ASTM F75-2018 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).pdf

1、Designation: F75 12F75 18Standard Specification forCobalt-28 Chromium-6 Molybdenum Alloy Castings andCasting Alloy for Surgical Implants (UNS R30075)1This standard is issued under the fixed designation F75; the number immediately following the designation indicates the year of originaladoption or, i

2、n 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 chemical, mechanical, and metallurgical requirements fo

3、r cobalt-28 chromium-6 molybdenumalloy unfinished investment product castings for surgical implant applications and casting alloy in the form of shot, bar, or ingotsto be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made fromcastings.

4、1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in eachsystem may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from thetwo systems may result in non-conformance wi

5、th the standard.1.3 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technica

6、l Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2A957 Specification for Investment Castings, Steel and Alloy, Common Requirements, for General Industrial UseE3 Guide for Preparation of Metallographic SpecimensE8/E8M Test Methods for Tension Testing of Metallic Materials

7、E18 Test Methods for Rockwell Hardness of Metallic MaterialsE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE165 Practice for Liquid Penetrant Examination for General IndustryE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, M

8、agnetic, and Other Similar Iron, Nickel, andCobalt AlloysE407 Practice for Microetching Metals and AlloysE601F601 Guide for Measuring Electromotive Force (emf) Stability of Base-Metal Thermoelement Materials with Time inAirPractice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF6

9、29 Practice for Radiography of Cast Metallic Surgical ImplantsF981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and Insertion into BoneIEEE/ASTM SI 10 American National Standard for Metric Practice2.2 Aerospace Material S

10、pecification:3AMS 2248 Chemical Check Analysis Limits: Corrosion and Heat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, and Iron AlloysAMS 2269 Chemical Check Analysis Limits: Nickel, Nickel Alloys and Cobalt Alloys2.3 ISO Standards:4ISO 5832-4 Implants for SurgeryMetallic Ma

11、terialsPart 4: Cobalt-Chromium-Molybdenum Casting AlloyISO 6892 Metallic MaterialsTensile Testing at Ambient Temperature1 This specification is under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and and is the direct responsibility of SubcommitteeF04.12 on Meta

12、llurgical Materials.Current edition approved May 15, 2012Nov. 15, 2018. Published June 2012January 2019. Originally approved in 1967. Last previous edition approved in 20072012 asF75 075.F75 12. DOI: 10.1520/F0075-12.10.1520/F0075-18.2 For referencedASTM standards, visit theASTM website, www.astm.or

13、g, 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., Warrendale, PA 15096-0001, http:/www.sae.org.4 Av

14、ailable from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.This document is 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. Becaus

15、eit 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 published by ASTM is to be considered the official document.*A Summary of Changes section appears

16、 at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1ISO 9001 Quality Management SystemsRequirements3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 investment casting, na metal casting tha

17、t is produced in a mold obtained by investing (surrounding) an expendablepattern with a ceramic slurry that is allowed to solidify. The expendable pattern may consist of wax, plastic, or other material andis removed prior to filling the mold with liquid metal.3.1.2 master heat, na quantity of metal

18、processed in a single furnace or refining vessel at one time in such a manner as toproduce the desired composition and properties.3.1.3 sub-heat, na portion of a master heat remelted without additional processing for pouring into castings. Synonyms: melt,production heat.NOTE 1Terminology section in

19、accordance with Specification A957.4. Ordering Information4.1 Include with inquiries and orders for material under this specification the following information:4.1.1 Quantity (number of product castings or weight of casting alloy),4.1.2 ASTM designation and date of issue,4.1.3 Units to be certifiedS

20、I or inch-pound.4.1.4 Form (product casting, shot, bar, ingot),4.1.5 Applicable dimensions or drawing number,4.1.6 Condition (as-cast, hot isostatically pressed (HIP), solution annealed, and so forth),4.1.7 Special tests, if any, and4.1.8 Other requirements.5. Materials and Manufacturing Requirement

21、s for Product Castings5.1 Final thermal processing for castings, if any, shall be specified by mutual agreement between the supplier and purchaser.5.2 Castings shall be free of visible investment shell material and scale when examined without magnification.5.3 Welding may be used to repair castings

22、as agreed upon between supplier and purchaser.5.3.1 Weld repair shall be performed in accordance with written procedures by individuals certified to perform those procedures.5.3.2 Weld filler metal conforming to the chemistry of Table 1 shall be used when it is needed.5.3.3 Weld repair, if any, shal

23、l be performed before final thermal processing.NOTE 2Under certain circumstances, a weld repair may act as a stress riser. Therefore, care should be exercised in the location and extent of weldrepair as it relates to regions of the implant where significant stresses might occur.6. Chemical Requireme

24、nts6.1 Both product castings and casting alloy shall conform to the chemical requirements prescribed in Table 1. The supplier shallnot ship material that is outside the limits specified in Table 1.TABLE 1 Chemical CompositionElement Composition, % (Mass/Mass)min maxChromium 27.00 30.00Molybdenum 5.0

25、0 7.00Nickel . 0.50Iron . 0.75Carbon . 0.35Silicon . 1.00Manganese . 1.00Tungsten . 0.20Phosphorous . 0.020Sulfur . 0.010Nitrogen . 0.25Aluminum . 0.10Titanium . 0.10Boron . 0.010CobaltA balance balanceA Approximately equal to the difference of 100 % and the sum percentage of theother specified elem

26、ents. The percentage of the cobalt difference is not required tobe reported.F75 1826.1.1 Chemical analysis shall be performed on a representative specimen of a sub heat cast from each master heat using the samegeneral foundry procedures used for casting implants.6.1.2 Requirements for the major and

27、minor 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.6.1.3 All commercial metals contain small amounts of elements other than those which are specified.

28、 It is neither practical nornecessary to specify limits for unspecified elements, whether residual elements or trace elements that can be present. The produceris permitted to analyze for unspecified elements and is permitted to report such analyses. The presence of an unspecified elementand the repo

29、rting of an analysis for that element shall not be a basis for rejection.6.1.4 Intentional elemental additions other than those specified in Table 1 are not permitted.6.1.5 Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.6.2 Product Analysis:6

30、.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations in themeasurement of chemical content between laboratories . The product analysis tolerances shall conform to the product tolerancesin Table 2.6.2.2 The product analysis is either for the pu

31、rpose of verifying the composition of a heat or manufacturing lot or to determinevariations in the composition within the heat.6.2.3 Acceptance or rejection of a heat or manufacturing lot of material may be made by the purchaser on the basis of thisproduct analyses. Product analysis outside the tole

32、rance limits allowed in Table 2 are cause for rejection of the product. A refereeanalysis may be used if agreed upon by supplier and purchaser.7. Mechanical Requirements7.1 Tensile Properties for Product Castings:7.1.1 As-cast material shall conform to the mechanical property requirements given in T

33、able 3 when tested in accordance withTest Methods E8/E8M.7.1.2 Tension test specimens shall be melted and cast from a sub heat of each master heat by the same general procedures usedin casting the surgical implants or machined from surgical implant castings.7.1.3 Specimens may be cast, ground, or ma

34、chined to final dimensions in accordance with the 0.25 in. (6.35 mm) diameterspecimen in Fig. 8 of Test Methods E8/E8M.7.1.4 Perform at least two tension tests per master heat. Should any of these test pieces not meet the specified requirements,test two additional representative test pieces, in the

35、same manner, for each failed test piece. The master heat shall be consideredin compliance only if all additional test pieces meet the specified requirements.7.1.5 Tensile tests results for which any specimen fractures outside the gage length shall be considered valid if both theelongation and reduct

36、ion of area meet the minimum requirements specified. If either the elongation or reduction of area is less thanthe minimum requirement, invalidate the specimen and retest. Retest one specimen for each invalidated specimen.7.1.6 If castings are supplied in a heat-treated condition, tensile property r

37、equirements shall be agreed upon between supplierand purchaser.7.2 Tensile Properties for Casting Alloy: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 0.0

38、3Tungsten 0.04Phosphorous 0.005Sulfur 0.003Nitrogen 0.02DAluminum 0.02Titanium 0.02Boron 0.002A See Test Methods E354.B Refer toAMS Standard 2269 for chemical check analysis limits (except nitrogen).C For elements in which only a maximum percentage is indicated, the “underminimum limit” is not appli

39、cable.D Refer to AMS 2248 for chemical check analysis limits.F75 1837.2.1 As-cast material shall conform to the mechanical property requirements given in Table 3 when tested in accordance withTest Methods E8/E8M.7.2.2 TensionTension test specimens shall be melted and cast from a sub heat of each mas

40、ter heat by the same generalprocedures used in casting of the surgical implants7.2.3 Specimens may be cast, ground, or machined to final dimensions in accordance with the 0.25 in. (6.35 mm) diameterspecimen in Fig. 8 of Test Methods E8/E8M.7.2.4 Perform at least two tension tests per master heat. Sh

41、ould any of these test pieces not meet the specified requirements,test two additional representative test pieces, in the same manner, for each failed test piece. The master heat shall be consideredin compliance only if all additional test pieces meet the specified requirements.7.2.5 Tensile tests re

42、sults for which any specimen fractures outside the gage length shall be considered valid if both theelongation and reduction of area meet the minimum requirements specified. If either the elongation or reduction of area is less thanthe minimum requirement, invalidate the specimen and retest. Retest

43、one specimen for each invalidated specimen.8. Special Testing for Product Castings8.1 Liquid Penetrant ExaminationSampling plans and acceptance criteria shall be mutually agreed upon by supplier andpurchaser. Individual parts should be examined in accordance with Test Method E601F601 or Test Method

44、E165, as appropriatefor the surface condition of the casting being tested.8.2 Radiographic ExaminationSampling plans and acceptance criteria shall be mutually agreed upon by supplier andpurchaser. Radiographic examination shall be in accordance with Practice F629.8.3 MetallographyThe microstructural

45、 requirements and frequency of examinations shall be mutually agreed upon by supplierand purchaser. Specimen preparation shall be in accordance with Guide E3 and Practice E407.8.4 Hardness:8.4.1 Materials conforming to this specification will typically have a hardness of 25 to 35 HRC in the as-cast

46、condition. Thehardness determination shall be performed in accordance with Test Methods E18.8.4.2 Hardness values are for information only and shall not be used as criteria for rejection.9. Dimensions and Permissible Variation9.1 Units of Measure:9.2 SelectionThis specification requires that the pur

47、chaser selects the units (SI or inch-pound) to be used for productcertification. In the absence of a stated selection of units on the purchase order, this selection may be expressed by the purchaserin several alternate forms listed in order of precedence.9.3 If the purchaser and supplier have a hist

48、ory of using specific units, these units shall continue to be certified until expresslychanged by the purchaser.9.4 In the absence of historic precedence, if the units used to define the product on the purchasers purchase order, specification,and engineering drawing are consistent, these units shall

49、 be used by the supplier for product certification.9.5 If the purchasers selection of units is unclear, the units of measure shall be agreed upon between the purchaser and supplier.9.6 Conversion of UnitsIf the suppliers test equipment does not report in the selected units, the test equipment units may beconverted to the selected units for certification purposes.Accurate arithmetic conversion and proper use of significant digits shouldbe observed when performing this conversion. IEEE/ASTM SI 10 provides guidelines for the use of SI units. Annex A ofIEEE/A