ASTM_F_1185_-_03_2014.pdf

Designation:F118503(Reapproved 2014)Standard Specification forComposition of Hydroxylapatite for Surgical Implants1This standard is issued under the fixed designation F1185;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.Scope1.1 This specification covers chemical and crystallographicrequirements for hydroxylapatite intended for surgical im-plants.For a material to be called hydroxylapatite,it mustconform to this specification.(See Appendix X1.)1.2 The biological response to hydroxylapatite in soft tissueand bone has been characterized by a history of clinical use(1-3)2and by laboratory studies(4-6).1.3 This specification includes powder,particulate,andforms intended for use as surgical implants,components ofsurgical implants,or as raw materials for manufacturingprocesses such as thermal spray coating,electrophoreticdeposition,physical vapor deposition,and so forth.1.4 This specification specifically excludes hydroxylapatitecoatings,amorphous calcium phosphate,ceramic-glasses,tribasic calcium phosphate,whitlockite,and alpha-and beta-tricalcium phosphate.(See Specification F1088.)1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1088 Specification for Beta-Tricalcium Phosphate for Sur-gical ImplantationF2024 Practice for X-ray Diffraction Determination of PhaseContent of Plasma-Sprayed Hydroxyapatite Coatings2.2 Code of Federal Regulations:4Title 21,Part 820.2.3 National Formulary:5Tribasic Calcium Phosphate2.4 United States Pharmacopeia:6Identification Tests for Calcium and Phosphate Lead Mercury Arsenic Heavy Metals Method 12.5 U.S.Geological Survey Method:7Cadmium2.6 American Society for Quality:8C1 Specification of General Requirements for a QualityProgram3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 hydroxylapatitethe chemical substance having theempirical formula Ca5(PO4)3OH.94.Chemical Requirements4.1 Elemental analysis for calcium and phosphorus will beconsistent with the expected stoichiometry of hydroxylapatite.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved March 1,2014.Published March 2014.Originallyapproved in 1988.Last previous edition approved in 2009 as F1185 03(2009).DOI:10.1520/F1185-03R14.2The boldface numbers in parentheses refer to the list of references at the end ofthis specification.3For 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.4Available from U.S.Government Printing Office,N.Capitol and H St.,NW,Washington,DC 20402.5National Formulary XVI.Available from U.S.Pharmacopeia Convention,Inc.,12601 Twinbrook Parkway,Rockville,MD 20852.6United States Pharmacopeia XXI.Available from U.S.PharmacopeiaConvention,Inc.,12601 Twinbrook Parkway,Rockville,MD 20852.7Crock,J.G.,Felichte,F.E.,and Briggs,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.335-340.8Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq.org.9Chemical Abstracts Service Registry Number 1306-06-5.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 The calcium and phosphorus contents shall be determinedusing a suitable method such as ion chromatography.4.2 A quantitative X-ray diffraction analysis shall indicate aminimum hydroxylapatite content of 95%as determined inaccordance with Practice F2024.Analysis of relative peakintensities shall be consistent with published data.104.3 For hydroxylapatite derived from natural sources,theconcentration of trace elements shall be limited as follows:Elementppm,maxAs3Cd5Hg5Pb30Either inductively coupled plasma/mass spectroscopy(ICP/MS),atomic absorption(AAS),or the methods listed in 2.4 a