1、Designation: F 1058 02Standard 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 (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the requirements
3、 for twogrades of wrought 40cobalt-20chromium-16iron-15nickel-7molybdenum alloy in the form of wire and strip used for themanufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents of the inch-pound untis maybe approximate.2. Refe
4、renced Documents2.1 ASTM Standards:A 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel Products2E 8 Test Methods for Tension Testing of Metallic Materials3E 18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic Materials3E 45 Test Methods for Det
5、ermining the Inclusion Contentof Steel3E 92 Test Method for Vickers Hardness of Metallic Mate-rials3E 112 Test Methods for Determining the Average GrainSize3E 140 Standard Hardness Conversion Tables for Metals3E 354 Test Methods for Chemical Analysis of High Tem-perature, Electrical, Magnetic, and O
6、ther Similar Iron,Nickel, and Cobalt Alloys42.2 Aerospace Material Specifications:AMS 2269 Chemical Check Analysis Limits WroughtNickel and Alloys and Cobalt Alloys5AMS 5833 Alloy Wire, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Treated and ColdDrawn5AMS 5834 Alloy Wire, Corrosi
7、on and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, ColdDrawn, and Aged5AMS 5875 Alloy Strip, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution Heat Treated, ColdRolled, and Aged5AMS 5876 Alloy Strip, Corrosion and Heat Resistant 20Cr-15Ni-40Co-7.0Mo-16Fe Solution He
8、at Treated and ColdRolled52.3 American Society for Quality:C1 Specification of General Requirements for a QualityProgram62.4 ISO Standard:ISO 5832-7 Implants for SurgeryMetallic MaterialsPart 7 Forgeable and Cold Formed Co-Cr-Ni-Mo-FeAlloy7ISO 6892 Metallic MaterialsTensile Testing73. Ordering Infor
9、mation3.1 Inquiries and orders for material under this specificationshall include the following information:3.1.1 Quantity (weight or number of pieces),3.1.2 ASTM designation, grade, and date of issue,3.1.3 Form (wire or strip),3.1.4 Applicable dimensions, including size, thickness,width, and length
10、 (exact, random, multiples) and toleranceswhere critical, and drawing number,3.1.5 Condition,3.1.6 Finish,3.1.7 Mechanical properties, if applicable, for special con-ditions,3.1.8 Special tests (if any), and3.1.9 Other requirements (if applicable).4. Materials and Manufacture4.1 ConditionWire and st
11、rip shall be furnished to thepurchaser in the annealed, cold worked, or cold worked andaged condition.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F4.12 on Metallurgical Materials.Curr
12、ent edition approved Apr. 10, 2002. Published June 2002. Originallyapproved as F 1058 - 91. Last previous edition F 1058 - 97.2Annual Book of ASTM Standards, Vol 01.03.3Annual Book of ASTM Standards, Vol 03.01.4Annual Book of ASTM Standards, Vol 03.05.5Available from Society of Automotive Engineers,
13、 400 Commonwealth Drive,Warrendale, PA 150960001.6Available from American Society for Quality Control, 600 N. Plankinton Ave.,Milwaukee, WI 53203.7Available from American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive,
14、PO Box C700, West Conshohocken, PA 19428-2959, United States.4.2 Finish:4.2.1 Types of finish available for wire are bright-annealed,pickled, cold-drawn, ground, ground and polished, or asspecified in the purchase order.4.2.2 Types of finish available for strip are bright-annealed,pickled, cold-roll
15、ed, polished, or as specified in the purchaseorder.5. Chemical Requirements5.1 The heat analysis shall conform to the chemical require-ments of Grade 1 or 2 as specified in Table 1. The supplier shallnot ship material that is outside the limits specified in Table 1for the applicable grade.5.1.1 Requ
16、irements 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 to verifycompliance with this specification.5.2 Product Analysis The product analysis i
17、s either for thepurpose of verifying the composition of a heat or lot or todetermine variations in the composition within a heat.5.2.1 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this productanalysis.5.2.2 Product analysis tolerances do not broade
18、n the speci-fied heat analysis requirements, but cover variations betweenlaboratories in the measurement of chemical content. Themanufacturer shall not ship material that is outside the limitsspecified in Table 1. Product analysis limits shall be specifiedin Table 2.5.3 Methods and practices relatin
19、g to chemical analysisrequired by this specification shall be in accordance with TestMethods A 751.6. Mechanical Requirements6.1 Tensile Properties:6.1.1 Tensile properties shall be determined in accordancewith Test Methods E 8.6.1.2 The mechanical properties of test specimens shallconform to the ap
20、propriate mechanical requirements specifiedin Table 3, Table 4, Table 5, Table 6, or Table 7.6.2 Hardness:6.2.1 When desired, hardness properties may be specified.Test Methods E 18 or E 92 and Tables E 140 shall be used.Hardness determination of cold worked or cold worked andaged material shall be m
21、ade on a product cross section,midway between the center and surface, if the cross sectionsize is adequate.6.2.2 Hardness values are for information only and shall notbe used as a basis for rejection.7. Special Tests and Requirements7.1 Microstructure:7.1.1 The materials shall have a homogeneous mic
22、rostruc-ture as observed at 1003 magnification.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 . 0.015Cobalt
23、 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 d
24、ifference is notrequired to be reported.TABLE 2 Product Analysis TolerancesAElementTolerances over the max (upper limit) orunder the min (lower limit), %Carbon 0.01Manganese 0.04Silicon 0.10Phosphorous 0.005Sulfur 0.003Cobalt 0.50Chromium 0.25Nickel 0.20Molybdenum 0.15Beryllium,Bmax 0.10 0.01max 0.0
25、01 0.0001ARefer to AMS 2269.BBased on beryllium analysis by flame atomic absorption with a detection limitof 0.0000001 % (1 ppb).TABLE 3 Mechanical Requirements, Cold Worked WireDiameter inch (mm)Ultimate Tensile Strength,min, psi (MPa)0.001 to 0.005, incl 260 000 (1795)(0.02 to 0.12)Over 0.005 to 0
26、.040, incl 240 000 (1655)(0.12 to 1.00)Over 0.040 to 0.060, incl 235 000 (1620)(1.00 to 1.50)Over 0.060 to 0.100, incl 225 000 (1550)(1.50 to 2.50)Over 0.100 to 0.140, incl 220 000 (1515)(2.50 to 3.50)TABLE 4 Mechanical Requirements, Cold Worked and AgedAWireDiameter inch (mm)Ultimate TensileStrengt
27、h, min, psi(MPa)Yield Strength(0.2 % offset),min, psi (MPa)0.001 to 0.005, incl 330 000 (2275) .(0.02 to 0.12)Over 0.005 to 0.040, incl 290 000 (2000) 210 000 (1450)(0.12 to 1.00)Over 0.040 to 0.060, incl 285 000 (1965) 200 000 (1380)(1.00 to 1.50)Over 0.060 to 0.080, incl 275 000 (1895) 200 000 (13
28、80)(1.50 to 2.00)Over 0.080 to 0.100, incl 275 000 (1895) 195 000 (1345)(2.00 to 2.50)Over 0.100 to 0.120, incl 270 000 (1860) 185 000 (1275)(2.50 to 3.00)Over 0.120 to 0.140, incl 270 000 (1860) 180 000 (1240)(3.00 to 3.50)AThermally aged, for example, by heating to a temperature within the range 9
29、00to 1000F (480 to 540C), holding at the selected temperature within 625F(615C) for 5 to 512 h, and cooling in air to room temperature.F 105827.1.2 The grain size shall be ASTM 5 or finer, based on theappropriate chart of Test Methods E 112.7.1.3 It is preferred that samples for grain size determina
30、tionshall be selected after the last annealing operation prior to thefinal cold working or cold working and aging operation.7.1.4 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 between
31、supplier and purchaser.7.1.5 The microcleanliness of the alloy as determined byPractice E 45, Method A, Plate I-r, on representative billet, bar,or hot band samples from the heat shall not exceed thefollowing:ABCDInclusionType(Sulfide) (Alumina) (Silicate)(GlobularOxide)Thin 1 3 1 3Heavy 0 0 0 08. C
32、ertification8.1 The manufacturers certification that the material wasmanufactured and tested in accordance with this specificationtogether with a report of the test results shall be furnished at thetime of shipment.9. Quality Program Requirements9.1 The supplier and any processors shall maintain a q
33、ualityprogram, such as defined in ASQ C1.10. Keywords10.1 cobalt alloys (for surgical implants); metals for surgicalimplants; wrought cobalt-chromium-nickel-molybdenum-ironalloyTABLE 5 Mechanical Requirements, Cold Worked StripThickness, inch (mm)Ultimate Tensile Strength, min, psi(MPa)Up to 0.0043,
34、 incl 260 000 (1795)(0.110)Over 0.0043 to 0.01875, incl 250 000 (1725)(0.110 to 0.4688)Over 0.01875 to 0.025, incl 240 000 (1655)(0.4688 to 0.62)Over 0.025 to 0.047, incl 220 000 (1515)(0.62 to 1.18)Over 0.047 to 0.075, incl 180 000 (1240)(1.18 to 1.88)Over 0.075 to 0.100, incl 130 000 (895)(1.88 to
35、 2.50)TABLE 6 Mechanical Requirements, Cold Worked and AgedAStripThickness, inch (mm)Ultimate TensileStrength, min,psi (MPa)Yield Strength(0.2 % offset)min, psi (MPa)Elongation in 2in. or 50 mm,min, %Up to 0.0043, incl 325 000 250 000 .(0.110) (2240) (1725)0.0043 to 0.01875, incl 315 000 225 000 .(0
36、.110 to 0.4688) (2170) (1550)0.01875 to 0.025, incl 300 000 225 000 1(0.4688 to 0.62) (2070) (1550)0.025 to 0.047, incl 275 000 225 000 1(0.62 to 1.18) (1895) (1550)0.047 to 0.075, incl 225 000 160 000 3(1.18 to 1.88) (1550) (1105)0.075 to 0.100, incl 170 000 100 000 17(1.88 to 2.50) (1170) (690)ATh
37、ermally aged, for example, by heating to a temperature within the range 850to 950F (455 to 510C), holding at the selected temperature within 6 25F(615C) for 5 to 512 h, and cooling in air to room temperature.TABLE 7 Mechanical Requirements, Annealed Wire and StripUltimate Tensile Strength,min, psi (
38、MPa)Yield Strength,(0.2 % offset) min,psi (MPa)ElongationAmin, %123 000 (850) 62 250 (450) 65AGage length shall be 4 D, 4 W, 2 in. (50 mm), or equal to 5.65 square root So,minimum 25 mm, corresponding to ISO 6892. The gage length shall be reported.F 10583APPENDIXES(Nonmandatory Information)X1. RATIO
39、NALEX1.1 The primary purpose of this specification is tocharacterize composition and properties to assure consistencyin the starting material used in the manufacture of medicaldevices.X1.2 The chemical composition and mechanical propertiesof Grade 1 and the mechanical properties of Grade 2 are inacc
40、ordance 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 a general consensus that a homogeneousmetallurgical structure will be superior with respect to corro-sion and fatigue resist
41、ance, based upon this, metallurgicalrequirements include fine grained single phase microstructurewith low micro-inclusion content.X1.4 Acceptable alloy conditions supplied to the implantmanufacturer include annealed, cold worked, or cold workedand thermally aged, the choice dependent upon the implan
42、tdesign 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 only. AlthoughISO standards listed in Section 2 are similar to the correspond-ing ASTM standards, they may not be identical.
43、Use of an ISOstandard in addition to or instead of a preferred ASTM 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
44、 overa decade.(1-6)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 of the use of thematerial referred to in this standard has shown that anacceptable level of biological response can be exp
45、ected, if thematerial is used in appropriate applications.REFERENCES(1) Yokoo, A., Sugita, K., and Kobayashi, S., “Tissue Reaction Causedby Implanted Aneurysm Clips”, Shinsu Medical Journal, Volume 28,1980. pp. 555557.(2) Greatbach, W., “Electrochemical Polarization of Physiological Elec-trodes” Med
46、ical Research Engineering, Volume 6, No. 2, 1967, pp.1318.(3) Braunwald, N., “Accelerated Fatigue Testing of Available PacemakerElectrodes and Elgiloy Wire Coils”, Surgery, 1965, p. 846.(4) Wible, J., “Spring Valve Mitral Prosthesis”, Journal of the MichiganState Medical Society, June 1957, p. 731.(
47、5) Dujovny, M., Kossovsky, N., Kossowsky, R., Segal, R., Diaz, F.,Kaufman, H., Perlin, A., Cook, E., “Mechanical and MetallurgicalProperties of Carotid Artery Clamps”, Neurosurgery, 1985, pp.760767.(6) Winkler, W., Ungethum, M., “Metallic Materials in Neurosurgery andVascular Surgery”, Aesculap Scie
48、ntific Information, March 1987, 1stEdition.F 10584SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 1058 97) that may impact the use of this standard.(1) The title of the standard was changed.(2) UNS designations and annealed con
49、ditions were added.(3) Annealed mechanical properties (Table 7) that meet ISO5832-7 were added.(4) Formatting changes were made, and editorial correctionswere made that were standardized by Subcommittee F04.12.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to rev
