1、Designation: F1813 06F1813 13Standard Specification forWrought Titanium12 Molybdenum6 Zirconium2 IronTitanium-12Molybdenum-6Zirconium-2Iron Alloy for SurgicalImplant (UNS R58120)1This standard is issued under the fixed designation F1813; the number immediately following the designation indicates the
2、 year oforiginal adoption or, in the 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
3、, and metallurgical requirements for wrought titanium12 molybdenum6zirconium2 iron alloy for surgical implants titanium-12molybdenum-6zirconium-2iron alloy mill products to be used in themanufacture of surgical implants.21.2 The values stated in inch pound units either SI units or inch-pound units a
4、re to be regarded separately as the standard. TheSI equivalents in parentheses are for information only.values stated in each system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combining values from the two systems may result in non-conformance with
5、thestandard.2. Referenced Documents2.1 ASTM Standards:3E8E8/E8M Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE1409 Test Method for Determina
6、tion of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas FusionTechniqueE1447 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
7、 Reactive Metals and Their Alloys by Combustion AnalysisE2371 Test Method forAnalysis of Titanium and TitaniumAlloys byAtomic Emission Plasma Spectrometry (Withdrawn 2013)4E2626 Guide for Spectrometric Analysis of Reactive and Refractory MetalsF67 Specification for Unalloyed Titanium, for Surgical I
8、mplant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesIEEE/ASTM SI 10 American National Standard for Metric Practice2.2 Aerospace Materials Specification:5AMS 2249 Chemical Check Analysis Limits, Titani
9、um and Titanium AlloysAMS 2631 Ultrasonic InspectionTitanium and Titanium Alloy Bar, Billet and PlateAMS 2380 Approval and Control of Premium-Quality Titanium Alloys2.3 ISO Standards:6ISO 6982 Metallic Materials Tensile Testing at Ambient TemperatureISO 9001 Quality Management Standard1 This specifi
10、cation is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2006March 1, 2013. Published January 2007April 2013. Originally approved in 1997. La
11、st previous edition approved in 20012006 asF1813 01.F1813 06. DOI: 10.1520/F1813-06.10.1520/F1813-13.2 FDA 510K application number K903630.3 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume
12、information, refer to the standards Document Summary page on the ASTM website.4 The last approved version of this historical standard is referenced on www.astm.org.5 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.6 Available f
13、rom 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 provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may n
14、ot 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 the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the e
15、nd of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.4 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Quality Program73. Terminology3.1 Definitions of Terms Specific to This St
16、andard:3.1.1 beta transus, nthe minimum temperature at which the alpha plus beta phase can transform to 100 % beta phase.3.1.2 hot work, nany mechanical deformation process performed above the recrystallization temperature.3.1.3 lot, nthe total number of mill products produced from the same melt hea
17、t under the same conditions at essentially thesame time.3.1.4 solution anneal, vto heat treat in order to remove precipitates.4. Product Classification4.1 BarRounds, flats or other shapes from 0.18750.188 in. (4.76 mm)4.76 mm to 44.0 in. (101.60 mm)102 mm in diameteror thickness. (Other sizes and sh
18、apes 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 as rolledhotworked condition.4.3 WireRounds, flats, or other shapes less than 3160.188 in. (4.76 mm)4.76 mm in diameter or thickness.5. Ordering Information5.1 Inclu
19、de with inquiries and orders for material under this specification the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Form (strip, sheet, plate, bar, forging bar or wire),5.1.4 Condition (see 6.36.2),5.1.5 Mechanical properties (if applicable for special conditio
20、ns),5.1.6 Finish (see 6.26.1),5.1.7 Applicable dimensions including size, thickness, width, length or drawing number,5.1.8 Special tests, if any,(if any), and5.1.9 Other requirements.6. Materials and Manufacture6.1 The various titanium mill products covered in this specification normally are formed
21、with the conventional forging androlling equipment found in primary ferrous and non ferrous plants. This alloy is usually multiple melted in arc furnaces (includingplasma arc and electron beam) of a type conventionally used for reactive metals.6.1 FinishThe mill product may be supplied as specified
22、by the purchaser with a descaled or pickled, abrasive blasted,chemically milled, ground, machined, peeled, or polished finish. On billets, bars, plates and forgings, it is permissible to removeminor surface imperfections by grinding if the resultant area meets the dimensional and surface finish requ
23、irements of thisspecification.6.2 ConditionMaterial shall be furnished in the solution annealed or warm worked (as rolled) condition.hot worked condition.7. Chemical Requirements7.1 The heat analysis shall conform to the chemical composition of Table 1. Ingot analysis may be used for reporting allch
24、emical requirements, except hydrogen. Samples for hydrogen shall be taken from the finished mill product. SupplierThe suppliershall not 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.
25、Also listed are important residualelements. Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.7.2 Product Analysis:7.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations betweenlaboratories
26、 in the measurement of chemical content. content between laboratories. The product analysis tolerances shall conformto the product tolerances in 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 c
27、omposition within the heat.7.2.3 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of thisproduct analyses.analysis. Product analysis outside the tolerance limits allowed in Table 2 are cause for rejection of the product.A referee analysis m
28、ay be used if agreed upon by the supplier and purchaser.F1813 1327.2.4 For referee purposes, use Test Methods E2371, E1409, E1941, E2626, and E1447 or other analytical methods agreed uponbetween the purchaser and the supplier.7.3 Samples for chemical analysis shall be representative of the material
29、being tested. The utmost care must be used in samplingtitanium for chemical analysis because of its 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 tool
30、s should be cleanand sharp. Samples for analysis should be stored in suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shall conform to the mechanical property requirements in Table 3.AlternativeTABLE 1 Chemical RequirementsElement Composition % mass/ma
31、ssMin MaxNitrogen 0.05Carbon 0.05Hydrogen 0.020Iron 1.5 2.5Oxygen 0.008 0.28Molybdenum 10.0 13.0Zirconium 5.0 7.0Titanium BalanceATABLE 1 Chemical RequirementsElement Composition % mass/massMin MaxNitrogen 0.05Carbon 0.05Hydrogen 0.020Iron 1.5 2.5Oxygen 0.008 0.28Molybdenum 10.0 13.0Zirconium 5.0 7.
32、0Titanium BalanceAA The percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 2 Product Analysis TolerancesAElementTolerance Under theMinimum or Over theMaximum LimitBNitrogen 0.02Carbon 0.002Hydrogen 0.0002Iron 0.20Molybdenum 0.25Zirconium over 4 to 6 %, in
33、clusive 0.20Zirconium over 4 to 6 %, inclusive 0.30Oxygen up to 0.2 % 0.02Oxygen over to 0.2 % 0.03A The percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 3 Mechanical PropertiesBar and WireConditionAUltimateTensile Strengthmin, psi (MPa)YieldStrength(0.
34、2 %offset),min, psi(MPa)ElongationBin 2 in. (50 mm),4D or 4W min %Reductionof Areamin, %Solutionannealed 135 000 (931.5)130 000(897) 12 30A Refer to AMS 2249.B Under the minimum limit not applicable for elements where only a maximumpercentage is indicated.F1813 133properties may be agreed upon betwe
35、en the purchaser and supplier.8.2 Specimens for tension tests shall be machined and tested in accordance with Test Methods E8. Tensile properties shall bedetermined using a strain rate of 0.003 to 0.007 in./in./min (mm/mm/min) through yield and then the crosshead speed may beincreased so as to produ
36、ce fracture in approximately one additional minute.8.2 Number of Tests: Specimens for tension tests shall be prepared and tested in accordance with Test Methods E8/E8M. Tensileproperties shall be determined using a strain rate of 0.003 to 0.007 in./in./min mm/mm/min through yield and then the crossh
37、eadspeed may be increased so as to produce fracture in approximately one additional minute.8.2.1 Bar, Forging Bar, Shapes and WireTest according to Test Methods E8/E8M. Perform at least one tension test from eachlot in the longitudinal direction. Should this test result not meet the specified requir
38、ements, test two additional test piecesrepresentative of the same lot, in the same manner, for each failed test piece. The lot shall be considered in compliance only if alladditional test pieces meet the specified requirements.8.2.2 Tensile tests results for which any specimen fractures outside the
39、gauge length shall be considered acceptable,valid, if boththe elongation and reduction of area meet the minimum requirements specified. Refer to Test MethodsIf either the elongation E8,sections 7.11.4 and 7.12.5.or reduction of area is less than the minimum requirement, invalidate the specimen and r
40、etest. Retestone specimen for each invalidated specimen.8.2.3 If either the elongation or reduction of area isShould any test specimen not meet the specified requirements (except asnoted in 8.2.2less than the minimum requirement, discard the test and retest. Retest one specimen for each specimen tha
41、t did notmeet the minimum), test two additional test pieces representative of the same lot, in the same manner, for each failed test specimen.The lot will be considered in compliance only if all additional test pieces meet the specified requirements.9. Dimensions and Permissible Variation9.1 Units o
42、f Measure:9.1.1 SelectionThis specification requires that the purchaser selects the units (SI or 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
43、order of precedence.9.1.1.1 If the purchaser and supplier have a history of using specific units, 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, specificat
44、ion, andengineering drawing are consistent, these units shall be used by the supplier for the product certification.9.1.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon between the purchaser andsupplier.9.1.2 Conversion of UnitsIf the suppliers test equi
45、pment does not report in the selected units, the test equipment units maybe converted to the selected units for certification purposes. Accurate arithmetic conversion and proper use of significant digitsshould be observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the u
46、se of SI units. Annex Aprovides conversion tables and Annex B provides rules for conversion and significant digits.10. Special Requirements10.1 The microstructure shall consist of a fully recrystallized beta phase structure. Primary alpha and alpha prime (also knownas martensitic alpha) are not perm
47、itted in the microstructure when viewed at 100 magnification. The grain size in the annealedcondition shall be 5 or finer based upon Test Methods E112.10.2 Determine the beta transus temperature for each heat by a suitable method and report on the material certification ifrequired by the purchaser.1
48、0.3 Alpha case is not permitted for products supplied with a machined, ground, or chemically milled surface finish. For otherproducts, there willshall be no continuous layer of alpha case when examined at 100 magnification.10.4 All centerless ground or peeled and polished round bar 0.375 in. 9.5 mm
49、in nominal diameter shall be ultrasonicallyinspected at final diameter according to AMS 2631 Class A1. Equivalent test methods may be substituted when agreed upon bythe purchaser and supplierNOTE 1AMS 2631 contains varying flat bottom hole (FBH) requirements based on melting grades per AMS 2380. Since the FBH requirement forClass A1 is the same regardless of the melting grade, it is not necessary to specify the melting grade.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limits in th
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