ASTM F1580-12
(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.
1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
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Designation:F1580 −12
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* rials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
1.1 Thisspecificationcoverstherequirementsforunalloyed
F1472 Specification for Wrought Titanium-6Aluminum-
titanium and Ti-6Al-4V alloy powders for use in fabricating
4VanadiumAlloyforSurgicalImplantApplications(UNS
coatings on titanium alloy implants.
R56400)
1.2 Powderscoveredunderthisspecificationmaybeusedto 3
2.2 ISO Standards:
form coatings by sintering or thermal spraying techniques.
ISO9001Quality Management System Requirements
4
1.3 This specification covers powder requirements only. It 2.3 Aerospace Material Specifications:
does not address properties of the coatings formed from them.
AMS2249Chemical Check Analysis Limits, Titanium and
Titanium Alloys
1.4 Finely divided titanium powder may be considered
AMS4998Powder, 6Al-4V
pyrophoric and should be handled in accordance with the
appropriate guidelines.
3. Significance and Use
1.5 The values stated in inch-pound units are to be regarded
3.1 Coatings formed from metallic powders have become
as standard. The values given in parentheses are mathematical
widely used as a means of improving tissue attachment to
conversions to SI units that are provided for information only
implants. Such coatings have also been demonstrated to
and are not considered standard.
improve bonding of acrylic cement to prostheses. This
specification addresses the special requirements of the metal
2. Referenced Documents
powders used to form these coatings.
2
2.1 ASTM Standards:
B214Test Method for Sieve Analysis of Metal Powders 4. Methods of Manufacture
B215Practices for Sampling Metal Powders
4.1 Powders may be manufactured by the plasma rotating
B299Specification for Titanium Sponge
electrode process, inert gas atomization, hydride-dehydride, or
E11Specification forWovenWireTest Sieve Cloth andTest
other method capable of producing powder meeting the re-
Sieves
quirements of this specification.
E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
5. Chemical Requirements
E2371Test Method for Analysis of Titanium and Titanium
5.1 The chemical analysis of the powder shall conform to
Alloys by Atomic Emission Plasma Spectrometry
the requirements specified in Table 1.
F67Specification for Unalloyed Titanium, for Surgical Im-
5.1.1 Requirements for the major and minor elemental
plant Applications (UNS R50250, UNS R50400, UNS
constituents for unalloyed titanium and Ti-6Al-4V alloy pow-
R50550, UNS R50700)
ders are listed in Table 1.Also listed are all important residual
F981Practice for Assessment of Compatibility of Biomate-
elements. Analysis for elements not listed in Table 1 is not
required to verify compliance with this specification.
1
5.2 The product analysis tolerance shall conform to the
This specification is under the jurisdiction of ASTM Committee F04 on
MedicalandSurgicalMaterialsandDevicesandisunderthedirectresponsibilityof
requirements set forth in Table 2.
Subcommittee F04.12 on Metallurgical Materials.
5.3 For referee purposes, Test Method E2371 shall be used.
Current edition approved March 1, 2012. Published March 2012. Originally
approved in 1995. Last previous edition approved in 2007 as F1580-07. DOI:
10.1520/F1580-12.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
4
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
---------------------- Page: 1 ----------------------
F1580−12
TABLE 1 Chemical Requirements
6. Particle Size
Unalloyed Ti Sponge Ti-6Al-4V
6.1 Powder shall be sieved to the customer’s requirements
A B C
Ti Powder Powder Powder
Element
% (mass/mass) % (mass/mass) % (mass/mass) with stainless steel screens conforming to Specification E11.
Min Max Min Max Min Max Analysis of sieved powder for conforman
...
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:F1580–07 Designation: F1580 – 12
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.
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.
1.4Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate
guidelines.
1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate
guidelines.
1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents
2
2.1 ASTM Standards:
B214 Test Method for Sieve Analysis of Metal Powders
B215 Practices for Sampling Metal Powders
B299 Specification for Titanium Sponge
E11 Specification for Woven Wire Test Sieve Cloth and Test Sieves
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Atomic Emission Plasma Spectrometry
F67 Specification for UnalloyedTitanium, for Surgical ImplantApplications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700) F981
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
3
2.2 ISO Standards:
ISO 9001 Quality Management System Requirements
2.3 American Society for Quality (ASQ) Standards:
ASQC1General Requirements for a Quality Program
4
2.4 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 4998 Powder, 6Al-4V
3. Significance and Use
3.1 Coatings formed from metallic powders have become widely used as a means of improving tissue attachment to implants.
Such coatings have also been demonstrated to improve bonding of acrylic cement to prostheses. This specification addresses the
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is under the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Dec.March 1, 2007.2012. Published December 2007.March 2012. Originally approved in 1995. Last previous edition approved in 20012007 as
F1580 - 017. DOI: 10.1520/F1580-07.10.1520/F1580-12.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
4
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 – 12
special requirements of the metal powders used to form these coatings.
4. Methods of Manufacture
4.1 Powders 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.
5. Chemical Requirements
5.1 The chemical analysis of the powder shall conform to the requirements specified in Table 1.
5.1.1 Requirements for the major and m
...
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