ASTM F2989-12

Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants.  
1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore each system shall be used independent of the other. Combining values from the two systems may result in non-conformance with the specification.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Nov-2012
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2989 −12
StandardSpecification for
Metal Injection Molded Unalloyed Titanium Components for
Surgical Implant Applications
This standard is issued under the fixed designation F2989; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E407Practice for Microetching Metals and Alloys
E539TestMethodforAnalysisofTitaniumAlloysbyX-Ray
1.1 This specification covers the chemical, mechanical, and
Fluorescence Spectrometry
metallurgical requirements for three grades of metal injection
E1409TestMethodforDeterminationofOxygenandNitro-
molded (MIM) unalloyed titanium components in two types to
gen in Titanium and Titanium Alloys by the Inert Gas
be used in the manufacture of surgical implants.
Fusion Technique
1.2 The Type 1 MIM components covered by this specifi-
E1447Test Method for Determination of Hydrogen in Tita-
cation may have been densified beyond their as-sintered
nium and Titanium Alloys by Inert Gas Fusion Thermal
density by post-sinter processing.
Conductivity/Infrared Detection Method
E1941Test Method for Determination of Carbon in Refrac-
1.3 Values in either inch-pound or SI are to be regarded
separately as standard. The values stated in each system may toryandReactiveMetalsandTheirAlloysbyCombustion
Analysis
not be exact equivalents; therefore each system shall be used
independent of the other. Combining values from the two E2371Test Method for Analysis of Titanium and Titanium
Alloys by Atomic Emission Plasma Spectrometry
systems may result in non-conformance with the specification.
E2626Guide for Spectrometric Analysis of Reactive and
1.4 This standard does not purport to address all of the
Refractory Metals
safety concerns, if any, associated with its use. It is the
F67Specification for Unalloyed Titanium, for Surgical Im-
responsibility of the user of this standard to establish appro-
plant Applications (UNS R50250, UNS R50400, UNS
priate safety and health practices and determine the applica-
R50550, UNS R50700)
bility of regulatory limitations prior to use.
F601Practice for Fluorescent Penetrant Inspection of Me-
2. Referenced Documents tallic Surgical Implants
2 F629Practice for Radiography of Cast Metallic Surgical
2.1 ASTM Standards:
Implants
B243Terminology of Powder Metallurgy
SI 10American National Standard for Use of the Interna-
B311Test Method for Density of Powder Metallurgy (PM)
tional System of Units (SI): The Modern Metric System
Materials Containing Less Than Two Percent Porosity
2.2 ISO Standards:
B923Test Method for Metal Powder Skeletal Density by
ISO5832-3ImplantsforSurgery—MetallicMaterials—Part
Helium or Nitrogen Pycnometry
3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy
E3Guide for Preparation of Metallographic Specimens
ISO 6892Metallic Materials—Tensile Testing at Ambient
E8/E8MTest Methods for Tension Testing of Metallic Ma-
Temperature
terials
ISO 9001Quality Management Systems—Requirements
E29Practice for Using Significant Digits in Test Data to
2.3 Aerospace Material Specifications:
Determine Conformance with Specifications
AMS 2249Chemical Check Analysis Limits, Titanium and
E165Practice for Liquid Penetrant Examination for General
Titanium Alloys
Industry
2.4 MPIF Standards:
Standard 10Determination of the Tensile Properties of
This specification is under the jurisdiction of ASTM Committee F04 on
Powder Metallurgy Materials
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2012. Published January 2013. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F2989-12. 4th Floor, New York, NY 10036, http://www.ansi.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromSAEInternational(SAE),400CommonwealthDr.,Warrendale,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM PA 15096-0001, http://aerospace.sae.org.
Standards volume information, refer to the standard’s Document Summary page on Available from Metal Powder Industries Federation (MPIF), 105 College Rd.
the ASTM website. East, Princeton, NJ 08540, http://www.mpif.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2989−12
Standard 42Determination of Density of Compacted or 3.3.10 relative density, n—the density ratio, often expressed
Sintered Powder Metallurgy Product as a percentage, of the density of a porous material to the
absolute density of the same material, completely free of
Standard 50 Preparing and Evaluating Metal Injection
Molded Sintered/Heat Treated Tension Specimens porosity.
Standard 63Density Determinations of MIM Components
3.3.11 sintering, v—themetallurgicalbondingofparticlesin
(Gas Pycnometry)
a MIM component resulting from a thermal treatment at a
Standard 64Terms Used in Metal Injection Molding
temperature below the melting point of the main constituent.
3.3.12 Type 1, n—a MIM component that may have been
3. Terminology
desified beyond its as-sintered density by post-sinter process-
ing.
3.1 DefinitionsofpowdermetallurgyandMIMtermscanbe
foundinTerminologyB243andMPIFStandard64.Additional
3.3.13 Type 2, n—a MIM component that shows the as-
descriptive information is available in the Related Material
sintered density and was not densified after sintering.
Section of Vol. 02.05 of the Annual Book of ASTM Standards.
4. Ordering Information
3.2 The materials produced by means of the metal injection
4.1 Include with inquiries and orders for material under this
moldingprocessaredesignatedbytheprefix,“MIM”,followed
specification the following information:
by the appropriate designation for the alloy grade. The MIM
4.1.1 Quantity,
designates that it was made by metal injection molding.
4.1.2 ASTM specification and date of issue,
3.3 Definitions of Terms Specific to This Standard:
4.1.3 Grade (MIM 1, MIM 2 or MIM 3),
3.3.1 absolute density, n—the value of density used to 4.1.4 Type (1 or 2),
characterize a powder material with a particular chemical 4.1.5 Units to be certified—SI or Inch-Pounds,
composition as if it were a fully dense material, completely 4.1.6 Component configuration (engineering drawing or 3D
free of porosity. solid model, or both) and dimensional requirements,
4.1.7 Condition (5.2),
3.3.1.1 Discussion—For the purposes of this specification,
4.1.8 Mechanical properties (if applicable),
the skeletal density (also referred to as pycnometer density)
4.1.9 Finish (5.2),
measured on the raw material powders using the pycnometry
4.1.10 Special tests (9, 10 and 11), if any, and
method of Test Method B923 shall be used to represent the
4.1.11 Other requirements.
absolute density of the particular chemical composition.
3.3.2 debinding, v—a step between molding and sintering
5. Materials and Manufacture
where the majority of the binder used in molding is extracted
5.1 Components conforming to this specification shall be
by heat, solvent, a catalyst, or other techniques.
produced by the metal injection molding process using unal-
loyed metal powders with major elemental composition meet-
3.3.3 feedstock, n—in metal injection molding, a moldable
mixture of metal powder and binder. ing the chemical requirements of Table 1.
5.2 Post-sintering operations may be employed to achieve
3.3.4 feedstock batch, n—a specified quantity of feedstock
the desired density, shape, size, surface finish, or other com-
made up of the same lot of metallic powders and the same lot
ponent properties. The post-sintering operations shall be
of binder materials mixed under the same conditions at
agreed upon between the supplier and purchaser.
essentially the same time.
5.3 The condition and finish of the components shall be
3.3.5 lot, n—a specified quantity of components made up of
agreed upon between the supplier and purchaser.
the same batch of feedstock, debound, sintered, and post-
processed under the same conditions at essentially the same
6. Chemical Requirements
time.
6.1 The components supplied under this specification shall
3.3.6 metal injection molded component, n—product fabri-
conform to the chemical requirements in Table 1.The supplier
cated by a metal injection molding process consisting of
shall not ship components with chemistry outside the require-
mixing metal powders with binders to make a feedstock,
ments specified in Table 1.
introducing this feedstock into a mold by injection or other
means, debinding to remove the binders, and sintering.
TABLE 1 Chemical Composition
3.3.7 near net component, n—a component that meets
Composition for both Type 1 and Type 2
dimensional tolerance as built with little post processing.
Composition, % (mass/mass)
3.3.8 net component, n—a component that meets dimen- Element Grade MIM 1 Grade MIM 2 Grade MIM 3
sional tolerance as built with no post processing. Nitrogen, max 0.03 0.03 0.05
Carbon, max 0.08 0.08 0.08
3.3.9 pre-alloyed powder, n—powder composed of two or
Hydrogen, max 0.015 0.015 0.015
Iron, max 0.020 0.030 0.030
more elements that are alloyed in the powder manufacturing
Oxygen, max 0.18 0.25 0.30
process in which the particles are of the same nominal
Titanium Balance Balance Balance
composition throughout.
F2989−12
6.2 Chemical analysis of the finished component or a 7.1.1 The components supplied under this specification
representative sample shall be used for reporting all chemical shallconformtothemechanicalpropertyrequirementsinTable
requirements. Any representative sample shall be produced 3.
from the same feedstock batch, debound, sintered, and post
7.1.2 TestspecimensshallbetakenfromaMIMcomponent
processed concurrently with the finished components that it
if possible, or from a representative sample or molded tensile
represents.
specimen.Arepresentative sample or molded tensile specimen
6.2.1 Requirements for the major and minor elemental
may only be used only if the component configuration is such
constituents are listed in Table 1. Also listed are important
that a tensile specimen cannot be obtained from the compo-
residualelements.Thepercentageoftitaniumisdeterminedby
nent.
difference and need not be determined or certified.
7.1.3 The number of tensile tests should be agreed upon
6.2.2 Intentional elemental additions other than those speci-
between the supplier and the purchaser.
fied in Table 1 are not permitted.
7.2 Representative samples or molded tensile specimens
6.2.3 Analysis for elements not listed in Table 1 is not
shall be produced from the same feedstock batch, debound,
required to verify compliance with this specification.
sintered and post processed concurrently with the finished
6.3 Product Analysis:
components that they represent.
6.3.1 Product analysis tolerances do not broaden the speci-
7.2.1 Specimens machined from components or representa-
fied heat analysis requirements but cover variations in the
tive samples shall be ground, or machined to final dimensions
measurement of chemical content between laboratories. The
in accordance Test Methods E8/E8M.
product analysis tolerances shall conform to the product
7.2.2 Alternate tensile specimen geometries may be agreed
tolerances in Table 2.
upon between the purchaser and supplier. Some examples of
6.3.2 The product analysis is either for the purpose of
the configurations for molded tensile specimens are described
verifying the composition of the manufacturing lot or to
in MPIF Standards 10 and 50.
determine variations in the composition within the lot.Accep-
tance or rejection of the manufacturing lot of components may
7.3 Specimens for tensile tests shall be tested in accordance
bemadebythepurchaseronthebasisofthisproductanalyses.
with Test Methods E8/E8M. Tensile properties shall be deter-
6.3.3 Samples for chemical analysis shall be representative
minedusingastrainrateof0.076to0.178mm/mm/min[0.003
of the component being tested. The utmost care shall be used
to 0.007 in./in./min] through yield and then the crosshead
in sampling titanium for chemical analysis because of its
speed may be increased so as to produce fracture in approxi-
affinity for elements such as oxygen, nitrogen, and hydrogen.
mately one additional minute.
In cutting samples for analysis, therefore, the operation should
7.4 Should any test piece not meet the specified
be carried out insofar as possible in a dust-free atmosphere.
requirements, test two additional representative test pieces, in
Cutting tools should be clean and sharp. Samples for analysis
the same manner, for each failed test piece. The lot shall be
should be stored in suitable containers.
consideredincomplianceonlyifalladditionaltestpiecesmeet
6.3.4 Product analysis outside the tolerance limits allowed
the specified requirements.
in Table 2 is cause for rejection of the product. A referee
analysis may be used if agreed upon by the supplier and
7.5 Tensile test results for which any specimen fractures
purchaser.
outside the gauge length shall be considered valid if both the
6.3.5 For referee purposes, use Test Methods E539, E1409,
elongation and reduction of area meet the minimum require-
E1447,E1941,andE2371andGuideE2626orotheranalytical
ments specified. If either the elongation or reduction of area is
methods agreed upon between the purchaser and the supplier.
less than the minimum requirement, invalidate the specimen
and retest. Retest one specimen for each invalidated specimen.
7. Mechanical Requirements
7.1 Tensile Properties:
8. Dimensions and Permissible Variation
8.1 Units of Measure:
8.1.1 Selection—This specification requires that the pur-
A
chaser selects the units (SI or inch-pound) to be used for
TABLE 2 Product Analysis Tolerance
product certification. In the absence of a stated selection of
Limit or Maximum of Tolerance Under the
Element Specified Range %, Minimum or Over the
unitsonthepurchaseorder,thisselectionmaybeexpressedby
B
(mass/mass) Maximum Limit
the purchaser in several alternate forms listed in order of
Nitrogen up to 0.05 0.02
precedence.
Carbon 0.10 0.02
Hydrogen up to 0.015 0.002
8.1.2 If the purchaser and supplier have a history of using
Iron up to 0.25 0.10
specific units, these units shall continue to be certified until
Iron over 0.25 0.15
expressly changed by the purchaser.
Oxygen up to 0.20 0.02
Oxygen over 0.20 0.03
8.1.3 Intheabsenceofhistoricprecedence,iftheunitsused
A
See AMS 2249.
to define the product on the purchaser’s purchase order,
B
Under the minimum limit is not applicable for elements where only a maximum
specification, and engineer
...