1、Designation: F 1537 07Standard Specification forWrought Cobalt-28Chromium-6Molybdenum Alloys forSurgical Implants (UNS R31537, UNS R31538, and UNSR31539)1This standard is issued under the fixed designation F 1537; the number immediately following the designation indicates the year oforiginal adoptio
2、n 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. Scope*1.1 This specification covers the chemical, mechanical, andmetallurgical requ
3、irements for three wrought cobalt-28chromium-6molybdenum alloys used for surgical implants.The properties specified apply specifically to wrought bar, rod,and wire.1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents in parentheses are forinformation only.2
4、. Referenced Documents2.1 ASTM Standards:2E8 Test Methods for Tension Testing of Metallic MaterialsE18 Test Methods for Rockwell Hardness of MetallicMaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE112 Test Methods for Determining Average Gr
5、ain SizeE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysF75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F 799 Specification for Cobalt-28Chromium
6、-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)2.2 Aerospace Material Specifications:3AMS 2248 Chemical Check Analysis Limits, Corrosionand Heat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron AlloysAMS 2269 Chemical Check Analysis Limits,
7、Nickel,Nickel Alloys and Cobalt AlloysAMS 2630 Ultrasonic Inspection2.3 ISO Standards:4ISO 583212 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum AlloyISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements2.4
8、 American Society for Quality Standard:5ASQ C1 Specification of General Requirements for a Qual-ity Program3. 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
9、.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, alloy number, and date of issue,4.1.3 Mechanical properties (See Section 7),4.1.4 Form (bar, rod or wire),4.1.5 Applicable dimensions i
10、ncluding size, thickness,width, and length (exact, random, or multiples) or drawingnumber,4.1.6 Condition (See Section 5),4.1.7 Special tests (if any), and4.1.8 Other requirements.5. Materials and Manufacture5.1 Product shall be furnished as specified below:5.1.1 The annealed condition is typically
11、supplied as a hotrolled and annealed product.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 July 1, 2007. Published August 2007
12、. Originallyapproved in 1994. Last previous edition approved in 2000 as F 1537 00.2For 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 pag
13、e 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 American Societ
14、y for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.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.5.1.2 The hot worked condition is ty
15、pically supplied as a hotrolled and unannealed product.5.1.3 The warm worked condition is typically supplied as athermomechanically processed product to achieve a strain-hardened structure.6. Chemical Requirements6.1 The cobalt-28chromium-6molybdenum alloys shall con-form to the chemical requirement
16、s prescribed in Table 1. Thesupplier shall not ship material that is outside the limitsspecified in Table 1 for the applicable alloy.6.1.1 Requirements for the major and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements. Analysis for elements not listed in
17、 Table 1 isnot required to verify compliance with this specification.6.2 Product AnalysisThe product analysis is either for thepurpose of verifying the composition of a heat or lot or todetermine variations in the composition within the heat.6.2.1 Acceptance or rejection of a heat or lot of material
18、may 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. Productanalysis limits shall be as specified in Table 2.7. Mec
19、hanical Requirements7.1 Tensile Properties:7.1.1 Perform at least two tension and two bend tests fromeach lot. Should any of these test pieces not meet the specifiedrequirements, test two additional test pieces representative ofthe same lot, in the same manner, for each failed test piece. Thelot sha
20、ll be considered in compliance only if all additional testpieces meet the specified requirements.7.1.2 Tensile test results for which any specimen fracturesoutside the gauge length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequirements specified. Ref
21、er to subsections 7.11.4 and 7.11.5of Test Methods E8.7.1.3 The mechanical properties of test specimens shallconform to the requirements specified in Table 3.7.2 Hardness:7.2.1 Hardness values shall be determined in accordancewith Test Methods E18.7.2.2 Hardness values are for information only and s
22、hall notbe used as a basis for rejection.8. Special Tests8.1 Bar, rod, and wire conforming to this specification shallhave a homogeneous microstructure with an average grain sizeof ASTM No. 5 or finer when measured in accordance withTest Methods E 112.8.2 Ultrasonic inspection shall be per AMS 2630,
23、 Class A1.9. Significance of Numerical Limits9.1 The following applies to all specified numerical limits inthis specification. 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
24、 limit, in accordance with the rounding method ofPractice E29.TABLE 1 Chemical CompositionComposition % (mass/mass)Element Alloy 1UNS R31537(Low Carbon)Alloy 2UNS R31538(High Carbon)Alloy 3UNS R31539(DispersionStrengthened)min max min max min maxCarbon 0.14 0.15 0.35 0.14Aluminum 0.30 1.00Lanthanum
25、0.03 0.20Chromium 26.0 30.0 26.0 30.0 26.0 30.0Molybdenum 5.0 7.0 5.0 7.0 5.0 7.0Nickel 1.0 1.0 1.0Iron 0.75 0.75 0.75Silicon 1.0 1.0 1.0Manganese 1.0 1.0 1.0Nitrogen 0.25 0.25 0.25CobaltABalance Balance BalanceAApproximately equal to the difference of 100 % and the sum percentage of theother specif
26、ied elements. The percentage of cobalt difference is not required to bereported.TABLE 2 Product Analysis TolerancesA,BElement Permissible Variation Under the MinimumLimit or Over the Maximum Limit, % (mass/mass)CCarbon 0.02Aluminum # 0.50 0.05Aluminum0.50upto1.00 0.10Lanthanum 0.01Chromium 0.30Molyb
27、denum 0.15Nickel 0.05Iron 0.03Silicon 0.05Manganese 0.03NitrogenD0.02ASee Test Methods E 354.BRefer to AMS 2269 for chemical check analysis limits (except nitrogen).CFor elements in which only a maximum percentage is indicated, the “underminimum limit” is not applicable.DRefer to AMS 2248.TABLE 3 Me
28、chanical RequirementsConditionUltimateTensileStrengthmin, psi(MPa)YieldStrength(0.2 %offset),min, psi(MPa)ElongationAmin, %Reductionin Areamin, %HardnessHRC,TypicalAnnealed 130 000(897)75 000(517)20 20 25HotWorked145 000(1000)101 000(700)12 12 28WarmWorked170 000(1172)120 000(827)12 12 35AElongation
29、 of material 0.062 in. (1.575 mm) or greater in diameter or thicknessshall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmust be reported with the test results. The method for determining elongation ofmaterial under 0.062 in. (1.57 mm) in diameter or thickness may be negotia
30、ted.Alternately, a gauge length corresponding to ISO 6892 may be used when agreedupon between supplier and purchaser (5.65 times the square root of So, where Sois the original cross sectional area).F153707210. Certification10.1 The supplier shall provide a certification that thematerial was manufact
31、ured and tested in accordance with therequirements of this specification. A report of the test resultsshall be furnished to the purchaser at the time of shipment.11. Quality Program Requirements11.1 The alloy supplier shall maintain a quality programsuch as that which is defined in ASQ C1 or other r
32、ecognizedquality management system such as ISO 9001.12. Keywords12.1 cobalt alloys (for surgical implants); cobalt-28chromium-6molybdenum; metals (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The purpose of this specification is to characterizecomposition and propertie
33、s to ensure consistency in wroughtcobalt-28chromium-6molybdenum bar, rod, and wire used inthe manufacturing of medical devices.X1.2 The carbon content of commercially available F 1537barstock varies to meet specific customer needs. The chemicalcomposition was expanded into low and high carbon alloys
34、(Alloys 1 and 2 in Table 1). Alloy 2 contains a greater volumefraction of carbides compared to Alloy 1.X1.3 Alloy 3 was added in Table 1 since bar, rod, and wireproduced with this composition meet the currentASTM F 1537requirements. Alloy 3 is a dispersion-strengthened alloy con-taining fine aluminu
35、m-lanthanum oxides/nitrides.6,7X1.4 The minimum mechanical properties of wrought bar,rod, and wire conforming to this specification are superior tothe minimum mechanical properties of Specification F75material in the as-cast condition.X1.5 Some complex metallic phases, such as carbides,oxides, or ca
36、rbonitrides, or combinations thereof, may bepresent in the microstructure of this alloy.X1.6 ISO standards are listed for reference only. Althoughthe ISO 583212 standard listed in Section 2 is similar to thecorresponding ASTM standard, they are not identical. Use ofthe ISO standard instead of the pr
37、eferred ASTM standard maybe agreed upon between purchaser and supplier. The mechani-cal properties of warm-worked condition material, subsection5.1.3, of this specification are equivalent to the ISO 583212cold-worked condition.X1.7 Wrought material, typically hot-worked and unan-nealed with a surfac
38、e suitable for forging, shall be fabricatedand supplied in accordance with this specification when used asforging stock in the manufacture of forgings in accordancewith Specification F 799.X2. BIOCOMPATIBILITYX2.1 The alloy compositions covered by this specificationhave been employed successfully in
39、 human implant applica-tions in contact with soft tissue and bone for over a decade(reference 510k #K852964 for Alloy 3, which has been usedsince 1985).X2.2 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. Long term clinical experienc
40、e of the use of the materialreferred to in this specification, however, has shown that anacceptable level of biological response can be expected, if thematerial is used in appropriate applications.6Wang, K. K., Gustavson, L. J., and Dumbleton, J. H., U.S. Patent #4,668,290,“Dispersion Strengthened C
41、obalt-Chromium-Molybdenum Alloy Produced By GasAtomization”, Filed August 13, 1985, Issued May 26, 1987.7Wang, K. K., Gustavson, L. J., and Dumbleton, J. H., “The Development of aNew Dispersion Strengthened Vitallium Alloy for Medical Implants”, ModernDevelopments in Powder Metallurgy, Volume 20, 19
42、88, pp. 361-375, Metal PowderIndustries Federation, 105 College Road East, Princeton, NJ 08540-6692F1537073SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue(F 1537 00) that may impact the use of this standard. (Approved July 1, 2007
43、.)(1) The value in Table 3 of 1172 MPa was incorrectlypublished as 1192 MPa in the 2000 version of the standard andwas corrected with this edition.(2) Editorial corrections have been made in order to meetterminology and formatting guidelines established for implantmaterial standards.ASTM Internation
44、al 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
45、own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be
46、addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards,
47、 at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F1537074
