ASTM F560-2007 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200 UNS R05400)《外科植入物用非合金钽的标准规范(UNS R05200、UNS R05400)》.pdf

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1、Designation: F 560 07Standard Specification forUnalloyed Tantalum for Surgical Implant Applications (UNSR05200, UNS R05400)1This standard is issued under the fixed designation F 560; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,

2、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.This standard has been approved for use by agencies of the Department of Defense.1. Scope*1.1 This specification cove

3、rs the chemical, mechanical, andmetallurgical requirements for unalloyed tantalum plate, sheet,strip, rod, and wire used in the manufacture of surgicalimplants.1.2 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI u

4、nits that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsF 981 Practice for Assessme

5、nt of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 American Society for Quality Control Standard:3ASQ C1 Specifications of General Requirements for aQuality Program2.3 ISO Standard:4ISO 6892 Metallic Materials Tensile Testing at Ambien

6、tTemperature3. Terminology3.1 Definitions of Terms Specific to This Standard: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 0.1875 in. (4.7 mm) inthicknes

7、s.3.1.3 rodmaterial 0.125 to 2.5 in. (3.18 to 63.50 mm) indiameter in round, hexagonal, or octagonal cross sectionsupplied in straight lengths.3.1.4 sheeta flat product 6 in. (152.4 mm) or more inwidth and from 0.005 to 0.1875 in. (0.13 to 4.76 mm) inthickness.3.1.5 stripa flat product, may be suppl

8、ied in coil, less than6 in. (152.4 mm) in width and from 0.005 to 0.1875 in. (0.13to 4.76 mm) in thickness.3.1.6 wirematerial 0.010 to 0.124 in. (0.254 to 3.15 mm)in diameter furnished in coils or on spools or reels. Materialless than 0.010 in. in diameter is not covered by this specifi-cation.4. Or

9、dering Information4.1 Inquiries and orders under this specification shall in-clude the following information:4.1.1 Quantity (weight or number of pieces),1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility o

10、fSubcommittee F04.12 on Metallurgical Materials.Current edition approved Oct. 15, 2007. Published October 2007. Originallyapproved in 1978. Last previous edition approved in 2005 as F 560 05.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serv

11、iceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.4Available from American National Standards Institute (ANSI), 25 W. 43rd St

12、.,4th Floor, New York, NY 10036.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.2 ASTM designation and date of issue,4.1.3 Composition designation (see 5.1)4.1.4 F

13、orm (strip, sheet, plate, rod, wire) (see 3.1),4.1.5 Condition (see 5.4),4.1.6 Applicable dimensions, including size, thickness,width, and length (random, exact, multiples), or drawingnumber,4.1.7 Special tests,4.1.8 Special requirements, and4.1.9 Mechanical properties (if applicable for special con

14、-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(R05200) or powder-metallurgy consolidated (R05400) unal-loyed tantalum.5.2 The various tantalum mill products covered by thisspecification are

15、 formed with the conventional extrusion,forming, swaging, rolling, and drawing equipment normallyavailable in metalworking plants.5.3 FinishThe mill product may be furnished as descaledor pickled, abrasive blasted, chemically milled, ground, ma-chined, peeled, polished, or as specified by the purcha

16、ser.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 Rod and wire products shall be supplied in theannealed or cold worked condition.6. Chemical Requirements6.1 The material shall conform to the chemical composi

17、tionrequirements in Table 1.6.1.1 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 certify compliance with this specification.6.2 The ingot analysis shall be con

18、sidered the chemicalanalysis for products supplied under this specification.6.3 When requested by the purchaser at the time of pur-chase, the supplier shall furnish a report certifying the values ofcarbon, oxygen, nitrogen, and hydrogen as specified in Table 2for each lot of material supplied.7. Mec

19、hanical 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 those included in Tables 3 and 4 shall be specified by thepurchaser.7.2 Specimens for tension tests s

20、hall 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 crosshead speed maybe increased so as to produce fracture in approximately oneadditional minute.7.3 Number of T

21、ests: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 ofthe same lot, in the same manner, for each failed test piece. Thelot shall be considered in compliance only if both ad

22、ditionaltest pieces meet the specified requirements.7.3.2 Tensile test results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to Test Method E8, sections7.11.4 and 7.11.

23、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 theminimum requirements.7.3.4 Sheet, Strip, and PlatePerform at least one tensiontest for each lot. Tension property requ

24、irements 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 8.0 in. (200 mm) in length for sheetand 2.50 in. (64 mm) in length for plate can be taken. Shouldany of these test pieces not meet t

25、he specified requirements,test two additional test pieces representative of the same lot, inthe same manner, for each failed test piece. The lot shall beconsidered in compliance only if both additional test piecesmeet the specified requirements.8. Certification8.1 The supplier shall provide a certif

26、ication that the mate-rial was tested in accordance with this specification and met allrequirements. A report of the test results shall be furnished tothe purchaser at the time of shipment.TABLE 1 Chemical RequirementsElementCompositions, max % mass/massR05200AR05400BCarbon 0.010 0.010Oxygen 0.015 0

27、.03Nitrogen 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 vacuum-arc cast tantalum.BSintered tantalum.CThe percentage of tantalum is deter

28、mined by difference and need not bedetermined or certified.TABLE 2 Additional Chemical Requirements for FinishedProduct (When Specified by Purchaser)Element Compositions, Maximum % mass/massR05200AR05400BCarbon 0.020 0.020Oxygen 0.025 0.035Nitrogen 0.010 0.010Hydrogen 0.0015 0.0015AElectron-beam or

29、vacuum-arc cast tantalum.BSintered tantalum.F5600729. Quality Program Requirements9.1 The supplier shall maintain a quality program, such asdefined in ASQ C1.10. Significance of Numerical Limits10.1 The following applies to all specified limits in thisspecification: For purposes of determining confo

30、rmance withthese specifications, an observed value or a calculated valueshall be rounded “to the nearest unit” in the last right-hand digitused in expressing the specification limit, in accordance withthe rounding method of Practice E29.11. Keywords11.1 metals (for surgical implants); orthopaedic me

31、dicaldevices; tantalumAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary purpose of this specification is tocharacterize the chemical, mechanical, and metallurgical prop-erties of wrought unalloyed tantalum to be used in themanufacture of surgical implants.X1.2 The minimum mechanical

32、properties specified ensurea baseline of strength and ductility for the highly stresseddevices for which this alloy is typically used.TABLE 3 Mechanical Properties, Flat Mill ProductsCondition Thickness, in. (mm)Ultimate TensileStrength, min, psi(MPa)Yield Strength,(0.2% offset) min,psi (MPa)Elongat

33、ionAin 1 inch (25.4 mm),min,%Cold worked all 75 000 (517) 50 000 (345) 2Stress relieved 0.0051 to 0.010(0.13 to 0.26)55 000 (379) 35 000 (241) 5over 0.010 to 0.020(0.26 to 0.51)55 000 (379) 35 000 (241) 10over 0.020( 0.51) 55 000 (379) 35 000 (241) 10Annealed 0.0051 to 0.010(0.13 to 0.26)30 000 (207

34、) 20 000 (138) 20over 0.010 to 0.020(0.26 to 0.51)30 000 (207) 20 000 (138) 25over 0.020 (0.51) 30 000 (207) 20 000 (138) 30AElongation of material 0.063 in. (1.6 mm) 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 w

35、ith the test results. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternately, agage length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 square root of So, where So is the origi

36、nal cross sectionalarea.)TABLE 4 Mechanical Properties, Rod and Wire ProductsCondition Diameter, in. (mm)Ultimate TensileStrength, min, psi(MPa)YieldStrength, (0.2%offset) min, psi (MPa)Elongation,min, %ACold Worked all 70 000 (482) 50 000 (345) 1Annealed 0.005 to 0.0099(0.12 to 0.25)35 000 (241) .

37、. . 80.010 to 0.0149(0.25 to 0.379)35 000 (241) . . . 100.015 to 0.0249(0.381 to 0.633)35 000 (241) . . . 150.025 to 0.1249(0.635 to 3.172)30 000 (207) . . . 200.125 to 2.5(3.2 to 64)25 000 (172) 20 000 (138) 25AElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall

38、be measured using a gage length of 2 in. or 4D or 4W. The gage length mustbe reported with the test results. The method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternately, agage length corresponding to ISO 6892 may be used when agr

39、eed upon between supplier and purchaser. (5.65 square root of So, where So is the original cross sectionalarea.)F560073X2. 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 ha

40、s shown anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.X2.2 The material in this specification has been subjectedto animal implant studies and has been shown to produce a wellcharacterized level of biological response that is equal to or

41、less than that produced by the reference material when testedby the procedures of Practice F 981 or the equivalent. Thismaterial has been used clinically for over a decade.5SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 560 05

42、)that may impact the use of this standard. (Approved Oct. 15, 2007.)(1) Table 4 was revised to correct a typographical error.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are ex

43、pressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revi

44、sed, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you ma

45、y attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United Sta

46、tes. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).5Black, Jonathan, “Biological Performance of Tantalum,” Clinical Materials,Elsevier Science Limited, Vol 16, 1994, pp. 167173.F560074