1、Designation:F160908(Reapproved 2014)Standard Specification forCalcium Phosphate Coatings for Implantable Materials1This standard is issued under the fixed designation F1609;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of
2、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.Scope1.1 This specification covers the material requirements forcalcium phosphate coatings for surgical implant applications.1.2 In
3、particulate and monolithic form,the calcium phos-phate materials system has been well-characterized regardingbiological response(1,2)2and laboratory characterization(2-4).Several publications(5-10)have documented the in vitroand in vivo properties of selected calcium phosphate coatingsystems.1.3 Thi
4、s specification includes hydroxylapatite coatings,tricalcium phosphate coatings,or combinations thereof,with orwithout intentional minor additions of other ceramic ormetallic,3and applied by methods including,but not limited to,the following:(1)mechanical capture,(2)plasma spraydeposition,(3)dipping
5、/sintering,(4)electrophoreticdeposition,(5)porcelainizing,and(6)sputtering.1.4 Substrates may include smooth,porous,textured,andother implantable topographical forms.1.5 This specification excludes organic coatings that maycontain calcium and phosphate ionic species.1.6 WarningMercury has been desig
6、nated by EPA andmany state agencies as a hazardous material that can causecentral nervous system,kidney,and liver damage.Mercury,orits vapor,may be hazardous to health and corrosive tomaterials.Caution should be taken when handling mercury andmercury-containing products.See the applicable product Ma
7、-terial Safety Data Sheet(MSDS)for details and EPAs website(http:/www.epa.gov/mercury/faq.htm)for additional informa-tion.Users should be aware that selling mercury or mercury-containing products,or both,in your state may be prohibited bystate law.2.Referenced Documents2.1 ASTM Standards:4E376 Pract
8、ice for Measuring Coating Thickness byMagnetic-Field or Eddy-Current(Electromagnetic)Test-ing MethodsF1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1088 Specification for Beta-Tricalcium Phosphate for Sur-gical ImplantationF1147 Test Method for Tension Testing
9、 of Calcium Phos-phate and Metallic CoatingsF1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic CoatingsF1185 Specification for Composition of Hydroxylapatite forSurgical ImplantsF1854 Test Method for Stereologica
10、l Evaluation of PorousCoatings on Medical ImplantsF1926 Test Method for Evaluation of the EnvironmentalStability of Calcium Phosphate CoatingsF2024 Practice for X-ray Diffraction Determination of PhaseContent of Plasma-Sprayed Hydroxyapatite Coatings2.2 Pharmacopeia Convention Documents:5National Fo
11、rmulary XVI,Tribasic Calcium PhosphateUnited States Pharmacopeia:U.S.Pharmacopeia(most current),Chemical Tests:Calcium(191),Phosphorous(191),Lead,Mercury,Arsenic,and Heavy Metals Method(1)2.3 Other Documents:U.S.Geological Survey Method,Cadmium6U.S.Code of Federal Regulations Title 21(CFR 21),Part82
12、0Quality System Regulation71This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved March 1,2014.Published March 2014.Originallyapproved in 1995
13、.Last previous edition approved in 2008 as F1609 08.DOI:10.1520/F1609-08R14.2The boldface numbers in parentheses refer to the list of references at the end ofthis specification.3The Joint Committee on Powdered Diffraction has established a PowderDiffraction File.The committee operates on an internat
14、ional basis and cooperatesclosely with the Data Commission of the International Union of Crystallinity andASTM.Hydroxylapatite data can be found on file card No.9-432;beta tricalciumphosphate data can be found on file card No.9-169.4For referenced ASTM standards,visit the ASTM website,www.astm.org,o
15、rcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.5Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.6Crock,J.G.,Felichte,F.E.,and Br
16、iggs,P.H.,“Determination of Elements inNational Bureau of Standards Geological Reference Materials SRM 278 Obsidianand SRM 688 Basalt by Inductively Coupled Argon PlasmaAtomic EmissionSpectrometry,”Geostandards Newsletter,Vol 7,1983,pp.335340.7Available from Standardization Documents Order Desk,DODSSP,Bldg.4,SectionD,700RobbinsAve.,Philadelphia,PA19111-5098,http:/dodssp.daps.dla.mil.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 X-Ra
