ASTM F1580-18
(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 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F1580 −18
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* E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
1.1 Thisspecificationcoverstherequirementsforunalloyed
E2371Test Method for Analysis of Titanium and Titanium
titanium and Ti-6Al-4V alloy powders for use in fabricating
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
coatings on titanium alloy implants.
Plasma Atomic Emission Spectrometry (Performance-
1.2 Powderscoveredunderthisspecificationmaybeusedto
Based Test Methodology)
form coatings by sintering or thermal spraying techniques.
F67Specification for Unalloyed Titanium, for Surgical Im-
plant Applications (UNS R50250, UNS R50400, UNS
1.3 This specification covers powder requirements only. It
does not address properties of the coatings formed from them. R50550, UNS R50700)
F981Practice for Assessment of Compatibility of Biomate-
1.4 Finely divided titanium powder may be considered
rials for Surgical Implants with Respect to Effect of
pyrophoric and should be handled in accordance with the
Materials on Muscle and Insertion into Bone
appropriate guidelines.
F1472 Specification for Wrought Titanium-6Aluminum-
1.5 Units—The values stated in either SI units or inch-
4VanadiumAlloyforSurgicalImplantApplications(UNS
pound units are to be regarded separately as standard. The
R56400)
values stated in each system may not be exact equivalents;
IEEE/ASTM SI 10 American National Standard for Metric
therefore,eachsystemshallbeusedindependentlyoftheother.
Practice
Combining values from the two systems may result in non-
3
2.2 ISO Standards:
conformance with the standard.
ISO9001Quality Management System Requirements
1.6 This international standard was developed in accor- 4
2.3 Aerospace Material Specifications:
dance with internationally recognized principles on standard-
AMS2249Chemical Check Analysis Limits, Titanium and
ization established in the Decision on Principles for the
Titanium Alloys
Development of International Standards, Guides and Recom-
AMS4998Powder, 6Al-4V
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
3. Significance and Use
3.1 Coatings formed from metallic powders have become
2. Referenced Documents
widely used as a means of improving tissue attachment to
2
2.1 ASTM Standards:
implants. Such coatings have also been demonstrated to
B214Test Method for Sieve Analysis of Metal Powders
improve bonding of acrylic cement to prostheses. This
B215Practices for Sampling Metal Powders
specification addresses the special requirements of the metal
B299Specification for Titanium Sponge
powders used to form these coatings.
E11Specification forWovenWireTest Sieve Cloth andTest
Sieves
4. Ordering Information
4.1 Include with inquiries and orders for material under this
1
specification the following information:
This specification is under the jurisdiction of ASTM Committee F04 on
MedicalandSurgicalMaterialsandDevicesandisunderthedirectresponsibilityof
4.1.1 Quantity (weight),
Subcommittee F04.12 on Metallurgical Materials.
4.1.2 ASTM specification and date of issue,
Current edition approved Nov. 15, 2018. Published December 2018. Originally
approved in 1995. Last previous edition approved in 2012 as F1580-12. DOI:
10.1520/F1580-18.
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 ----------------------
F1580−18
4.1.3 Method of Manufacture—Typeofpowder(un-alloyed, 6.2 Product Analysis:
sponge or Ti-6Al-4V), 6.2.1 The product analysis tolerance shall conform to the
4.1.4 Units to be Certified—SI or inch-pound, re
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM 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 − 12 F1580 − 18
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.
1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriate
guidelines.
1.5 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values given
in parentheses are mathematical conversions to SI units that are provided for information only and are not considered stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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 Direct Current Plasma and Inductively Coupled Plasma
Atomic Emission Spectrometry (Performance-Based Test Methodology)
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
IEEE/ASTM SI 10 American National Standard for Metric Practice
3
2.2 ISO Standards:
ISO 9001 Quality Management System Requirements
4
2.3 Aerospace Material Specifications:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 4998 Powder, 6Al-4V
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 on Metallurgical Materials.
Current edition approved March 1, 2012Nov. 15, 2018. Published March 2012December 2018. Originally approved in 1995. Last previous edition approved in 20072012
as F1580 - 07.F1580 - 12. DOI: 10.1520/F1580-12.10.1520/F1580-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM 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 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 − 18
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
special requirements of the metal powders used to form these coatings.
4. Ordering Informa
...
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