ASTM F1108-97a
(Specification)Standard Specification for Ti6Al4V Alloy Castings for Surgical Implants (UNS R56406)
Standard Specification for Ti6Al4V Alloy Castings for Surgical Implants (UNS R56406)
SCOPE
1.1 This specification provides material requirements for titanium-6 aluminum-4 vanadium alloy castings to be used in the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as the standard. The metric equivalents of inch-pound units may be approximate.
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Designation: F 1108 – 97a
Standard Specification for
Titanium-6 Aluminum-4 Vanadium Alloy Castings for
Surgical Implants (UNS R56406)
This standard is issued under the fixed designation F 1108; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope C1 Specification of General Requirements for a Quality
Control Program
1.1 This specification provides material requirements for
titanium-6 aluminum-4 vanadium alloy castings to be used in
3. Materials and Manufacture
the manufacture of surgical implants.
3.1 Parts conforming to this specification shall be produced
1.2 The values stated in inch-pound units are to be regarded
by vacuum investment casting.
as the standard. The metric equivalents of inch-pound units
3.2 Parts covered by this specification shall be an annealed
may be approximate.
condition in the hot isostatically pressed condition.
2. Referenced Documents
NOTE 1—While hot isostatic processing (HIP) may enhance mechanical
2.1 ASTM Standards: properties of Ti6A14V castings, it has also been shown to reduce the
scatter in mechanical properties and therefore increases the confidence in
B 367 Specification for Titanium and Titanium Alloy Cast-
reliability of castings.
ings
B 381 Specification for Titanium and Titanium Alloy Forg-
3.3 Surface defects may be repaired by welding.
ings
3.3.1 Weld repair shall be carefully executed as per written
B 600 Practice for Descaling and Cleaning Titanium and
procedures by individuals qualified to perform those proce-
Titanium Alloy Surfaces
dures.
E 8 Test Methods of Tension Testing of Metallic Materials
3.3.2 ELI weld rod conforming to Specification F 136 shall
E 120 Test Methods for Chemical Analysis of Titanium and
be used where filler metal is needed.
Titanium Alloys
3.3.3 Weld repairs shall be performed prior to final thermal
E 1409 Test Method for Determination of Oxygen in Tita-
processing.
nium and Titanium Alloys by the Inert Gas Fusion Tech-
NOTE 2—Under certain circumstances, a weld repair will act as a stress
nique
riser. Therefore, care should be exercised in the location and extent of
E 1447 Test Method for Determination Hydrogen in Tita-
weld repair as it relates to regions of the implant where significant stresses
nium and Titanium Alloys by the Inert Gas Fusion Thermal
might be incurred.
Conductivity Method NOTE 3—While not covered by this specification, there are other
thermal processes which meet specific needs of the implant manufacturer.
F 136 Specification for Wrought Titanium 6A1-4V ELI
These thermal treatments may be mutually agreed upon by the casting
Alloy for Surgical Implant Applications
vendor and the implant manufacturer.
F 601 Practice for Fluorescent Penetrant Inspection of Me-
3.4 All alpha case shall be removed by suitable means such
tallic Surgical Implants
as chemical milling or machining prior to HIP processing.
F 629 Practice for Radiography of Cast Metallic Surgical
3.5 Parts shall be furnished in the descaled and cleaned
Implants
condition in accordance with B 600.
2.2 ASQC Standard:
4. Chemical Composition
4.1 The analysis for chemical composition of the castings
This specification is under the jurisdiction of ASTM Committee F04 on
shall conform to the requirements prescribed in Table 1.
Medical and Surgical Materials and Devices and is the direct responsibility of
Chemical analysis shall be performed on a representative
Subcommittee F04.12 on Metallurgical Materials.
specimen cast from each heat using the same general proce-
Current edition approved April 10, 1997. Published March 1998. Originally
published as F 1108 - 88. Last previous edition F 1108 - 97. dures used in casting implants.
Annual Book of ASTM Standards, Vol 02.04.
4.1.1 Requirements for the major and minor elemental
Annual Book of ASTM Standards, Vol 03.01.
constituents are listed in Table 1. Also listed are important
Annual Book of ASTM Standards, Vol 03.05.
Annual Book of ASTM Standards, Vol 03.06.
Annual Book of ASTM Standards, Vol 13.01.
Available from American Society for Quality Control, 161 W. Wisconsin Ave.,
Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1108
A
TABLE 1 Chemical Composition TABLE 3 Mechanical Requirements
Element Composition, Weight % Ultimate Tensile Strength 125 000 psi (860 MPa) min
Yield Strength (0.2 % offset) 110 000 psi (758 MPa) min
Nitrogen 0.05 max
B
Elongation 8 % min
Carbon 0.10 max
Reduction of Area 14 % min
Hydrogen 0.015 max
A
In the cast, HIP, and annealed condition.
Iron 0.30 max
B
Oxygen 0.20 max Gage length = 4 3 diameter.
Aluminum 5.5 to 6.75
Vanadium 3.5 to 4.5
A
Titanium Balance
5.4 Mechanical test specimens shall be produced by the
A
The remainder of the percent of titanium is determined by the difference. same general procedures used in casting surgical implants and
Residual metallic element tolerance levels will be agreed upon between producer
shall be tested in accordance with Test Methods E 8 which may
and manufacturer.
have a ground finish on the reduced section. Alternatively, test
residual elements. Analysis for elements not listed in Table 1 is
specimens may be machined from surgical implant castings.
not required to verify compliance with this specification.
5.5 A minimum of two test specimens per heat shall be
4.2 Check analysis chemical requirements for samples taken
tested. If one specimen fails below the specified mechanical
from castings shall conform to the tolerances prescribed in
requirements or breaks outside the gage limits, two additional
Table 2.
specimens
...
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