1、Designation: F 1108 04Standard Specification forTitanium-6Aluminum-4Vanadium Alloy Castings for SurgicalImplants (UNS R56406)1This standard is issued under the fixed designation F 1108; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revisio
2、n, 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 cast titanium-6
3、aluminum-4vanadium alloy (UNS R56406).1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents of inch-pound units may beapproximate.2. Referenced Documents2.1 ASTM Standards:2B 600 Guide for Descaling and Cleaning Titanium andTitanium Alloy SurfacesE 8 Test Me
4、thods for Tension Testing of Metallic MaterialsE 120 Test Methods for Chemical Analysis of Titanium andTitanium Alloys3E 165 Test Method for Liquid Penetrant ExaminationE 1409 Test Method for Determination of Oxygen in Tita-nium and Titanium Alloys by the Inert Gas Fusion Tech-niqueE 1447 Test Metho
5、d for Determination Hydrogen in Tita-nium and Titanium Alloys by the Inert Gas Fusion ThermalConductivity MethodF 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 601 Practice for Fluorescent Penetrant Inspec
6、tion of Me-tallic Surgical ImplantsF 629 Practice for Radiography of Cast Metallic SurgicalImplants2.2 ISO Standard:ISO 6892 Metallic MaterialsTensile Testing at AmbientTemperature42.3 Aerospace Material Specification:AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys52.4 American
7、Society for Quality Standard:ASQ C1 Specification of General Requirements for a Qual-ity Control Program62.5 Society of Automotive Engineers:SAE J1086 Practice for Numbering Metals and Alloys(UNS)53. Ordering Information3.1 Inquiries and orders for material under this specificationshall include the
8、following information:3.1.1 Quantity,3.1.2 ASTM designation and issue date,3.1.3 Applicable dimensions or drawing number,3.1.4 Condition (see 4.1 and 4.2),3.1.5 Finish (see 4.4 and 4.5),3.1.6 Special tests (see Section 7),3.1.7 Other requirements.4. Materials and Manufacture4.1 Castings conforming t
9、o this specification shall be pro-duced by vacuum investment casting.4.2 Castings covered by this specification shall be in theannealed and hot isostatically pressed condition.NOTE 1While hot isostatic processing (HIP) may enhance mechanicalproperties of Ti6A1-4V castings, it has also been shown to
10、reduce thescatter in mechanical properties and therefore increases the confidence inreliability of castings.4.3 Surface defects may be repaired by welding.4.3.1 Weld repair shall be carefully executed as per writtenprocedures by individuals qualified to perform those proce-dures.4.3.2 ELI weld rod c
11、onforming to Specification F 136 shallbe used where filler metal is needed.4.3.3 Weld repairs shall be performed prior to final thermalprocessing.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcom
12、mittee F04.12 on Metallurgical Materials.Current edition approved Apr. 1, 2004. Published April 2004. Originallyapproved in 1988. Last previous edition approved in 2002 as F 1108 - 02.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm
13、.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.4Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York NY 10036.5Available from Society of Automotive Engineers, Inc., 400 Commonwe
14、alth Dr.,Warrendale, PA 15096-0001.6Available from American Society for Quality, 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 St
15、ates.NOTE 2Under certain circumstances, a weld repair will act as a stressriser. Therefore, care should be exercised in the location and extent ofweld repair as it relates to regions of the implant where significant stressesmight be incurred.4.4 All alpha case shall be removed by suitable means such
16、as chemical milling or machining prior to HIP processing.4.5 Parts shall be furnished in the descaled and cleanedcondition in accordance with Guide B 600.4.6 Other thermal processes that meet the specific needs ofthe purchaser may be mutually agreed upon by the supplier andpurchaser.5. Chemical Comp
17、osition5.1 Product castings shall conform to the requirementsprescribed in Table 1. The supplier shall not ship materialoutside the limits of Table 1. Chemical analysis shall beperformed on a representative specimen cast from each heatusing the same general procedures used in casting implants.5.1.1
18、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 specification.5.2 Product AnalysisProduct analysis tolerances do notbroaden the spec
19、ified heat analysis requirements but covervariations between laboratories in the measurement of chemi-cal content. The supplier shall not ship material that is outsidethe limits specified in Table 1. The product analysis tolerancesshall conform to the product tolerances in Table 2.5.2.1 The product
20、analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.5.2.2 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analysis.5.3 For
21、 referee purposes, use Test Methods E 120, E 1409,and E 1447 or other analytical methods agreed upon betweenthe purchaser and the supplier.5.4 Ensure that the samples for chemical analysis arerepresentative of the material being tested. The utmost caremust be used in sampling titanium for chemical a
22、nalysisbecause of its affinity for elements such as oxygen, nitrogen,and hydrogen. In cutting samples 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 co
23、ntainers.6. Mechanical Requirements6.1 Material supplied under this specification shall conformto the mechanical property requirements prescribed in Table 3.6.2 Specimens for tension tests shall conform to the me-chanical property requirements prescribed in Table 3.6.3 Specimens for tension tests sh
24、all be machined and testedin accordance with the methods in Test Methods E 8. Tensileproperties shall be determined using a strain rate of 0.003 to0.007 in./in./min (mm/mm/min) through yield and then thecrosshead speed may be increased so as to produce fracture inapproximately one additional minute.
25、6.4 Mechanical test specimens shall be produced by thesame general procedures used in casting surgical implants andshall be tested in accordance with Test Methods E 8 which mayhave a cast, ground, or machined finish on the reduced section.Alternatively, test specimens may be machined from surgicalim
26、plant castings.6.5 Number of TestsPerform a minimum of two tensiontests from each master heat. Should either of the two testspecimens not meet the specified requirements, test two addi-tional test pieces representative of the same master heat in thesame manner. The lot will be considered in complian
27、ce only ifboth additional test pieces meet the specified requirements.6.6 Tension test results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to Test Methods E 8, sectio
28、ns7.11.4 and 7.11.5. If either the elongation or reduction of areais less than the minimum requirement, discard the test andretest. Retest one specimen for each specimen that did not meetthe minimum requirements.7. Nondestructive Examination7.1 Fluorescent Penetrant ExaminationEach individualpart sh
29、all be subject to fluorescent penetrant examination inTABLE 1 Chemical RequirementsElementComposition,% (mass/mass)Nitrogen 0.05 maxCarbon 0.10 maxHydrogen 0.015 maxIron 0.30 maxOxygen 0.20 maxAluminum 5.5 to 6.75Vanadium 3.5 to 4.5Titanium BalanceAAThe percentage of titanium is determined by differ
30、ence and need not bedetermined or certified. Residual metallic element tolerance levels will be agreedupon between supplier and purchaser.TABLE 2 Product Analysis TolerancesAElementTolerance Under the Minimum orOver the Maximum Limit % (mass/mass)BNitrogen 0.02Carbon 0.02Hydrogen 0.0030Iron 0.08Oxyg
31、en 0.04Aluminum 0.40Vanadium 0.15ASee AMS 2249.BUnder the minimum limit not applicable for elements where only a maximumpercentage is indicated.TABLE 3 Mechanical RequirementsATensile Strength,min, psi (MPa)Yield Strength,(0.2% offset),min, psi (MPa)ElongationBmin, %Reduction of Areamin, %125 000 (8
32、60) 110 000 (758) 8 14AIn the cast, HIP, and annealed condition.BElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width(W) shall be measured using a gage length of 2 in. or 4D or 4W. The gage lengthmust be reported with the test results. The method for determining elongation o
33、fmaterial under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.Alternately, a gage length corresponding to ISO 6892 may be used when agreedupon between supplier and purchaser. (5.65 square root So, where So is theoriginal cross sectional area.)F1108042accordance with Test Method E 165
34、 or Practice F 601, asappropriate for the surface condition of the casting beingtested.7.2 Radiographic ExaminationEach individual part shallbe subject to radiographic examination in accordance withPractice F 629. Acceptance criteria to be mutually agreed uponbetween supplier and purchaser.7.3 Other
35、 additional methods of nondestructive inspectionmay be used as mutually agreed upon by supplier andpurchaser.8. Certification8.1 The supplier shall provide a certification that the mate-rial was tested in accordance with this specification. A report ofthe test results shall be furnished to the purch
36、aser at the time ofshipment.9. Quality Program Requirements9.1 The supplier shall maintain a quality program as definedin ASQ C1.10. Keywords10.1 castings-surgical; orthopaedic medical devices-titanium/titanium alloy; titanium/titanium alloys (for surgicalimplants)APPENDIXES(Nonmandatory Information
37、)X1. RATIONALEX1.1 This specification is intended to provide generalguidelines for material requirements for Ti 6A1-4V castings foruse in surgical implants. It is in no way intended to usurp therole of the design engineer in the development and manufac-ture of a functionally sound implant. For examp
38、le, this speci-fication does not preclude the use of ELI grade titanium; andthe weld repair of defects. The engineer needs to be aware ofthe ramifications of such processing, though, on the safety andefficacy of the implant for its intended use.X1.2 The UNS designation has been added for clarificati
39、on,and a biocompatibility section has been added as an appendix.X1.3 ISO Standards are listed for reference only. Althoughthe ISO standards listed in Section 2 are similar to thecorresponding ASTM standards, they may not identical. Use ofan ISO standard, in addition to or instead of a preferred ASTM
40、standard may be negotiated between the purchaser andsupplier.X2. BIOCOMPATIBILITYX2.1 The material compositions covered by this specifica-tion have been employed successfully in human implantapplication in contact with soft tissue and bone for over adecade.X2.2 No known surgical implant material has
41、 ever beenshown to be completely free of adverse reactions in the humanbody. However, long term clinical experience has shown anacceptable level of biological response can be expected, ifthese materials are used in appropriate applications (1,2,3,4).77The boldface numbers in parentheses refer to the
42、 list of references at the end ofthis standard.F1108043REFERENCES(1) Laing, P. G., Ferguson, A. B., Jr., and Hodge, E. S., “Tissue Reactionin Rabbit Muscle Exposed to Metallic Implants,” Journal of Biomedi-cal Materials Research, Vol 1, 1967, pp 135149.(2) Laing, P. G., “Compatibility of Biomaterial
43、s,” Orthopedic Clinics ofNorth America, Vol 4, No. 2, April 1973, pp 249273.(3) Street, D. M., and Stevens, P. S., “A Humeral Replacement ofProsthesis for the Elbow,” Journal of Bone and Joint Surgery,Vol56A, No. 6, September 1974.(4) Lynch, J. A., “Replacement Arthroplasty of the Elbow with Coonrad
44、Total Elbow Prosthesis,” Orthopaedic Digest, January 1976.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 1108 02) that may impact the use of this standard. (Approved Apr. 1, 2004.)(1) The wording of paragraph 6.6 was revised.A
45、STM 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
46、entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standard
47、sand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committe
48、e on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F1108044
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