ASTM F1580-95

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.

General Information

• Status: Historical
• Publication Date: 09-Oct-2001
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaced By: ASTM F1580-95e1 - Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 10-Oct-2001
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 10-Oct-2001

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1580 – 95
Standard Specification for
Titanium and Titanium-6 % Aluminum-4 % Vanadium Alloy
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. Scope AMS 4998A Powder, 6Al-4V, Premium Quality (noncur-
rent)
1.1 This specification covers the requirements for unalloyed
titanium and Ti-6Al-4V alloy powders for use in fabricating
3. Significance and Use
coatings on titanium alloy implants.
3.1 Coatings formed from metallic powders have become
1.2 Powders covered under this specification may be used to
widely used as a means of improving tissue attachment to
form coatings by sintering or thermal spraying techniques.
implants. Such coatings have also been demonstrated to
1.3 This specification covers powder requirements only. It
improve bonding of acrylic cement to prostheses. This speci-
does not address properties of the coatings formed from them.
fication addresses the special requirements of the metal pow-
2. Referenced Documents ders used to form these coatings.
2.1 ASTM Standards:
4. Methods of Manufacture
B 214 Test Method Sieve Analysis of Granular Metal Pow-
2 4.1 Powders may be manufactured by the plasma rotating
ders
electrode process, inert gas atomization, hydride-dehydride, or
B 215 Methods of Sampling Finished Lots of Metal Pow-
2 other method capable of producing powder meeting the re-
ders
3 quirements of this specification.
B 299 Specification for Titanium Sponge
E 11 Specification for Wire-Cloth Sieves for Testing Pur-
5. Chemical Requirements
poses
5.1 The chemical analysis of the powder shall conform to
E 120 Test Methods for Chemical Analysis of Titanium and
5 the requirements set forth in Table 1. Analysis shall be
Titanium Alloys
performed prior to the addition of any processing aids.
F 67 Specification for Unalloyed Titanium for Surgical
3 5.1.1 Requirements for the major and minor elemental
Implant Applications
constituents for unalloyed titanium and Ti-6Al-4V alloy pow-
F 1472 Specification for Wrought Ti-6Al-4V Alloy for Sur-
6 ders are listed in Table 1. Also listed are all important residual
gical Implant Applications
elements. Analysis for elements not listed in Table 1 is not
2.2 American Society for Quality Control (ASQC) Stan-
7 required to verify compliance with this specification.
dards:
5.2 The product analysis tolerance shall conform to the
ASQC C1 General Requirements for a Quality Control
requirements set forth in Table 2.
Program
8 5.3 For referee purposes, Test Methods E 120 shall be used.
2.3 Aerospace Material Specifications:
5.4 Intentional elemental additions other than those speci-
AMS 2249 Chemical Check Analysis Limits, Titanium and
fied in Table 1 are not permitted.
Titanium Alloys
5.5 For powder that includes particle size fractions finer
than 200 mesh (74 microns), the oxygen content limits shall be
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
agreed upon between buyer and seller.
and Surgical Devices and is under the direct responsibility of Subcommittee F04.12
on Metallurgical Materials.
6. Particle Size
Current edition approved Feb. 15, 1995. Published July 1995.
Annual Book of ASTM Standards, Vol 02.05.
6.1 Powder shall be sieved to the customer’s requirements
Annual Book of ASTM Standards, Vol 02.04.
with stainless steel screens conforming to Specification E 11.
Annual Book of ASTM Standards, Vol 14.02.
5 Analysis of sieved powder for conformance to the customer’s
Annual Book of ASTM Standards, Vol 03.05.
Annual Book of ASTM Standards, Vol 13.01. particle size range requirements shall be in accordance with
Available from the American Society for Quality Control, 161 W. Wisconsin
Test Method B 214.
Ave., Milwaukee, WI 53203.
Available from Society of Automotive Engineers, 400 Commonwealth Drive,
Warrendale, PA 15096.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 1580
TABLE 1 Chemical Requirements
magnification. No foreign material shall be visible under these
Unalloyed Ti powder Ti-6Al-4V powder conditions. Powder cleanliness shall be determined prior to the
weight per cent weight per cent
Element addition of any processing aids.
min. max. min. max.
8. Special Requirements
Al 5.50 6.75
V 3.50 4.50
8.1 Various materials known as processing aids may be
O 0.40 0.20
Fe 0.50 0.30 added to the powder to provide enhanced processibility. The
C 0.10 0.08
powder supplier shall identify the chemical composition and
H 0.05 0.015
weight percentage of any added processing aids on the material
N 0.05 0.05
Cu 0.10 certification.
Sn 0.10
8.2 Processing aids shall have no detrimental effect on the
Si 0.04
A corrosion resistance or biocomptability of the final coating.
Cl 0.20
A
Na 0.19
NOTE 1—Finely divided titanium powder may be considered pyro-
B B
Ti balance balance
phoric and should be handled in accordance with the appropriate guide-
A
Lower maximum chlorine and sodium contents may be agreed upon between
lines in the Material Safety Data Sheet.
buyer and seller.
B
The percentage of titanium is determined by difference and need not be
9. Certification
measured.
9.1 Powder shipped under this specification shall be accom-
A
TABLE 2 Product Analysis Tolerances
panied by certification that includes:
9.1.1 ASTM designation.
Element Variation Under Min. or Over Max.
9.1.2 Quantity (weight).
Aluminum 0.04
Vanadium 0.015
9.1.3 Method of manufacture.
B
Oxygen 0.03
9.1.4 Chemical analysis per 5.1.
C
Oxygen 0.02
9.1.5 Sieve analysis per 6.1.
Iron 0.10
Hydrogen 0.002
9.1.6 Powder cleanliness per 7.2.
Carbon 0.02
9.1.7 Special requirement per 8.2.
Nitrogen 0.02
9.1.8 Other requirements.
Copper 0.05
Tin 0.15
Silicon 0.02
10. Quality Program Requirements
A
R
...