ASTM_F_1377_-_13.pdf

Designation:F137713Standard Specification forCobalt-28Chromium-6Molybdenum Powder for Coating ofOrthopedic Implants(UNS R30075)1This standard is issued under the fixed designation F1377;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 cobalt-28chromium-6molybdenum alloy powders for use in fabricat-ing coatings on cobalt-28chromium-6molybdenum alloy ortho-pedic 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 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.2.Referenced Documents2.1 ASTM Standards:2B214 Test Method for Sieve Analysis of Metal PowdersB215 Practices for Sampling Metal PowdersE11 Specification for Woven Wire Test Sieve Cloth and TestSievesE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE354 Test Methods for Chemical Analysis of High-Temperature,Electrical,Magnetic,and Other Similar Iron,Nickel,and Cobalt AlloysF75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)2.2 ISO Standard:3ISO 9001 Quality Management Standard3.Ordering Information3.1 Inquiries and orders for material under this specificationshall include the following information:3.1.1 Quantity,3.1.2 ASTM designation and date of issue,3.1.3 Method of powder manufacturing,3.1.4 Chemistry requirements,3.1.5 Sieve analysis requirements,3.1.6 Special tests,if any,and3.1.7 Other requirements.4.Significance and Use4.1 Coatings formed from metallic powders have becomewidely used as a means of improving tissue attachment touncemented orthopedic joint prosthesis.Such coatings havealso been demonstrated to improve bonding of acrylic cementto prostheses.This specification addresses the special require-ments of the metal powders used to form these coatings.5.Materials and Manufacture5.1 Powders may be manufactured by the rotating electrodeprocess,inert gas atomization,or other methods capable ofproducing powder meeting the requirements of this specifica-tion.6.Chemical Composition6.1 The heat analysis of stock used to manufacture thepowder shall conform to the chemical analysis set forth inTable 1 of Specifications F75 or F1537(Alloy 1 and Alloy 2only).6.2 The product analysis tolerance shall conform to therequirements set forth in Table 2 of Specifications F75 orF1537.6.3 For referee purposes,Test Methods E354 shall be used.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved June 1,2013.Published August 2013.Originallyapproved in 1992.Last previous edition approved in 2008 as F1377 08.DOI:10.1520/F1377-13.2For 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.*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 7.Sieve Analysis Requirements7.1 Powder shall be sieved to the customers requirementswith screens conforming to Specification E11.Sieve analysistesting of the sieved powder for conformance to purchasersparticle size range requirements shall be performed accordingto Test Method B214.Powder sampling shall be performedaccording to Test Method B215.8.Cleanliness Requirements8.1 Powder shall be handled at all times so as to minimizepossible contamination with nonmetallic materials or othermetal alloy powders,or both.8.2 Powder cleanliness shall be determined by examining arepresentative sample of the powder.Powder sampling shall beperformed according to Practices B215.Powder testing shallbe performed by examining either(a)at least 1 in.2(645 mm2)of a closely packed mono-layer of powder at 20,or(b)by analternative testing practice,as agreed upon between purchaserand supplier.No foreign ma