ASTM F1580-07
(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
ABSTRACT
This specification covers the chemical, particle size, and cleanliness requirements for unalloyed titanium and titanium-6aluminum-4vanadium alloy powders for use as coatings, formed by sintering or thermal spraying techniques, onto titanium alloy surgical implants. The powders may be manufactured by the plasma rotating electrode, inert gas atomization, or hydride-dehydride process, or other method capable of producing powder meeting the requirements of this specification. This specification addresses only the powder requirements, and not the properties of the coatings formed from them.
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.
1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate guidelines.
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Designation: F1580 – 07
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 F1580; 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.
3
1. Scope* 2.2 ISO Standards:
ISO 9001 Quality Management System Requirements
1.1 This specification covers the requirements for unalloyed
4
2.3 American Society for Quality (ASQ) Standards:
titanium and Ti-6Al-4V alloy powders for use in fabricating
ASQ C1 General Requirements for a Quality Program
coatings on titanium alloy implants.
5
2.4 Aerospace Material Specifications:
1.2 Powderscoveredunderthisspecificationmaybeusedto
AMS 2249 Chemical Check Analysis Limits, Titanium and
form coatings by sintering or thermal spraying techniques.
Titanium Alloys
1.3 This specification covers powder requirements only. It
AMS 4998 Powder, 6Al-4V
does not address properties of the coatings formed from them.
1.4 Finely divided titanium powder may be considered
3. Significance and Use
pyrophoric and should be handled in accordance with the
3.1 Coatings formed from metallic powders have become
appropriate guidelines.
widely used as a means of improving tissue attachment to
2. Referenced Documents implants. Such coatings have also been demonstrated to
2
improve bonding of acrylic cement to prostheses. This
2.1 ASTM Standards:
specification addresses the special requirements of the metal
B214 Test Method for Sieve Analysis of Metal Powders
powders used to form these coatings.
B215 Practices for Sampling Metal Powders
B299 Specification for Titanium Sponge
4. Methods of Manufacture
E11 SpecificationforWovenWireTestSieveClothandTest
4.1 Powders may be manufactured by the plasma rotating
Sieves
electrode process, inert gas atomization, hydride-dehydride, or
E29 Practice for Using Significant Digits in Test Data to
other method capable of producing powder meeting the re-
Determine Conformance with Specifications
quirements of this specification.
E2371 Test Method for Analysis of Titanium and Titanium
Alloys by Atomic Emission Plasma Spectrometry
5. Chemical Requirements
F67 Specification for Unalloyed Titanium, for Surgical
5.1 The chemical analysis of the powder shall conform to
Implant Applications (UNS R50250, UNS R50400, UNS
the requirements specified in Table 1.
R50550, UNS R50700)
5.1.1 Requirements for the major and minor elemental
F981 Practice forAssessment of Compatibility of Biomate-
constituents for unalloyed titanium and Ti-6Al-4V alloy pow-
rials for Surgical Implants with Respect to Effect of
ders are listed in Table 1.Also listed are all important residual
Materials on Muscle and Bone
elements. Analysis for elements not listed in Table 1 is not
F1472 Specification for Wrought Titanium-6Aluminum-
required to verify compliance with this specification.
4Vanadium Alloy for Surgical Implant Applications (UNS
5.2 The product analysis tolerance shall conform to the
R56400)
requirements set forth in Table 2.
5.3 For referee purposes, Test Method E2371 shall be used.
1
5.4 Intentional elemental additions other than those speci-
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is under the direct responsibility of
fied in Table 1 are not permitted.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2007. Published December 2007. Originally
3
approved in 1995. Last previous edition approved in 2001 as F1580 - 01. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F1580-07. 4th Floor, New York, NY 10036, http://www.ansi.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available from Society of Automotive Engineers (SAE), 400 Commonwealth
the ASTM website. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
*A Summary of Changes section appears at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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F1580 – 07
TABLE 1 Chemical Requirements
Analysis of sieved powder for conformance to the customer’s
Unalloyed Ti Sponge Ti-6Al-4V particle size range requirements shall be in accordance with
A B C
Ti Powder Pow
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F1580–01 Designation: F 1580 – 07
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. 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.
1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate
guidelines.
2. Referenced Documents
2
2.1 ASTM Standards:
B 214 Test Method for Sieve Analysis of Granular Metal Powders
2
B 215Practices for Sampling Finished Lots of Metal Powders Practices for Sampling Metal Powders
B 299 Specification for Titanium Sponge
E 11Specification for Wire-Cloth Sieves for Testing Purposes Specification for Wire Cloth and Sieves for Testing Purposes
E 29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E120Test Methods for Chemical Analysis of Titanium and Titanium Alloys 2371 Test Method for Analysis of Titanium and
Titanium Alloys by Atomic Emission Plasma Spectrometry
F 67Specification for UnalloyedTitanium for Surgical ImplantApplications Specification for UnalloyedTitanium, for Surgical
Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F 981 Practice forAssessment of Compatibility of Biomaterials for Surgical Implants Withwith Respect to Effect of Materials
on Muscle and Bone
F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
3
2.2 ISO Standards:
ISO 9001 Quality Management System Requirements
4
2.3 American Society for Quality (ASQ) Standards:
ASQ C1 General Requirements for a Quality Program
2.3
5
2.4 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS4998APowder, 6Al-4V, Premium Quality (noncurrent) AMS 4998 Powder, 6Al-4V
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Devices and is under the direct responsibility of Subcommittee F04.12
on Metallurgical Materials.
e1
Current edition approved October 10, 2001. Published January 2002. Orginally published as F1580-95. Plast previous edition F1580-95 .
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is under the direct responsibilityof
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2007. Published December 2007. Originally approved in 1995. Last previous edition approved in 2001 as F 1580 - 01.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 02.05.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Annual Book of ASTM Standards, Vol 02.04.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Annual Book of ASTM Standards, Vol 14.02.
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
5
Annual Book of ASTM Standards, Vol 03.05.
5
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
*A Summary of Changes section appears at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F1580–07
3. Methods of Manufacture
3.1Powders may be manufactured by the plasma rotating electrode process, inert gas atomization, hydride-dehydride, or other
method capable of producing powder meeting the requirements of this specification.
4.Chemical Requirements Chemical Requirements
4.1The chemical analysis of the powder shall conform to the requirements set
...
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