumAlloy for Surgical Implan
7、tApplications (UNSR56400)2.2 Aerospace Material Specification:AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys52.3 American Society for Quality (ASQ) Standard:ASQ C1 Specifications of General Requirements for a Qual-ity Program62.4 ISO Standards:ISO 5832-3 Implants for SurgeryMet
8、allic MaterialsPart3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy7ISO 6892 Metallic Materials Tensile Testing at AmbientTemperature7ISO 9001 Quality Management SystemsRequirements73. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta transus, nthe minimum temperature at which
9、the alpha plus beta phase can transform to 100 % beta phase.3.1.2 capability-aged, adjthe condition of the materialthat is obtained if, following solution treatment, a sample of themill product is subjected to an aging treatment such as givenbelow, for certification testing.3.1.2.1 Age for 6 6 0.25
10、h at 923 6 25F (495 6 14C).3.1.2.2 Remove from furnace and air cool to room tempera-ture.3.1.3 cold work, nany mechanical deformation processperformed below the recrystallization temperature which re-sults in strain hardening of the material.3.1.4 hot work, nany mechanical deformation processperform
11、ed above the recrystallization temperature.3.1.5 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the
12、 direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved March 1, 2013. Published March 2013. Originallyapproved in 1996. Last previous edition approved in 2008 as F1713 08. DOI:10.1520/F1713-08R13.2The boldface numbers in parentheses refer to the list of refe
13、rences 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 website.4The last approved version
14、of this historical standard is referenced onwww.astm.org.5Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.6Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.7Availab
15、le from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.6 solution-treated, adjthe condition of the materialthat is obt
16、ained if, following the final hot-working or cold-working operation, the mill product is rapidly quenched, forexample, by water quenching, from a temperature above1112F (600C).3.1.7 unannealed, adjthe condition of the material that isobtained after the normal hot-working or cold-working opera-tion u
17、sed for fabrication of the mill product. There are nosubsequent heat treatment requirements.4. Product Classification4.1 BarRounds or flats from 0.188 in. (4.76 mm) to 4 in.(101.6 mm), inclusive, in diameter or thickness. (Other sizesand shapes by special order.)4.2 WireRounds or flats less than 0.1
18、88 in. (4.76 mm) indiameter or thickness.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecification the following information:5.1.1 Quantity (weight or number of pieces);5.1.2 Applicable ASTM designation and year of issue;5.1.3 Form (wire or bar, see Section 4)
19、;5.1.4 Condition (see 6.2);5.1.5 Mechanical properties (if applicable, for special con-ditions) (see 8.1);5.1.6 Finish (see 6.1);5.1.7 Applicable dimensions including size, diameter, thick-ness (for rectangular wire), or print number;5.1.8 Special tests (if any); and5.1.9 Other requirements.6. Mater
20、ials and Manufacture6.1 FinishThe mill product may be supplied as specifiedby the purchaser with a descaled or pickled, abrasive blasted,chemically milled, ground, machined, peeled, or polishedfinish. On bars, it is permissible to remove minor surfaceimperfections by grinding if the resultant area m
21、eets thedimensional and surface finish requirements of this specifica-tion.6.2 ConditionMaterial shall be furnished in theunannealed, solution-treated, or capability-aged condition, asspecified in the purchase order. Conditions and mechanicalproperties other than those listed in Table 3 may be estab
22、lishedby agreement between the supplier and the purchaser.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 mi
23、ll product. The suppliershall not ship material with chemistry outside the requirementsspecified 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
24、 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 in themeasurement of chemical content between laboratories. Theproduct analysis tolerances shall conform to the producttoler
25、ances 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 the heat.TABLE 1 Chemical RequirementsElement Composition(% mass/mass)Nitrogen, max 0.05Carbon, max 0.08Hydrogen, max 0
26、.012AIron, max 0.25Oxygen, max 0.15Niobium 12.514.0Zirconium 12.514.0TitaniumBbalanceAMaterial 0.032 in. (0.813 mm) and under may have hydrogen content up to0.015 %.BThe percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 2 Product Analysis ToleranceAEleme
27、ntTolerance Under the MinimumorOver the Maximum Limit(% mass/mass)BNitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Oxygen 0.02Niobium 0.30Zirconium 0.40ARefer to AMS 2249.BUnder the minimum limit not applicable for elements where only a maximumpercentage is indicated.TABLE 3 Mechanical PropertiesA,B
28、ConditionTensileStrengthmin,psi (MPa)YieldStrength(0.2 %offset),min psi(MPa)Elongationmin,%CReductionof Area min,%DCapability aged 125 000(860)105 000(725)815Solution treated 80 000(550)50 000(345)15 30Unannealed 80 000(550)50 000(345)815AUp to 4 in. (101.60 mm) inclusive diameter.BSolution treated
29、or unannealed material is not intended for use as a final productwithout subsequent hot working or heat treatment, or both.CLimits apply to tests taken both longitudinal and transverse to the direction ofrolling. Elongation of material 0.063 in. (1.575 mm) or greater in diameter (D) orthickness (T)
30、shall be measured using a gage length of 2 in. or 4D or 4T. The gagelength shall be reported with the test results. The method for determiningelongation of material under 0.063 in. (1.575 mm) in diameter or thickness may benegotiated. Alternately, a gage length corresponding to ISO 6892 may be usedw
31、hen agreed upon between the supplier and purchaser. (5.65 square root So,where Sois the original cross sectional area.)DApplies to bar only.F1713 08 (2013)27.2.3 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analyses. Produ
32、ct analysis outside the tolerance limitsallowed in Table 2 shall be cause for rejection of the product.A referee analysis may be used if agreed upon by supplier andpurchaser.7.2.4 For referee purposes, useTest Methods E1409, E1447,E1941, and E2371 or other analytical methods agreed uponbetween the p
33、urchaser and the supplier.7.3 Samples for chemical analysis shall be representative ofthe material being tested. The utmost care shall be used insampling titanium for chemical analysis because of its affinityfor elements such as oxygen, nitrogen, and hydrogen. Incutting samples for analysis, therefo
34、re, the operation 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 proper
35、ty requirements in Table 3.Alternative properties may be agreed upon between the pur-chaser and supplier.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)
36、through yield and then the crosshead speed maybe increased so as to produce fracture in approximately oneadditional minute.8.3 Number of Tests:8.3.1 Bar and WirePerform at least one tension test fromeach lot in the longitudinal direction. Should the test result notmeet the specified requirements, te
37、st two additional test piecesrepresentative of the same lot, in the same manner, for eachfailed test piece.The lot shall be considered in compliance onlyif all additional test pieces meet the specified requirements.8.3.2 Tensile tests results for which any specimen fracturesoutside the gage length s
38、hall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. 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 require
39、ments.9. Special Requirements9.1 Ensure that the microstructure is martensitic with finelydispersed alpha or beta phases, or both. The alpha or betaphases, or both, may be too fine to be visible metallographi-cally but shall be present to ensure adequate strength. Nocontinuous alpha network at prior
40、 beta grain boundaries will bepresent. The microstructure within the prior beta grain bound-aries will be acicular. Perform metallographic evaluation in theaged condition.9.2 Determine the beta transus temperature for each heat bya suitable method and reported on the materials certification, ifrequi
41、red by the purchaser.9.3 Alpha case is not permitted for products supplied with amachined, ground, or chemically milled surface finish. Forother products, there will be no continuous layer of alpha case,when examined at 100.10. Significance of Numerical Limits10.1 The following applies to all specif
42、ied numerical limitsin this specification. 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 thespecification limit, in accordance with the rounding method ofPractice E29.11. Certification11.1
43、The supplier shall provide 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 producer shall maintain a quality pro
44、gram, such asis defined in ASQ C1, ISO 9001, or similar.13. Keywords13.1 metals (for surgical implants); orthopaedic medicaldevices; titanium alloys; titanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thec
45、hemical, mechanical, and metallurgical properties of wroughttitanium-13niobium-13zirconium alloy to be used in the manu-facture of surgical implants.X1.2 The microstructural requirements contained in thisspecification represent the current general consensus withrespect to optimization of mechanical
46、properties for implantapplications.F1713 08 (2013)3X1.3 The minimum mechanical properties specified ensurea baseline of strength and ductility for the highly stresseddevices for which this alloy is typically used.X1.4 The stress corrosion cracking resistance of this alloy issimilar to that of standa
47、rd grade titanium-6 aluminum-4vanadium ELI alloy (2).X1.5 ISO standards are listed for reference only. Althoughthe ISO 5832-3 Standard listed in section 2.4 is similar to thecorresponding ASTM standards, they are not identical. Use ofthe ISO standard instead of the preferredASTM standards maybe agre
48、ed upon between the purchaser and supplier.X1.6 The various titanium mill products covered in thisspecification normally are formed with the conventional forg-ing and rolling equipment found in primary ferrous andnonferrous plants. The material is multiple melted in arcfurnaces (including furnaces s
49、uch as plasma arc and electronbeam) of a type conventionally used for reactive metals.X2. BIOCOMPATIBILITYX2.1 The suitability of this material from a human implantperspective depends on the specific application. The biologictests appropriate for the specific site, such as recommended inPractice F748 should be used as a guideline.Asummary of thein vitro and animal testing that has been performed as of theapproval date of this specification is provided in X2.3.X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reacti
