ASTM F560-2017 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200 UNS R05400)《外科植入物(UNS R05200 UNS R05400)用纯钽的标准规格》.pdf

1、Designation: F560 17Standard 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, th

2、e 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.1. Scope*1.1 This specification covers chemical, mechanical, andmetallurgical requirements for unalloyed tantalum plate,

3、 sheet,strip, bar, and wire used in the manufacture of surgicalimplants.1.2 UnitsThe values stated in either SI units or inch-pound units are to be regarded separately as standard. Thevalues stated in each system may not be exact equivalents;therefore, each system shall be used independently of the

4、other.Combining values of the two systems may result in non-conformance with this standard.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standar

5、ds, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance wi

6、th SpecificationsF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Insertion into BoneIEEE/ASTM SI 10 American National Standard for Use ofthe International System of Units (SI): The Modern MetricSystem2.2 ISO Standa

7、rds: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 Standard:3.1.1 lotall mater

8、ial 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, hexagonal, or octagona

9、l 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,which may be supplied in coi

10、l.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, alloy number, and dat

11、e of issue;4.1.3 Units to be used for certification (SI 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, multiples), or drawi

12、ngnumber;4.1.8 Special tests;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 approved Nov. 1, 2017. Published November 2017. Originallyap

13、proved in 1978. Last previous edition approved in 2013 as F560 131. DOI:10.1520/F0560-17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summ

14、ary 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 Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohoc

15、ken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organiz

16、ation Technical Barriers to Trade (TBT) Committee.14.1.9 Special requirements; and4.1.10 Mechanical properties (if applicable for special con-ditions) (see 7.1).5. Materials and Manufacture5.1 Material covered by this specification shall be madefrom vacuum-arc melted or electron-beam melted ingots(R

17、05200) 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 ma

18、y 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 produc

19、ts 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.

20、 Analysis for elements not listed in Table 1 isnot required to certify compliance with this specification.6.1.2 All commercial metals contain small amounts ofelements other than those that are specified. It is neitherpractical nor necessary to specify limits for unspecifiedelements, whether residual

21、 elements or trace elements that canbe present. The producer is permitted to analyze for unspecifiedelements and is permitted to report such analyses. The presenceof an unspecified element and the reporting of an analysis forthat element shall not be a basis for rejection.6.1.3 Intentional elemental

22、 additions other than those speci-fied in Table 1 are not permitted6.2 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 furnish a report certifying thevalues of ca

23、rbon, 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 for material in conditions otherthan t

24、hose 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 0.007 in./in./min through yield andthen

25、 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 additional test pieces representative oft

26、he 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 considered acceptable if boththe elongat

27、ion 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 for each specimen that did not meet th

28、eminimum 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 aspecimen is not less than 200 mm 8.0 in

29、. 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 shall beTABLE 1 Chemical RequirementsElem

30、entCompositions, max % (mass/mass)R05200AR05400BCarbon 0.010 0.010Oxygen 0.015 0.030Nitrogen 0.010 0.010Hydrogen 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

31、 vacuum-arc cast Tantalum.BSintered Tantalum.CAssumed equal to the difference of 100 % and the sum percentage of the otherspecified elements. The percentage of the Tantalum difference is not required to bereported.TABLE 2 Additional Chemical Requirements for Finished Product(When Specified by the Pu

32、rchaser)Element Compositions, Maximum % (mass/mass)R05200AR05400BCarbon 0.020 0.020Oxygen 0.025 0.035Nitrogen 0.010 0.010Hydrogen 0.0015 0.0015AElectron-beam or vacuum-arc cast Tantalum.BSintered Tantalum.F560 172considered in compliance only if both additional test piecesmeet the specified requirem

33、ents.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 certification. In the absence of a stated selection ofunits on the purchase order (PO), this se

34、lection 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 certified untilexpressly changed by the purchaser.8.1.1.2 In the absence of historic preceden

35、ce, if the unitsused to define the product on the purchasers purchase order(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 upo

36、n between the purchaserand supplier.8.1.2 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

37、observed when performing thisconversion. 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 a

38、nd tested in accordance with therequirements 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.

39、Significance of Numerical Limits11.1 The 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 sp

40、ecification limit, in accordance with 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

41、.2% offset) MPa psiMinimum ElongationAin 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 2

42、0 000 25over 0.51 0.020 210 30 000 140 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

43、 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 the supplierand purchaser.TABLE 4 Mechanical Properties, Bar and Wire P

44、roductsCondition Diameter, mm in.Minimum 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 0.63

45、0.015 to 0.0249240 35 000 . . . 15over 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 length

46、shall be reported with the test results. 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 a

47、greed upon between supplier andpurchaser.F560 173APPENDIXES(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.X

48、1.2 The minimum mechanical properties specified ensurea baseline of strength and ductility for the highly stresseddevices for which this alloy is typically used.X1.3 Units of Measure:X1.3.1 ASTM PolicyASTM is promoting the use of ratio-nalized SI (metric) units in their standards. SubcommitteeF04.12

49、 has modified this specification to facilitate the transi-tion by the medical materials industry to SI between 2012 and2018. Where possible, the SI units for the mechanical proper-ties listed in Tables 3 and 4 have been harmonized with ISO13782.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 biol