ASTM F1580-95e1
(Specification)Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
SCOPE
1.1 This specification covers the requirements for unalloyed titanium and Ti-6Al-4V alloy powders for use in fabricating coatings on titanium alloy implants.
1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.
1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.
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Standards Content (Sample)
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Designation: F 1580 – 95
Standard Specification for
Titanium and Titanium-6 % Aluminum-4 % Vanadium Alloy
1
Powders for Coatings of Surgical Implants
This standard is issued under the fixed designation F 1580; 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
e NOTE—Table 1 was editorially corrected in May 2001.
1. Scope AMS 2249 Chemical Check Analysis Limits, Titanium and
Titanium Alloys
1.1 This specification covers the requirements for unalloyed
AMS 4998A Powder, 6Al-4V, Premium Quality (noncur-
titanium and Ti-6Al-4V alloy powders for use in fabricating
rent)
coatings on titanium alloy implants.
1.2 Powders covered under this specification may be used to
3. Significance and Use
form coatings by sintering or thermal spraying techniques.
3.1 Coatings formed from metallic powders have become
1.3 This specification covers powder requirements only. It
widely used as a means of improving tissue attachment to
does not address properties of the coatings formed from them.
implants. Such coatings have also been demonstrated to
2. Referenced Documents improve bonding of acrylic cement to prostheses. This speci-
fication addresses the special requirements of the metal pow-
2.1 ASTM Standards:
ders used to form these coatings.
B 214 Test Method Sieve Analysis of Granular Metal Pow-
2
ders
4. Methods of Manufacture
B 215 Methods of Sampling Finished Lots of Metal Pow-
2 4.1 Powders may be manufactured by the plasma rotating
ders
3
electrode process, inert gas atomization, hydride-dehydride, or
B 299 Specification for Titanium Sponge
other method capable of producing powder meeting the re-
E 11 Specification for Wire-Cloth Sieves for Testing Pur-
4 quirements of this specification.
poses
E 120 Test Methods for Chemical Analysis of Titanium and
5. Chemical Requirements
5
Titanium Alloys
5.1 The chemical analysis of the powder shall conform to
F 67 Specification for Unalloyed Titanium for Surgical
3 the requirements set forth in Table 1. Analysis shall be
Implant Applications
performed before the addition of any processing aids.
F 1472 Specification for Wrought Ti-6Al-4V Alloy for Sur-
6 5.1.1 Requirements for the major and minor elemental
gical Implant Applications
constituents for unalloyed titanium and Ti-6Al-4V alloy pow-
2.2 American Society for Quality Control (ASQC) Stan-
7 ders are listed in Table 1. Also listed are all important residual
dards:
elements. Analysis for elements not listed in Table 1 is not
ASQC C1 General Requirements for a Quality Control
required to verify compliance with this specification.
Program
8 5.2 The product analysis tolerance shall conform to the
2.3 Aerospace Material Specifications:
requirements set forth in Table 2.
5.3 For referee purposes, Test Methods E 120 shall be used.
5.4 Intentional elemental additions other than those speci-
1
fied in Table 1 are not permitted.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Devices and is under the direct responsibility of Subcommit-
5.5 For powder that includes particle size fractions finer
tee F04.12on Metallurgical Materials.
than 200 mesh (74 μm), the oxygen content limits shall be
Current edition approved Feb. 15, 1995. Published July 1995.
2
agreed upon between buyer and seller.
Annual Book of ASTM Standards, Vol 02.05.
3
Annual Book of ASTM Standards, Vol 02.04.
4
6. Particle Size
Annual Book of ASTM Standards, Vol 14.02.
5
Annual Book of ASTM Standards, Vol 03.05.
6.1 Powder shall be sieved to the customer’s requirements
6
Annual Book of ASTM Standards, Vol 13.01.
7
with stainless steel screens conforming to Specification E 11.
Available from the American Society for Quality Control, 161 W. Wisconsin
Ave., Milwaukee, WI 53203. Analysis of sieved powder for conformance to the customer’s
8
Available from Society of Automotive Engineers, 400 Commonwealth Dr.,
Warrendale, PA 15096.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
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F 1580
TABLE 1 Chemical Requirements
7.2 Powder cleanliness shall be determined by examining a
A B C
Unalloyed Ti Powder Ti Sponge Powder Ti-6Al-4V Powder representative sample, per Methods B 215 or as agreed upon
2 2
% (Mass/Mass) % (Mass/Mass) % (Mass/Mass)
Element
between buyer and seller, comprising at least 1 in. (6.45 cm )
min max min max min max
of a closely packed mono-layer of powder per lot at 203
Al 0.05 5.50 6.75 magnification. No foreign material shall be visible under these
V 3.50 4.50
conditions. Powder cleanliness shall be determined before the
D
O 0.40
...
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