1、Designation: F90 09F90 14Standard Specification forWrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy forSurgical Implant Applications (UNS R30605)1This standard is issued under the fixed designation F90; the number immediately following the designation indicates the year of originaladoption or, in
2、 the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for wrought cobalt-20chromium-15tungsten-10
3、nickel alloy used for surgicalimplants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixationwire (see Specification F1091).1.2 The values stated in SI units in this standard are the primary units. Values in primary SI or secon
4、dary inch-pound units areto be regarded separately as standard. The values given in parentheses are mathematical conversions to SI units that are providedfor information only and are not considered standard.stated in each system may not be exact equivalents; therefore each systemshall be used indepe
5、ndent of the other. Combining values from the two systems may result in non-conformance with thespecification.2. Referenced Documents2.1 ASTM Standards:2A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel ProductsE8E8/E8M Test Methods for Tension Testing of Metallic Material
6、sE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE45 Test Methods for Determining the Inclusion Content of SteelE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, andCobalt AlloysF981 P
7、ractice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneF1091 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)F2527 Specification for Wrought Seamless and Welded and Dr
8、awn Cobalt Alloy Small Diameter Tubing for Surgical Implants(UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System2.2 Aerospace Material Specification:3AMS 2269 Chemical Ch
9、eck Analysis Limits, Wrought Nickel Alloys and Cobalt AlloysAMS 5759 Cobalt Alloy, Corrosion and Heat Resistant Bars, Forgings, and Rings, 52Co 20 Cr 10Ni 15W, Solution HeatTreated2.3 ISO Standards:4ISO 5832-5 Wrought Cobalt-Chromium-Tungsten-Nickel AlloyISO 6892 Metallic Materials Tensile Testing a
10、t Ambient TemperatureISO 9001 Quality SystemRequirements2.4 American Society for Quality (ASQ) Standard:C1 Specification of General Requirements for a Quality Program51 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct
11、responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved June 1, 2009Nov. 1, 2014. Published July 2009January 2015. Originally approved in 1968. Last previous edition approved in 20072009 asF90 07.F90 09. DOI: 10.1520/F0090-09.10.1520/F0090-14.2 For referencedASTM sta
12、ndards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrend
13、ale, PA 15096-0001, http:/www.sae.org.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.5 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.This document is
14、not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropri
15、ate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*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 States1
16、3. Classification3.1 BarRound, rectangular, or other complex shaped product delivered straightened and cut to defined lengths, with amaximum cross-sectional area of 16 in.2 (103 cm2).3.2 WireRound, rectangular, or other complex shaped product produced and delivered in coils.3.3 Fine WireWire with di
17、ameter or major dimension less than 0.063 in. (1.6 mm).4. Ordering Information4.1 Inquiries and orders for material under this specification shall 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, ro
18、d, wire, sheet, strip),4.1.5 Applicable dimensions including size, thickness, width, and length (exact, random, or multiples) or drawing number,4.1.6 Condition (see 5.1),4.1.7 Finish (see 5.2),4.1.8 Other requirements.5. Materials and Manufacture5.1 ConditionBar, wire, sheet, and strip shall be furn
19、ished to the purchaser, as specified, in the annealed or cold-workedcold-worked, or cold worked and aged condition.5.2 Finish:5.2.1 Bar and wire shall be furnished bright annealed, cold drawn, pickled, ground, or ground and polished, as specified by thepurchaser.5.2.2 Sheet shall be furnished bright
20、 annealed, pickled, cold-rolled, or polished, as specified by the purchaser.6. Chemical Requirements6.1 The heat analysis shall conform to the chemical composition of Table 1. The supplier shall not ship material that is outsidethe limits specified in Table 1.6.1.1 Requirements for the major and min
21、or elemental constituents are listed in Table 1. Also listed are important residualelements. Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.6.2 Product AnalysisThe product analysis is either for the purpose of verifying the composition of a h
22、eat or lot or to determinevariations in the composition within the heat.6.2.1 Acceptance or rejection of a heat or lot of material may be made by the purchaser on the basis of this product analysis.6.2.2 Product analysis tolerances do not broaden the specified heat analysis requirements but instead
23、cover variations betweenlaboratories in the measurement of chemical content. Product analysis limits shall be as specified in Table 2.6.3 For referee purposes, Test Methods E354 shall be used.6.4 Methods and practices relating to chemical analysis required by this specification shall be in accordanc
24、e with Test MethodsA751.TABLE 1 Chemical RequirementsElement Composition, % (mass/mass)min maxCarbon 0.05 0.15Manganese 1.00 2.00Silicon . 0.40Phosphorus . 0.040Sulfur . 0.030Chromium 19.00 21.00Nickel 9.00 11.00Tungsten 14.00 16.00Iron . 3.00CobaltA balance balanceA Approximately equal to the diffe
25、rence between 100 % and the sum percentageof the other specified elements. The percentage of the cobalt difference is notrequired to be reported.F90 1427. Mechanical Requirements7.1 The material in the annealed condition shall conform to the mechanical properties specified in Tables 3 and 4.7.2 Mate
26、rial in the cold worked condition shall conform to the mechanical properties specified in Table 3.7.3 The cold worked and aged condition may be ordered in accordance with mechanical property requirements agreed uponbetween supplier and purchaser.7.4 Tensile properties shall be determined in accordan
27、ce with Test Methods E8E8/E8M. Perform at least one tension test fromeach lot. Should any test piece not meet the specified requirements, test two additional test pieces representative of the same lot,in the same manner, for each failed test piece. The lot shall be considered in compliance only if a
28、ll additional test pieces meet thespecified requirements.7.4.1 Tensile tests results for which any specimen fractures outside the gauge length shall be considered validacceptable if boththe elongation and reduction of area meet meets the minimum requirements specified. If either the elongation or re
29、ductionre-quirement specified. Refer to 7.11.4 of Test Methods E8/E8Mof area . If the elongation is less than the minimum requirement,invalidatediscard the specimentest and retest. Retest one specimen for each invalidated specimen.specimen that did not meet theminimum requirements.8. Metallurgical R
30、equirements8.1 The microcleanliness of the alloy as determined by MethodAof Test Methods E45, except using Plate I-r, on representativebillet or bar samples from the heat shall not exceed the limits of Table 5.9. Units of Measure9.1 SelectionThis specification requires that the purchaser selects the
31、 units (SI or inch-pound) to be used for productcertification.TABLE 2 Product Analysis TolerancesAElement Tolerance 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.
32、07A Refer to AMS 2269.B Under minimum limit not applicable for elements where only a maximumpercentage is indicated.TABLE 3 Mechanical Requirements, Bar and WireACondition Ultimate Tensile Strength,min psi (MPa) Yield Strength (0.2 % Offset),min, psi (MPa) ElongationB,C in 4D or 4W,min, %Annealed 12
33、5 000 (860) 45 000 (310) 30Cold-worked 180 000 (1250) 110 000 (760) 15TABLE 3 Mechanical Requirements, Bar and WireACondition Ultimate Tensile Strength,MPa (psi), min Yield Strength (0.2 % Offset),MPa (psi), min ElongationB ,C in 4D or 4W,min, %Annealed 860 (125 000) 310 (45 000) 30Cold-workedD 1250
34、 (180 000) 760 (110 000) 15A Annealed wire less than 0.063 in. (160 mm) diameter is covered in Specification F1091.B 4D = 4 diameter; 4W = 4 width.C ElongationElongation of material 0.062 in. (1.575 mm) or greater in diameter (D)(D) or width (W)(W ) shall be measured using a gauge length of 2 in. or
35、 4D4D or 4W.4W.The gauge length mustshall be reported with the test results. The method for determining elongation of material under 0.062 in. (1.575 mm) in diameter or thickness maybe negotiated. Alternately, a gauge length corresponding to ISO 6892 may be used when agreed upon between supplier and
36、 purchaser (purchaser; 5.655.65So timesthe square root of So, where SoSo is the original cross-sectional area).DCold worked and aged condition may be ordered in accordance with mechanical requirements agreed upon between supplier and purchaser.F90 1439.2 Conversion of UnitsIf the suppliers test equi
37、pment does not normally report in the selected units, the test equipment unitsmay be converted to the selected units for certification purposes.Accurate arithmetic conversion and proper use of significant digitsshould be observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines f
38、or the use of SI units. Annex A ofIEEE/ASTM SI 10 provides conversion tables and Annex B of IEEE/ASTM SI 10 provides rules for conversion and significantdigits.10. Significance of Numerical Limits10.1 The following applies to all specified numerical limits in this specification. To determine conform
39、ance to these limits, anobserved or calculated value shall be rounded to the nearest unit in the last right-hand digit used in expressing the specificationlimit, in accordance with the rounding method of Practice E29.11. Certification11.1 Certification shall be provided by the supplier The supplier
40、shall provide a certification that the material meets therequirements of this specification. was tested in accordance with this specification and met all requirements. A report of the testresults shall be furnished to the purchaser at the time of shipment.12. Quality Program Requirements12.1 The all
41、oy producer and any processors supplier shall maintain a quality program, such as defined in ASQ C1 ISO 9001,or ISO 9001.similar.13. Keywords13.1 cobalt alloys (for surgical implants); cobalt chromium; L-605 alloy; metals (for surgical implants)cobalt alloysAPPENDIXES(Nonmandatory Information)X1. RA
42、TIONALEX1.1 The primary reason for this specification is to characterize composition and properties to ensure consistency in the startingmaterial used, directly or as modified by forging, casting, or shape forming, in the manufacturing of medical devices.X1.2 The minimum mechanical properties for sh
43、eet and strip supplied in the annealed condition are generally recognized ascommercially attainable for the thickness range cited in this specification.TABLE 4 Mechanical Requirements, Sheet and StripCondition Thickness, in. (mm) Ultimate Tensile Strength,min, psi (MPa) Yield Strength (0.2 % Offset)
44、,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 0.020 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.
45、75), incl 130 000 (896) 55 000 (379) 45TABLE 4 Mechanical Requirements, Sheet and StripCondition Thickness, in. (mm) Ultimate Tensile Strength,MPa (psi), min Yield Strength (0.2 % Offset),MPa (psi), min Elongation in 2 in.(50 mm), min, %Annealed 0.010 to 0.020 (0.254 to 0.508), incl 896 (130 000) 37
46、9 (55 000) 30over 0.020 to 0.032 (0.508 to 0.813), incl 896 (130 000) 379 (55 000) 35over 0.032 to 0.043 (0.813 to 1.09), incl 896 (130 000) 379 (55 000) 40over 0.043 to 0.187 (1.09 to 4.75), incl 896 (130 000) 379 (55 000) 45TABLE 5 Microcleanliness Requirementscolwidth=“0.52in“/COLSPECInclusionTyp
47、eA(Sulfide)B(Alumina)C(Silicate)D(GlobularOxides)Thin 1.5 1.5 1.5 1.5Heavy 1.0 1.0 1.0 1.0F90 144X1.3 ISO standards are listed for reference only. Use of an ISO standard, in addition to, or instead of a preferred ASTM standardmay be negotiated between the purchaser and supplier.X1.4 This cobalt base
48、 alloy, UNS R30605, is known generically as “L-605” and has been used extensively in the aerospaceindustry since the early 1980s. Aerospace Material Specification AMS 5759 includes the chemical and mechanical properties forthe UNS 30605, Cobalt Alloy, Corrosion and Heat Resistant, Bars, Forgings, an
49、d Rings, 52Co - 20Cr - 10Ni 15W, SolutionHeat-Treated. ISO standard 5832-5 for Wrought Cobalt-Chromium-Tungsten-Nickel Alloy also describes cobalt base alloy UNSR30605.X1.5 Units of MeasureX1.5.1 ASTM PolicyASTM is promoting the use of rationalized SI (metric) units in their standards. The F12.04 Committee hasmodified this specification to facilitate the transition by the medical materials industry to SI between now and 2018. In the firstphase of this transition, running to 2013, the specifications will be structured to allow the use of either SI or
