1、Designation: F 1813 06Standard Specification forWrought Titanium12 Molybdenum6 Zirconium2 Iron Alloyfor Surgical Implant (UNS R58120)1This standard is issued under the fixed designation F 1813; the number immediately following the designation indicates the year oforiginal adoption or, in the case of
2、 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 wrought
3、 titanium12 molybde-num6 zirconium2 iron alloy for surgical implants to be usedin the manufacture of surgical implants.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 Documents2.1 ASTM Standards:3E8
4、 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE 1409 Test Method for Determination of Oxygen andNitrogen in Titanium and Titanium Alloys by t
5、he Inert GasFusion TechniqueE 1447 Test Method for Determination of Hydrogen inTitanium and Titanium Alloys by the Inert Gas FusionThermal Conductivity/Infrared Detection MethodE 2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma SpectrometryF 748 Practice for Sel
6、ecting Generic Biological Test Meth-ods for Materials and Devices2.2 Aerospace Materials Specification:AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium Alloys42.3 ISO Standards:ISO 6982 Metallic Materials Tensile Testing at AmbientTemperature5ISO 9001 Quality Management Standard52.4 Ame
7、rican Society for Quality Standard:ASQ C1 Specification of General Requirements for a Qual-ity Program63. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 beta transus, nthe minimum temperature at whichthe alpha plus beta phase can transform to 100 % beta phase.3.1.2 lot, nthe tot
8、al number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.4. Product Classification4.1 BarRounds, flats or other shapes from 0.1875 in.(4.76 mm) to 4 in. (101.60 mm) in diameter or thickness.(Other sizes and shapes by special order.)4.2 Forgin
9、g BarBar as described in 4.1 used in theproduction of forgings. This product may be furnished in the asrolled condition.4.3 WireRounds, flats or other shapes less than316 in.(4.76 mm) in diameter or thickness.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecifi
10、cation 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 6.3),5.1.5 Mechanical properties (if applicable for special con-ditions),5.1.6 Finish (see 6.2),5.1.7 Applicable dimensions includi
11、ng size, thickness,width, length or drawing number,5.1.8 Special tests, if any, and1This 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 approv
12、ed Dec. 1, 2006. Published January 2007. Originallyapproved in 1997. Last previous edition approved in 2001 as F 1813 01.2FDA 510K application number K903630.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of A
13、STMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th F
14、loor, New York, NY 10036, http:/www.ansi.org.6Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Con
15、shohocken, PA 19428-2959, United States.5.1.9 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 and nonferrous plants. This alloy is usua
16、lly multiple melted in arcfurnaces (including plasma arc and electron beam) of a typeconventionally used for reactive metals.6.2 FinishThe mill product may be supplied as specifiedby the purchaser with a descaled or pickled, abrasive blasted,chemically milled, ground, machined, peeled, or polishedfi
17、nish. On billets, bars, plates and forgings, it is permissible toremove minor surface imperfections by grinding if the resultantarea meets the dimensional and surface finish requirements ofthis specification.6.3 ConditionMaterial shall be furnished in the solutionannealed or warm worked (as rolled)
18、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 allchemical requirements, except hydrogen. Samples for hydro-gen shall be taken from the finished mill product. Supplier shallnot ship material with
19、 chemistry outside the requirementsspecified in Table 1.7.1.1 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.7.2 Prod
20、uct Analysis:7.2.1 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. Theproduct analysis tolerances shall conform to the producttolerances in Table 2.7.2.2 The product analysis is eith
21、er for the purpose ofverifying the composition of a heat or manufacturing lot or todetermine variations in the composition within the heat.7.2.3 Acceptance or rejection of a heat or manufacturing lotof material may be made by the purchaser on the basis of thisproduct analyses. Product analysis outsi
22、de the tolerance limitsallowed in Table 2 are cause for rejection of the product. Areferee analysis may be used if agreed upon by supplier andpurchaser.7.2.4 For referee purposes, use Test Methods E2371,E 1409, and E 1447 or other analytical methods agreed uponbetween the purchaser and the supplier.
23、7.3 Samples for chemical analysis shall be representative ofthe material being tested. The utmost care must be used insampling titanium for chemical analysis because of its affinityfor elements such as oxygen, nitrogen, and hydrogen. Incutting samples for analysis, therefore, the operation should be
24、carried out insofar as possible in a dust-free atmosphere.Cutting tools should be clean and sharp. Samples for analysisshould be stored in suitable containers.8. Mechanical Requirements8.1 The material supplied under this specification shallconform to the mechanical property requirements in Table 3.
25、Alternative properties may be agreed upon between the pur-chaser and supplier.8.2 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 yield and then the
26、crosshead speed maybe increased so as to produce fracture in approximately oneadditional minute.8.3 Number of Tests:8.3.1 Bar, Forging Bar, Shapes and WirePerform at leastone tension test from each lot in the longitudinal direction.Should this test result not meet the specified requirements, testtwo
27、 additional test pieces representative of the same lot, in thesame manner, for each failed test piece. The lot shall beconsidered in compliance only if all additional test pieces meetthe specified requirements.TABLE 1 Chemical RequirementsElementComposition % mass/massMin MaxNitrogen 0.05Carbon 0.05
28、Hydrogen 0.020Iron 1.5 2.5Oxygen 0.008 0.28Molybdenum 10.0 13.0Zirconium 5.0 7.0Titanium BalanceAAThe percentage of titanium is determined by difference and need not bedetermined or certified.TABLE 2 Product Analysis TolerancesAElementTolerance Under theMinimum or Over theMaximum LimitBNitrogen 0.02
29、Carbon 0.002Hydrogen 0.0002Iron 0.20Molybdenum 0.25Zirconium over 4 to 6 %, inclusive 0.20Zirconium over 4 to 6 %, inclusive 0.30Oxygen up to 0.2 % 0.02Oxygen over to 0.2 % 0.03ARefer to AMS 2249.BUnder the minimum limit not applicable for elements where only a maximumpercentage is indicated.TABLE 3
30、 Mechanical PropertiesBar and WireConditionAUltimateTensile Strengthmin, psi (MPa)Yield Strength(0.2 % offset),min, psi (MPa)ElongationBin 2 in. (50 mm),4D or 4W min %Reductionof Areamin, %Solutionannealed135 000 (931.5) 130 000 (897) 12 30AMechanical properties for conditions other than those liste
31、d in this table maybe established by agreement between the supplier and purchaser.BElongation of material 0.063 in. (1.6 mm) or greater in diameter (D)orwidth(W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmust be reported with the test results. The method for determ
32、ining elongation ofmaterial under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.Alternately, a gauge length corresponding to ISO 6892 may be used when agreedupon between supplier and purchaser (5.65 times the square root of So, where Sois the original cross sectional area).F18130628.
33、3.2 Tensile tests results for which any specimen fracturesoutside the gauge length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to Test Methods E8, sections7.11.4 and 7.12.5.8.3.3 If either the elongation or reduction of ar
34、ea is less thanthe minimum requirement, discard the test and retest. Retestone specimen for each specimen that did not meet theminimum requirements.9. Special Requirements9.1 The microstructure shall consist of a fully recrystallizedbeta phase structure. Primary alpha and alpha prime (alsoknown as m
35、artensitic alpha) are not permitted in the micro-structure when viewed at 1003 magnification. The grain sizein the annealed condition shall be 5 or finer based upon TestMethods E112.9.2 Determine the beta transus temperature for each heat bya suitable method and report on the material certification
36、ifrequired by the purchaser.9.3 Alpha case is not permitted 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. Significance of Numerical Limits10.1 The following
37、applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.1
38、1. Certification11.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification andmet all requirements. A report of the test results shall befurnished to the purchaser at the time of shipment.11.2 Gauge length must be reported with elongation.12. Qu
39、ality Program Requirements12.1 The supplier shall maintain a quality program such asdefined in ASQ C1 or ISO 9001.13. Keywords13.1 metals (for surgical implants); orthopaedic medicaldevices; titanium alloys; titanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALENOTE
40、 X1.1Choose the appropriate paragraphs for your alloy andproduct forms.X1.1 The purpose of this specification is to characterize thechemical, mechanical, and metallurgical properties of wroughttitanium12 molybdenum6 zirconium2 iron alloy to be usedin the manufacture of surgical implants.X1.2 The mic
41、rostructural requirements contained in thisspecification represent current general consensus with respectto optimization of mechanical properties for implant applica-tions.X1.3 The minimum mechanical properties specified ensurea baseline of strength and ductility for the highly stresseddevices for w
42、hich this alloy is typically used.X1.4 The stress corrosion cracking resistance of this alloyis similar to that of titanium 6 aluminum 4 vanadium ELIalloy.X1.5 ISO Standards are listed for reference only. Althoughstandards listed in section 2.3 are similar to the correspondingASTM standards, they ar
43、e not identical. Use of the ISOstandard instead of the preferred ASTM standards may beagreed upon between the purchaser and supplier.X1.6 The various titanium mill products covered in thisspecification normally are formed with the conventional forg-ing and rolling equipment found in primary ferrous
44、andnonferrous plants. The material is usually multiple melted inarc furnaces (including furnaces such as plasma arc andelectron beam) of a type conventionally used for reactivemetals.F1813063X2. BIOCOMPATIBILITYX2.1 The suitability of this material from a human implantperspective is dependent on the
45、 specific application. Thebiological tests appropriate for the specific site, such asrecommended in Practice F 748 should be used as a guideline.A summary of the in vitro and animal testing that has beenperformed as of the approval date of this specification isprovided in X2.3.X2.2 No known surgical
46、 implant material has ever beenshown to be completely free of adverse reactions in the humanbody. The alloy composition covered by this specification,however, has been subjected to testing in laboratory animals,and has been used clinically for more than a decade (ifappropriate). The results of these
47、 studies indicate a well-characterized level of local biological response that is equal toor less than that produced by the reference material unalloyedtitanium (see Specification F 67) that has a long history ofsuccessful clinical application in soft tissue and bone implantsin humans.X2.3 As of the
48、 time of the original approval of thisspecification, this titanium alloy material had a limited historyof clinical use in humans. An extensive series of in vitro andanimal studies had been performed as follows, comparing thebiological response to that of a reference material. These testswere conduct
49、ed to support the usage of this material in surgicalimplant devices In all cases, the results indicated that thismaterial was no more reactive with the environment than thereference material.X2.3.1 Acute systemic toxicity by mouse injection,2X2.3.2 Cytotoxicity by agar overlay,2X2.3.3 Hemolytic potential by direct exposure,2X2.3.4 Dermal sensitization by guinea pig maximization,2X2.3.5 Mutagenicity by the Amestest (saline and DMSOextracts),2andX2.3.6 Response to particulate debris (release of IL-1, IL-6,and PGE2in cell culture and ex-vivo histology ra
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