ASTM F1609-2003 Standard Specification for Calcium Phosphate Coatings for Implantable Materials《可植入材料用磷酸钙涂层标准规范》.pdf
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1、Designation: F 1609 03Standard Specification forCalcium Phosphate Coatings for Implantable Materials1This standard is issued under the fixed designation F 1609; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revis
2、ion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 part
3、iculate 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 T
4、his specification includes hydroxylapatite coatings,tricalcium phosphate coatings, or combinations thereof, with orwithout intentional minor additions of other ceramic or metal-lic,3and applied by methods including, but not limited to, thefollowing: (1) mechanical capture, (2) plasma spray depositio
5、n,(3) dipping/sintering, (4) electrophoretic deposition, (5) porce-lainizing, 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.2. Refer
6、enced Documents2.1 ASTM Standards:E 376 Practice for Measuring Coating Thickness byMagnetic-Field or Eddy-Current (Electromagnetic) TestMethods4F 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic Coatings5F 1088 Specification for Beta-Tricalcium Phosphate forSurgical Imp
7、lantation5F 1147 Test Method for Tension Testing of Calcium Phos-phate Coatings and Metallic Coatings5F 1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallis Medical and CompositeCalcium Phosphate Metallic Coatings5F 1185 Specification for Composition of Ceramic Hyd
8、roxy-lapatite for Surgical Implants5F 1854 Shear and Bending Fatigue Testing of CalciumPhosphate and Metallis Medical and Composite CalciumPhosphate Metallic Coatings5F 1926 Test Method for Evaluation of the EnvironmentalStability of Calcium Phosphate Coatings5F 2024 Practice for X-Ray Diffraction D
9、etermination ofPhase Content of Plasma-Sprayed Hydroxylapatite Coat-ings52.2 Pharmacopeia Convention Documents:6National Formulary XVI, Tribasic Calcium PhosphateUnited States Pharmacopeia:U.S. Pharmacopeia XXI, Chemical Tests CaP (191), Lead, Mercury , Arsenic , and HeavyMetals Method (1)2.3 Other
10、Documents:U.S. Geological Survey Method, Cadmium7U.S. Code of Federal Regulations Title 21 (CFR 21), Part820Quality System Regulation8X-Ray Diffraction Analyses33. Terminology3.1 Definitions:3.1.1 amorphous calcium phosphatea non-crystalline cal-cium phosphate.3.1.2 beta tricalcium phosphatea calciu
11、m phosphate sub-stance of empirical chemical formula, Ca3(PO4)2(see Specifi-cation F 1088).3.1.3 calcium phosphateany one of a number of inorganicchemical compounds containing calcium and phosphate ions asits principal constituents.1This specification is under the jurisdiction of ASTM Committee F04
12、onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved Sept. 10, 2003. Published October 2003. Originallyapproved in 1995. Last previous edition approved in 1995 as F 1609 95.2The boldface numbers in parenthes
13、es 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 international basis and cooperatesclosely with the Data Commission of the International Union of Crystallinity andAST
14、M. Hydroxylapatite data can be found on file card No. 9-432; beta tricalciumphosphate data can be found on file card No. 9-169.4Annual Book of ASTM Standards, Vol 03.03.5Annual Book of ASTM Standards, Vol 13.01.6Available from U.S. Pharmacopeia Convention, Inc., 12601 Twinbrook Park-way, Rockville,
15、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. 335340.8A
16、vailable from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 19111-5098, Attn: NPODS.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.4 coatinga layer of mechanically or chemically at-ta
17、ched material covering a substrate material.3.1.5 hydroxylapatitea calcium phosphate crystallinecompound of empirical chemical formula, Ca5(PO4)3OH (seeSpecification F 1185).4. Chemical or Crystallographic Requirements, or Both4.1 Chemical:4.1.1 Elemental analysis for calcium and phosphorous andinte
18、ntional additions (other than trace elements) will be con-sistent with the expected stoichiometry of the specific calciumphosphate compound(s).4.1.2 Trace Element Analysis for Hydroxylapatite and BetaTricalcium PhosphateThe concentration of trace elements inthe coating shall be limited as follows:El
19、ement ppm, maxAs 3Cd 5Hg 5Pb 30total heavy metals (as lead) 50For reference purposes, the U.S. Pharmacopeia XXI and U.S.Geological Survey Method, Cadmium, shall be used.4.1.3 The analysis of other trace elements may be required,based on the conditions, apparatus, or environments specific tothe coati
20、ng application technique used.4.1.4 The analysis of intentional additional elements orcompounds such as fluorine, manganese, magnesium, carbon-ate, and so forth must be specified for calcium phosphatecoatings.4.1.5 Calcium to Phosphorus ratio (Ca/P) shall be per-formed on both the powder and coating
21、 forms using a suitablemethod.4.2 Crystallographic Characterization:4.2.1 Crystallographic characterization shall be in accor-dance with Practice F 2024.4.2.2 Testing shall include quantitative phase analysis andamorphous calcium phosphate content.4.2.3 FTIR (Fourier Transform Infrared Spectroscopy)
22、 shallbe performed to identify functional groups.4.3 Environmental StabilityEnvironmental stability test-ing shall be performed in accordance with Test Method F 1926to access the relative dissolution behavior of the material.5. Physical Characterization5.1 Coverage of Substrate:5.1.1 Microscopic exa
23、mination of the surface will be madeat 103 magnification; “bare” areas, “pinholes,” cracking,foreign debris, unmelts, chips, delamination and the appear-ance at the coating/substrate interface, and so forth will bereported.5.2 ThicknessThe thickness will be measured from crosssections in accordance
24、with Test Method F 1854. If distinctlayers exist, they should be reported.5.2.1 Alternatively, a magnetic field or eddy current tech-nique may be used if it has been shown to be equivalent to TestMethod F 1854.5.3 PorosityThe microporosity and macroporosity char-acterization shall be determined in a
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