1、Designation: F 136 02aStandard Specification forWrought Titanium-6Aluminum-4Vanadium ELI (Extra LowInterstitial) Alloy for Surgical Implant Applications (UNSR56401)1This standard is issued under the fixed designation F 136; the number immediately following the designation indicates the year oforigin
2、al adoption or, in the case 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, andmetallu
3、rgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy(R56401) to be used in the manufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents in parentheses are providedfor informati
4、on only.2. Referenced Documents2.1 ASTM Standards:E 8 Test Methods of Tension Testing of Metallic Materials2E 120 Test Methods for Chemical Analysis of Titanium andTitanium Alloys3E 290 Test Method for Bend Testing of Materials forDuctility3E 527 Practice for Numbering Metals and Alloys (UNS)4E 1409
5、 Test Method for Determination of Oxygen in Tita-nium and Titanium Alloys by the Inert Gas Fusion Tech-nique5E 1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity Method3F 981 Practice for Assessment of Compatibility of Bioma-teri
6、als for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone62.2 ASQ Standard:ASQ C1 Specifications of General Requirements for aQuality Control Program72.3 Aerospace Material Specifications:8AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium AlloysAMS 4930 Titanium All
7、oy Bars, Forgings, and Rings6AL-4V Extra Low Interstitial Annealed2.4 Society of Automotive Engineers Standard:SAE J1086 Practice for Numbering Metals and Alloys(UNS)93. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lot, nthe total number of mill products producedfrom one heat
8、under the same conditions at essentially the sametime.4. Product Classification4.1 StripAny product under 0.1875 in. (4.75 mm) inthickness and under 24 in. (610 mm) wide.4.2 SheetAny product under 0.1875 in. (4.75 mm) inthickness and 24 in. (610 mm) or more in width.4.3 PlateAny product 0.1875 in. (
9、4.75 mm) thick andover and 10 in. (254 mm) wide and over, with widths greaterthan five times thickness. Plate up to 4.00 in. (101.60 mm),thick inclusive is covered by this specification.4.4 BarRound bars and flats from 0.1875 in. (4.75 mm) to4.00 in. (101.60 mm) in diameter or thickness (other sizes
10、 andshapes by special order).4.5 Forging BarBar as described in 4.4, used for produc-tion of forgings, may be furnished in the hot rolled condition.4.6 WireRounds less than 0.1875 in. (4.75 mm) in diam-eter.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecifica
11、tion the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,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 ap
12、proved Nov. 10, 2002. Published December 2002. Originallypublished in 1984. Last previous edition approved in 2002 as F 136 02.2Annual Book of ASTM Standards, Vol 03.01.3Annual Book of ASTM Standards, Vol 03.05.4Annual Book of ASTM Standards, Vol 01.01.5Annual Book of ASTM Standards, Vol 03.06.6Annu
13、al Book of ASTM Standards, Vol 13.01.7Available from American Society for Quality, 600 N. Plankinton Ave.,Milwaukee, WI 53203.8Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001.9New designation established in accordance with E 527 and SAE J1086.1*A
14、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 by ASTM Intl (all rights reserved); Mon Nov 3 21:34:46 EST 2008Downloaded/printed byGuo Dehua (CNIS) pursuant to
15、License Agreement. No further reproductions authorized.5.1.3 Form (sheet, strip, plate, bar, or wire),5.1.4 Condition (See 6.3),5.1.5 Mechanical properties (if applicable, for special con-ditions),5.1.6 Finish (See 6.2),5.1.7 Applicable dimensions including size, thickness,width, or drawing number,5
16、.1.8 Special tests, if any, and5.1.9 Other requirements.6. Materials and Manufacture6.1 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 alloy is usually multipl
17、e melted in arcfurnaces (including furnaces such as plasma arc and electronbeam) of a type conventionally used for reactive metals.6.2 FinishThe mill product may be furnished to theimplant manufacturer as mechanically descaled or pickled,sandblasted, chemically milled, ground, machined, peeled,polis
18、hed, combinations of these operations, or as specified bythe purchaser.6.3 ConditionMaterial shall be furnished in the annealedor cold-worked condition.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical com-position of Table 1. Ingot analysis may be used for reporting allche
19、mical requirements, except hydrogen. Samples for hydro-gen shall be taken from the finished mill product. Supplier shallnot 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 ar
20、e importantresidual elements. Analysis for elements not listed in Table 1 isnot required to verify compliance with this specification.7.2 Product AnalysisProduct analysis tolerances do notbroaden the specified heat analysis requirements but covervariations between laboratories in the measurement of
21、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 2.7.2.1 The product analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot or
22、 todetermine variations in the composition within the heat.7.2.2 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analysis.7.2.3 For referee purposes, use Test Methods E 120, E 1409,and E 1447 or other analytical methods agree
23、d upon betweenthe purchaser and the supplier.7.3 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
24、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 containers.8. Mechanical Requirements8.1 The material supplied under this specification shallcon
25、form to the mechanical property requirements in Table 3.8.2 Specimens for tension tests shall be machined and testedin accordance with Test Methods E 8. 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
26、 increased so as to produce fracture in approximately oneadditional minute.8.3 For sheet and strip, the bend test specimen shall with-stand being bent cold through an angle of 105 without fracturein the outside surface of the bent portion. The bend shall bemade around a mandrel which has a diameter
27、equal to thatshown in Table 3.8.4 Number of Tests:8.4.1 Bar, Forging Bar, Shapes, and WirePerform at leastone tension test from each lot. Should any of these testspecimens not meet the specified requirements, test two addi-tional test pieces representative of the same lot, in the samemanner, for eac
28、h failed test specimen. The lot will be consid-ered in compliance only if both additional test pieces meet thespecified requirements.8.4.2 Sheet, Strip, and PlatePerform at least one tensionand one bend test from each lot. Tension and bend propertyrequirements apply in both the longitudinal and tran
29、sversedirections. Tests in the transverse direction need be made onlyon product from which a specimen not less than 8.0 in. (200mm) in length for sheet and 2.50 in. (64 mm) in length for platecan be taken. Should any of these test specimens not meet thespecified requirements, test two additional tes
30、t pieces represen-tative of the same lot, in the same manner, for each failed testTABLE 1 Chemical RequirementsElement Composition, %Nitrogen, max 0.05Carbon, max 0.08Hydrogen, max 0.012AIron, max 0.25Oxygen, max 0.13Aluminum 5.56.50Vanadium 3.54.5TitaniumBbalanceAMaterial 0.032 in. (0.813 mm) and u
31、nder may have hydrogen content up to0.0150 %.BThe percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 2 Product Analysis ToleranceAElementTolerance Under the Minimum orOver the Maximum Limit(Composition %)BNitrogen 0.02Carbon 0.02Hydrogen 0.0020Iron 0.10Ox
32、ygen 0.02Aluminum 0.40Vanadium 0.15ASee AMS 2249.BUnder minimum limit not applicable for elements where only a minimumpercentage is indicated.F 136 02a2Copyright by ASTM Intl (all rights reserved); Mon Nov 3 21:34:46 EST 2008Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No fur
33、ther reproductions authorized.specimen. The lot will be considered in compliance only ifboth additional test pieces meet the specified requirements.9. Special Requirements9.1 The microstructure shall be a fine dispersion of the alphaand beta phases resulting from processing in the alpha plus betafie
34、ld. There shall be no continuous alpha network at prior betagrain boundaries. There shall be no coarse, elongated alphaplatelets.9.2 Determine the beta transus temperature for each heat bya suitable method and report on the material certification ifrequired by the purchaser.9.3 Alpha case is not per
35、mitted for products supplied with amachined, ground, or chemically milled surface finish. Forother products, there will be no continuous layer of alpha casewhen examined at 1003 magnification.10. Certification10.1 The supplier shall provide a certification that thematerial was tested in accordance w
36、ith this specification. Areport of the test results shall be furnished to the purchaser atthe time of shipment.11. Quality Program Requirements11.1 The producer shall maintain a quality program asdefined in ASQ C1.12. Keywords12.1 metals (for surgical implants); orthopaedic medicaldevices; titanium
37、alloys; titanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechemical, physical, mechanical, and metallurgical properties ofwrought annealed titanium-6aluminum-4vanadium ELI (extralow interstitial) alloy
38、to be used in the manufacture of surgicalimplants.X1.2 The microstructural requirements contained in thisstandard represent the current general consensus of opinionwith respect to optimization of mechanical properties forimplant applications.X1.3 The minimum mechanical properties specified assurea b
39、aseline of strength and ductility for the highly stresseddevices for which this alloy is typically used.TABLE 3 Annealed Mechanical PropertiesANominal Diameter or DistanceBetween Parallel Sides, in. (mm)Tensile Strength min,psi (MPa)Yield Strength(0.2 % offset) min,psi (MPa)ElongationBin 4D or 4W mi
40、n,% Reduction of AreaCmin, %LLTSTLLTSTUnder 0.187 (4.75) thickness ordiameter125 000 (860) 115 000 (795) 10 . . . . .0.187 (4.75) to under 1.75 (44.45), incl 125 000 (860) 115 000 (795) 10 . . 25 . .1.75 (44.45) to under 2.50 (63.50), incl 120 000 (825) 110 000 (760) 8 . . 20 . .2.50 (63.50) to 4.00
41、 (101.60), incl 120 000 (825) 110 000 (760) 8 8D8D15 15D15DBend TestEUnder 0.070 (1.778) in thickness 9 T0.070 (1.778) to 0.187 (4.75), incl 10 TAMechanical properties for conditions other than those listed in this table may be established by agreement between the supplier and the implant manufactur
42、er.BElongation of material 0.062 in. (1.575 mm) or greater in diameter or thickness shall be measured using a gage length of 2 in. or4Dor4W.Thegage length mustbe reported with the test results. Elongation of material under 0.062 in. (1.575 mm) in diameter or thickness may be obtained by negotiation.
43、 L = longitudinal; LT = longtransverse; ST = short transverse.CApplies to bar, plate, and forgings only. L = longitudinal; LT = long transverse; ST = short transverse. For round bar the long and short transverse are identical tests,therefore only one transverse is required.DTransverse requirements i
44、n Table 3 apply only to product from which a tensile specimen not less that 2.50 in. (63.5 mm) in length can be obtained.EBend test applicable to sheet and strip products; T = thickness of bend specimen in reference to diameter of bend.F 136 02a3Copyright by ASTM Intl (all rights reserved); Mon Nov
45、3 21:34:46 EST 2008Downloaded/printed byGuo Dehua (CNIS) pursuant to License Agreement. No further reproductions authorized.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been employed successfully in human implant applicationsin contact with soft tissue and bone for
46、 over a decade. Due tothe well-characterized level of biological response exhibited bythis alloy, it has been used as a control material in PracticeF 981.X2.2 No known surgical implant material has ever beenshown to be completely free from adverse reactions in thehuman body. Long-term clinical exper
47、ience of the use of thematerial referred to in this specification, however, has shownthat an acceptable level of biological response can be expected,if the material is used in appropriate applications.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard si
48、nce the last issue (F 136 02)that may impact the use of this standard.(1) Section 3, Terminology, was added.(2) Section 8.4 was revised, and subsections 8.4.1 and 8.4.2were added.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item me
49、ntionedin 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 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 standardsand should be addressed to ASTM International Headquarters. Your comments will rece
