1、Designation: F562 07F562 13Standard Specification forWrought 35Cobalt-35Nickel-20Chromium-10MolybdenumAlloy for Surgical Implant Applications (UNS R30035)1This standard is issued under the fixed designation F562; the number immediately following the designation indicates the year of originaladoption
2、 or, in 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 requirements of wrought 35cobalt-35nickel-20chromium-
3、10molybdenum alloy (UNS R30035) inthe form of bar and wire, used for the manufacture of surgical implants.This alloy depends on combinations of work-strengthening,and work-strengthening and work strengthening and aging to attain a variety of combinations of strength and ductility.1.2 The values stat
4、ed in either SI units or inch-pound units are to be regarded separately as the standard. The SI equivalents ofthe inch-pound units may be approximate.standard. The values stated in each system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combining val
5、ues from the two systems may result in non-conformance with thestandard.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 MaterialsE29 Practice for Using Significant Di
6、gits in Test Data to Determine Conformance with SpecificationsE112 Test Methods for Determining Average Grain SizeE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, andCobalt AlloysF981 Practice for Assessment of Compatibility of Biomat
7、erials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneIEEE/ASTM SI 10 American National Standard for Metric Practice2.2 ISO Standards:3ISO 5832/6ISO 5832/6 Implants for SurgeryMetallic Materials Part 6: Wrought cobalt-nickel-chromium-molybdenumalloyAlloyISO 6892 Metallic
8、MaterialsTensile Testing at Ambient TemperatureISO 9001 Quality Management Systems2.3 Aerospace Material Specification:Specifications:4AMS 2269 Chemical Check Analysis LimitsWrought Nickel Alloys and Cobalt AlloysAMS 2630 Inspection, Ultrasonic Product over 0.5 inch (12.7 mm) ThickAMS 2632 Ultrasoni
9、c Inspection of Thin Materials2.4 American Society for Quality Standard:ASQ C1 Specification of General Requirements for a Quality Program52.5 Society of Automotive Engineers:SAE J1086 Practice for Numbering Metals and Alloys (UNS)41 This specification is under the jurisdiction of ASTM Committee F04
10、 on Medical and Surgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved June 1, 2007March 1, 2013. Published July 2007 March 2013. Originally approved in 1978. Last previous edition approved in 20022007 asF562 02.F562 0
11、7. DOI: 10.1520/F0562-07.10.1520/F0562-13.2 For referencedASTM standards, 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 St
12、andardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.4 Available from Society of Automotive Engineers, Inc., 400 Commonwealth Drive, Warrendale, PA 150960001.This document is not an ASTM standard and is intended only to provide the user of
13、 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 appropriate. In all cases only the current versionof the standard as pub
14、lished 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 States13. Terminology3.1 Definitions of Terms Specific to This Standard
15、:3.1.1 bar, nrounds, flats, or other shapes from 0.1875 to 4.00 in. 4.76 to 101.60 mm in diameter or thickness (other sizesand shapes by special order).3.1.2 fine wire, nrounds, flats, or other shapes less than 0.063 in. 1.60 mm in diameter or thickness.3.1.3 forging bar, nbar as described in 3.1.1,
16、 used for the production of forgings; may be furnished in the hot-workedcondition.3.1.4 lotlot, nthe total number of mill products produced from the same melt heat under the same conditions at essentiallythe same time.3.1.5 wire, nround, flats, or other shapes less than 0.1875 in. 4.76 mm in diamete
17、r or thickness.4. Classification4.1 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).4.2 WireRound, rectangular, or other complex-shaped product produced and delivered in coils.4.3 Fine W
18、ireWire with diameter or major dimension less than 0.63 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 (Section 87),4.1.4 Fo
19、rm (bar or wire),4.1.5 Applicable dimensions, including size, thickness, width, and length (exact, random, multiples), or drawing number,4.1.6 Condition (6.15.1),4.1.7 Finish (6.25.2),4.1.8 Special tests, if applicable, and4.1.9 Other requirements.5. Materials and Manufacture5.1 ConditionBar and wir
20、e shall be furnished, as specified, in the solution-annealed, cold-worked, or cold-worked and agedaged, or hot-worked condition.5.2 FinishBar and wire shall be furnished in the cold drawn, cold-drawn, pickled, ground, or ground and polished, as specifiedby the purchaser.6. Chemical Requirements6.1 C
21、hemical analysis shall be in accordance with Test Methods E354 and A751.6.2 The cobalt-35nickel-20chromium-10molybdenum alloy shall conform to the chemical requirements prescribed in Table 1.The supplier shall not ship material that is outside the limits specified in Table 1.TABLE 1 Chemical Require
22、mentsElement Composition,% (mass/mass)min maxCarbon . 0.025Manganese . 0.15Silicon . 0.15Phosphorus . 0.015Sulfur . 0.010Chromium 19.0 21.0Nickel 33.0 37.0Molybdenum 9.0 10.5Iron . 1.0Titanium . 1.0Boron . 0.015CobaltA balance balanceA Approximately equal to the difference between 100 % and the sum
23、percentageof the other specified elements. The percentage cobalt content by difference is notrequired to be reported.F562 1326.2.1 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residualelements. Analysis for elements not listed in Table
24、1 is not required to verify compliance with this specification.6.3 Product AnalysisThe product analysis is either for the purpose of verifying the composition of a heat or lot or to determinevariations in the composition within the heat.6.3.1 Acceptance or rejection of a heat or lot of material may
25、be made by the purchaser on the basis of this product analysis.6.3.2 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations betweenlaboratories in the measurement of chemical content. Product analysis limits shall be as specified in Table 2.TABLE 2 P
26、roduct Analysis TolerancesA,BElementTolerance Under theMinimum orOver the Maximum Limit %(mass/mass)CCarbon 0.01Manganese 0.03Silicon 0.02Phosphorus 0.005Sulfur 0.005Chromium 0.25Nickel 0.30Molybdenum 0.15Iron 0.05Titanium 0.04Boron 0.005A See Test Method E354.B See AMS 2269 for chemical check analy
27、sis limits.C Under minimum limit not applicable for elements where only a maximumpercentage is indicated.F562 1337. Mechanical Requirements7.1 Tensile Properties:7.1.1 Tensile properties shall be determined in accordance with Test Methods E8E8/E8M. Perform a tension test on at least onetension test
28、piece from each lot. Should any test piece not meet the specified requirements, test two additional test piecesrepresentative of the same lot, in the same manner, for each failed test piece. The lot shall be considered in compliance only if alladditional test pieces meet the specified requirements.7
29、.1.2 Tensile tests result for which any specimen fractures outside the gauge length shall be considered acceptable, if both theelongation and reduction of area meet the minimum requirements specified. Refer to subsections 7.11.4 and 7.11.5 of Test MethodsE8E8/E8M. If either the elongation or reducti
30、on of area is less than the minimum requirement, discard the test and retest. Retestone specimen for each specimen that did not meet the minimum requirements7.2 Solution-annealed bar and wire shall conform to the mechanical properties specified in Tables 3 and 4.7.3 Mechanical properties for the col
31、d-worked and cold-worked and aged conditions: medium hard, hard and extra hard shallconform to the mechanical property requirements specified in Tables 3 and 4.7.3.1 Material may be provided in the cold worked cold-worked condition, capable of meeting the cold work cold-worked andaged condition. In
32、this case, the capability heat treated heat-treated tensile properties shall be tested and reported.7.4 Mechanical properties for fine wire in the annealed, cold worked cold-worked hard and spring conditions shall conform tothe mechanical property requirements specified in Table 5.7.5 The level of m
33、echanical properties for material in other conditions shall be specified in the purchase order.8. Dimensions and Permissible Variations8.1 Units of Measure:8.1.1 SelectionThis specification requires that the purchaser select the units (SI or inch-pound) to be used for productclarification. In the ab
34、sence of a stated selection of units on the purchase order, this selection may be expressed by the purchaserin several alternative forms listed in order of precedence.8.1.1.1 If the purchaser and supplier have a history of using specific units, these units shall continue to be certified untilexpress
35、ly changed by the purchaser.8.1.1.2 In the absence of historic precedence, if the units used 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 certification.8.1.1.3 If the purchaser
36、s selection of units is unclear, the units of measure shall be agreed upon between the purchaser andsupplier.8.1.2 Conversion of UnitsIf the suppliers test equipment does not report in the selected units, the test equipment units maybe converted to the selected units for certification purposes. Accu
37、rate arithmetic conversion and proper use of significant digitsTABLE 3 Mechanical Properties (Bar Products)Condition Tensile Strength,Apsi (MPa)MPaYield Strength,A(0.2 % Offset)psi (MPa)MPaElongationBmin, %Reduction in Area,min, %Solution annealedC 115 000 to 155 000(793 to 1069)35 000 to 85 000(241
38、 to 586)50.0 65.0Solution-annealedC 115 000 to 155 000793 to 106935 000 to 85 000241 to 58650.0 65.0Cold-worked:medium hard 145 000(1000) min.95 000(655) min.20.0 60.0medium hard 145 0001000 min.95 000655 min.20.0 60.0hard 175 000(1207) min.145 000(1000) min.10.0 50.0hard 175 0001207 min.145 0001000
39、 min.10.0 50.0Cold-worked and agedD 260 000(1793) min230 000(1586) min8.0 35.0Cold-worked and agedD 260 0001793 min230 0001586 min8.0 35.0A Tension and yield requirements apply to tests taken longitudinally to the direction of rolling.B Elongation of material 0.063 in. (1.6 mm)1.6 mm or greater in d
40、iameter (D) or width (W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmustshall be reported with the test results.The method for determining elongation of material under 0.063 in. (1.6 mm)1.6 mm in diameter or thickness may be negotiated.Alternately, a gauge length co
41、rresponding to ISO 6892 may be used when agreed upon between the supplier and purchaser (5.65 square root So, where So is the originalcross sectional area).C 1925 25F (10501050 15C),15C, 1 to 2 h at temperature, air coolcooled or water quenchquenched to room temperature.D Capability TestCold worked
42、TestCold-worked and aged within the range 1000 to 1200F 25F (540540 to 645C 15C)15C for 4 h and air cool.cooled.F562 134should be observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the use of SI units. Annex A ofthis specification provides conversion tables and Annex B
43、 provides rules for conversion and significance.9. Special Tests9.1 The grain size of bar product shall be predominantly No. 4 or finer with occasional grains as large as No. 2 permissible whentested in accordance with Test Methods E112.TABLE 4 Mechanical PropertiesWire Products (d $ 0.063 in. 1.6 m
44、m)ACondition Tensile Strength,Bpsi (MPa)MPaYield Strength,B(0.2 % Offset)psi (MPa)MPaElongationCmin, %Reduction in Area,min, %Solution annealed 115 000 to 155 000(793 to 1069)35 000 to 85 000(241 to 586)50.0 65.0Solution-annealed 115 000 to 155 000793 to 106935 000 to 85 000241 to 58650.0 65.0Cold-w
45、orked:medium hard 145 000(1000) min.95 000(655) min.20.0 60.0medium hard 145 0001000 min.95 000655 min.20.0 60.0hard 175 000(1207) min.145 000(1000) min.10.0 50.0hard 175 0001207 min.145 0001000 min.10.0 50.0extra hardD 260 000(1793) min230 000(1586) min8.0 35.0extra hardD 260 0001793 min230 0001586
46、 min8.0 35.0A Mechanical properties for material under 0.063 in. (1.6 mm)1.6 mm shall be in accordance with Table 5.B Tension and yield requirements apply to tests taken longitudinally to the direction of rolling.C Elongation of material 0.063 in. (1.6 mm)1.6 mm or greater in diameter (D) or width (
47、W) shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge lengthmustshall be reported with the test results.The method for determining elongation of material under 0.063 in. (1.6 mm)1.6 mm in diameter or thickness may be negotiated.Alternately, a gauge length corresponding to ISO 689
48、2 may be used when agreed upon between the supplier and purchaser. (5.65 square root So, where So is the originalcross sectional area.)TABLE 5 Mechanical PropertiesFine Wire (d 0.063 in. 1.6 mm)ConditionAnnealed Cold WorkedAnnealed Cold-WorkedHard SpringDiameter,in. (mm)Tensile Strength,psi (MPa)Elo
49、ngationmin, %Tensile Strength,psi (MPa)Elongationmin, %Tensile Strength,psi (MPa)ElongationAmin, %Diameter,in. mmTensile Strength,psi MPaElongationmin, %Tensile Strength,psi MPaElongationmin, %Tensile Strength,psi MPaElongationAmin, %0.063 to 0.058(1.600 to 1.473)120 000 to 150 000(827 to 1034)40.0 % 240 000 to 270 000(1655 to 1862)2.0 % 270 000 to 300 000(1862 to 2068)2.0 %0.063 to 0.0581.600 to 1.473120 000 to 150 000827 to 103440.0 % 240 000 to 270 00016
