1、Designation: F 90 07Standard Specification forWrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy forSurgical Implant Applications (UNS R30605)1This standard is issued under the fixed designation F 90; the number immediately following the designation indicates the year of originaladoption or, in the
2、 case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for wroughtcobalt-20chromium-15tungsten-10
3、nickel alloy used for surgi-cal implants. The properties specified apply specifically towrought bar, rod, wire, sheet, and strip, but do not apply tosurgical fixation wire (see Specification F 1091).1.2 The values stated in inch-pound units are to be regardedas the standard. The SI equivalents in pa
4、rentheses are forinformation 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 MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance wi
5、th SpecificationsE45 Test Methods for Determining the Inclusion Contentof SteelE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants wit
6、h Respect to Effect ofMaterials on Muscle and BoneF 1091 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire UNSR30605F 2527 Specification for Wrought Seamless and Welded andDrawn Cobalt Alloy Small Diameter Tubing for SurgicalImplants (UNS R30003, UNS R30008
7、, UNS R30035, UNSR30605, and UNS R31537)2.2 Aerospace Material Specification:3AMS 2269 Chemical Check Analysis Limits, WroughtNickel Alloys and Cobalt AlloysAMS 5759 Cobalt Alloy, Corrosion and Heat ResistantBars, Forgings, and Rings, 52Co 20 Cr 10Ni 15W,Solution Heat Treated2.3 ISO Standards:4ISO 5
8、832-5 Wrought Cobalt-Chromium-Tungsten-NickelAlloyISO 6892 Metallic Materials Tensile Testing at AmbientTemperatureISO 9001 Quality SystemRequirements2.4 American Society for Quality (ASQ) Standard:C1 Specification of General Requirements for a QualityProgram53. Classification3.1 BarRound, rectangul
9、ar, or other complex shapedproduct delivered straightened and cut to defined lengths, witha maximum cross-sectional area of 16 in.2(103 cm2).3.2 WireRound, rectangular, or other complex shapedproduct produced and delivered in coils.3.3 Fine WireWire with diameter or major dimension lessthan 0.063 in
10、. (1.6 mm).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 and date of issue,4.1.3 Mechanical properties (see Section 7),4.1.4 Form (bar, rod, wire, sheet, strip),4.1.5 Applicable dimen
11、sions including size, thickness,width, and length (exact, random, or multiples) or drawingnumber,4.1.6 Condition (see 5.1),4.1.7 Finish (see 5.2),1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcom
12、mittee F04.12 on Metallurgical Materials.Current edition approved May 15, 2007. Published June 2007. Originallyapproved in 1968. Last previous edition approved in 2001 as F 90 01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org.
13、 For Annual Book of ASTMStandards volume information, refer to the standards Document 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),
14、 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from American Society 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,
15、PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.8 Other requirements.5. Materials and Manufacture5.1 ConditionBar, wire, sheet, and strip shall be furnishedto the purchaser, as specified, in the annealed or cold-workedcondition.5.2 Finish:5.2.1 Bar and wire shall be furnished bright
16、 annealed, colddrawn, pickled, ground, or ground and polished, as specified bythe purchaser.5.2.2 Sheet shall be furnished bright annealed, pickled,cold-rolled, or polished, as specified by the purchaser.6. Chemical Requirements6.1 The heat analysis shall conform to the chemical com-position of Tabl
17、e 1. The supplier shall not ship material that isoutside the limits specified in Table 1.6.1.1 Requirements for the major and minor elementalconstituents are listed in Table 1. Also listed are importantresidual elements. Analysis for elements not listed in Table 1 isnot required to verify compliance
18、 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 materialmay be made by the purchaser on the basis of
19、 this productanalysis.6.2.2 Product analysis tolerances do not broaden the speci-fied heat analysis requirements but instead cover variationsbetween laboratories in the measurement of chemical content.Product analysis limits shall be as specified in Table 2.6.3 For referee purposes, Test Methods E 3
20、54 shall be used.6.4 Methods and practices relating to chemical analysisrequired by this specification shall be in accordance with TestMethods A 751.7. Mechanical Requirements7.1 The material in the annealed condition shall conform tothe mechanical properties specified in Tables 3 and 4.7.2 Material
21、 in the cold worked condition shall conform tothe mechanical properties specified in Table 3.7.3 Tensile properties shall be determined in accordancewith Test Methods E8. Perform at least one tension test fromeach lot. Should any test piece not meet the specified require-ments, test two additional t
22、est pieces representative of the samelot, in the same manner, for each failed test piece. The lot shallbe considered in compliance only if all additional test piecesmeet the specified requirements.7.3.1 Tensile tests result for which any specimen fracturesoutside the gauge length shall be considered
23、 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. If either the elongation or reduction ofarea is less than the minimum requirement, discard the test andretest. Retest one specimen for each speci
24、men that did not meetthe minimum requirements.8. Metallurgical Requirements8.1 The microcleanliness of the alloy as determined byMethod A of Test Methods E45, except using Plate I-r, onrepresentative billet or bar samples from the heat shall notexceed the limits of Table 5.9. Significance of Numeric
25、al 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 the specifi-cation limit, in accordance with the rou
26、nding method ofPractice E29.10. Certification10.1 Certification shall be provided by the supplier that thematerial meets the requirements of this specification. A reportof the test results shall be furnished at the time of shipment.11. Quality Program Requirements11.1 The alloy producer and any proc
27、essors shall maintain aquality program, such as defined in ASQ C1 or ISO 9001.12. Keywords12.1 cobalt alloys (for surgical implants); cobalt chromium;L-605 alloy; metals (for surgical implants)cobalt alloysTABLE 1 Chemical RequirementsElementComposition, % (mass/mass)min maxCarbon 0.05 0.15Manganese
28、 1.00 2.00Silicon . 0.40Phosphorus . 0.040Sulfur . 0.030Chromium 19.00 21.00Nickel 9.00 11.00Tungsten 14.00 16.00Iron . 3.00CobaltAbalance balanceAApproximately equal to the difference between 100 % and the sum percentageof the other specified elements. The percentage of the cobalt difference is not
29、required to be reported.TABLE 2 Product Analysis TolerancesAElementTolerance Under the Minimum Limit or Over theMaximum LimitBCarbon 0.01Manganese 0.04Silicon 0.03Phosphorous 0.005Sulfur 0.005Chromium 0.25Nickel 0.15 under min; 0.20 over maxTungsten 0.25Iron 0.07ARefer to AMS 2269.BUnder minimum lim
30、it not applicable for elements where only a maximumpercentage is indicated.F90072APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to char-acterize composition and properties to ensure consistency inthe starting material used, directly or as modified
31、by forging,casting, or shape forming, in the manufacturing of medicaldevices.X1.2 The minimum mechanical properties for sheet andstrip supplied in the annealed condition are generally recog-nized as commercially attainable for the thickness range citedin this specification.X1.3 ISO standards are lis
32、ted for reference only. Use of anISO standard, in addition to, or instead of a preferred ASTMstandard may be negotiated between the purchaser and sup-plier.X1.4 This cobalt base alloy, UNS R30605, is knowngenerically as “L-605” and has been used extensively in theaerospace industry since the early 1
33、980s. Aerospace MaterialSpecificationAMS 5759 includes the chemical and mechanicalproperties for the UNS 30605, Cobalt Alloy, Corrosion andHeat Resistant, Bars, Forgings, and Rings, 52Co - 20Cr - 10Ni15W, Solution Heat-Treated. ISO standard 5832-5 for WroughtCobalt-Chromium-Tungsten-Nickel Alloy als
34、o describes co-balt base alloy UNS R30605.X2. BIOCOMPATIBILITYX2.1 The material composition covered by this standardhas been employed successfully in human implant applicationsin contact with soft tissue and bone for over a decade. Due tothe well characterized level of local biological response esta
35、b-lished by this material, it has been used as a control material inPractice F 981.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
36、 expected, if thematerial is used in appropriate applications.TABLE 3 Mechanical Requirements, Bar and WireAConditionUltimate Tensile Strength,min psi (MPa)Yield Strength (0.2 % Offset),min, psi (MPa)ElongationB,Cin 4D or 4W,min, %Annealed 125 000 (860) 45 000 (310) 30Cold-worked 180 000 (1250) 110
37、000 (700) 8AAnnealed wire less than 0.063 in. (160 mm) diameter is covered in Specification F 1091.B4D =43 diameter; 4W =43 width.CElongation of material 0.062 in. (1.575 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 lengthmust be
38、reported with the test results. The method for determining elongation of material under 0.062 in. (1.575 mm) in diameter or thickness may be negotiated.Alternately, a gauge length corresponding to ISO 6892 may be used when agreed upon between supplier and purchaser (5.65 =So where So is the original
39、cross-sectional area).TABLE 4 Mechanical Requirements, Sheet and StripCondition Thickness, in. (mm)Ultimate Tensile Strength,min, psi (MPa)Yield Strength (0.2 % Offset),min, psi (MPa)Elongation in 2 in.(50 mm), min, %Annealed 0.010 to 0.020 (0.254 to 0.508), incl 130 000 (896) 55 000 (379) 30over 0.
40、020 to 0.032 (0.508 to 0.813), incl 130 000 (896) 55 000 (379) 35over 0.032 to 0.043 (0.813 to 1.09), incl 130 000 (896) 55 000 (379) 40over 0.043 to 0.187 (1.09 to 4.75), incl 130 000 (896) 55 000 (379) 45TABLE 5 Microcleanliness RequirementsInclusion TypeA(Sulfide)B(Alumina)C(Silicate)D(Globular O
41、xides)Thin 1.5 1.5 1.5 1.5Heavy 1.0 1.0 1.0 1.0F90073SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 90 01)that may impact the use of this standard. (Approved May 15, 2007.)(1) Defined bar, wire, and fine wire to be consistent
42、with actualindustry practice.(2) Added the cold-drawn condition to Section 7 and Table 3for bar product.(3) Added microcleanliness requirements to Section 8 and anew Table 5. These requirements are equivalent to Specifica-tion F 2527.(4) Added the significance of numerical limits in Section 9.ASTM I
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46、Standards, 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).F90074
