ASTM F2885-17(2023)
(Specification)Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for two types of metal injection molded (MIM) titanium-6aluminum-4vanadium components 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 Units—The 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 nonconformance 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2885 − 17 (Reapproved 2023)
Standard Specification for
Metal Injection Molded Titanium-6Aluminum-4Vanadium
Components for Surgical Implant Applications
This standard is issued under the fixed designation F2885; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope B923 Test Method for Metal Powder Skeletal Density by
Helium or Nitrogen Pycnometry
1.1 This specification covers chemical, mechanical, and
E3 Guide for Preparation of Metallographic Specimens
metallurgical requirements for two types of metal injection
E8/E8M Test Methods for Tension Testing of Metallic Ma-
molded (MIM) titanium-6aluminum-4vanadium components
terials
to be used in the manufacture of surgical implants.
E29 Practice for Using Significant Digits in Test Data to
1.2 The Type 1 MIM components covered by this specifi-
Determine Conformance with Specifications
cation may have been densified beyond their as-sintered
E165/E165M Practice for Liquid Penetrant Testing for Gen-
density by post sinter processing.
eral Industry
1.3 Units—The values in either inch-pound or SI are to be E407 Practice for Microetching Metals and Alloys
E539 Test Method for Analysis of Titanium Alloys by
regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system Wavelength Dispersive X-Ray Fluorescence Spectrometry
E1409 Test Method for Determination of Oxygen and Nitro-
shall be used independent of the other. Combining values from
the two systems may result in nonconformance with the gen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Re-
specification.
active Metals and Reactive Metal Alloys by Inert Gas
1.4 This standard does not purport to address all of the
Fusion with Detection by Thermal Conductivity or Infra-
safety concerns, if any, associated with its use. It is the
red Spectrometry
responsibility of the user of this standard to establish appro-
E1941 Test Method for Determination of Carbon in Refrac-
priate safety, health, and environmental practices and deter-
tory and Reactive Metals and Their Alloys by Combustion
mine the applicability of regulatory limitations prior to use.
Analysis
1.5 This international standard was developed in accor-
E2371 Test Method for Analysis of Titanium and Titanium
dance with internationally recognized principles on standard-
Alloys by Direct Current Plasma and Inductively Coupled
ization established in the Decision on Principles for the
Plasma Atomic Emission Spectrometry (Performance-
Development of International Standards, Guides and Recom-
Based Test Methodology)
mendations issued by the World Trade Organization Technical
E2626 Guide for Spectrometric Analysis of Reactive and
Barriers to Trade (TBT) Committee.
Refractory Metals (Withdrawn 2017)
F601 Practice for Fluorescent Penetrant Inspection of Me-
2. Referenced Documents
tallic Surgical Implants
2.1 ASTM Standards:
F629 Practice for Radiography of Cast Metallic Surgical
B243 Terminology of Powder Metallurgy
Implants
B311 Test Method for Density of Powder Metallurgy (PM)
F1108 Specification for Titanium-6Aluminum-4Vanadium
Materials Containing Less Than Two Percent Porosity
Alloy Castings for Surgical Implants (UNS R56406)
F1472 Specification for Wrought Titanium-6Aluminum-
4Vanadium Alloy for Surgical Implant Applications (UNS
This specification is under the jurisdiction of ASTM Committee F04 on
R56400)
Medical and Surgical Materials and Devices and is the direct responsibility of
IEEE/ASTM SI 10 American National Standard for Use of
Subcommittee F04.12 on Metallurgical Materials.
the International System of Units (SI): The Modern Metric
Current edition approved Feb. 1, 2023. Published February 2023. Originally
approved in 2011. Last previous edition approved in 2017 as F2885 – 17. DOI: System
10.1520/F2885-17R23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on www.ast-
the ASTM website. m.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2885 − 17 (2023)
2.2 ISO Standards: mixing metal powders with binders to make a feedstock,
ISO 5832-3 Implants for Surgery—Metallic Materials—Part introducing this feedstock into a mold by injection or other
3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy means, debinding to remove the binders, and sintering.
Third Edition
3.2.7 pre-alloyed powder, n—powder composed of two or
ISO 6892 Metallic Materials—Tensile Testing at Ambient
more elements that are alloyed in the powder manufacturing
Temperature
process in which the particles are of the same nominal
ISO 9001 Quality Management Systems—Requirements
composition throughout.
2.3 Aerospace Material Specifications:
3.2.8 relative density, n—the density ratio, often expressed
AMS 2249 Chemical Check Analysis Limits, Titanium and
as a percentage, of the density of a porous material to the
Titanium Alloys
absolute density of the same material, completely free of
2.4 MPIF Standards:
porosity.
Standard 10 Determination of the Tensile Properties of
3.2.9 sintering, v—the metallurgical bonding of particles in
Powder Metallurgy Materials
a MIM component resulting from a thermal treatment at a
Standard 42 Determination of Density of Compacted or
temperature below the melting point of the main constituent.
Sintered Powder Metallurgy Product
Standard 50 Preparing and Evaluating Metal Injection
4. Ordering Information
Molded Sintered/Heat-Treated Tension Specimens
4.1 Include with inquiries and orders for material under this
Standard 63 Density Determinations of MIM Components
specification the following information:
(Gas Pycnometry)
4.1.1 Quantity,
Standard 64 Terms Used in Metal Injection Molding
4.1.2 ASTM specification and date of issue,
3. Terminology
4.1.3 Type 1 or Type 2,
4.1.4 Units to be certified—SI or inch-pounds,
3.1 Definitions of powder metallurgy and MIM terms can be
4.1.5 Component configuration (engineering drawing
found in Terminology B243 and MPIF Standard 64. Additional
and/or 3D solid model) and dimensional requirements,
descriptive information is available in the Related Material
4.1.6 Condition (5.2),
Section of Vol. 02.05 of the Annual Book of ASTM Standards.
4.1.7 Mechanical properties (if applicable),
3.2 Definitions of Terms Specific to This Standard:
4.1.8 Finish (5.2),
3.2.1 absolute density, n—the value of density used to
4.1.9 Special tests (Sections 9, 10, and 11), if any, and
characterize a powder material with a particular chemical
4.1.10 Other requirements.
composition as if it were a fully dense material, completely
free of porosity.
5. Materials and Manufacture
3.2.1.1 Discussion—For the purposes of this specification,
5.1 Components conforming to this specification shall be
the skeletal density (also referred to as pycnometer density)
produced by the metal injection molding process using preal-
measured on the raw material powders using the pycnometry
loyed metal powders with major elemental composition meet-
method of Test Method B923 will be used to represent the
ing the chemical requirements of Table 1.
absolute density of the particular chemical composition.
5.2 Post-sintering operations may be employed to achieve
3.2.2 debinding, v—a step between molding and sintering
the desired density, shape, size, surface finish, or other com-
where the majority of the binder used in molding is extracted
ponent properties. The post-sintering operations shall be
by heat, solvent, a catalyst or other techniques.
agreed upon between the supplier and purchaser.
3.2.3 feedstock, n—in metal injection molding, a moldable
5.3 Condition and finish of the components shall be agreed
mixture of metal powder and binder.
upon between the supplier and purchaser.
3.2.4 feedstock batch, n—a specified quantity of feedstock
made up of the same lot of metallic powders and the same lot
of binder materials mixed under the same conditions at
TABLE 1 Chemical Composition
essentially the same time.
Composition for both Type 1 and Type 2 Alloys
3.2.5 lot, n—a specified quantity of components made up of
Composition, % (Mass/Mass)
Element
the same batch of feedstock, debound, sintered, and post
min max
processed under the same conditions at essentially the same
Nitrogen . 0.05
Carbon . 0.08
time.
Hydrogen . 0.015
3.2.6 metal injection molded component, n—product fabri-
Iron . 0.30
Oxygen . 0.20
cated by a metal injection molding process consisting of
Aluminum 5.5 6.75
Vanadium 3.5 4.5
Yttrium . 0.005
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
A
Titanium Balance
4th Floor, New York, NY 10036, http://www.ansi.org.
A
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Approximately equal to the difference of 100 % and the sum of percentage of the
Milwaukee, WI 53203, http://www.asq.org.
other specified elements. The percentage of the titanium difference is not required
Available from Metal Powder Industries Federation (MPIF), 105 College Rd. to be reported.
East, Princeton, NJ 08540, http://www.mpif.org.
F2885 − 17 (2023)
6. Chemical Requirements affinity for elements such as oxygen, nitrogen, and hydrogen.
In cutting samples for analysis, therefore, the operation should
6.1 The components supplied under this specification shall
be carried out insofar as possible in a dust-free atmosphere.
conform to the chemical requirements in Table 1. Supplier
Cutting tools should be clean and sharp. Samples for analysis
shall not ship components with chemistry outside the require-
should be stored in suitable containers.
ments specified in Table 1.
6.2.4 Product analysis outside the tolerance limits allowed
6.1.1 Chemical analysis of a finished component or repre-
in Table 2 is cause for rejection of the product. A referee
sentative sample shall be used for reporting all chemical
analysis may be used if agreed upon by supplier and purchaser.
requirements. Any representative samples shall be produced
6.2.5 For referee purposes, use Test Methods E539, E1409,
from the same feedstock batch, debound, sintered, and post
E1447, E1941, E2371 and Guide E2626 or other analytical
processed concurrently with the finished components they
methods agreed upon between the purchaser and the supplier.
represent.
6.1.2 Requirements for the major and minor elemental
7. Mechanical Requirements
constituents are listed in Table 1. Also listed are important
7.1 Tensile Properties:
residual elements. The percentage of Titanium is determined
7.1.1 The components supplied under this specification
by difference and need not be determined or certified.
shall conform to the mechanical property requirements in Table
6.1.3 All commercial metals contain small amounts of
3.
elements other than those which are specified. It is neither
7.1.2 Test specimens shall be taken from a MIM component
practical nor necessary to specify limits for unspecified
if possible, or from a representative sample or molded tensile
elements, whether residual elements or trace elements, that can
specimen. A representative sample or molded tensile specimen
be present. The producer is permitted to analyze for unspecified
may only be used if the component configuration is such that
elements and is permitted to report such analyses. The presence
a tensile specimen cannot be obtained from the component.
of an unspecified element and the reporting of an analysis for
that element shall not be a basis for rejection.
7.2 Representative samples or molded tensile specimens
Intentional elemental additions other than those specified in
shall be produced from the same feedstock batch, debound,
Table 1 are not permitted.
sintered, and post processed concurrently with finished com-
6.1.4 Intentional elemental additions other than those speci-
ponents that they represent.
fied in Table 1 are not permitted.
7.2.1 Specimens machined from components or representa-
6.1.5 Analysis for elements not listed in Table 1 is not
tive samples shall be ground, or machined to final dimensions
required to verify compliance with this specification.
in accordance with Test Methods E8/E8M.
7.2.2 Alternate tensile specimen geometries may be agreed
6.2 Product Analysis:
upon between purchaser and supplier. Some examples of the
6.2.1 Product analysis tolerances do not broaden the speci-
configurations for molded tensile specimens are described in
fied heat analysis requirements but cover variations in the
MPIF Standard 10 and Standard 50.
measurement of chemical content between laboratories. The
product analysis tolerances shall conform to the product
7.3 Specimens for tensile tests shall be tested in accordance
tolerances in Table 2.
with Test Methods E8/E8M. Tensile properties shall be deter-
6.2.2 The product analysis is either for the purpose of
mined using a strain rate of 0.003 to 0.007 mm/mm/min
verifying the composition of the manufacturing lot or to
(in./in./min) through yield and then the crosshead speed may be
determine variations in the composition within the lot. Accep-
increased so as to produce fracture in approximately one
tance or rejection of the manufacturing lot of components may
additional minute.
be made by the purchaser on the basis of this product analyses.
7.4 Should any test piece not meet the specified
6.2.3 Samples for chemical analysis shall be representative
requirements, test two additional representative test pieces, in
of the component being tested. The utmost care must be used
the same manner, for each failed test piece. The lot shall be
in sampling titanium for chemical analysis because of its
A
TABLE 3 Mechanical Requirements
TABLE 2 Product Analysis Tolerance
Tolerance Under the Minimum Type 1 Type 2
or Densified Sintered
Element
Over the Maximum Limit
Ultimate Tensile Strength 900 MPa min 780 MPa min
B
Composition (% mass/mass)
(130 000 psi) (113 000 psi)
Nitrogen 0.02 Yield Strength (0.2 % offset) 830 MPa min 680 MPa min
Carbon 0.02 (120 000 psi) (99 000 psi)
A
Hydrogen 0.002 Elongation 10 % min 10 % min
Iron, max 0.10
Reduction of Area 15 % min 15 % mi
...
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