1、Designation: F 1058 08Standard Specification forWrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical ImplantApplications (UNS R30003 and UNS R30008)1This standard is issued under the fixed designation F 1058; the number immediately following the designation indic
2、ates 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 chemical, me
3、chanical, andmetallurgical requirements for two grades of wrought40cobalt-20chromium-16iron-15nickel-7molybdenum alloy inthe form of wire and strip used for the manufacture of surgicalimplants.1.2 The values stated in SI units are to be regarded asstandard. The inch-pound equivalents of the SI units
4、 inparentheses are for information only.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 MaterialsE18 Test Methods for Rockwell Hardness of MetallicMaterialsE29 Practice for
5、 Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Contentof SteelE92 Test Method for Vickers Hardness of Metallic Mate-rialsE112 Test Methods for Determining Average Grain SizeE 140 Hardness Conversion Tables for Metals R
6、elationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness, Knoop Hardness, andScleroscope HardnessE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt Alloys2.2 Aerospace Material Specification
7、s:3AMS 2269 Chemical Check Analysis Limits WroughtNickel and Alloys and Cobalt AlloysAMS 5833 Alloy Wire, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Treated and ColdDrawnAMS 5834 Alloy Wire, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, ColdDrawn,
8、 and AgedAMS 5875 Alloy Strip, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, ColdRolled, and AgedAMS 5876 Alloy Strip, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated and ColdRolled2.3 American Society for Quality Standards:ASQ C1 Specific
9、ation of General Requirements for a Qual-ity Program42.4 ISO Standards:5ISO 5832-7 Implants for SurgeryMetallic MaterialsPart 7 Forgeable and Cold Formed Co-Cr-Ni-Mo-FeAlloyISO 6892 Metallic MaterialsTensile TestingISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms
10、 Specific to This Standard:3.1.1 lot, nthe total number of mill products producedfrom the same melt heat under the same conditions at essen-tially the same time.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1.1 Quantity
11、 (weight or number of pieces),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 edition approved May 1, 2008. Published June 2008. Originallyapprov
12、ed in 1991. Last previous edition approved in 2002 as F 1058 02.2For 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 websi
13、te.3Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from American National Standards Institute (ANSI),
14、25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.2 ASTM designation, grade, and date of issue,4.1.3
15、 Form (wire or strip),4.1.4 Applicable dimensions, including size, thickness,width, and length (exact, random, multiples) and toleranceswhere critical, and drawing number,4.1.5 Condition,4.1.6 Finish,4.1.7 Mechanical properties, if applicable, for special con-ditions,4.1.8 Special tests (if any), an
16、d4.1.9 Other requirements (if applicable).5. Materials and Manufacture5.1 ConditionWire and strip shall be furnished to thepurchaser in the annealed, cold worked, or cold worked andaged condition.5.2 Finish:5.2.1 Types of finish available for wire are bright-annealed,pickled, cold-drawn, ground, gro
17、und and polished, or asspecified in the purchase order.5.2.2 Types of finish available for strip are bright-annealed,pickled, cold-rolled, polished, or as specified in the purchaseorder.6. Chemical Requirements6.1 The heat analysis shall conform to the chemical require-ments of Grade 1 or 2 as speci
18、fied in Table 1. The supplier shallnot ship material that is outside the limits specified in Table 1for the applicable grade.6.1.1 Requirements for the major and minor elementalconstituents for Grade 1 and 2 of this alloy are listed in Table1. Also listed are important residual elements. Analysis fo
19、relements not listed in Table 1 is not required to verifycompliance with this specification.6.2 Product Analysis The product analysis is either for thepurpose of verifying the composition of a heat or lot or todetermine variations in the composition within a heat.6.2.1 Acceptance or rejection of a h
20、eat or lot of materialmay be made by the purchaser on the basis of this productanalysis.6.2.2 Product analysis tolerances do not broaden the speci-fied heat analysis requirements, but cover variations betweenlaboratories in the measurement of chemical content. Themanufacturer shall not ship material
21、 that is outside the limitsspecified in Table 1. Product analysis limits shall be specifiedin Table 2.6.3 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods, Practices, and Terminology A 751.7. Mechanical Requirements7.1 Tensile
22、Properties:7.1.1 Perform tension tests per Test Methods E8. Shouldany of the test specimens not meet the specified requirements,test two additional test pieces representative of the same lot, inthe same manner, for each failed test piece. The lot shall beconsidered in compliance only if all addition
23、al test pieces meetthe specified requirements.7.1.2 Tensile test results for which any specimen fracturesoutside the gage length shall be considered acceptable if theelongation meets the minimum requirements specified. Referto subsections 7.11.4 and 7.11.5 of Test Methods E8.Iftheelongation is less
24、than the minimum requirement, discard thetest and retest. Retest one specimen for each specimen that didnot meet the minimum requirement.7.1.3 The mechanical properties of test specimens shallconform to the appropriate mechanical requirements specifiedin Table 3, Table 4, Table 5, Table 6,orTable 7.
25、7.2 Hardness:7.2.1 When desired, hardness properties may be specified.Test Methods E18or E92and Tables E 140 shall be used.Hardness determination of cold worked or cold worked andaged material shall be made on a product cross section,midway between the center and surface, if the cross sectionsize is
26、 adequate.7.2.2 Hardness values are for information only and shall notbe used as a basis for rejection.8. Special Tests and Requirements8.1 Microstructure:8.1.1 The materials shall have a homogeneous microstruc-ture as observed at 1003 magnification.8.1.2 The grain size shall be ASTM 5 or finer, bas
27、ed on theappropriate chart of Test Methods E112.TABLE 1 Chemical Requirements, Heat AnalysisElementComposition, (% mass/mass)Grade 1 (UNS R30003) Grade 2 (UNS R30008)min max min maxCarbon . 0.15 . 0.15Manganese 1.5 2.5 1.0 2.0Silicon . 1.20 . 1.20Phosphorus . 0.015 . 0.015Sulfur . 0.015 . 0.015Cobal
28、t 39.0 41.0 39.0 42.0Chromium 19.0 21.0 18.5 21.5Nickel 14.0 16.0 15.0 18.0Molybdenum 6.0 8.0 6.5 7.5Beryllium . 0.10 . 0.001IronABalance Balance Balance BalanceAApproximately equal to the difference between 100 % and the sum percentageof the other specified elements. The percentage iron content by
29、difference is notrequired to be reported.TABLE 2 Product Analysis TolerancesAElementTolerances over the max (upper limit) orunder the min (lower limit),% mass/massGrade 1 (UNSR30003)Grade 2 (UNSR30008)Carbon 0.01 0.01Manganese 0.04 0.04Silicon 0.10 0.10Phosphorous 0.005 0.005Sulfur 0.003 0.003Cobalt
30、 0.50 0.50Chromium 0.25 0.25Nickel 0.20 0.20Molybdenum 0.15 0.15Beryllium,B0.010 0.0001ARefer to AMS 2269.BBased on beryllium analysis by flame atomic absorption with a detection limitof 0.0000001 % (1 ppb).F10580828.1.3 It is preferred that samples for grain size determinationshall be selected afte
31、r the last annealing operation prior to thefinal cold working or cold working and aging operation.8.1.4 If samples are selected after a final cold working orcold working and aging operation, specimens shall be tested inaccordance with Test Methods E 112 or as agreed betweensupplier and purchaser.8.1
32、.5 The microcleanliness of the alloy as determined byPractice E45, Method A, Plate I-r, on representative billet, bar,or hot band samples from the heat shall not exceed the limitsin Table 8.9. Significance of Numerical Limits9.1 The following applies to all specified numerical limits inthis specific
33、ation. To determine conformance to these limits anobserved or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.10. Certification10.1 The supplier shall provide a certific
34、ation that thematerial was manufactured and tested in accordance with thisspecification. A report of the test results shall be furnished tothe purchaser at the time of shipment.11. Quality Program Requirements11.1 The supplier and any processors shall maintain aquality program, such as defined in AS
35、Q C1, ISO 9001,orsimilar.12. Keywords12.1 cobalt alloys (for surgical implants); metals for surgicalimplants; wrought cobalt-chromium-nickel-molybdenum-ironalloyTABLE 3 Mechanical Requirements, Cold Worked WireDiameter, mm (in.)Ultimate Tensile Strength,min, MPa (psi)0.02 to 0.12, incl 1795(0.001 to
36、 0.005) (260 000)Over 0.12 to 1.00, incl 1655(0.005 to 0.040) (240 000)Over 1.0 to 1.50, incl 1620(0.040 to 0.060) (235 000)Over 1.50 to 2.50, incl 1550(0.060 to 0.100) (225 000)Over 2.5 to 3.50, incl 1515(0.100 to 0.140) (220 000)TABLE 4 Mechanical Requirements, Cold Worked and AgedAWireDiameter mm
37、 (in.)Ultimate TensileStrength, min, MPa(psi)Yield Strength(0.2 % offset),min, MPa (psi)0.02 to 0.12, incl 2275 .(0.001 to 0.005) (330 000)Over 0.12 to 1.00, incl 2000 1450(0.005 to 0.040) (290 000) (210 000)Over 1.00 to 1.50, incl 1965 1380(0.040 to 0.060) (285 000) (200 000)Over 1.50 to 2.00, incl
38、 1895 1380(0.060 to 0.080) (275 000) (200 000)Over 2.00 to 2.50, incl 1895 1345(0.080 to 0.100) (275 000) (195 000)Over 2.50 to 3.00, incl 1860 1275(0.100 to 0.120) (270 000) (185 000)Over 3.00 to 3.50, incl 1860 1240(0.120 to 0.140) (270 000) (180 000)AThermally aged, for example, by heating to a t
39、emperature within the range 480to 540C (900 to 1000F), holding at the selected temperature within 615C(625F) for 5 to 512 h, and cooling in air to room temperature.TABLE 5 Mechanical Requirements, Cold Worked StripThickness, mm (in.)Ultimate Tensile Strength, min,MPa (psi)Up to 0.110, incl 1795(0.00
40、43) (260 000)Over 0.110 to 0.4688, incl 1725(0.0043 to 0.01875) (250 000)Over 0.4688 to 0.62, incl 1655(0.01875 to 0.025) (240 000)Over 0.62 to 1.18, incl 1515(0.025 to 0.047) (220 000)Over 1.18 to 1.88, incl 1240(0.047 to 0.075) (180 000)Over 1.88 to 2.50, incl 895(0.075 to 0.100) (130 000)TABLE 6
41、Mechanical Requirements, Cold Worked and AgedAStripThickness, mm (in.)Ultimate TensileStrength, min,MPa (psi)Yield Strength(0.2 % offset)min, MPa (psi)Elongation in 50mm or 2 in, min,%Up to 0.110, incl 2240 1725 .(0.0043) (325 000) (250 000)0.110 to 0.4688, incl 2170 1550 .(0.0043 to 0.01875) (315 0
42、00) (225 000)0.4688 to 0.62, incl 2070 1550 1(0.01875 to 0.025) (300 000) (225 000)0.62 to 1.18, incl 1895 1550 1(0.025 to 0.047) (275 000) (225 000)1.18 to 1.88, incl 1550 1105 3(0.047 to 0.075) (225 000) (160 000)1.88 to 2.50, incl 1170 690 17(0.075 to 0.100) (170 000) (100 000)AThermally aged, fo
43、r example, by heating to a temperature within the range 455to 510C (850 to 950F), holding at the selected temperature within 615C(625F) for 5 to 512 h, and cooling in air to room temperature.TABLE 7 Mechanical Requirements, Annealed Wire and StripUltimate Tensile Strength,min, MPa (psi)Yield Strengt
44、h,(0.2 % offset) min,MPa (psi)ElongationAmin, %850 (123 000) 450 (62 250) 65AGage length shall be 4 D, 4 W, 50 mm (2 in.), or equal to 5.65 square root So,minimum 25 mm, corresponding to ISO 6892. The gage length shall be reported.TABLE 8 Microcleanliness RequirementsABCDInclusionType(Sulfide) (Alum
45、ina) (Silicate)(GlobularOxide)Thin 1.0 3.0 1.0 3.0Heavy 0.0 0.0 0.0 0.0F1058083APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary purpose of this specification is tocharacterize composition and properties to ensure consistencyin the starting material used in the manufacture of medical
46、devices.X1.2 The chemical composition and mechanical propertiesof Grade 1 and the mechanical properties of Grade 2 are inaccordance with AMS 5833, 5834, 5875, and 5876. Thechemical composition of Grade 2 is in agreement with thecomposition limits specified in ISO 5832-7, except for Si.X1.3 There is
47、a general consensus that a homogeneousmetallurgical structure will be superior with respect to corro-sion and fatigue resistance, based upon this, metallurgicalrequirements include fine grained single phase microstructurewith low micro-inclusion content.X1.4 Acceptable alloy conditions supplied to t
48、he implantmanufacturer include annealed, cold worked, or cold workedand thermally aged, the choice dependent upon the implantdesign and application.X1.5 Grade 1 is commonly referred to as Elgiloy alloywhile Grade 2 is commonly referred to as Phynox alloy.X1.6 ISO standards are listed for reference o
49、nly. AlthoughISO standards listed in Section 2 are similar to the correspond-ing ASTM standards, they may not be identical. Use of an ISOstandard in addition to or instead of a preferredASTM standardmay be negotiated between the purchaser and supplier.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this standard hasbeen employed successfully in human implant applications incontact with soft tissue and bone for over a decade.(1-6)6X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. Howeve
