1、Designation: F 1713 08Standard Specification forWrought Titanium-13Niobium-13Zirconium Alloy for SurgicalImplant Applications (UNS R58130)1This standard is issued under the fixed designation F 1713; the number immediately following the designation indicates the year oforiginal adoption or, in the ca
2、se of revision, 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 wr
3、ought 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 the standard. The SI equivalents in parentheses are providedfor information only.2. Referenced Documents2.1 ASTM Standards:3E8 Test Methods
4、 for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE 1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by the Inert GasFusion TechniqueE 1447 Test Method for Determination
5、of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity/Infrared Detection MethodE 1941 Test Method for Determination of Carbon in Refrac-tory and Reactive Metals and Their AlloysE 2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma S
6、pectrometryF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)2.2 Aerospace Material Specification:AMS 2249 Chemical Check Analysis Limits, Titanium an
7、dTitanium Alloys42.3 American Society for Quality (ASQ) Standard:ASQ C1 Specifications of General Requirements for aQuality Program52.4 ISO Standards:ISO 5832-3 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminium 4-Vanadium Al-loy6ISO 6892 Metallic Materials Tensile Testing at
8、 AmbientTemperature6ISO 9001 Quality Management SystemsRequirements63. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta transus, nthe minimum temperature at whichthe alpha plus beta phase can transform to 100 % beta phase.3.1.2 capability-aged, adjthe condition of the materia
9、lthat 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 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 mec
10、hanical deformation processperformed below the recrystallization temperature which re-sults in strain hardening of the material.3.1.4 hot work, nany mechanical deformation processperformed above the recrystallization temperature.3.1.5 lot, nthe total number of mill products producedfrom the same mel
11、t 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 direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Feb. 1, 2008. Pub
12、lished March 2008. Originallyapproved in 1996. Last previous edition approved in 2003 as F 1713 03.2The 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
13、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., Warrendale, PA 15096-0001, http:/www.sae.org.5Available from American Society for Quality
14、(ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.6Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Bar
15、r Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.6 solution-treated, adjthe condition of the materialthat is obtained if, following the final hot-working or cold-working operation, the mill product is rapidly quenched, forexample, by water quenching, from a temperatur
16、e above1112F (600C).3.1.7 unannealed, adjthe condition of the material that isobtained after the normal hot-working or cold-working opera-tion used for fabrication of the mill product. There are nosubsequent heat treatment requirements.4. Product Classification4.1 BarRounds or flats from 0.188 in. (
17、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 0.188 in. (4.76 mm) indiameter or thickness.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecification the following inf
18、ormation: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);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
19、 including size, diameter, thick-ness (for rectangular wire), or print number;5.1.8 Special tests (if any); and5.1.9 Other requirements.6. Materials and Manufacture6.1 FinishThe mill product may be supplied as specifiedby the purchaser with a descaled or pickled, abrasive blasted,chemically milled,
20、ground, machined, peeled, or polishedfinish. On bars, it is permissible to remove minor surfaceimperfections by grinding if the resultant area meets thedimensional and surface finish requirements of this specifica-tion.6.2 ConditionMaterial shall be furnished in the unan-nealed, solution-treated, or
21、 capability-aged condition, as speci-fied in the purchase order. Conditions and mechanical proper-ties other than those listed in Table 3 may be established byagreement between the supplier and the purchaser.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position of
22、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. The suppliershall not ship material with chemistry outside the requirementsspecified in Table 1.7.1.1 Requirements for the major and minor
23、 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 analysis requirem
24、ents but cover variations in themeasurement of chemical content between laboratories. Theproduct analysis tolerances shall conform to the producttolerances 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 variat
25、ions 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 analyses. Product analysis outside the tolerance limitsallowed in Table 2 shall be cause for rejection of the product.A referee ana
26、lysis may be used if agreed upon by supplier andpurchaser.7.2.4 For referee purposes, use Test Methods E1409,E 1447, E 1941, and E 2371 or other analytical methods agreedupon between the purchaser and the supplier.TABLE 1 Chemical RequirementsElement Composition(% mass/mass)Nitrogen, max 0.05Carbon,
27、 max 0.08Hydrogen, max 0.012AIron, 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
28、Analysis ToleranceAElementTolerance Under the Minimum orOver 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
29、 Mechanical PropertiesA,BConditionTensileStrength min,psi (MPa)Yield Strength(0.2 % offset),min psi (MPa)Elongationmin,%CReductionof Area min,%DCapability aged 125 000 (860) 105 000 (725) 8 15Solution treated 80 000 (550) 50 000 (345) 15 30Unannealed 80 000 (550) 50 000 (345) 8 15AUp to 4 in. (101.6
30、0 mm) inclusive diameter.BSolution treated or unannealed material is not intended for use as a finalproduct without 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)
31、or greater in diameter (D) orthickness (T) 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 le
32、ngth corresponding to ISO 6892 may be usedwhen agreed upon between the supplier and purchaser. (5.65 square root So,where Sois the original cross sectional area.)DApplies to bar only.F17130827.3 Samples for chemical analysis shall be representative ofthe material being tested. The utmost care shall
33、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 tools should be clean and sharp. Samples f
34、or 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.Alternative properties may be agreed upon between the pur-chaser and supplier.8.2 Specimens for tension test
35、s 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 yield and then the crosshead speed maybe increased so as to produce fracture in approximately oneadditional minute.8.3 Number o
36、f 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, test two additional test piecesrepresentative of the same lot, in the same manner, for eachfailed test piece. The lot shall be considered
37、 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 shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. If either the elong
38、ation 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.9. Special Requirements9.1 Ensure that the microstructure is martensitic with finelydispersed alpha or beta phases, or both. The
39、 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 beta grain boundaries will bepresent. The microstructure within the prior beta grain bound-aries will be acicular. Perform metallogra
40、phic evaluation in theaged condition.9.2 Determine the beta transus temperature for each heat bya suitable method and reported on the materials certification, ifrequired by the purchaser.9.3 Alpha case is not permitted for products supplied with amachined, ground, or chemically milled surface finish
41、. Forother products, there will be no continuous layer of alpha case,when examined at 1003.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value shall be rounded
42、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 The supplier shall provide a certification that thematerial was tested in accordance with this specification andmet all requirements.
43、 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 program, such asis defined in ASQ C1, ISO 9001, or similar.13. Keywords13.1 metals (for surgical implants); orthopaedic medicaldevices;
44、titanium alloys; titanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, mechanical, and metallurgical properties of wroughttitanium-13niobium-13zirconium alloy to be used in the manu-facture of su
45、rgical implants.X1.2 The microstructural requirements contained in thisspecification represent the current general consensus withrespect to optimization of mechanical properties for implantapplications.X1.3 The minimum mechanical properties specified ensurea baseline of strength and ductility for th
46、e highly stresseddevices for which this alloy is typically used.X1.4 The stress corrosion cracking resistance of this alloyis similar to that of standard grade titanium-6 aluminum-4vanadium ELI alloy (2).X1.5 ISO standards are listed for reference only. Althoughthe ISO 5832-3 Standard listed in sect
47、ion 2.4 is similar to thecorresponding ASTM standards, they are not identical. Use ofthe ISO standard instead of the preferredASTM standards maybe agreed upon between the purchaser and supplier.X1.6 The various titanium mill products covered in thisspecification normally are formed with the conventi
48、onal forg-ing and rolling equipment found in primary ferrous andF1713083nonferrous plants. The material is multiple melted in arcfurnaces (including furnaces such as plasma arc and electronbeam) of a type conventionally used for reactive metals.X2. BIOCOMPATIBILITYX2.1 The suitability of this materi
49、al from a human implantperspective depends on the specific application. The biologictests appropriate for the specific site, such as recommended inPractice F 748 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 reactions in the humanbody. The alloy composition covered by this specification,however, has been subjected to testing in laboratory animals,and has b
