1、Designation: F2886 10F2886 17Standard Specification forMetal Injection Molded Cobalt-28Chromium-6MolybdenumComponents for Surgical Implant Applications1This standard is issued under the fixed designation F2886; the number immediately following the designation indicates the year oforiginal adoption o
2、r, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope Scope*1.1 This specification covers the chemical, mechanical, and metallurgical r
3、equirements for metal injection molded (MIM)cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinterprocessing.1.3 UnitsThe values stated in
4、either SI units or inch-pound units are to be regarded separately as standard. The values statedin each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining valuesfrom the two systems may result in non-conformance with the standard.1.4 This
5、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 Technical Barriers to Trade (TBT)
6、 Committee.2. Referenced Documents2.1 ASTM Standards:2B243 Terminology of Powder MetallurgyB311 Test Method for Density of Powder Metallurgy (PM) Materials Containing Less Than Two Percent PorosityB923 Test Method for Metal Powder Skeletal Density by Helium or Nitrogen PycnometryE3 Guide for Prepara
7、tion of Metallographic SpecimensE8/E8M Test Methods for Tension Testing 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 o
8、f High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, andCobalt AlloysE407 Practice for Microetching Metals and AlloysF75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F601 Practice for Fluorescent Penetrant In
9、spection of Metallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic Surgical ImplantsF1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)IEEE/ASTM SI 10 American National Standard for Use of the Internatio
10、nal System of Units (SI): The Modern Metric System2.2 ISO Standards:3ISO 6892 Metallic Materials Tensile Testing at Ambient TemperatureISO 9001 Quality Management SystemsRequirements1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and
11、 is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2010Sept. 1, 2017. Published January 2011October 2017. Originally approved in 2010. Last previous edition approved in 2010 asF2886 10. DOI 10.1520/F288610.10.1520/F2886-17.2 For referenced
12、ASTM 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 American National Standards Institute (ANSI), 25 W. 43rd St.
13、, 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. Becauseit may not be technically possible to adequately depict all changes accu
14、rately, 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 at the end of this standardCopyright ASTM International, 100 Barr Harbor
15、 Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.3 AMS Standards:4AMS 2269 Chemical Check Analysis Limits, Nickel, Nickel Alloys and Cobalt AlloysAMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and OtherHighly-Alloyed Steels, an
16、d Iron Alloys2.4 MPIF Standards:5MPIF Standard 10 Determination of the Tensile Properties of Powder Metallurgy MaterialsMPIF Standard 42 Determination of Density of Compacted or Sintered Powder Metallurgy ProductsMPIF Standard 50 Preparing and Evaluating Metal Injection Molded Sintered/Heat Treated
17、Tension SpecimensMPIF Standard 63 Density Determinations of MIM Components (Gas Pycnometry)MPIF Standard 64 Terms Used in Metal Injection Molding3. Terminology3.1 Definitions of Terms Specific to This Standard:3.2 Definitions of powder metallurgy and MIM terms can be found in Terminology B243 and MP
18、IF Standard 64. Additionaldescriptive information is available in the Related Material Section of Vol. 02.05 of the Annual Book of ASTM Standards.3.3 absolute density, nthe value of density used to characterize a powder material with a particular chemical composition asif it were a fully dense mater
19、ial, completely free of porosity.3.3.1 DiscussionFor the purposes of this specification, the skeletal density (also referred to as pycnometer density) measured on the raw materialpowders using the pycnometry method of Test Method B923 will be used to represent the absolute density of the particularc
20、hemical composition.3.4 debinding, na step between molding and sintering where the majority of the binder used in molding is extracted by heat,solvent, a catalyst or other techniques.3.5 feedstock, nin metal injection molding, a moldable mixture of metal powder and binder.3.6 feedstock batch, na spe
21、cified quantity of feedstock made up of the same lot of metallic powders and the same lot of bindermaterials mixed under the same conditions at essentially the same time.3.7 lot, na specified quantity of components made up of the same batch of feedstock, debound, sintered and post processedunder the
22、 same conditions at essentially the same time.3.8 metal injection molded component, nproduct fabricated by a metal injection molding process consisting of mixing metalpowders with binders to make a feedstock, introducing this feedstock into a mold by injection or other means, debinding to removethe
23、binders, and sintering.3.9 pre-alloyed powder, npowder composed of two or more elements that are alloyed in the powder manufacturing processin which the particles are of the same nominal composition throughout.3.10 relative density, nthe density ratio, often expressed as a percentage, of the density
24、 of a porous material to the absolutedensity of the same material, completely free of porosity.3.11 sinteringthe metallurgical bonding of particles in a MIM component resulting from a thermal treatment at a temperaturebelow the melting point of the main constituent.4. Ordering Information4.1 Include
25、 with inquiries and orders for material under this specification the following information:4.1.1 Quantity,4.1.2 ASTM specification and date of issue,4.1.3 Alloy 1 (low carbon) or Alloy 2 (high carbon),4.1.4 Units to be certifiedSI or inch-pound,4.1.5 Component configuration (engineering drawing and/
26、or 3D solid model) and dimensional requirements,4.1.6 Condition (5.3),4.1.7 Mechanical properties (if applicable),4.1.8 Finish (5.3),4.1.9 Special Tests (Section 9, Section 10), if any, and4.1.10 Other requirements.4 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwauke
27、e, WI 53203, http:/www.asq.org.5 Available from Metal Powder Industries Federation (MPIF), 105 College Road East, Princeton, New Jersey 08540, http:/www.mpif.org.F2886 1725. Materials and Manufacture5.1 Components conforming to this specification shall be produced by the metal injection molding proc
28、ess using prealloyedmetal powders with major elemental composition meeting the chemical requirements of Table 1.5.2 Post-sintering operations may be employed to achieve the desired density, shape, size, surface finish or other componentproperties. The post-sintering operations to be used shall be ag
29、reed upon between the supplier and purchaser.5.3 The condition and finish of the components shall be agreed upon between the supplier and purchaser.6. Chemical Requirements6.1 The components supplied under this specification shall conform to the chemical requirements in Table 1. The supplier shallno
30、t ship components with chemistry outside the requirements specified in Table 1.6.1.1 Chemical analysis of thea finished component or representative sample shall be used for reporting all chemicalrequirements. Any representative samplesamples shall be produced from the same feedstock batch, debound,
31、sintered, and postprocessed concurrently with the finished components that it represents.they represent.6.1.2 Requirements for the major and minor elemental constituents are listed in Table 1. Also listed are important residualelements. The percentage of cobalt is determined by difference and need n
32、ot be determined or certified.6.1.3 All commercial metals contain small amounts of elements other than those which are specified. It is neither practical nornecessary to specify limits for unspecified elements, whether residual elements or trace elements, that can be present. The produceris permitte
33、d to analyze for unspecified elements and is permitted to report such analyses. The presence of an unspecified elementand the reporting 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
34、.5 Analysis for elements not listed in Table 1 is not required to verify compliance with this specification.6.2 Product Analysis:6.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations in themeasurement of chemical content between laboratories.
35、The product analysis tolerances shall conform to the product tolerancesin Table 2.6.2.2 The product analysis is either for the purpose of verifying the composition of the manufacturing lot or to determinevariations in the composition within the lot. Acceptance or rejection of the manufacturing lot o
36、f components may be made by thepurchaser on the basis of this product analysis.6.2.3 Samples for chemical analysis shall be representative of the components being tested.6.2.4 Product analysis outside the tolerance limits allowed in Table 2 is cause for rejection of the product. A referee analysisma
37、y be used if agreed upon by the supplier and purchaser.6.2.5 For referee purposes, use Test Methods E354, or other analytical methods agreed upon between the purchaser and thesupplier.TABLE 1 Chemical RequirementsElement Chemical CompositionAlloy 1(Low Carbon)(% mass/mass)Chemical CompositionAlloy 2
38、(High Carbon)(% mass/mass)min max min maxCarbon . 0.14 0.15 0.35Chromium 27.0 30.0 27.0 30.0Molybdenum 5.0 7.0 5.0 7.0Nickel . 0.5 . 0.5Iron . 0.75 . 0.75Silicon . 1.0 . 1.0Manganese . 1.0 . 1.0Tungsten . 0.20 . 0.20Phosphorus . 0.020 . 0.020Sulfur . 0.010 . 0.010Nitrogen . 0.25 . 0.25Aluminum . 0.1
39、0 . 0.10Titanium . 0.10 . 0.10Boron . 0.010 . 0.010CobaltA . Balance . BalanceA The percentage of cobalt is determined by difference and need not be deter-mined or certified. Approximately equal to the difference of 100% and the sumpercentage of the other specified elements. The percentage of the Co
40、baltdifference is not required to be reported.F2886 1737. Mechanical Requirements7.1 Tensile Properties:7.1.1 The components supplied under this specification shall conform to the mechanical property requirements in Table 3.7.1.2 Test specimens shall be taken from a MIM component if possible, or fro
41、m a representative sample or molded tensilespecimen. A representative sample or molded tensile specimen may only be used if the component configuration is such that atensile specimen cannot be obtained from the component.7.2 Representative samples or molded tensile specimens shall be produced from t
42、he same feedstock batch, debound, sinteredand post processed concurrently with the finished components that they represent.7.2.1 Test specimens machined from components or representative samples shall be ground, or machined to final dimensionsin accordance Test Methods E8/E8M.7.2.2 Alternate tensile
43、 specimen geometries may be agreed upon by the purchaser and supplier. Some examples of theconfigurations for molded tensile specimens are described in MPIF Standard 10 and MPIF Standard 50.7.3 Specimens for tensile tests shall be tested in accordance with Test Methods E8/E8M.7.4 Should any test pie
44、ce not meet the specified requirements, test two additional representative test pieces, in the same manner,for each failed test piece. The lot shall be considered in compliance only if all additional test pieces meet the specifiedrequirements.7.5 Tensile tests result for which any specimen fractures
45、 outside the gauge length shall be considered valid, if both theelongation and reduction of area meet the minimum requirements specified. Refer to subsections 7.11.4 and 7.11.5 of Test MethodsE8/E8M. If either the elongation or reduction of area is less than the minimum requirement, invalidate the s
46、pecimen and retest.Retest one specimen for each invalidated specimen.TABLE 2 Product Analysis ToleranceA,BElement Tolerance Under the Minimum orOver the Maximum LimitComposition (% mass/mass)CCarbon 0.02Chromium 0.30Molybdenum 0.15Nickel 0.05Iron 0.03Silicon 0.05Manganese 0.03Tungsten 0.04Phosphorus
47、 0.005Sulfur 0.003NitrogenD 0.02Aluminum 0.02Titanium 0.02Boron 0.002A See Test Method E354.B See AMS 2269 for chemical check analysis limits except nitrogen.C Under minimum limit not applicable for elements where only a maximumpercentage is indicated.D Refer to AMS 2248.TABLE 3 Mechanical Requireme
48、ntsRelative DensityAlloy 1 (Low Carbon) Alloy 2 (High Carbon)MPa (psi) MPA (psi)Ultimate TensileStrength725 (105 000) min 825 (120 000) minYield Strength (0.2 %offset)450 (65 000) min 480 (70 000) minElongationA 10 % min 10 % minReduction of Area 10 % min 10 % minA Elongation of material 1.575 mm 0.
49、062 in. or greater in diameter (D) or width(W) shall be measured using a gagegauge length of 2 in. or 4D or 4W. Thegagegauge length shall be reported with the test results. The method fordetermining elongation of material under 1.575 mm 0.062 in. in diameter orthickness may be negotiated. Alternatively, a gagegauge length corresponding toISO 6892 (5.65 times the square root of So,So where SoSo is the originalcross-sectional area) may be used when agreed upon between the supplier andpurchaser.F2886 1748. Dimensions and Permissible Variation8.1 Units of Meas
