1、Designation: F560 131Standard Specification forUnalloyed Tantalum for Surgical Implant Applications (UNSR05200, UNS R05400)1This standard is issued under the fixed designation F560; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, t
2、he year of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1NOTEThe designation was corrected editorially in December 2013.1. Scope*1.1 This specification covers the chemical, me
3、chanical, andmetallurgical requirements for unalloyed tantalum plate, sheet,strip, bar, and wire used in the manufacture of surgicalimplants.1.2 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 equival
4、ents; therefore, eachsystem shall be used independently of the other. Combiningvalues of the two systems may result in non-conformance withthis standard.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits
5、in Test Data toDetermine Conformance with SpecificationsF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneIEEE/ASTM SI 10 American National Standard for Use ofthe International System of Units (SI): The Modern Me
6、tricSystem2.2 ISO Standards:3ISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirementsISO 13782 Implants for SurgeryMetallic MaterialsUnalloyed Tantalum for Surgical Implant Applications3. Terminology3.1 Definitions of Terms Specific to This Sta
7、ndard:3.1.1 lotall material produced from the same ingot or asingle powder blend with the same cross section under thesame conditions at essentially the same time.3.1.2 platea flat product more than 4.75 mm 0.1875 in.in thickness.3.1.3 barmaterial 3.15 to 63.5 mm 0.125 to 2.5 in. indiameter in round
8、, hexagonal, or octagonal cross sectionsupplied in straight lengths.3.1.4 sheeta flat product 150 mm 6 in. or more in widthand from 0.13 to 4.75 mm 0.005 to 0.1875 in. in thickness.3.1.5 stripa flat product less than 150 mm 6 in. in widthand from 0.13 to 4.75 mm 0.005 to 0.1875 in. in thickness,may
9、be supplied in coil.3.1.6 wirematerial up to 3.15 mm 0.124 in. in diameterfurnished in coils or on spools or reels.4. Ordering Information4.1 Inquiries and orders under this specification shall in-clude the following information:4.1.1 Quantity (weight or number of pieces),4.1.2 ASTM designation, all
10、oy number, and date of issue,4.1.3 Units to be used for certificationSI or inch-pound.4.1.4 Composition designation (see 5.1)4.1.5 Form (strip, sheet, plate, bar, wire) (see 3.1),4.1.6 Condition (see 5.4),4.1.7 Applicable dimensions, including size, thickness,width, and length (random, exact, multip
11、les), or drawingnumber,4.1.8 Special tests,4.1.9 Special requirements, and4.1.10 Mechanical properties (if applicable for special con-ditions) (see 7.1).1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility o
12、fSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2013. Published November 2013. Originallyapproved in 1978. Last previous edition approved in 2008 as F560 08. DOI:10.1520/F0560-13E01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM
13、Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.*A Summary of Chang
14、es section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15. Materials and Manufacture5.1 Material covered by this specification shall be madefrom vacuum-arc melted or electron-beam melted ingots(R0
15、5200) or powder-metallurgy consolidated (R05400) unal-loyed tantalum.5.2 The various tantalum mill products covered by thisspecification are formed with the conventional extrusion,forming, swaging, rolling, and drawing equipment normallyavailable in metalworking plants.5.3 FinishThe mill product may
16、 be furnished as descaledor pickled, abrasive blasted, chemically milled, ground,machined, peeled, polished, or as specified by the purchaser.5.4 Condition:5.4.1 Flat mill products shall be supplied in the cold-worked, cold-worked and stress-relieved or annealed condi-tion.5.4.2 Bar and wire product
17、s shall be supplied in the an-nealed or cold worked condition.6. Chemical Requirements6.1 The material shall conform to the chemical compositionrequirements in Table 1.6.1.1 Requirements for the major and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements.
18、Analysis for elements not listed in Table 1 isnot required to certify compliance with this specification.6.2 The ingot analysis shall be considered the chemicalanalysis for products supplied under this specification.6.3 When requested by the purchaser at the time ofpurchase, the supplier shall furni
19、sh a report certifying thevalues of carbon, oxygen, nitrogen, and hydrogen as specifiedin Table 2 for each lot of material supplied.7. Mechanical Properties7.1 The material supplied under this specification shallconform to the mechanical property requirements in Tables 3and 4. Mechanical properties
20、for material in conditions otherthan those included in Tables 3 and 4 shall be specified by thepurchaser.7.2 Specimens for tension tests shall be prepared and testedin accordance with Test Methods E8/E8M. Tensile propertiesshall be determined using a strain rate of 0.076 to 0.178mm/mm/min 0.003 to 0
21、.007 in./in./min through yield andthen the crosshead speed may be increased so as to producefracture in approximately one additional minute.7.3 Number of Tests:7.3.1 Bar and WirePerform at least one tension for eachlot. Should any of these test pieces not meet the specifiedrequirements, test two add
22、itional test pieces representative ofthe same lot, in the same manner, for each failed test piece. Thelot shall be considered in compliance only if all additional testpieces meet the specified requirements.7.3.2 Tensile test results for which any specimen fracturesoutside the gage length shall be co
23、nsidered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to Test Method E8/E8M, sections7.11.4 and 7.11.5.7.3.3 If either the elongation or the reduction of area is lessthan the minimum requirement, discard the test and retest.Retest one specimen
24、 for each specimen that did not meet theminimum requirements.7.3.4 Sheet, Strip, and PlatePerform at least one tensiontest for each lot. Tension property requirements apply in boththe longitudinal and transverse directions. Tests in the trans-verse direction need be made only on product from which a
25、specimen is not less than 200 mm 8.0 in. in length for sheetand 64 mm 2.5 in. in length for plate can be taken. Shouldany of these test pieces not meet the specified requirements,test two additional test pieces representative of the same lot, inthe same manner, for each failed test piece. The lot sh
26、all beconsidered in compliance only if both additional test piecesmeet the specified requirements.8. Dimensions, Mass, and Permissible Variations8.1 Units of Measure:8.1.1 SelectionThis specification requires that the pur-chaser select the units of measure (SI or inch-pound) to be usedfor product ce
27、rtification. In the absence of a stated selection ofunits on the purchase order (PO), this selection may beexpressed by the purchaser in several alternate forms listed inorder of precedence.8.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be
28、certified untilexpressly changed by the purchaser.8.1.1.2 In the absence of historic precedence, if the unitsused to define the product on the purchasers purchase orderTABLE 1 Chemical RequirementsElementCompositions, max % mass/massR05200AR05400BCarbon 0.010 0.010Oxygen 0.015 0.030Nitrogen 0.010 0.
29、010Hydrogen 0.0015 0.0015Niobium 0.10 0.10Iron 0.010 0.010Titanium 0.010 0.010Tungsten 0.050 0.050Molybdenum 0.020 0.020Silicon 0.005 0.005Nickel 0.010 0.010Tantalum balanceCbalanceCAElectron-beam or vacuum-arc cast tantalum.BSintered tantalum.CThe percentage of tantalum is determined by difference
30、and need not bedetermined or certified.TABLE 2 Additional Chemical Requirements for Finished Product(When Specified by the Purchaser)Element Compositions, Maximum % mass/massR05200AR05400BCarbon 0.020 0.020Oxygen 0.025 0.035Nitrogen 0.010 0.010Hydrogen 0.0015 0.0015AElectron-beam or vacuum-arc cast
31、tantalum.BSintered tantalum.F560 1312(PO), specification, and engineering drawing are consistent,these units shall be used by the supplier for product certifica-tion.8.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.8.
32、1.2 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-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversio
33、n. IEEE/ASTM SI 10 provides guidelines for the useof SI units. Annex A provides conversion tables and Annex Bprovides rules for conversion and significant digits.9. Certification9.1 The supplier shall provide a certification that the mate-rial was manufactured and tested in accordance with therequir
34、ements of this specification. A report of the test resultsshall be furnished to the purchaser at the time of shipment.10. Quality Program Requirements10.1 The supplier shall maintain a quality program orquality management system, such as defined in ISO 9001.11. Significance of Numerical Limits11.1 T
35、he following applies to all specified limits in thisspecification: For purposes of determining conformance withthis specification, an observed value or a calculated value shallbe rounded “to the nearest unit” in the last right-hand digit usedin expressing the specification limit, in accordance with
36、therounding method of Practice E29.12. Keywords12.1 metals (for surgical implants); orthopaedic medicaldevices; tantalumTABLE 3 Mechanical Properties, Flat Mill ProductsCondition Thickness, mm in.Minimum Ultimate TensileStrength, MPa psiMinimum Yield Strength,(0.2% offset) MPa psiMinimum ElongationA
37、in 25 mm 1 in. %Cold worked all 520 75 000 345 50 000 2Stress relieved 0.13 to 0.260.0051 to 0.01380 55 000 240 35 000 5over 0.260.01380 55 000 240 35 000 10Annealed 0.13 to 0.260.0051 to 0.01210 30 000 140 20 000 20over 0.26 to 0.50.010 to 0.020210 30 000 140 20 000 25over 0.51 0.020 210 30 000 140
38、 20 000 30AElongation of material 1.6 mm 0.063 in. or greater in diameter (D) or width (W) shall be measured using a gage length of 50 mm 2 in. or 4D or 4W. The gage lengthshall be reported with the test results. The method for determining elongation of material under 1.6 mm 0.063 in. in diameter or
39、 thickness may be negotiated. Alternately,a gage length corresponding to ISO 6892 (5.65 square root of So, where So is the original cross sectional area) may be used when agreed upon between the supplierand purchaser.TABLE 4 Mechanical Properties, Bar and Wire ProductsCondition Diameter, mm in.Minim
40、um Ultimate TensileStrength, MPa psiMinimum YieldStrength,(0.2% offset) MPa psiMinimum Elongation,%ACold Worked all 480 70 000 345 50 000 1Annealed 0.12 to under 0.250.005 to 0.0099240 35 000 . . . 80.25 to 0.380.010 to 0.0149240 35 000 . . . 10over 0.38 to 0.630.015 to 0.0249240 35 000 . . . 15over
41、 0.63 to 3.140.025 to 0.1249210 30 000 . . . 20over 3.14 to 63.50.125 to 2.5170 25 000 140 20 000 25AElongation of material 1.6 mm 0.063 in. or greater in diameter (D) or width (W) shall be measured using a gage length of 50 mm 2 in. or 4D or 4W. The gage lengthshall be reported with the test result
42、s. The method for determining elongation of material under 1.6 mm 0.063 in. in diameter or thickness may be negotiated. Alternately,a gage length corresponding to ISO 6892 (5.65 square root of So, where So is the original cross sectional area) may be used when agreed upon between supplier andpurchas
43、er.F560 1313APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary purpose of this specification is to char-acterize the chemical, mechanical, and metallurgical propertiesof wrought unalloyed tantalum to be used in the manufacture ofsurgical implants.X1.2 The minimum mechanical properties
44、 specified ensurea baseline of strength and ductility for the highly stresseddevices for which this alloy is typically used.X1.3 Units of MeasureX1.3.1 ASTM PolicyASTM is promoting the use of ratio-nalized SI (metric) units in their standards. The F04.12Committee has modified this specification to f
45、acilitate thetransition by the medical materials industry to SI between 2012and 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 eachspecification will be determined by
46、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. Harmonization withcorresponding ISO documents sho
47、uld be considered whenassigning the SI values.X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has 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, if the
48、material is used in appropriate applications.X2.2 The material in this specification has been subjected toanimal implant studies and has been shown to produce a wellcharacterized level of biological response that is equal to orless than that produced by the reference material when testedby the proce
49、dures of Practice F981 or the equivalent. Thismaterial has been used clinically for over a decade.4SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F560 08)that may impact the use of this standard. (Approved October 1, 2013.)(1) Editorial corrections have been made to meet terminologyand formatting guidelines established for implant materialstandards.(2) Changed primary units from i
