1、Designation:F108804a(Reapproved 2010)Standard Specification forBeta-Tricalcium Phosphate for Surgical Implantation1This standard is issued under the fixed designation F1088;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 Thisastm specification covers chemical and crystallo-graphic requirements for biocompatible beta-tricalcium phos-phate(b-TC
3、P)for surgical implant applications.For a materialto be identified as medical grade beta-tricalcium phosphate,itmust conform to this specification(see Appendix X1).2.Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Pract
4、ice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2American Society for Quality(ASQ)Document:C1 Specification of General Requirements for a QualityProgram32.3 International Organization for Standardization Docu-ment:ISO
5、10993 Biological Evaluation of Medical Devices42.4United States Pharmacopeia(USP)Documents:5Identification Tests for Calcium and Phosphate Lead Mercury Arsenic Heavy Metals Method 12.5 Other Reference:U.S.Geological Survey Method63.Chemical Requirements3.1 Elemental analysis for calcium and phosphor
6、us will beconsistent with the expected stoichiometry of beta-tricalciumphosphate(Ca3(PO4)2.The calcium and phosphorus contentshall be determined using a suitable method such as USP(see 2.4)or X-ray fluorescence.3.2 A quantitative X-ray diffraction analysis shall indicate aminimum beta-tricalcium pho
7、sphate content of 95%as deter-mined using Powder Diffraction File#5508987and a methodequivalent to Forman8or Rietveld.9,103.3 For beta-tricalcium phosphate,the concentration oftrace elements shall be limited as follows:ElementOther Metalsppm,maxPb30Hg5As3Cd5Inductively coupled plasma/mass spectrosco
8、py(ICP/MS),atomic absorption spectroscopy(AAS),or the methods listedin 2.4 and 2.5 shall be used.3.3.1 The analysis of other trace elements may be required,based on the conditions,apparatus,or environments specific tothe manufacturing techniques and raw materials.3.4 The maximum allowable limit of a
9、ll heavy metalsdetermined as lead will be 50 ppm as described in 2.4 orequivalent.Sample preparation will be identical to that fortribasic calcium phosphate as specified in the National Formu-latory(see 2.4).1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical M
10、aterials and Devicesand is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved Sept.1,2010.Published November 2010.Originallyapproved in 1987.Last previous edition approved in 2004 as F1088 04a1.DOI:10.1520/F1088-04AR10.2For referenced ASTM standards,visit t
11、he 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 Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq
12、.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.5Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.6Crock,J.G.,Felichte,F.E.,and Briggs,P.H.,“Determination of Elements inN
13、ational Bureaus of Standards Geological Reference Materials SRM 278 Obsidianand SRM 688 Basalt by Inductively Coupled PlasmaAtomic EmissionSpectrometry,”Geostandards Newsletter,Vol 7,1983,pp.335340.7International Centre for Diffraction Data,12 Campus Blvd,Newtown Square,PA 19073-3273.8Forman,D.W.and
14、 Metsger,D.S.,“The Determination of Phase Compositionof Calcium Phosphate Ceramics by X-Ray Diffraction,”Transactions of the SeventhAnnual Meeting of the American Society for Bone and Mineral Research,Kelseyville,CA,1985 p.391.9Jackson,L.E.,Barralet,J.E.,and Wright,A.J.,“RietveldAnalysis in Sinterin
15、gStudies of Ca-Deficient Hydrxyapatite,”Bioceramics 16,Key EngineeringMaterials,Vols 254-256,2004,pp.297300.10Rietveld,H.M.,Acta Crystallogr.,Vol 22,1967,p.151.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.5 It is recommended that all
16、 metals or oxides present inconcentrations equal or greater than 0.1%be noted in materialdescriptions.4.Quality Program Requirements4.1 The producer shall maintain a quality program,such asthe program defined in ASQ C1.5.Keywords5.1 advanced ceramics;b-TCP;beta-tricalcium phosphate;calcium phosphate material;ceramic;surgical implantAPPENDIXES(Nonmandatory Information)X1.RATIONALEX1.1 This specification is needed to ensure a high qualitymaterial for use in medical device applications.The chemical