1、Designation: F2384 10 (Reapproved 2016)Standard Specification forWrought Zirconium-2.5Niobium Alloy for Surgical ImplantApplications (UNS R60901)1This standard is issued under the fixed designation F2384; the number immediately following the designation indicates the year oforiginal adoption or, in
2、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. Scope1.1 This specification covers the chemical, mechanical, andmetallurgical requirements fo
3、r wrought zirconium-2.5niobiumalloy to be used in the manufacture of surgical implants (1).21.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used indepen
4、dently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:3B550/B550M Specification for Zirconium and ZirconiumAlloy Bar and WireE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Usi
5、ng Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE1552 Test Method for Determining Hafnium in Zirconiumand ZirconiumAlloys By Direct Current PlasmaAtomicEmission SpectrometryE1941 Test Method for Determination of Carbon
6、 in Refrac-tory and Reactive Metals and TheirAlloys by CombustionAnalysisE2626 Guide for Spectrometric Analysis of Reactive andRefractory MetalsF67 Specification for Unalloyed Titanium, for Surgical Im-plant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F748 Practice for Selecting Gene
7、ric Biological Test Methodsfor Materials and DevicesSI 10 American National Standard for Use of the Interna-tional System of Units (SI): The Modern Metric System2.2 ISO Standard:4ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements3. Termin
8、ology3.1 Definitions of Terms Specific to This Standard:3.1.1 annealed, adjmaterial that exhibits a recrystalizedgrain structure.3.1.2 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.4. Product Classification4.1 barround
9、s, flats or shapes from 4.76 to 101.60 mm0.1875 to 4 in. in diameter or thickness (other sizes andshapes by special order).4.2 wirerounds or flats less than 4.76 mm 0.1875 in. indiameter or thickness.5. Ordering Information5.1 Include with inquiries and orders for material under thisspecification th
10、e following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Units to be certifiedSI or inch-pound,5.1.4 Grade (if applicable),5.1.5 Form (bar, or wire),5.1.6 Condition (see 6.3),5.1.7 Mechanical properties (if applicable for specialconditions),5.1.8 Finish (see 6.2),5.1.9 A
11、pplicable dimension including size, thickness, width,or drawing number,5.1.10 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.C
12、urrent edition approved April 1, 2016. Published June 2016. Originallyapproved in 2005. Last previous edition approved in 2010 as F2384 10. DOI:10.1520/F2384-10R16.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For referenced ASTM standards, visit th
13、e ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY
14、10036.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.1.11 Other requirements.6. Materials and Manufacture6.1 Materials covered by this specification shall be pro-duced by multiple vacuum melting in arc furnaces, electronbeam meltin
15、g, or other melting processes conventionally usedfor reactive metals.6.2 FinishThe mill product may be furnished to theimplant manufacturer as descaled or pickled, abrasivelyblasted, chemically milled, ground, machined, peeled,polished, or as specified by the purchaser.6.3 ConditionBarstock shall be
16、 furnished in the annealedcondition unless otherwise specified.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, oxygen, and nitro-gen. Samples for hydrogen, oxygen
17、and nitrogen shall be takenfrom the finished mill product. The supplier shall not shipmaterial with chemistry outside the requirements specified inTable 1. Guide E2626 may be used as a guide for chemicalanalysis techniques.7.1.1 Requirements for the major and minor elementalconstituents are listed i
18、n 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 Product Analysis:7.2.1 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations betweenl
19、aboratories in the measurement of chemical content. Theproduct analysis tolerances shall conform to the producttolerances in Table 2.7.2.2 The product analysis is either for the purpose ofverifying the composition of a heat or manufacturing lot, or todetermine variations in the composition within th
20、e 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 analysis.7.3 For referee purposes, use Test Method E1552 and E1941or other analytical methods, as agreed upon between thepurchaser and the supplier.7.4 The samples
21、for chemical analysis shall be representa-tive of the material being tested. The utmost care must be usedin sampling zirconium for chemical analysis because of itsaffinity for elements such as oxygen, nitrogen, and hydrogen.In cutting samples for analysis, therefore, the operation shouldbe carried o
22、ut 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 3.8.2 Speci
23、mens for tension tests shall be machined from barin the longitudinal direction and tested in accordance with TestMethods E8/E8M. Tensile properties shall be determined usinga strain rate of 0.003 to 0.007 in./in./min mm/mm/minthrough yield and then the crosshead speed may be increasedso as to produc
24、e fracture in approximately one additionalminute.8.3 Number of TestsPerform a minimum of two tensiontests from each lot (see 3.1.2). Should either of the two testspecimens not meet the specified requirements, test two addi-tional test pieces representative of the same lot in the samemanner. The lot
25、will be considered in compliance only if bothadditional test pieces meet the specified requirements.8.4 Tension test results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and reduction of area meets the minimumrequirements specified. Re
26、fer to Test Methods E8/E8M, sec-tions 7.11.4 and 7.11.5. If either the elongation or reduction ofarea is less than the minimum requirement, discard the test andTABLE 1 Chemical RequirementsElementComposition % mass/massmin maxNiobium 2.40 2.80Oxygen 0.09 0.13Carbon 0.027Chromium 0.020Hafnium 0.010Hy
27、drogen 0.0025Iron 0.15Nitrogen 0.0080Tin 0.0050Zirconium balanceAbalanceAAThe percentage of zirconium is determined by difference and need not bedetermined or certified.TABLE 2 Product Analysis TolerancesAlloying ElementPermissible Variation fromthe Specified Range,% mass/massNiobium 0.050Oxygen 0.0
28、20Carbon 0.002Chromium 0.002Hafnium 0.002Hydrogen 0.0005Iron 0.002Nitrogen 0.0016Tin 0.001TABLE 3 Mechanical PropertiesAConditionTensile Strength,min, MPa psiYield Strength(0.2 % offset),min, MPa psiElongationBin2 in. or 4D or 4W,min, %Annealed 450 65 000 310 45 000 15AMechanical properties for cond
29、itions other than those listed in this table may beestablished by agreement between the supplier and the implant manufacturer.BElongation of material 1.6 mm 0.063 in. or greater in diameter (D) or width (W)shall be measured using a gage length of 2 in. or 4D or 4W. The gage length mustbe reported wi
30、th the test results. The method for determining elongation of materialunder 1.6 mm 0.063 in. in diameter or thickness may be negotiated. Alternately,a gage length corresponding to ISO 6892 may be used when agreed upon bysupplier and purchaser. (5.65 =So, where So is the original cross sectional area
31、).F2384 10 (2016)2retest. Retest one specimen for each specimen that did not meetthe minimum requirements.9. Significance of Numerical Limits9.1 The following applies to all specified limits in thisspecification: For purposes of determining conformance withthese specifications, an observed value or
32、calculated value shallbe rounded to the nearest unit in the last right-hand digit usedin expressing the specification limit, in accordance with theRounding Method of Practice E29.10. Units of Measure10.1 SelectionThis specification requires that the pur-chaser selects the units (SI or inch-pound) to
33、 be used forproduct certification. In the absence of a stated selection ofunits on the purchase order, this selection may be expressed bythe purchaser in several alternate forms listed in order ofprecedence.10.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall
34、 continue to be certified untilexpressly changed by the purchaser.10.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers PO, specification,and engineering drawing are consistent, these units shall beused by the supplier for product certification10.1.3
35、If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between purchaser andsupplier.10.2 Conversion of UnitsIf the suppliers test equipmentdoes not report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-p
36、oses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. ASTM SI 10 provides guidelines for the use of SIunits. Annex A provides conversion tables and Annex Bprovides rules for conversion and significant digits.11. Special Requiremen
37、ts11.1 The microstructure shall be a fine dispersion of thealpha and beta phases resulting from processing in the alphaplus beta field. There shall be no coarse, elongated alphaplatelets. The average grain size of forgings shall be ASTMNo. 8 or finer when tested in accordance with Test MethodsE112.1
38、2. Certification12.1 The supplier shall provide a certification that thematerial was tested in accordance with this specification. Areport of the test results shall be furnished to the purchaser atthe time of shipment.13. Quality Program Requirements13.1 The supplier shall maintain a quality program
39、 asdefined in ISO 9001 or similar quality program.14. Keywords14.1 metals (for surgical implants); orthopaedic medicaldevices; zirconium alloys; zirconium alloys (for surgical im-plants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterize thechem
40、ical, mechanical, and metallurgical properties of wroughtzirconium-2.5niobium alloy to be used in the manufacture ofsurgical implants.X1.2 ISO standards are listed for reference only. Use of anISO standard in addition to or instead of a preferred ASTMstandard may be agreed upon between the purchaser
41、 andsupplier.X1.3 This zirconium alloy is based on Specification B550/B550M, Grade R60705, and has been used extensively in thechemical industry since the 1970s.X1.4 Units of Measure:X1.4.1 ASTM PolicyASTM is promoting the use of ratio-nalized SI (metric) units in their standards. The F04.12Committe
42、e has modified this specification to facilitate thetransition by the medical materials industry to SI between nowand 2018. In the first phase of this transition, running to 2013,the specifications will be structured to allow the use of either SIor inch pound units. The choice of primary units in eac
43、hspecification will be determined by the industry using thespecification. The change to SI units during this period may beinitiated by the purchaser through his purchase documentation.In the second phase of this transition, the specifications will bewritten with SI as the primary units.F2384 10 (201
44、6)3X2. BIOCOMPATIBILITYX2.1 The suitability of this material from a human implantperspective is dependent on the specific application. Thebiological tests appropriate for the specific site, such asrecommended in Practice F748, should be used as a guideline.A summary of the in vitro and animal testin
45、g that has beenperformed as of the approval date of this specification isprovided in X2.3.X2.2 No known surgical 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
46、 in laboratory animals,and has been used clinically since January 1996 (2-4). Theresults of these studies indicate a well-characterized level oflocal biological response that is equal to or less than thatproduced by the reference material unalloyed titanium (seeSpecification F67) that has a long his
47、tory of successful clinicalapplication in soft tissue and bone implants in humans.X2.3 As of the time of the original approval of thisspecification, this zirconium alloy material had a limitedhistory of clinical use in humans.An extensive series of in vitroand animal studies had been performed as fo
48、llows, comparingthe biological response to that of a reference material. Thesetests were conducted to support the usage of this material insurgical implant devices (1,5). In all cases, the results indicatedthat this material was no more reactive with the environmentthan the reference material.X2.3.1
49、 L929 MEM-Cytotoxicity (Mouse Fibroblasts),X2.3.2 Sensitization Assay (Kligman Maximization Study),X2.3.3 Rabbit Pyrogen Test,X2.3.4 Mammalian Mutagenicity Test (Rodent Bone Mar-row Micronucleus Test),X2.3.5 Rabbit Intramuscular Implantation Test,X2.3.6 Rabbit Blood Hemolysis Test,X2.3.7 Ames Mutagenicity Assay, andX2.3.8 Systemic Toxicity and Irritation Test (USP XXIIBiological Test).REFERENCES(1) Davidson, J. A., Asgian, C. M., Mishra, A. K., and Kovacs, P.,“Zirconia (ZrO2)-coated Zirconium-2.5Nb Alloy for Prosthetic KneeBearing
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