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This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization. This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: mechanical capture, plasma spray deposition, dipping/sintering, electrophoretic deposition, porcelainizing, and sputtering. Substrates may include smooth, porous, textured, and other implantable topographical forms. This specification excludes organic coatings that may contain calcium and phosphate ionic species. Materials shall be tested and the individual grades shall conform to chemical requirements such as elemental analysis for calcium and phosphates, and intentional additions, trace element analysis for hydroxylapatite and beta tricalcium phosphate; crystallographic characterization such as Fourier Transform infrared spectroscopy, and environmental stability; physical characterization such as coverage of substrate, thickness, porosity, color, surface topography, and density; and mechanical characterization such as tensile bond strength, shear strength, and fatigue strength. The test specimen fabrication and contact with calcium phosphate coatings are also detailed.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.
1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.
1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic,3 and applied by methods including, but not limited to, the following: (1) mechanical capture, (2) plasma spray deposition, (3) dipping/sintering, (4) electrophoretic deposition, (5) porcelainizing, and (6) sputtering.
1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms.
1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species.
1.6 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E376 Practice for Measuring Coating Thickness by Magnetic-Field or Eddy-Current (Electromagnetic) Testing Methods
F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F1160 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
F1185 Specification for Composition of Hydroxylapatite for Surgical Implants
F1854 Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F1926 Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
F2024 Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 73181100(Coating services); 42295500(Surgical implants and expanders and extenders and surgical wires and related products)