1、Designation: F1058 16Standard Specification forWrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for SurgicalImplant Applications (UNS R30003 and UNS R30008)1This standard is issued under the fixed designation F1058; the number immediately following the designa
2、tion 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 ch
3、emical, mechanical, andmetallurgical requirements for two grades of wrought40cobalt-20chromium-16iron-15nickel-7molybdenum alloy inthe form of wire, strip and bar used for the manufacture ofsurgical implants.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as
4、 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 Te
5、rminology for Chemi-cal Analysis of Steel ProductsE8/E8M Test Methods for Tension Testing of Metallic Ma-terialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE45 Test Methods for Determin
6、ing the Inclusion Content ofSteelE92 Test Methods for Vickers Hardness and Knoop Hard-ness of Metallic MaterialsE112 Test Methods for Determining Average Grain SizeE140 Hardness Conversion Tables for Metals RelationshipAmong Brinell Hardness, Vickers Hardness, RockwellHardness, Superficial Hardness,
7、 Knoop Hardness, Sclero-scope Hardness, and Leeb HardnessE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysIEEE/ASTM SI 10 American National Standard for MetricPractice2.2 Aerospace Material Specifications:3AMS 2269 Che
8、mical 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, and AgedAMS 58
9、75 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 ISO Standards:4ISO 5832-7 Implants for SurgeryMetallic MaterialsPart7
10、 Forgeable and Cold Formed Co-Cr-Ni-Mo-Fe AlloyISO 68921 Metallic materialsTensile testingPart 1:Method of test at room temperatureISO 9001 Quality Management SystemsRequirements2.4 Society of Automotive Engineers:5SAE J1086 Practice for Numbering Metals and Alloys(UNS)3. Terminology3.1 Definitions
11、of Terms Specific to This Standard: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 Nov. 1, 2016. Published January 2017. Origina
12、llyapproved in 1991. Last previous edition approved in 2008 as F1058 08. DOI:10.1520/F1058-16.2For 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
13、 Summary page onthe ASTM website.3Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from SAE
14、 International (SAE), 400 Commonwealth Dr., Warrendale,PA 15096, http:/www.sae.org.*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 StatesThis international standard was develop
15、ed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.1.1 bar, nround bar
16、s and flats from 4.75 to 101.60 mm0.1875 to 4.00 in. in diameter or thickness (other shapes byspecial order).3.1.2 fine wire, nwire as described in 3.1.5, less than 1.60mm 0.063 in. in diameter or thickness.3.1.3 lot, nthe total number of mill products producedfrom the same melt heat under the same
17、conditions at essen-tially the same time.3.1.4 strip, nany product under 4.76 mm 0.188 in. inthickness and under 610 mm 24 in. wide.3.1.5 wire, nrounds, flats or other shapes less than 4.76mm 0.1875 in. in diameter or thickness.4. Ordering Information4.1 Inquiries and orders for material under this
18、specificationshall include the following information:4.1.1 Quantity (weight or number of pieces);4.1.2 ASTM designation, grade, and date of issue;4.1.3 Form (wire, strip, or bar);4.1.4 Applicable dimensions, including size, thickness,width, and length (exact, random, multiples) and toleranceswhere c
19、ritical, 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); and4.1.9 Other requirements (if applicable).5. Materials and Manufacture5.1 ConditionWire and strip shall be furnished to thepurchaser in the ann
20、ealed, cold worked, or cold worked andaged condition. Bars shall be furnished to the purchaser in thecold worked or cold worked and aged condition.5.2 Finish:5.2.1 Types of finish available for wire are bright-annealed,pickled, cold-drawn, ground, ground and polished, or asspecified in the purchase
21、order.5.2.2 Types of finish available for strip are bright-annealed,pickled, cold-rolled, polished, or as specified in the purchaseorder.5.2.3 Types of finish available for bar are cold-drawn,cold-drawn and aged, ground, ground and polished, or asspecified in the purchase order.6. Chemical Requireme
22、nts6.1 Chemical analysis shall be in accordance with TestMethods E354 and A751.6.2 The 40cobalt-20chromium-16iron-15nickel-7molyb-denum alloy heat analysis shall conform to the chemicalrequirements of Grade 1 or 2 as specified in Table 1. Thesupplier shall not ship material that is outside the limit
23、sspecified in Table 1 for the applicable grade.6.2.1 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 forelements not listed in Table 1 is not required but is allowed toverify compli
24、ance with this specification.6.2.2 All commercial metals contain small amounts ofelements other than those which are specified. It is neitherpractical nor necessary to specify limits for unspecifiedelements, whether residual elements or trace elements, that canbe present.The producer is permitted to
25、 analyze for unspecifiedelements and is permitted to report such analyses.The presenceof an unspecified element and the reporting of an analysis forthat element shall not be a basis for rejection.6.3 Product Analysis The product analysis is either for thepurpose of verifying the composition of a hea
26、t or lot or todetermine variations in the composition within a heat.6.3.1 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this productanalysis.6.3.2 Product analysis tolerances do not broaden the speci-fied heat analysis requirements, but cover variat
27、ions betweenlaboratories in the measurement of chemical content. Productanalysis limits shall be as specified in Table 2.7. Mechanical Requirements7.1 Tensile Properties:TABLE 1 Chemical Requirements, Heat AnalysisElementComposition, (% mass/mass)Grade 1 (UNS R30003) Grade 2 (UNS R30008)min max min
28、maxCarbon . 0.15 . 0.15Manganese 1.5 2.5 1.0 2.0Silicon . 1.20 . 1.20Phosphorus . 0.015 . 0.015Sulfur . 0.015 . 0.015Cobalt 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 . 0.001B. 0.001IronABalance Balance Balance BalanceAApproximately e
29、qual to the difference between 100 % and the sum percentageof the other specified elements. The percentage iron content by difference is notrequired to be reported.BDenotes more restrictive limit than UNS.TABLE 2 Product Analysis TolerancesAElementTolerances over the max (upper limit) orunder the mi
30、n (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 0.50 0.50Chromium 0.25 0.25Nickel 0.20 0.20Molybdenum 0.15 0.15Beryllium,B0.0001 0.0001ARefer to AMS 2269.BBased on beryllium analysis
31、by flame atomic absorption with a detection limit of0.0000001 % (1 ppb).F1058 1627.1.1 Tension properties shall be determined in accordancewith Test Methods E8/E8M. Perform at least one tension testfrom each lot. Should any of the test specimens not meet thespecified requirements, test two additiona
32、l test pieces represen-tative of the same lot, in the same manner, for each failed testpiece. The lot shall be considered in compliance only if alladditional test pieces meet the specified requirements.7.1.2 Tensile test results for which any specimen fracturesoutside the gage length shall be consid
33、ered acceptable if theelongation meets the minimum requirements specified. Referto subsections 7.11.4 and 7.11.5 of Test Methods E8/E8M.Ifthe elongation is less than the minimum requirement, discardthe test and retest. Retest one specimen for each specimen thatdid not meet the minimum requirement.7.
34、1.3 The mechanical properties of test specimens shallconform to the appropriate mechanical requirements specifiedin Table 3, Table 4, Table 5, Table 6, Table 7, Table 8,orasspecified on the purchase order7.2 Hardness:7.2.1 When desired, hardness properties may be specified.Test Methods E18 or E92 an
35、d Tables E140 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 adequate.7.2.2 Hardness values are for information only and shall notbe used as a basis for re
36、jection.8. Dimensions and Permissible Variations8.1 Units of Measure:8.1.1 SelectionThis specification requires that the pur-chaser select the units (SI or inch-pound) to be used for productclarification. In the absence of a stated selection of units on thepurchase order, this selection may be expre
37、ssed by the pur-chaser in several alternate forms listed in order of precedence.8.1.1.1 If the purchaser and supplier have a history of usingspecific units, these units shall continue to be certified untilexpressly changed by the purchaser.8.1.1.2 In the absence of historic precedence, if the unitsu
38、sed to define the product on the purchasers purchase order(PO), specification, and engineering drawing are consistent,these units shall be used by the supplier for product certifica-tion.TABLE 3 Mechanical Requirements, Cold Worked WireDiameter, mm in.Ultimate Tensile Strength,min, MPa psi0.02 to 0.
39、12, incl 17950.001 to 0.005 260 000Over 0.12 to 1.00, incl 16550.005 to 0.040 240 000Over 1.0 to 1.50, incl 16200.040 to 0.060 235 000Over 1.50 to 2.50, incl 15500.060 to 0.100 225 000Over 2.5 to 3.50, incl 15150.100 to 0.140 220 000TABLE 4 Mechanical Requirements, Cold Worked and AgedAWireDiameter
40、mm in.Ultimate TensileStrength, min, MPapsiYield Strength(0.2 % offset),min, MPa psi0.02 to 0.12, incl 2275 .0.001 to 0.005 330 000Over 0.12 to 1.00, incl 2000 14500.005 to 0.040 290 000 210 000Over 1.00 to 1.50, incl 1965 13800.040 to 0.060 285 000 200 000Over 1.50 to 2.00, incl 1895 13800.060 to 0
41、.080 275 000 200 000Over 2.00 to 2.50, incl 1895 13450.080 to 0.100 275 000 195 000Over 2.50 to 3.00, incl 1860 12750.100 to 0.120 270 000 185 000Over 3.00 to 3.50, incl 1860 12400.120 to 0.140 270 000 180 000AThermally aged, for example, by heating to a temperature within the range 480to 540C 900 t
42、o 1000F, holding at the selected temperature within 15C25F 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 psiUp to 0.110, incl 17950.0043 260 000Over 0.110 to 0.4688, incl 17250.0043 to 0.01
43、875 250 000Over 0.4688 to 0.62, incl 16550.01875 to 0.025 240 000Over 0.62 to 1.18, incl 15150.025 to 0.047 220 000Over 1.18 to 1.88, incl 12400.047 to 0.075 180 000Over 1.88 to 2.50, incl 8950.075 to 0.100 130 000TABLE 6 Mechanical Requirements, Cold Worked and AgedAStripThickness, mm in.Ultimate T
44、ensileStrength, min,MPa psiYield Strength(0.2 % offset)min, MPa psiElongation in 50mm or 2 in, min,%Up to 0.110, incl 2240 1725 .0.0043 325 000 250 0000.110 to 0.4688, incl 2170 1550 .0.0043 to 0.01875 315 000 225 0000.4688 to 0.62, incl 2070 1550 10.01875 to 0.025 300 000 225 0000.62 to 1.18, incl
45、1895 1550 10.025 to 0.047 275 000 225 0001.18 to 1.88, incl 1550 1105 30.047 to 0.075 225 000 160 0001.88 to 2.50, incl 1170 690 170.075 to 0.100 170 000 100 000AThermally aged, for example, by heating to a temperature within the range 455to 510C 850 to 950F, holding at the selected temperature with
46、in 15C 25Ffor 5 to 512 h, and cooling in air to room temperature.TABLE 7 Mechanical Requirements, Annealed Wire and StripUltimate TensileStrength,min, MPa psiYield Strength,(0.2 % offset) min,MPa psiElongationAmin, %850 123 000 450 62 250 65AGage length shall be 4 D, 4 W, 50 mm 2 in., or equal to 5.
47、65 square root So,minimum 25 mm, corresponding to ISO 6892-1. The gage length shall be reported.F1058 1638.1.1.3 If the purchasers selection of units is unclear, theunits of measure shall be agreed upon between the purchaserand supplier.8.1.2 Conversion of UnitsIf the suppliers test equipmentdoes no
48、t report in the selected units, the test equipment unitsmay be converted to the selected units for certification pur-poses. Accurate arithmetic conversion and proper use ofsignificant digits should be observed when performing thisconversion. IEEE/ASTM SI 10 provides guidelines for the useof SI units
49、.AnnexAof this standard provides conversion tablesand Annex B provides rules for conversion and significance.9. Special Tests and Requirements9.1 Microstructure:9.1.1 The materials shall have a homogeneous microstruc-ture as observed at 100 magnification.9.1.2 The grain size shall be ASTM 5 or finer, based on theappropriate chart of Test Methods E112.9.1.3 It is preferred that samp
