ASTM_F_562_-_13.pdf

Designation:F56213Standard Specification forWrought 35Cobalt-35Nickel-20Chromium-10MolybdenumAlloy for Surgical Implant Applications(UNS R30035)1This standard is issued under the fixed designation F562;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This specification covers requirements of wrought35cobalt-35nickel-20chromium-10molybdenum alloy(UNSR30035)in the form of bar and wire,used for the manufactureof surgical implants.This alloy depends on combinations ofwork strengthening and aging to attain a variety of combina-tions of strength and ductility.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,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.2.Referenced Documents2.1 ASTM Standards:2A751 Test Methods,Practices,and Terminology for Chemi-cal Analysis of Steel ProductsE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE354 Test Methods for Chemical Analysis of High-Temperature,Electrical,Magnetic,and Other Similar Iron,Nickel,and Cobalt AlloysF981 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 MetricPractice2.2 ISO Standards:3ISO 5832/6 Implants for SurgeryMetallic Materials Part6:Wrought cobalt-nickel-chromium-molybdenum AlloyISO 6892 Metallic MaterialsTensile Testing at AmbientTemperatureISO 9001 Quality Management Systems2.3 Aerospace Material Specifications:4AMS 2269 Chemical Check Analysis LimitsWroughtNickel Alloys and Cobalt AlloysAMS 2630 Inspection,Ultrasonic Product over 0.5 inch(12.7 mm)ThickAMS 2632 Ultrasonic Inspection of Thin Materials3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bar,nrounds,flats,or other shapes from 0.1875 to4.00 in.4.76 to 101.60 mm in diameter or thickness(othersizes and shapes by special order).3.1.2 fine wire,nrounds,flats,or other shapes less than0.063 in.1.60 mm in diameter or thickness.3.1.3 forging bar,nbar as described in 3.1.1,used for theproduction of forgings;may be furnished in the hot-workedcondition.3.1.4 lot,nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.3.1.5 wire,nround,flats,or other shapes less than0.1875 in.4.76 mm in diameter or thickness.4.Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1.1 Quantity,4.1.2 ASTM designation and date of issue,4.1.3 Mechanical properties(Section 7),4.1.4 Form(bar or wire),1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved March 1,2013.Published March 2013.Originallyapproved in 1978.Last previous edition approved in 2007 as F562 07.DOI:10.1520/F0562-13.2For 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 Standardization Documents Order Desk,Bldg.4 Section D,700Robbins Ave.,Philadelphia,PA 19111-5094,Attn:NPODS.4Available from Society of Automotive Engineers,Inc.,400 CommonwealthDrive,Warrendale,PA 150960001.*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 States1 4.1.5 Applicable dimensions,including size,thickness,width,and length(exact,random,multiples),or drawingnumber,4.1.6 Condition(5.1),4.1.7 Finish(5.2),4.1.8 Special tests,if applicable,and4.1.9 Other requirements.5.Materials and Manufacture5.1 ConditionBar and wire shall be furnished,asspecified,in the solution-annealed,cold-worked,cold-workedand aged,or hot-worked condition.5.2 FinishBar and wire shall be furnished in cold-drawn,pickled,ground,or ground and polished,as specified by thepurchaser.6.Chemical Requirements6.1 Chemical analysis shall be in accordance with TestMethods E354 and A751.6.2 The cobalt-35nickel-20chromium-10molybdenum alloyshall conform to the chemical requirements prescribed in Table1.The supplier shall not ship material that is outside the limitsspecified in Table 1.6.2.1 Requirements for the major and minor elementalconstituents are listed in Ta