1、Designation: F 562 07Standard Specification forWrought 35Cobalt-35Nickel-20Chromium-10MolybdenumAlloy for Surgical Implant Applications (UNS R30035)1This standard is issued under the fixed designation F 562; the number immediately following the designation indicates the year oforiginal adoption or,
2、in the case of revision, 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.1. Scope*1.1 This specification covers requirements of wrought35cobalt-35nickel-20chromium-1
3、0molybdenum alloy (UNSR30035) in the form of bar and wire, used for the manufactureof surgical implants. This alloy depends on combinations ofwork-strengthening, and work-strengthening and aging to at-tain a variety of combinations of strength and ductility.1.2 The values stated in inch-pound units
4、are to be regardedas the standard. The SI equivalents of the inch-pound units maybe approximate.2. Referenced Documents2.1 ASTM Standards:2A 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel ProductsE8 Test Methods for Tension Testing of Metallic MaterialsE29 Practice for Us
5、ing Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysF 981 Practice for Assessment of Comp
6、atibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 ISO Standards:ISO 5832/6 Implants for SurgeryMetallic Materials Part6: Wrought cobalt-nickel-chromium-molybdenum alloy3ISO 6892 Metallic MaterialsTensile Testing at AmbientTemperature3ISO 9001 Q
7、uality Management Systems2.3 Aerospace Material Specification:AMS 2269 Chemical Check Analysis LimitsWroughtNickel Alloys and Cobalt Alloys42.4 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Qual-ity Program52.5 Society of Automotive Engineers:SAE J1086 Prac
8、tice for Numbering Metals and Alloys(UNS)43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 lotthe total number of mill products produced fromthe same melt heat under the same conditions at essentially thesame time.4. Classification4.1 BarRound, rectangular, or other complex-sha
9、pedproduct delivered straightened and cut to defined lengths, witha maximum cross-sectional area of 16 in.2(103 cm2).4.2 WireRound, rectangular, or other complex-shapedproduct produced and delivered in coils.4.3 Fine WireWire with diameter or major dimension lessthan 0.63 in. (1.6 mm).5. Ordering In
10、formation5.1 Inquiries and orders for material under this specificationshall include the following information:5.1.1 Quantity,5.1.2 ASTM designation and date of issue,5.1.3 Mechanical properties (Section 8),5.1.4 Form (bar or wire),5.1.5 Applicable dimensions, including size, thickness,width, and le
11、ngth (exact, random, multiples), or drawingnumber,5.1.6 Condition (6.1),5.1.7 Finish (6.2),5.1.8 Special tests, if applicable, and5.1.9 Other requirements.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility
12、 ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved June 1, 2007. Published July 2007. Originally approvedin 1978. Last previous edition approved in 2002 as F 562 02.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at servic
13、eastm.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 Eng
14、ineers, Inc., 400 CommonwealthDrive, Warrendale, PA 150960001.5Available from American Society for Quality, 600 N. Plankinton Ave.,Milwaukee, WI 53203.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocke
15、n, PA 19428-2959, United States.6. Materials and Manufacture6.1 ConditionBar and wire shall be furnished, as speci-fied, in the solution-annealed, cold-worked, or cold-workedand aged condition.6.2 FinishBar and wire shall be furnished in the colddrawn, pickled, ground, or ground and polished, as spe
16、cified bythe purchaser.7. Chemical Requirements7.1 Chemical analysis shall be in accordance with TestMethods E 354 and A 751.7.2 The cobalt-35nickel-20chromium-10molybdenum alloyshall conform to the chemical requirements prescribed in Table1. The supplier shall not ship material that is outside the
17、limitsspecified in Table 1.7.2.1 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 verify compliance with this specification.7.3 Product AnalysisThe product analy
18、sis is either for thepurpose of verifying the composition of a heat or lot or todetermine variations in the composition within the heat.7.3.1 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this productanalysis.7.3.2 Product analysis tolerances do not
19、 broaden the speci-fied heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. Productanalysis limits shall be as specified in Table 2.8. Mechanical Requirements8.1 Tensile Properties:8.1.1 Tensile properties shall be determined in accordancewith
20、Test Methods E8. Perform at least one tension test fromeach lot. Should any test piece not meet the specified require-ments, test two additional test pieces representative of the samelot, in the same manner, for each failed test piece. The lot shallbe considered in compliance only if all additional
21、test piecesmeet the specified requirements.8.1.2 Tensile tests result for which any specimen fracturesoutside the gauge length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Refer to subsections 7.11.4 and 7.11.5of Test Methods E8.
22、 If either the elongation or reduction ofarea is less than the minimum requirement, discard the test andretest. Retest one specimen for each specimen that did not meetthe minimum requirements8.2 Solution-annealed bar and wire shall conform to themechanical properties specified in Tables 3 and 4.8.3
23、Mechanical properties for the cold-worked and cold-worked and aged conditions: medium hard, hard and extra hardshall conform to the mechanical property requirements speci-fied in Tables 3 and 4.8.3.1 Material may be provided in the cold worked condi-tion, capable of meeting the cold work and aged co
24、ndition. Inthis case, the capability heat treated tensile properties shall betested and reported.8.4 Mechanical properties for fine wire in the annealed, coldworked hard and spring conditions shall conform to themechanical property requirements specified in Table 5.8.5 The level of mechanical proper
25、ties for material in otherconditions shall be specified in the purchase order.9. Special Tests9.1 The grain size of bar product shall be predominantly No.4 or finer with occasional grains as large as No. 2 permissiblewhen tested in accordance with Test Methods E112.9.1.1 It is preferred that samples
26、 for grain size determinationbe selected after the final annealing operation and prior to thefinal cold-working operation.9.1.2 If samples are selected after a final cold workingoperation, specimens shall be tested in accordance with TestMethods E112 or as agreed upon between supplier andpurchaser.9
27、.2 For other than bar product, the grain size shall be agreedupon between the purchaser and the supplier.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limitsin this specification. To determine conformance to these limits,an observed or calculated value sha
28、ll be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.TABLE 1 Chemical RequirementsElementComposition,% (mass/mass)min maxCarbon . 0.025Manganese . 0.15Silicon . 0.15Phosphorus . 0.015Sulfur . 0.
29、010Chromium 19.0 21.0Nickel 33.0 37.0Molybdenum 9.0 10.5Iron . 1.0Titanium . 1.0Boron . 0.015CobaltAbalance balanceAApproximately equal to the difference between 100 % and the sum percentageof the other specified elements. The percentage cobalt content by difference is notrequired to be reported.TAB
30、LE 2 Product Analysis TolerancesA,BElementTolerance Under the Minimum orOver the Maximum Limit % (mass/mass)CCarbon 0.01Manganese 0.03Silicon 0.02Phosphorus 0.005Sulfur 0.005Chromium 0.25Nickel 0.30Molybdenum 0.15Iron 0.05Titanium 0.04Boron 0.005ASee Test Method E 354.BSee AMS 2269 for chemical chec
31、k analysis limits.CUnder minimum limit not applicable for elements where only a maximumpercentage is indicated.F56207211. Certification11.1 Certification shall be provided by the supplier that thematerial meets the requirements of this specification. A reportof the test results shall be furnished at
32、 the time of shipment.12. Quality Program Requirements12.1 The bar and wire producer and any processors shallmaintain a quality program as defined in ASQ C1 or ISO 9000.TABLE 3 Mechanical Properties (Bar Products)ConditionTensile Strength,Apsi (MPa)Yield Strength,A(0.2 % Offset)psi (MPa)ElongationBm
33、in, %Reduction in Area,min, %Solution annealedC115 000 to 155 000(793 to 1069)35 000 to 85 000(241 to 586)50.0 65.0Cold-worked:medium hard 145 000(1000) min.95 000(655) min.20.0 60.0hard 175 000(1207) min.145 000(1000) min.10.0 50.0Cold-worked and agedD260 000(1793) min230 000(1586) min8.0 35.0ATens
34、ion and yield requirements apply to tests taken longitudinally to the direction of rolling.BElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length mustbe reported with the test results. The metho
35、d for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. Alternately, agauge length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser (5.65 square root So, where So is the original cross sectionalarea).C1925 6 2
36、5F (1050 6 15C), 1 to2hattemperature, air cool or water quench to room temperature.DCapability TestCold worked and aged within the range 1000 to 1200F 6 25F (540 to 645C 6 15C) for 4 h and air cool.TABLE 4 Mechanical PropertiesWire Products (d $ 0.063 in. 1.6 mm)AConditionTensile Strength,Bpsi (MPa)
37、Yield Strength,B(0.2 % Offset)psi (MPa)ElongationCmin, %Reduction in Area,min, %Solution annealed 115 000 to 155 000(793 to 1069)35 000 to 85 000(241 to 586)50.0 65.0Cold-worked:medium hard 145 000(1000) min.95 000(655) min.20.0 60.0hard 175 000(1207) min.145 000(1000) min.10.0 50.0extra hardD260 00
38、0(1793) min230 000(1586) min8.0 35.0AMechanical properties for material under 0.063 in. (1.6 mm) shall be in accordance with Table 5.BTension and yield requirements apply to tests taken longitudinally to the direction of rolling.CElongation of material 0.063 in. (1.6 mm) or greater in diameter (D) o
39、r width (W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge 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, agauge length corresponding to ISO 6892
40、 may be used when agreed upon between supplier and purchaser. (5.65 square root So, where So is the original cross sectionalarea.)TABLE 5 Mechanical PropertiesFine Wire (d 0.063 in. 1.6 mm)ConditionAnnealed Cold WorkedHard SpringDiameter,in. (mm)Tensile Strength,psi (MPa)Elongationmin, %Tensile Stre
41、ngth,psi (MPa)Elongationmin, %Tensile Strength,psi (MPa)ElongationAmin, %0.063 to 0.058(1.600 to 1.473)120 000 to 150 000(827 to 1034)40.0 % 240 000 to 270 000(1655 to 1862)2.0 % 270 000 to 300 000(1862 to 2068)2.0 %0.058 to 0.034(1.473 to 0.864)125 000 to 155 000(862 to 1069)40.0 % 245 000 to 275 0
42、00(1689 to 1896)2.0 % 275 000 to 305 000(1896 to 2103)2.0 %0.034 to 0.016(0.864 to 0.406)135 000 to 165 000(931 to 1138)40.0 % 255 000 to 285 000(1758 to 1965)2.0 % 285 000 to 315 000(1965 to 2172)2.0 %0.016 to 0.003(0.406 to 0.0762)145 000 to 175 000(1000 to 1207)30.0 % 265 000 to 295 000(1827 to 2
43、034)2.0 % 295 000 to 325 000(2034 to 2241)2.0 %0.003 to 0.002(0.0762 to 0.0508)150 000 to 190 000(1034 to 1310)30.0 % 275 000 to 305 000(1896 to 2103)2.0 % 305 000 to 335 000(2103 to 2310)2.0 %0.002(0.0508)170 000 to 210 000(1172 to 1448)25.0 % 290 000 to 330 000(1999 to 2275)1.8 % 320 000 to 360 00
44、0(2206 to 2482)1.8 %AThe method for determining elongation of material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated, or a 10 in. gauge length may be used.Alternatively, a gauge length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser. (5.65
45、times the square root of So, where Sois the original cross sectional area.) The gauge length must be reported with the test resultsF56207313. Keywords13.1 cobalt alloys (for surgical implants) cobalt-nickel-chromium-molybdenum alloy; metals (for surgical implants)-cobalt alloysAPPENDIXES(Nonmandator
46、y Information)X1. RATIONALEX1.1 The primary reason for this specification is to char-acterize the composition and properties to assure consistency inthe starting material used in the manufacture of medicaldevices.X1.2 The acceptable metal conditions include solutionannealed, cold worked or cold work
47、ed and aged; the choicedependent upon the medical device design and its intendedapplication.X1.3 A boron limit has been added to the chemicalrequirements to coincide with industry melting practice for thisalloy.X1.4 ISO standards are listed for reference only. Althoughthe ISO standards listed in Sec
48、tion 2 are similar to thecorrespondingASTM standards, they may not identical. Use ofan ISO standard in addition to or instead of a preferred ASTMstandard may be negotiated between the purchaser andsupplier.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specificationhas been successfu
49、lly employed in human implants (1-5)6forover a decade. This material has been found to produce a wellcharacterized level of local biological response when tested inaccordance with Practice F 981 or equivalent.X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody; however, long-term clinical experience has shown anacceptable level of biological response can be expected, if thismaterial is used in appropriate applications.REFERENCES(1) Gaechter, A., Galante, G., “MP35N, A Corrosion Resistant High-
