1、Designation: F 1295 05Standard Specification forWrought Titanium-6Aluminum-7Niobium Alloy for SurgicalImplant Applications (UNS R56700)1This standard is issued under the fixed designation F 1295; the number immediately following the designation indicates the year oforiginal adoption or, in the case
2、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 wroug
3、ht annealed, cold worked,or hot rolled titanium-6aluminum-7niobium alloy bar and wireto be used in the manufacture of surgical implants (1-4).21.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents in parentheses are forinformation only.2. Referenced Document
4、s2.1 ASTM Standards:3E8 Test Methods for Tension Testing of Metallic MaterialsE 120 Test Methods for Chemical Analysis of Titanium andTitanium Alloys4E 1409 Test Method for Determination of Oxygen in Tita-nium and Titanium Alloys by the Insert Gas FusionTechniqueE 1447 Test Method for Determination
5、of Hydrogen inTitanium and Titanium Alloys by the Insert Gas FusionThermal Conductivity MethodF 981 Practice for Assessment of Compatibility of Biioma-terials for Surgical Implants with Respect to Effect ofMaterials in Muscle and Bone2.2 ISO Standards:5ISO 583211 Implants for SurgeryMetallic Materia
6、lsPart 11: Wrought Titanium 6Aluminum 7Niobium Al-loyISO 6892 Metallic MaterialsTensile Testing2.3 Aerospace Material Specification:6AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys2.4 American Society for Quality Standard:7ASQ C1 Specification of General Requirements for a Qual-
7、ity Program3. Product Classification3.1 barrounds or flats from 0.1875 to 4 in. (4.76 to 101.60mm) in diameter or thickness. Other sizes and shapes byspecial order.3.2 forging barbar as described in 3.1, used for theproduction of forgings, may be furnished in the hot rolledcondition.3.3 wirerounds o
8、r flats less than 0.1875 in. (4.76 mm) indiameter or thickness.4. Ordering Information4.1 Include with inquiries and orders for material under thisspecification the following information:4.1.1 Quantity (weight or number of pieces),4.1.2 Applicable ASTM designation, date of issue.4.1.3 Form (bar or w
9、ire),4.1.4 Condition (see 5.3),4.1.5 Mechanical Properties (if applicable for special con-ditions),4.1.6 Finish (see 5.2),4.1.7 Applicable dimensions including size, thickness,width, or drawing number,4.1.8 Special tests, if any,4.1.9 Other requirements.5. Materials and Manufacture5.1 The various ti
10、tanium mill products covered in thisspecification normally are formed with the conventional forg-ing and rolling equipment found in primary ferrous andnonferrous plants. The alloy is usually multiple melted in arcfurnaces (including furnaces such as plasma arc and electronbeam) of a type conventiona
11、lly used for reactive metals.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 Jan. 1, 2005. Published January 2005. Originallyapp
12、roved in 1992. Last previous edition approved in 2001 as F 1295 01.2The boldface numbers in parentheses refer to a list of references at the end ofthe text.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of AST
13、MStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Withdrawn.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.6Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale,
14、 PA 15096-0001.7Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Copyright
15、 by ASTM Intl (all rights reserved); Mon Nov 3 21:34:10 EST 2008Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No further reproductions authorized.5.2 FinishThe mill product may be furnished to theimplant manufacturer as descaled or pickled, sandblasted,chemically milled, groun
16、d, machined, peeled, polished, colddrawn, or as specified by the purchaser.5.3 ConditionMaterial shall be furnished in the annealed,cold worked, or hot rolled condition.6. Chemical Requirements6.1 The heat analysis shall conform to the chemical com-position of Table 1. Ingot analysis may be used for
17、 reporting allchemical requirements, except hydrogen. Samples for hydro-gen shall be taken from the finished mill product. The suppliershall not ship material outside the limits specified in Table 1.6.1.1 Requirements for the major and minor elementalconstituents are listed in Table 1. Also listed a
18、re importantresidual elements. Analysis for elements not listed in Table 1 isnot required to certify compliance with this specification.6.2 Product Analysis:6.2.1 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations betweenlaboratories in the meas
19、urement of chemical content. Themanufacturer shall not ship material that is outside the limitsspecified in Table 1. The product analysis tolerances shallconform to Table 2.6.2.2 The product analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot or todetermine
20、variations in the composition within the heat.6.2.3 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analysis tolerance.6.3 For referee purposes, use Test Methods E 120, E 1409,and E 1447 or other analytical methods agreed upo
21、n betweenthe purchaser and the supplier.6.4 Ensure that the samples for chemical analysis arerepresentative of the material being tested. The utmost caremust be used in sampling titanium for chemical analysisbecause of its affinity for elements such as oxygen, nitrogen,and hydrogen. In cutting sampl
22、es for analysis, therefore, theoperation should be carried out insofar as possible in adust-free atmosphere. Cutting tools should be clean and sharp.Samples for analysis should be stored in suitable containers.7. Mechanical Requirements7.1 The material supplied under this specification shallconform
23、to the mechanical properties given in Table 3.7.2 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) through the specified yield and then the cross-head speed s
24、hall be increased so as to produce fracture inapproximately one additional minute.7.3 Number of TestsPerform a minimum of two tensiontests from each lot. A lot is defined as the total number of aspecific mill product produced under the same conditions atessentially the same time. Should either of th
25、e two testspecimens not meet the specified requirements, test two addi-tional test pieces representative of the same lot in the samemanner. The lot will be in compliance only if both additionaltest pieces meet the specified requirements. If a specimen failsoutside the gage, the test is null in accor
26、dance with TestMethods E8, and a retest shall be performed.8. Special Requirements8.1 The microstructure shall be a fine dispersion of the alphaand beta phases resulting from processing in the alpha plus betafield. There shall be no continuous alpha network at prior betagrain boundaries. There shall
27、 be no coarse, elongated alphaplatelets.8.2 Determine the beta transus temperature for each heat bya suitable method and report on the material certification ifrequired by the purchaser.8.3 Alpha case is not permitted for products supplied with amachined, ground, or chemically milled surface finish.
28、 Forother products, there shall be no continuous layer of alpha casewhen examined at 1003 magnification.9. Certification9.1 The suppliers certification that the material was manu-factured in accordance with this specification together with aTABLE 1 Chemical RequirementsElement Composition, %Aluminum
29、 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 maxTitaniumABalanceAThe percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 2 Product Analysis TolerancesATolerance Under the Minim
30、umBor Over the Maximum LimitAluminum 0.10Niobium 0.10Tantalum 0.10Iron 0.10Oxygen 0.02Carbon 0.02Nitrogen 0.02Hydrogen 0.002ARefer to AMS 2249.BUnder minimum limit not applicable for elements where only a maximumpercentage is indicated.TABLE 3 Mechanical PropertiesAfor Bar and WireBUltimate Tensile
31、Strength,min, psi, (MPa)Yield Strength (0.2 %Offset), min, psi,(MPa)Elongation,Cmin, %Reductionof Area,min, %130 500 (900) 116 000 (800) 10 25AMechanical properties for the hot rolled condition may be established byagreement between the supplier and purchaser.BUp to 4.00-in. (101.60-mm) diameter or
32、thickness.CElongation of material 0.062 in. (1.575 mm) or greater in diameter or thicknessshall be measured using a gage length of 4D or 4W or 5.65 = So, where So is theoriginal cross-sectional area. The gage length must be reported with the testresults. The method for determining elongation of mate
33、rial under 0.062 in. (1.57mm) in diameter or thickness may be negotiated. Alternately, a gage lengthcorresponding to ISO 6892 may be used when agreed upon between supplier andpurchaser.F1295052Copyright by ASTM Intl (all rights reserved); Mon Nov 3 21:34:10 EST 2008Downloaded/printed byGuo Dehua (CN
34、IS) pursuant to License Agreement. No further reproductions authorized.report of the test results shall be furnished to the implantmanufacturer at the time of shipment.10. Program Requirements10.1 The producer shall maintain a quality assurance pro-gram as defined in ASQ C1.10.2 The manufacturer of
35、surgical implants shall be assuredof the producers quality assurance program for conformanceto the intent of ASQ C1 or other recognized program.11. Keywords11.1 metals (for surgical implants); orthopaedic medicaldevices; titanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1.
36、RATIONALEX1.1 The purpose of this specification is to characterize thecomposition and properties of wrought annealed, cold worked,or hot rolled Ti-6A1-7Nb titanium alloy bar and wire to ensureconsistency in the starting material used in the manufacture ofmedical devices, in particular of surgical im
37、plants.X1.2 The microstructural requirements contained in thisspecification represent the current general consensus of opinionwith respect to optimization of mechanical properties forimplant applications.X1.3 The minimum mechanical properties specified ensurea baseline of strength and ductility for
38、the highly stresseddevices that may be manufactured from this alloy.X1.4 The stress corrosion cracking resistance of this alloyis similar to Ti-6A1-4V alloy.X1.5 The UNS designation has been added, residualelement language has been included, alpha case informationhas been clarified, the inclusion re
39、quirement has been deletedbecause no standard method exists for determining the inclu-sion content in titanium alloys, and Appendix X2 Biocompat-ibility section has been added to the Rationale.X1.6 ISO standards are listed for reference only. Use of theISO standards in addition to or instead of the
40、preferred ASTMstandard may be negotiated between the purchaser andsupplier.X2. BIOCOMPATIBILITYX2.1 The material composition covered by this specifica-tion has been employed successfully in contact with soft tissueand bone for over a decade.X2.2 No known surgical implant has ever been shown to becom
41、pletely free of adverse reactions in the human body.However, long-term clinical experience has shown an accept-able level of biological response can be expected, if thematerial is used in appropriate applications.X2.3 The material in this specification has been subjectedto animal studies (5) and has
42、 been shown to produce a wellcharacterized level of biological response that is equal to orless than that produced by the reference material titanium. Thismaterial has been used clinically since 1986 (6, 7).F1295053Copyright by ASTM Intl (all rights reserved); Mon Nov 3 21:34:10 EST 2008Downloaded/p
43、rinted byGuo Dehua (CNIS) pursuant to License Agreement. No further reproductions authorized.REFERENCES(1) Semlitsch, M., Straub, F., and Weber, H., “Titanium-Aluminium-Niobium Alloy, Development of Biocompatible, High Strength Surgi-cal Implants,” Biomedizinische Technik 30, 12, 1985, pp. 334339.(2
44、) Maeusli, P.A., Block, P. R., Geret, V., and Steinemann, S. G., “SurfaceCharacterization of Titanium and Titanium Alloys,” Biological andBiomechanical Performance of Biomaterials, edited by Christel,Meunier, and Lee, Elsevier Science Publ., 1986, pp. 5762.(3) Simpson, J. P., “The Electrochemical Be
45、haviour of Titanium andTitanium Alloys with Respect to their Use as Surgical ImplantMaterials,” Biological and Biomechanical Performance of Biomateri-als, 1986, pp. 6368.(4) Semlitsch, M., Staub, F., and Weber, H., “Development of a Vital,High-Strength Titanium-Aluminium-Niobium Alloy for Surgical I
46、m-plant Materials,” Biological and Biomechanical Performance of Bio-materials, 1986, pp. 6974.(5) Perren, S. M., Geret, V., Tepic, M., and Rahn, B. A., “QuantitativeEvaluation of Biocompatibility of Vanadium-Free Titanium Alloys,”Biological and Biomechanical Performance of Biomaterials, 1986, pp.397
47、402.(6) Semlitsch, M.,“ TitaniumAlloys for Hip Joint Replacements,” ClinicalMaterials, 2, 1987, pp. 113.(7) Zweymller, K. A., Lintner, F. K., and Semlitsch, M. F., “BiologicFixation of a Press-Fit Titanium Hip Joint Endoprosthesis,” ClinicalOrthopaedics and Related Research 235, Oct. 1988, pp. 19520
48、6.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue(F 1295 01) that may impact the use of this standard. (Approved Jan. 1, 2005.)(1) “Cold worked or hot rolled” was added to 1.1.(2) “Cold drawn” was added to 5.2.(3) “Cold worked” wa
49、s added to 5.3.(4) “Annealed” was deleted from the title of Table 3.(5) X1.1 was editorially corrected and changed to coincidewith the latest changes.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical
