1、Designation: F1295 11F1295 16Standard Specification forWrought Titanium-6Aluminum-7Niobium Alloy for SurgicalImplant Applications (UNS R56700)1This standard is issued under the fixed designation F1295; the number immediately following the designation indicates the year oforiginal adoption or, in the
2、 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. Scope*1.1 This specification covers the chemical, mechanical, and metallurgical requirements for
3、 wrought annealed, cold-worked, orhot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants(1-4).21.2 The SI units in this standard are the primary units.The values stated in either primary SI units or secondary inch-pound unit
4、sare to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each systemshall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.2. Referenced Documents2.1 ASTM Standards:3
5、E8/E8M Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE290 Test Methods for Bend Testing of Material for DuctilityE1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titan
6、ium Alloys by Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion AnalysisE2371
7、Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled PlasmaAtomic Emission Spectrometry (Performance-Based Test Methodology)E2626 Guide for Spectrometric Analysis of Reactive and Refractory MetalsIEEE/ASTM SI 10 American National Standard for Use
8、of the International System of unitsUnits (SI): The Modern MetricSystem2.2 Aerospace Material Specification:4AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium AlloysAMS 2630 Inspection, Ultrasonic Product Over 0.5 Inch (12.7 mm) ThickAMS 2631 Ultrasonic Inspection-Titanium and Titanium
9、Alloy Bar and Billet2.3 ISO Standards:5ISO 583211 Implants for SurgeryMetallic MaterialsPart 11: Wrought Titanium 6Aluminum 7Niobium AlloyISO 689268921 Metallic MaterialsTensile TestingPart 1: Method of Test at Room TemperatureISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definiti
10、ons of Terms Specific to This Standard:3.1.1 beta transus, nthe minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase.1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility
11、 of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Nov. 15, 2011Oct. 1, 2016. Published December 2011October 2016. Originally approved in 1992. Last previous edition approved in 20052011as F1295 05.F1295 11. DOI: 10.1520/F1295-11.10.1520/F1295-16.2 The boldface numbers in par
12、entheses refer to a list of references at the end of the text.3 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website
13、.4 Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.5 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.This document is not an ASTM standard and is intended only to
14、 provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof
15、 the standard as published by ASTM is to be considered the official document.*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 States13.1.2 cold workany mechanical deformation pr
16、ocess performed below the recrystallization temperature which results in strainhardening of the material.3.1.3 lot, nthe total number of mill products produced from the same melt heat under the same conditions at essentially thesame time.3.1.4 hot workany mechanical deformation process performed abo
17、ve the recrystallization temperature.3.1.5 stress reliefthermal treatment that reduces the residual stresses in the material without affecting the mechanicalproperties.4. Product Classification4.1 BarRounds, or flats, or other shapes from 0.188 in. (4.76 mm) to 4.0 in. (102 mm) in diameter or thickn
18、ess. Other sizesand shapes by special order.4.2 Forging BarBar as described in 4.1, used in the production of forgings. This product may be furnished in the hot-workedcondition.4.3 WireRounds, flats, or other shapes less than 0.188 in. (4.76 mm) in diameter or thickness.4.4 StripAny product 0.188 in
19、. (4.76 mm) and under in thickness and less than 24 in. (610 mm) in width.4.5 SheetAny product 0.188 in. (4.76 mm) and under in thickness and 24 in. (610 mm) or more in width.4.6 PlateAny product 0.188 in (4.76 mm) thick and over 10 in. (254 mm) wide and over, with widths greater than five timesthic
20、kness. Plate up to 4 in. (101.60 mm), thick inclusive is covered by this specification.5. Ordering Information5.1 Include with inquiries and orders for material under this specification the following information:5.1.1 Quantity (weight or number of pieces),5.1.2 Applicable ASTM designation, date of i
21、ssue.5.1.3 Form (bar, wire, sheet, strip, or plate),5.1.4 Condition (see 6.2),5.1.5 Mechanical Properties (if applicable for special conditions),5.1.6 Finish (see 6.1),5.1.7 Applicable dimensions including size, thickness, width, or drawing number,5.1.8 Special tests, if any,5.1.9 Other requirements
22、.6. Materials and Manufacture6.1 FinishThe mill product may be supplied as specified by the purchaser with a descaled or pickled, abrasive-blasted,chemically milled, ground, machined, peeled, or polished finish.6.2 ConditionMaterial shall be furnished in the annealed, cold-worked, or hot-worked cond
23、ition. The purchaser shall includeon drawings or purchase orders whether the material shall be stress-relieved.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical composition of Table 1. Ingot analysis may be used for reporting allchemical requirements, except hydrogen. Sampl
24、es for hydrogen shall be taken from the finished mill product. The supplier shallnot ship material with chemistry outside the requirements specified in Table 1.7.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residualelements. Analysi
25、s for elements not listed in Table 1 is not required to certify compliance with this specification.TABLE 1 Chemical RequirementsElement Composition, %Aluminum 5.50 to 6.50Niobium 6.50 to 7.50Tantalum 0.50 maxIron 0.25 maxOxygen 0.20 maxCarbon 0.08 maxNitrogen 0.05 maxHydrogen 0.009 maxTitaniumA Bala
26、nceA The percentage of titanium is determined by difference and need not bedetermined or certified.F1295 1627.2 Product Analysis:7.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations in themeasurement of chemical content between laboratories.
27、The product analysis tolerances shall conform to the product tolerancesin Table 2.7.2.2 The product analysis is either for the purpose of verifying the composition of a heat or manufacturing lot or to determinevariations in the composition within the heat.7.2.3 Acceptance or rejection of a heat or m
28、anufacturing lot of material may be made by the purchaser on the basis of thisproduct analysis. Product analysis outside the tolerance limits allowed in Table 2 are cause for rejection of the product. A refereeanalysis may be used if agreed by supplier and purchaser.7.3 For referee purposes, use Tes
29、t Methods E1409, E1447, E1941, E2371, and E2626 or other analytical methods agreed uponbetween the purchaser and the supplier.7.4 Samples for chemical analysis shall be representative of the material being tested. The utmost care must be used in samplingtitanium for chemical analysis because of its
30、affinity for elements such as oxygen, nitrogen, and hydrogen. In cutting samples foranalysis, therefore, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting tools should be cleanand sharp. Samples for analysis should be stored in suitable containers.8. Mechanic
31、al Requirements8.1 The material supplied under this specification shall conform to the mechanical properties given in Table 3. Alternativeproperties may be agreed upon between the purchaser and supplier.8.2 Specimens for tension tests shall be machined and tested in accordance with Test Methods E8/E
32、8M. 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 crossheadspeed shall be increased so as to produce fracture in approximately one additional minute.8.2.1 Bar, Forging Bar, and WireTest according to Test M
33、ethods E8/E8M.8.2.2 Tensile tests result for which any specimen fractures outside the gauge length shall be considered valid, if both theelongation and reduction of area meet the minimum requirements specified. If either the elongation or reduction of area is less thanthe minimum requirement, invali
34、date the specimen and retest. Retest one specimen for each invalidated specimen.8.2.3 Should any test specimen not meet the specified requirements, test two additional test pieces representative of the samelot, in the same manner, for each failed test specimen. The lot will be considered in complian
35、ce only if all additional test piecesmeet the specified requirements.8.3 Sheet, Strip, and Plate:8.3.1 Test according to Test Methods E8/E8M. Perform at least one tensile test from each lot in both the longitudinal andtransverse directions. Tests in the transverse direction need be made only on prod
36、uct from which a specimen not less than 8.0 in.(200 mm) in length for strip can be taken. Should any of these test specimens not meet the specified requirements, test twoadditional test pieces representative of the same lot, in the same manner, for each failed test specimen. The lot will be consider
37、edin compliance only if all additional test pieces meet the specified requirements.8.3.2 For sheet and strip, the bend test specimen shall withstand being bent cold through an angle of 105 without fracture inthe outside surface of the bent portion. The bend shall be made around a mandrel which has a
38、 diameter equal to that shown in Table4. Test conditions shall conform to Test Method E290.9. Dimensions and Permissible Variations9.1 Units of Measure:TABLE 2 Product Analysis TolerancesATolerance Under the MinimumB or Over the Maximum Limit (%)Aluminum 0.10Aluminum 0.40Niobium 0.10Niobium 0.20 und
39、er min0.25 over maxTantalum 0.10Iron 0.10Oxygen 0.02Carbon 0.02Nitrogen 0.02Hydrogen 0.002A Refer to AMS 2249.B Under minimum limit not applicable for elements where only a maximumpercentage is indicated.F1295 1639.1.1 SelectionThis specification requires that the purchaser selects the units (SI or
40、inch-pound) to be used for productcertification. In the absence of a stated selection of units on the purchase order, this selection may be expressed by the purchaserin several alternate forms listed in order of precedence.9.1.1.1 If the purchaser and supplier have a history of using specific units,
41、 these units shall continue to be certified untilexpressly changed by the purchaser.9.1.1.2 In the absence of historic precedence, if the units used to define the product on the purchasers PO, specification, andengineering drawing are consistent, these units shall be used by the supplier for product
42、 certification certification.9.1.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon between purchaser and supplier.9.1.2 Conversion of UnitsIf the suppliers test equipment does not report in the selected units, the test equipment units maybe converted to t
43、he selected units for certification purposes. Accurate arithmetic conversion and proper use of significant digitsshould be observed when performing this conversion.ASTM IEEE/ASTM SI 10 provides guidelines for the use of SI units.AnnexA of IEEE/ASTM SI 10 provides conversion tables and Annex B of IEE
44、E/ASTM SI 10 provides rules for conversion andsignificance.significant digits.10. Special Requirements10.1 The microstructure shall be a fine dispersion of the alpha and beta phases resulting from processing in the alpha plus betafield.There shall be no continuous alpha network at prior beta grain b
45、oundaries.There shall be no coarse, elongated alpha platelets.10.2 Determine the beta transus temperature for each heat by a suitable method and report on the material certification ifrequired by the purchaser.TABLE 3 Mechanical Properties for Bar and WireConditionA Ultimate Tensile Strength,min, ps
46、i, (MPa)Yield Strength (0.2 %Offset), min, psi, (MPa)Elongation,Bmin, %Reductionof Area,min, %Annealed 130 500 (900) 116 000 (800) 10 25Hot Worked 130 500 (900) 116 000 (800) 10 25Cold Worked 159 500 (1100) 116 000 (800) 10 25TABLE 3 Mechanical Properties for Bar and WireConditionA Ultimate Tensile
47、Strength,min, MPa (psi) Yield Strength (0.2 %Offset), min, MPa (psi) Elongation,Bmin, %Reductionof Area,min, %Annealed 900 (130 500) 800 (116 000) 10 25Hot Worked 900 (130 500) 800 (116 000) 10 25Cold Worked 1100 (159 500) 800 (116 000) 10 25A Mechanical properties for conditions other than those li
48、sted in this table may be established by agreement between the supplier and purchaser.B Elongation of material 0.063 in. (1.6 mm)1.6 mm (0.063 in.) or greater in diameter (D) or thickness (T) shall be measured using a gauge length of 2 in. or 4D or 4W. Thegauge length must be reported with the test
49、results. The method for determining elongation of material under 0.063 in. (1.6 mm)1.6 mm (0.063 in.) in diameter or thicknessmay be negotiated.Alternatively, a gauge length of 5.65 times the square root of So, where So is the original cross-sectional area corresponding to ISO 689268921 maybe used when agreed upon between supplier and purchaser.TABLE 4 Mechanical Properties for Sheet, Strip, and PlateConditionA Ultimate Tensile Strengthmin, psi (MPa)Yield Strength (0.2 %offset),min, psi (MPa)ElongationB in 2 in. (50mm),min %Bend Test Mandrel Di
