1、Designation: F2885 11F2885 17Standard Specification forMetal Injection Molded Titanium-6Aluminum-4VanadiumComponents for Surgical Implant Applications1This standard is issued under the fixed designation F2885; the number immediately following the designation indicates the year oforiginal adoption or
2、, 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 re
3、quirements for two types of metal injection molded(MIM) titanium-6aluminum-4vanadium components to be used in the manufacture of surgical implants.1.2 TheType 1 MIM components covered by this specification may have been densified beyond their as-sintered density by postsinter processing.1.3 UnitsVal
4、ues The values in either inch-pound or SI are to be regarded separately as standard. The values stated in eachsystem may not be exact equivalents; therefore, each system shall be used independent of the other. Combining values from thetwo systems may result in non-conformance with the specification.
5、1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine theapplicability of regulatory limitations p
6、rior to use.1.5 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 Technical Ba
7、rriers to Trade (TBT) 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 Pycnometr
8、yE3 Guide for Preparation 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 IndustryE407 Practice for Mi
9、croetching Metals and AlloysE539 Test Method for Analysis of Titanium Alloys by X-Ray Fluorescence SpectrometryE1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas FusionE1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys
10、 by Inert Gas Fusion ThermalConductivity/Infrared Detection MethodE1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion AnalysisE2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Pla
11、smaAtomic Emission Spectrometry (Performance-Based Test Methodology)E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals (Withdrawn 2017)3F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic Surgical Implan
12、ts1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved March 1, 2011Sept. 1, 2017. Published March 2011October 2017. Originally app
13、roved in 2011. Last previous edition approved in 2011 asF2885 11. DOI: 10.1520/F288511.10.1520/F2885-17.2 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
14、 Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.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. Be
15、causeit 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 app
16、ears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)F1472 Specification for Wrought Titanium-6Aluminum-4
17、Vanadium Alloy for Surgical Implant Applications (UNS R56400)IEEE/ASTM SI 10 American National Standard for Use of the International System of Units (SI): The Modern Metric System2.2 ISO Standards:4ISO 5832-3 Implants for SurgeryMetallic MaterialsPart 3:WroughtTitanium 6-Aluminum 4-VanadiumAlloyThir
18、d EditionISO 6892 Metallic MaterialsTensile Testing at Ambient TemperatureISO 9001 Quality Management SystemsRequirements2.3 Aerospace Material Specifications:5AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys2.4 MPIF Standards:6Standard 10 Determination of the Tensile Properties
19、 of Powder Metallurgy MaterialsStandard 42 Determination of Density of Compacted or Sintered Powder Metallurgy ProductStandard 50 Preparing and Evaluating Metal Injection Molded Sintered/Heat-Treated Tension SpecimensStandard 63 Density Determinations of MIM Components (Gas Pycnometry)Standard 64 Te
20、rms Used in Metal Injection Molding3. Terminology3.1 Definitions of powder metallurgy and MIM terms can be found in Terminology B243 and MPIF Standard 64. Additionaldescriptive information is available in the Related Material Section of Vol. 02.05 of the Annual Book of ASTM Standards.3.2 Definitions
21、 of Terms Specific to This Standard:3.2.1 absolute density, nthe value of density used to characterize a powder material with a particular chemical compositionas if it were a fully dense material, completely free of porosity.3.2.1.1 DiscussionFor the purposes of this specification, the skeletal dens
22、ity (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 particularchemical composition.3.2.2 metal injection molded component, debinding, nvproduct fabricated by a metal inj
23、ection molding process consistingof mixing metal powders with binders to make a feedstock, introducing this feedstock into a mold by injection or other means,debinding to remove the binders, and sintering.a step between molding and sintering where the majority of the binder used inmolding is extract
24、ed by heat, solvent, a catalyst or other techniques.3.2.3 feedstock, nin metal injection molding, a moldable mixture of metal powder and binder.3.2.4 feedstock batch, na specified quantity of feedstock made up of the same lot of metallic powders and the same lot ofbinder materials mixed under the sa
25、me conditions at essentially the same time.3.2.5 lot, na specified quantity of components made up of the same batch of feedstock, debound, sintered and post processedunder the same conditions at essentially the same time.3.2.6 debinding, metal injection molded component, vna step between molding and
26、 sintering where the majority of thebinder used in molding is extracted by heat, solvent, a catalyst or other techniques. product fabricated by a metal injection moldingprocess consisting of mixing metal powders with binders to make a feedstock, introducing this feedstock into a mold by injectionor
27、other means, debinding to remove the binders, and sintering.3.2.6 sintering, vthe metallurgical bonding of particles in a MIM component resulting from a thermal treatment at atemperature below the melting point of the main constituent.3.2.7 pre-alloyed powder, npowder composed of two or more element
28、s that are alloyed in the powder manufacturing processin which the particles are of the same nominal composition throughout.3.2.8 absolute density, nthe value of density used to characterize a powder material with a particular chemical compositionas if it were a fully dense material, completely free
29、 of porosity.3.2.8.1 Discussion4 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.6 Available from Metal P
30、owder Industries Federation (MPIF), 105 College Rd. East, Princeton, NJ 08540, http:/www.mpif.org.F2885 172For 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 use
31、d to represent the absolute density of the particularchemical composition.3.2.8 relative density, nthe density ratio, often expressed as a percentage, of the density of a porous material to the absolutedensity of the same material, completely free of porosity.3.2.9 sintering, vthe metallurgical bond
32、ing of particles in a MIM component resulting from a thermal treatment at atemperature below the melting point of the main constituent.4. Ordering Information4.1 Include with inquiries and orders for material under this specification the following information:4.1.1 Quantity,4.1.2 ASTM specification
33、and date of issue,4.1.3 Type 1 or Type 2,4.1.4 Units to be certifiedSI or Inch-Pounds,4.1.5 Component configuration (engineering drawing and/or 3D solid model) and dimensional requirements,4.1.6 Condition (5.2),4.1.7 Mechanical properties (if applicable),4.1.8 Finish (5.2),4.1.9 Special tests (Secti
34、ons 9, 10, and 11), if any, and4.1.10 Other requirements.5. Materials and Manufacture5.1 Components conforming to this specification shall be produced by the metal injection molding process using prealloyedmetal powders with major elemental composition meeting the chemical requirements of Table 1.5.
35、2 Post sintering operations may be employed to achieve the desired density, shape, size, surface finish or other componentproperties. The post sintering operations shall be agreed upon between the supplier and purchaser.5.3 Condition and finish of the components shall be agreed upon between the supp
36、lier and purchaser.6. Chemical Requirements6.1 The components supplied under this specification shall conform to the chemical requirements in Table 1. Supplier shall notship components with chemistry outside the requirements specified in Table 1.6.1 Chemical analysis of the finished component or rep
37、resentative sample shall be used for reporting all chemical requirements.AnyThe components supplied under this specification shall conform to the chemical requirements in Table 1representative sampleshall be produced from the same feedstock batch,. Supplier shall not ship components with chemistry o
38、utside the requirementsspecified in Table 1debound, sintered, and post processed concurrently with the finished components that it represents6.1.1 Chemical analysis of a finished component or representative sample shall be used for reporting all chemical requirements.Any representative samples shall
39、 be produced from the same feedstock batch, debound, sintered, and post processed concurrentlywith the finished components 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 Titanium is
40、 determined by difference and need not be determined or certified.TABLE 1 Chemical CompositionComposition for both Type 1 and Type 2 AlloysElement Composition, % (Mass/Mass)min maxNitrogen . 0.05Carbon . 0.08Hydrogen . 0.015Iron . 0.30Oxygen . 0.20Aluminum 5.5 6.75Vanadium 3.5 4.5Yttrium . 0.005Tita
41、niumA BalanceA The percentage of titanium is determined by difference and need not bedetermined or certified. Approximately equal to the difference of 100% and thesum of percentage of the other specified elements.The percentage of theTitaniumdifference is not required to be reported.F2885 1736.1.3 A
42、ll 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 permitted to analyze for unspecified elements
43、 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.Intentional elemental additions other than those specified in Table 1 are not permitted.6.1.4 Intentional elemental additions other th
44、an 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:6.2.1 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations in themea
45、surement 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 purpose of verifying the composition of the manufacturing lot or to determinevariations in the composition within the lot.
46、 Acceptance or rejection of the manufacturing lot of components may be made by thepurchaser on the basis of this product analyses.6.2.3 Samples for chemical analysis shall be representative of the component being tested. The utmost care must be used insampling titanium for chemical analysis because
47、of its affinity for elements such as oxygen, nitrogen, and hydrogen. In cuttingsamples for analysis, therefore, the operation should be carried out insofar as possible in a dust-free atmosphere. Cutting toolsshould be clean and sharp. Samples for analysis should be stored in suitable containers.6.2.
48、4 Product analysis outside the tolerance limits allowed in Table 2 is cause for rejection of the product. A referee analysismay be used if agreed upon by supplier and purchaser.6.2.5 For referee purposes, use Test Methods E539, E1409, E1447, E1941, E2371 and Guide E2626 or other analytical methodsag
49、reed upon between the purchaser and the supplier.7. 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 from 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
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