1、Designation: F 75 07Standard Specification forCobalt-28 Chromium-6 Molybdenum Alloy Castings andCasting Alloy for Surgical Implants (UNS R30075)1This standard is issued under the fixed designation F 75; the number immediately following the designation indicates the year of originaladoption or, in th
2、e 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 cobalt-28chromium-6 molybdenum alloy
3、unfinished investment productcastings for surgical implant applications and casting alloy inthe form of shot, bar, or ingots to be used in the manufactureof surgical implants. This specification does not apply tocompleted surgical implants made from castings.1.2 The values stated in inch-pound units
4、 are to be regardedas the standard. The SI equivalents in parentheses are forinformation only.2. Referenced Documents2.1 ASTM Standards:2A 957 Specification for Investment Castings, Steel andAlloy, Common Requirements, for General Industrial UseE3 Guide for Preparation of Metallographic SpecimensE8
5、Test Methods for Tension Testing of Metallic MaterialsE18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE 165 Test Method for Liquid Penetrant ExaminationE 354
6、 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysE 407 Practice for Microetching Metals and AlloysE 601 Test Method for Comparing EMF Stability of Single-Element Base-Metal Thermocouple Materials in Air3F 629 Practice for
7、Radiography of Cast Metallic SurgicalImplantsF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 Aerospace Material Specification:4AMS 2248 Chemical CheckAnalysis Limits: Corrosion andHeat Resistant Steels and
8、 Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron AlloysAMS 2269 Chemical Check Analysis Limits: Nickel,Nickel Alloys and Cobalt Alloys2.3 ISO Standards:5ISO 5832-4 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-Chromium-Molybdenum Casting AlloyISO 6892 Metallic Materials Tensile Test
9、ing at AmbientTemperatureISO 9001 Quality Management SystemsRequirements2.4 American Society for Quality Standard:6ASQ Cl Specification of General Requirements for a Qual-ity Program3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 investment casting, na metal casting that is pr
10、o-duced in a mold obtained by investing (surrounding) anexpendable pattern with a ceramic slurry that is allowed tosolidify. The expendable pattern may consist of wax, plastic, orother material and is removed prior to filling the mold withliquid metal.3.1.2 master heat, na quantity of metal processe
11、d in asingle furnace or refining vessel at one time in such a manneras to produce the desired composition and properties.3.1.3 sub-heat, na portion of a master heat remeltedwithout additional processing for pouring into castings. Syn-onyms: melt, production heat.NOTE 1Terminology section in accordan
12、ce with Specification A 957.4. Ordering Information4.1 Inquiries and orders for material under this specificationshall include the following information:4.1.1 Quantity (number of product castings or weight ofcasting alloy),1This specification is under the jurisdiction of ASTM Committee F04 onMedical
13、 and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved Jan. 1, 2007. Published January 2007. Originallyapproved in 1967. Last previous edition approved in 2001 as F 75 01.2For referenced ASTM standards, visit the
14、 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 page onthe ASTM website.3Withdrawn.4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA
15、15096-0001, http:/www.sae.org.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.6Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.1*A Summary of Changes sectio
16、n appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.2 ASTM designation and date of issue,4.1.3 Form (product casting, shot, bar, ingot),4.1.4 Applicable dimensions or drawing number,4.1.5 Conditio
17、n (as-cast, hot isostatically pressed (HIP),solution annealed, and so forth),4.1.6 Special tests, if any, and4.1.7 Other requirements.5. Materials and Manufacturing Requirements forProduct Castings5.1 Final thermal processing for castings, if any, shall bespecified by mutual agreement between the su
18、pplier andpurchaser.5.2 Castings shall be free of visible investment shell mate-rial and scale when examined without magnification.5.3 Welding may be used to repair castings as agreed uponbetween supplier and purchaser.5.3.1 Weld repair shall be performed in accordance withwritten procedures by indi
19、viduals certified to perform thoseprocedures.5.3.2 Weld filler metal conforming to the chemistry of Table1 shall be used when it is needed.5.3.3 Weld repair, if any, shall be performed before finalthermal processing.NOTE 2Under certain circumstances, a weld repair may act as a stressriser. Therefore
20、, care should be exercised in the location and extent ofweld repair as it relates to regions of the implant where significant stressesmight occur.6. Chemical Requirements6.1 Both product castings and casting alloy shall conform tothe chemical requirements prescribed in Table 1. The suppliershall not
21、 ship material that is outside the limits specified inTable 1.6.1.1 Chemical analysis shall be performed on a represen-tative specimen of a sub heat cast from each master heat usingthe same general procedures used in casting implants.6.1.2 Requirements for the major and minor elementalconstituents a
22、re listed in Table 1. Also listed are importantresidual elements. Analysis is not required for elements, whichare not listed in Table 1, to verify compliance with thisspecification.6.2 Product Analysis The product analysis is either for thepurpose of verifying the composition of a heat or lot or tod
23、etermine 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 this productanalysis.6.2.2 Product analysis tolerances do not broaden the speci-fied chemical requirements but instead cover variations be-twe
24、en laboratories in the measurement of chemical content.Product analysis limits shall be as specified in Table 2.7. Mechanical Requirements7.1 Tensile Properties for Product Castings:7.1.1 As-cast material shall conform to the mechanicalproperty requirements given in Table 3 when tested in accor-danc
25、e with Test Methods E8.7.1.2 Tension test specimens shall be melted and cast froma sub heat of each master heat by the same general proceduresused in casting the surgical implants or machined from surgicalimplant castings.7.1.3 Specimens may be cast, ground, or machined to finaldimensions in accorda
26、nce with the 0.25 in. (6.35 mm) diameterspecimen in Fig. 8 of Test Methods E8.7.1.4 Perform at least two tension tests per master heat.Should any of these test pieces not meet the specified require-ments, test two additional representative test pieces, in thesame manner, for each failed test piece.
27、The master heat shallbe considered in compliance only if all additional test piecesmeet the specified requirements.7.1.5 Tensile tests results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe elongation and reduction of area meet the minimumrequireme
28、nts specified. Refer to Test Methods E8, sections7.11.4 and 7.11.5. If either the elongation or reduction of areais less than the minimum requirement, discard the test andTABLE 1 Chemical CompositionElementComposition, % (Mass/Mass)min maxChromium 27.00 30.00Molybdenum 5.00 7.00Nickel . 0.50Iron . 0
29、.75Carbon . 0.35Silicon . 1.00Manganese . 1.00Tungsten . 0.20Phosphorous . 0.020Sulfur . 0.010Nitrogen . 0.25Aluminum . 0.10Titanium . 0.10Boron . 0.010CobaltAbalance balanceAApproximately equal to the difference of 100 % and the sum percentage of theother specified elements. The percentage of the c
30、obalt difference is not required tobe reported.TABLE 2 Product Analysis TolerancesA,BElementTolerance Under the Minimumor Over the Maximum Limit,% (Mass/Mass)CChromium 0.30Molybdenum 0.15Nickel 0.05Iron 0.03Carbon 0.02Silicon 0.05Manganese 0.03Tungsten 0.04Phosphorous 0.005Sulfur 0.003Nitrogen 0.02D
31、Aluminum 0.02Titanium 0.02Boron 0.002ASee Test Methods E 354.BRefer to AMS Standard 2269 for chemical check analysis limits (exceptnitrogen).CFor elements in which only a maximum percentage is indicated, the “underminimum limit” is not applicable.DRefer to AMS 2248 for chemical check analysis limits
32、.F75072retest. Retest one specimen for each specimen that did not meetthe minimum requirements.7.1.6 If castings are supplied in a heat-treated condition,tensile property requirements shall be agreed upon betweensupplier and purchaser.7.2 Tensile Properties for Casting Alloy:7.2.1 As-cast material s
33、hall conform to the mechanicalproperty requirements given in Table 3 when tested in accor-dance with Test Methods E8.7.2.2 Tensionepsis test specimens shall be melted and castfrom a sub heat of each master heat by the same generalprocedures used in casting of the surgical implants7.2.3 Specimens may
34、 be cast, ground, or machined to finaldimensions in accordance with the 0.25 in. (6.35 mm) diameterspecimen in Fig. 8 of Test Methods E8.7.2.4 Perform at least two tension tests per master heat.Should any of these test pieces not meet the specified require-ments, test two additional representative t
35、est pieces, in thesame manner, for each failed test piece. The master heat shallbe considered in compliance only if all additional test piecesmeet the specified requirements.7.2.5 Tensile tests results for which any specimen fracturesoutside the gage length shall be considered acceptable, if boththe
36、 elongation and reduction of area meet the minimumrequirements specified. Refer to Test Methods E8, sections7.11.4 and 7.11.5. If either the elongation or reduction of areais less than the minimum requirement, discard the test andretest. Retest one specimen for each specimen that did not meetthe min
37、imum requirements.8. Special Testing for Product Castings8.1 Liquid Penetrant ExaminationSampling plans andacceptance criteria shall be mutually agreed upon by supplierand purchaser. Individual parts should be examined in accor-dance with Test Method F 601 or Test Method E 165,asappropriate for the
38、surface condition of the casting beingtested.8.2 Radiographic ExaminationSampling plans and accep-tance criteria shall be mutually agreed upon by supplier andpurchaser. Radiographic examination shall be in accordancewith Practice F 629.8.3 MetallographyThe microstructural requirements andfrequency o
39、f examinations shall be mutually agreed upon bysupplier and purchaser. Specimen preparation shall be inaccordance with Guide E3and Practice E 407.8.4 Hardness:8.4.1 Materials conforming to this specification will typi-cally have a hardness of 25 to 35 HRC in the as-cast condition.The hardness determ
40、ination shall be performed in accordancewith Test Methods E18.8.4.2 Hardness values are for information only and shall notbe used as criteria for rejection.9. Significance of Numerical Limits9.1 The following applies to all specified numerical limits inthis specification. To determine conformance to
41、 these limits, anobserved or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.10. Certification10.1 A certification, including a complete test report, shallbe provided by
42、 the supplier at the time of shipment stating thatthe product castings or the casting alloy were manufacturedand tested in accordance with this specification.10.2 If the supplier and purchaser are one and the same,equivalent internal documentation shall be acceptable in lieu ofcertification.11. Qual
43、ity Program Requirements11.1 The foundry, its ingot suppliers, any processors anddistributors shall all maintain quality programs, such as isdefined in ASQ C1 or other recognized quality managementsystem such as ISO 9001.12. Keywords12.1 castingssurgical; cobalt alloys (for surgical im-plants); coba
44、lt-chromium-molybdenum-metals (for surgicalimplants); cobalt alloysTABLE 3 As-Cast Mechanical RequirementsPropertyUltimate tensile strength, min, psi (MPa) 95 000 (655)Yield strength, (0.2 % offset), min, psi (MPa) 65 000 (450)Elongation,Amin, % 8Reduction of area, min, % 8AElongation of material 0.
45、063 in. (1.6 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 reported with the test results. The method for determining elongation ofmaterial under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated.Alternatel
46、y, 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.)F75073APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The mechanical properties listed in Table 3 are used to
47、verify the capability of the alloy to produce castings ofacceptable strength and ductility. For consistency of testresults, it is advisable to subject test bars to the sameradiographic and penetrant requirements as will be used for thecastings they represent.X1.2 Cast microstructure and mechanical p
48、roperties aredependent on cross sectional thickness. The mechanical prop-erties measured on as-cast14-in. diameter test bars may not bethe same as those in castings of different cross-sectionalthickness.X1.3 Various heat treatments, including hot isostatic press-ing, solution annealing, and sinterin
49、g, may be used oncobalt-28 chromium-6 molybdenum alloy surgical implantcastings. This specification is not intended to cover the effectsof such processes.X1.4 If castings are straightened, bent or welded, they mayrequire subsequent annealing or special testing per Section 8.X1.5 Because of the wide variety of devices made from thisalloy, 100 % radiographic inspection may not be required.X1.6 The approximate ISO standard equivalent for thismaterial is ISO 5832-4. (Such ISO standards are listed forreference only. Although ISO standards are similar to thecorrespondin
