1、Designation: F560 08F560/F560M 13Standard Specification forUnalloyed Tantalum for Surgical Implant Applications (UNSR05200, UNS R05400)1This standard is issued under the fixed designation F560;F560/F560M; the number immediately following the designation indicates theyear of original adoption or, in
2、the case of revision, the year of last revision. A number in parentheses indicates the year of lastreapproval. A superscript epsilon () 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 Th
3、is specification covers the chemical, mechanical, and metallurgical requirements for unalloyed tantalum plate, sheet, strip,rod,bar, and wire used in the manufacture of surgical implants.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The value
4、s given inparentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values of thetwo systems may result in non-confor
5、mance with this standard.2. Referenced Documents2.1 ASTM Standards:2E8E8/E8M Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsF981 Practice for Assessment of Compatibility of Biomaterials for Surg
6、ical Implants with Respect to Effect of Materials onMuscle and BoneIEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System2.2 American Society for Quality Control Standard:3ASQ C1 Specifications of General Requirements for a Quality Prog
7、ram2.2 ISO Standard:Standards:3ISO 6892 Metallic Materials Tensile Testing at Ambient TemperatureISO 9001 Quality Management SystemsRequirementsISO 13782 Implants for SurgeryMetallic MaterialsUnalloyed Tantalum for Surgical Implant Applications3. Terminology3.1 Definitions of Terms Specific to This
8、Standard:3.1.1 lotall material produced from the same ingot or a single powder blend with the same cross section under the sameconditions at essentially the same time.3.1.2 platea flat product more than 0.1875 in. (4.7 mm)4.75 mm 0.1875 in. in thickness.3.1.3 rodbarmaterial 0.125 to 2.5 in. (3.18 to
9、 63.50 mm)3.15 to 63.5 mm 0.125 to 2.5 in. in diameter in round, hexagonal,or octagonal cross section supplied in straight lengths.3.1.4 sheeta flat product 6 in. (152.4 mm)150 mm 6 in. or more in width and from 0.005 to 0.1875 in. (0.13 to 4.76 mm)0.13to 4.75 mm 0.005 to 0.1875 in. in thickness.1 T
10、his specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved May 1, 2008Oct. 1, 2013. Published May 2008November 2013. Originally approved in
11、1978. Last previous edition approved in 20072008 asF560 07.F560 08. DOI: 10.1520/F0560-08.10.1520/F0560_F0560M-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the
12、 standards Document Summary page on the ASTM website.3 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.10036, http:/www.ansi.org.This document i
13、s not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as approp
14、riate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United State
15、s13.1.5 stripa flat product, may be supplied in coil, less than 6 in. (152.4 mm)product less than 150 mm 6 in. in width andfrom 0.005 to 0.1875 in. (0.13 to 4.76 mm) in thickness.0.13 to 4.75 mm 0.005 to 0.1875 in. in thickness, may be supplied incoil.3.1.6 wirematerial to 0.124 in. (0.254 to 3.15 m
16、m) up to 3.15 mm 0.124 in. in diameter furnished in coils or on spools orreels.4. Ordering Information4.1 Inquiries and orders under this specification shall include the following information:4.1.1 Quantity (weight or number of pieces),4.1.2 ASTM designation designation, alloy number, and date of is
17、sue,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, rod,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 drawing num
18、ber,4.1.8 Special tests,4.1.9 Special requirements, and4.1.10 Mechanical properties (if applicable for special conditions) (see 7.1).5. Materials and Manufacture5.1 Material covered by this specification shall be made from vacuum-arc melted or electron-beam melted ingots (R05200) orpowder-metallurgy
19、 consolidated (R05400) unalloyed tantalum.5.2 The various tantalum mill products covered by this specification are formed with the conventional extrusion, forming,swaging, rolling, and drawing equipment normally available in metalworking plants.5.3 FinishThe mill product may be furnished as descaled
20、 or 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 condition.5.4.2 RodBar and wire products shall be supplied in
21、 the annealed or cold worked condition.6. Chemical Requirements6.1 The material shall conform to the chemical composition requirements in Table 1.6.1.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residualelements. Analysis for elements
22、 not listed in Table 1 is not required to certify compliance with this specification.6.2 The ingot analysis shall be considered the chemical analysis for products supplied under this specification.6.3 When requested by the purchaser at the time of purchase, the supplier shall furnish a report certif
23、ying the values of carbon,oxygen, nitrogen, and hydrogen as specified in Table 2 for each lot of material supplied.TABLE 1 Chemical RequirementsElement Compositions, max % mass/massR05200A R05400BCarbon 0.010 0.010Oxygen 0.015 0.03Oxygen 0.015 0.030Nitrogen 0.010 0.010Hydrogen 0.0015 0.0015Niobium 0
24、.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 balanceC balanceCA Electron-beam or vacuum-arc cast tantalum.B Sintered tantalum.C The percentage of tantalum is determined by difference and need not bedetermined or c
25、ertified.F560/F560M 1327. Mechanical Properties7.1 The material supplied under this specification shall conform to the mechanical property requirements in Tables 3 and 4.Mechanical properties for material in conditions other than those included in Tables 3 and 4 shall be specified by the purchaser.7
26、.2 Specimens for tension tests shall be machinedprepared and tested in accordance with Test Methods E8E8/E8M. Tensileproperties shall be determined using a strain rate of 0.003 to 0.007 in./in./min (mm/mm/min) 0.076 to 0.178 mm/mm/min 0.003to 0.007 in./in./min through yield and then the crosshead sp
27、eed may be increased so as to produce fracture in approximately oneadditional minute.7.3 Number of Tests:7.3.1 Bar and WirePerform at least one tension for each lot. Should any of these test pieces not meet the specifiedrequirements, test two additional test pieces representative of the same lot, in
28、 the same manner, for each failed test piece. The lotshall be considered in compliance only if bothall additional test pieces meet the specified requirements.7.3.2 Tensile test results for which any specimen fractures outside the gage length shall be considered acceptable, if both theelongation and
29、reduction of area meet the minimum requirements specified. Refer to Test Method E8E8/E8M, sections 7.11.4 and7.11.5.7.3.3 If either the elongation or the reduction of area is less than the minimum requirement, discard the test and retest. Retestone specimen for each specimen that did not meet the mi
30、nimum requirements.TABLE 2 Additional Chemical Requirements for Finished Product(When Specified by the Purchaser)Element Compositions, Maximum % mass/massR05200A R05400BCarbon 0.020 0.020Oxygen 0.025 0.035Nitrogen 0.010 0.010Hydrogen 0.0015 0.0015A Electron-beam or vacuum-arc cast tantalum.B Sintere
31、d tantalum.TABLE 3 Mechanical Properties, Flat Mill ProductsCondition Thickness, in. (mm)Ultimate TensileStrength, min, psi(MPa)Yield Strength,(0.2% offset) min,psi (MPa)ElongationAin 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
32、 (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) 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) 3
33、0TABLE 3 Mechanical Properties, Flat Mill ProductsCondition Thickness, mm in. Minimum Ultimate TensileStrength, MPa psiMinimum Yield Strength,(0.2% offset) MPapsiMinimum 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 5
34、over 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 20 000 30A Elongation of material 0.063 in. (1.6 mm)1.6 mm 0.063 in. or greater in diameter (D) or width (W) shall be m
35、easured using a gage length of 2 in. 50 mm 2 in. or 4Dor 4W.The gage length mustshall be reported with the test results.The method for determining elongation of material under 0.063 in. (1.6 mm)1.6 mm 0.063 in. in diameteror thickness may be negotiated.Alternately, a gage length corresponding to ISO
36、 6892 may be used when agreed upon between supplier and purchaser. (5.65 square rootof So, where So is the original cross sectional area.)area) may be used when agreed upon between the supplier and purchaser.F560/F560M 1337.3.4 Sheet, Strip, and PlatePerform at least one tension test for each lot. T
37、ension property requirements apply in both thelongitudinal and transverse directions. Tests in the transverse direction need be made only on product from which a specimen isnot less than 8.0 in. (200 mm)200 mm 8.0 in. in length for sheet and 2.50 in. (64 mm)64 mm 2.5 in. in length for plate canbe ta
38、ken. Should any of these test pieces not meet the specified requirements, test two additional test pieces representative of thesame lot, in the same manner, for each failed test piece. The lot shall be considered in compliance only if both additional test piecesmeet the specified requirements.8. Dim
39、ensions, Mass, and Permissible Variations8.1 Units of Measure:8.1.1 SelectionThis specification requires that the purchaser select the units of measure (SI or inch-pound) to be used forproduct certification. In the absence of a stated selection of units on the purchase order (PO), this selection may
40、 be expressed bythe purchaser in several alternate forms listed in order of precedence.8.1.1.1 If the purchaser and supplier have a history of using specific units, these units shall continue to be certified untilexpressly changed by the purchaser.8.1.1.2 In the absence of historic precedence, if th
41、e units used 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 certification.8.1.1.3 If the purchasers selection of units is unclear, the units of measure shall be agreed upon betwe
42、en the purchaser andsupplier.8.1.2 Conversion of UnitsIf the suppliers test equipment does not report in the selected units, the test equipment units maybe converted to the selected units for certification purposes. Accurate arithmetic conversion and proper use of significant digitsshould be observe
43、d when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the use of SI units. Annex Aprovides conversion tables and Annex B provides rules for conversion and significant digits.9. Certification9.1 The supplier shall provide a certification that the material was manufactured and tes
44、ted in accordance with this specificationand met all requirements. the requirements of this specification. A report of the test results shall be furnished to the purchaser atthe time of shipment.TABLE 4 Mechanical Properties, Rod and Wire ProductsCondition Diameter, in. (mm)Ultimate TensileStrength,
45、 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) . . . 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 t
46、o 3.172)30 000 (207) . . . 200.125 to 2.5(3.2 to 64)25 000 (172) 20 000 (138) 25TABLE 4 Mechanical Properties, Bar and Wire ProductsCondition Diameter, mm in. Minimum Ultimate TensileStrength, MPa psiMinimumYield Strength,(0.2%offset) MPa psiMinimum Elongation,%ACold Worked all 480 70 000 345 50 000
47、 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 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 25A Elongation of material 0.063 in. (1
48、.6 mm)1.6 mm 0.063 in. or greater in diameter (D) or width (W) shall be measured using a gage length of 2 in. 50 mm 2 in. or 4Dor 4W.The gage length mustshall be reported with the test results.The method for determining elongation of material under 0.063 in. (1.6 mm)1.6 mm 0.063 in. in diameteror th
49、ickness may be negotiated.Alternately, a gage length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65 square rootof So, where So is the original cross sectional area.)area) may be used when agreed upon between supplier and purchaser.F560/F560M 13410. Quality Program Requirements10.1 The supplier shall maintain a quality program, program or quality management system, such as defined in ASQ C1.ISO9001.11. Signi
