1、Designation:F560131Standard 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,the year
2、 of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()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,mechanical,andmet
3、allurgical 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 equivalents;therefore,eachs
4、ystem 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 in Test Data toDetermine
5、 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 MetricSystem2.2 ISO Standard
6、s: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 material
7、 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 octagonal cros
8、s 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 be supplied in coil.3.1.6 wiremate
9、rial 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 date of issue,4.1.3 Unit
10、s 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,multiples),or drawingnumber,4.1.8 Special tests,4.1.9 Speci
11、al 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 ofSubcommittee F04.12 on Metallurgical Materials.Current e
12、dition 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 Customer Service at serviceastm.org.For Annual Book of ASTMStandar
13、ds 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 Changes section appears at the end of this standardCopyright ASTM International
14、,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 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 vario
15、us 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 be furnished as descaledor pickled,abrasive blasted,chemically milled,ground,machine
16、d,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 products 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 elem