ASTM_F_1580_-_12.pdf

Designation:F158012Standard Specification forTitanium and Titanium-6 Aluminum-4 Vanadium AlloyPowders for Coatings of Surgical Implants1This standard is issued under the fixed designation F1580;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This specification covers the requirements for unalloyedtitanium and Ti-6Al-4V alloy powders for use in fabricatingcoatings on titanium alloy implants.1.2 Powders covered under this specification may be used toform coatings by sintering or thermal spraying techniques.1.3 This specification covers powder requirements only.Itdoes not address properties of the coatings formed from them.1.4 Finely divided titanium powder may be consideredpyrophoric and should be handled in accordance with theappropriate guidelines.1.5 The values stated in inch-pound units are to be regardedas standard.The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2.Referenced Documents2.1 ASTM Standards:2B214 Test Method for Sieve Analysis of Metal PowdersB215 Practices for Sampling Metal PowdersB299 Specification for Titanium SpongeE11 Specification for Woven Wire Test Sieve Cloth and TestSievesE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE2371 Test Method for Analysis of Titanium and TitaniumAlloys by Atomic Emission Plasma SpectrometryF67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications(UNSR56400)2.2 ISO Standards:3ISO 9001 Quality Management System Requirements2.3 Aerospace Material Specifications:4AMS 2249 Chemical Check Analysis Limits,Titanium andTitanium AlloysAMS 4998 Powder,6Al-4V3.Significance and Use3.1 Coatings formed from metallic powders have becomewidely used as a means of improving tissue attachment toimplants.Such coatings have also been demonstrated toimprove bonding of acrylic cement to prostheses.Thisspecification addresses the special requirements of the metalpowders used to form these coatings.4.Methods of Manufacture4.1 Powders may be manufactured by the plasma rotatingelectrode process,inert gas atomization,hydride-dehydride,orother method capable of producing powder meeting the re-quirements of this specification.5.Chemical Requirements5.1 The chemical analysis of the powder shall conform tothe requirements specified in Table 1.5.1.1 Requirements for the major and minor elementalconstituents for unalloyed titanium and Ti-6Al-4V alloy pow-ders are listed in Table 1.Also listed are all important residualelements.Analysis for elements not listed in Table 1 is notrequired to verify compliance with this specification.5.2 The product analysis tolerance shall conform to therequirements set forth in Table 2.5.3 For referee purposes,Test Method E2371 shall be used.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is under the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved March 1,2012.Published March 2012.Originallyapproved in 1995.Last previous edition approved in 2007 as F1580-07.DOI:10.1520/F1580-12.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from Society of Automotive Engineers(SAE),400 CommonwealthDr.,Warrendale,PA 15096-0001,http:/www.sae.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.4 Intentional elemental additions other than those speci-fied in Table 1 are not permitted.5.5 For powder that includes particle size fractions finerthan 200 mesh(74 m),the oxygen content limits shall beagreed upon between buyer and seller.6.Particle Size6.1 Powder shall be sieved to the customers requirementswith stainless steel screens conforming to Specification E11.Analysis of sieved powder for conformance to the customersparticle size range requirements shall be in accordance withTest Method B214.7.Cleanliness7.1 Powder shall be handled at all times so as to ensurefreedom from contamination with nonmetallic materials orother metal alloy powd