1、Designation:F252710Standard Specification forWrought Seamless and Welded and Drawn Cobalt AlloySmall Diameter Tubing for Surgical Implants(UNS R30003,UNS R30008,UNS R30035,UNS R30605,and UNS R31537)1This standard is issued under the fixed designation F2527;the number immediately following the design
2、ation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This specification covers the requirem
3、ents for wroughtseamless and welded and drawn cobalt alloy small diametertubing used for the manufacture of surgical implants.Materialshall conform to the applicable requirements of SpecificationsF90,F562,F688,F1058 or F1537,Alloy 1.This specificationaddresses those product variables that differenti
4、ate small diam-eter medical tubing from the bar,wire,sheet and strip productforms covered in these specifications.1.2 This specification applies to straight length tubing with6.3 mm 0.250 in.and smaller nominal outside diameter(OD)and 0.76 mm 0.030 in.and thinner nominal wall thickness.1.3 The speci
5、fications in 2.1 are referred to as the ASTMmaterial standard(s)in this specification.1.4 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,eachsystem shall be used independently of
6、 the other.Combiningvalues from the two systems may result in non-conformancewith the standard.2.Referenced Documents2.1 ASTM Material Standards:2F90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F562 SpecificationforWrought35Cobalt-
7、35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications(UNS R30035)F1058 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip forSurgical Implant Applications(UNS R30003 and UNSR30008)F1537 Specification for Wrought Cobalt-28Chromium-6Molybde
8、num Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)2.2 ASTM Standards:E8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeSI 10
9、 American National Standard for Use of the Interna-tional System of Units(SI):The Modern Metric System2.3 ISO Standards:3ISO 5832-5 Implants for SurgeryMetallic Materials Part5:Wrought Cobalt,Chromium,Tungsten,Nickel AlloyISO 5832-6 Implants for SurgeryMetallic Materials Part6:Wrought Cobalt,Nickel,
10、Chromium,MolybdenumAlloyISO 5832-7 Implants for SurgeryMetallic Materials Part7:Wrought Cobalt,Chromium,Molybdenum AlloyISO 5832-8 Implants for SurgeryMetallic Materials Part8:Wrought Cobalt,Nickel,Chromium,Molybdenum,Tungsten,Iron AlloyISO 5832-12 Implants for SurgeryMetallic Materials Part12:Wroug
11、ht Cobalt,Chromium,Molybdenum AlloyISO 6892 Metallic MaterialsTensile TestingISO 9001 Quality Management SystemsRequirements2.4 ASME Standard:ASME Y14.5.1M 1994(R2004)Mathematical Definition ofDimensioning and Tolerancing Principles43.Terminology3.1 Definitions of Terms Specific to This Standard:1Th
12、is 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 Dec.1,2010.Published January 2011.Originallyapproved in 2005.Last previous edition
13、approved in 2005 as F2527 051.DOI:10.1520/F2527-10.2For 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 Summary page onthe ASTM website.3Available from
14、 American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from American Society of Mechanical Engineers(ASME),ASMEInternational Headquarters,Three Park Ave.,New York,NY 10016-5990,http:/www.asme.org.*A Summary of Changes section appears at t
15、he end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.1 average wall thicknessthe arithmetic average of theminimum wall thickness and the maximum wall thicknessmeasured on any one transverse cross section of the tube.
16、3.1.2 individual wall thickness measurementAny one ofthe wall thickness measurements taken around the circumfer-ence on any one transverse cross section of a single sample ofthe tube.3.1.3 lotThe total quantity of product produced from thesame melt heat under the same conditions,at essentially thesame time.3.1.4 lot average concentricityThe arithmetic average ofthe sample concentricities measured on a statistically represen-tative number of samples from the lot.3.1.5 lot average wall thicknessTh