1. Scope

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) 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, 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.

ASTM Standards

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

Keywords

bone implant; calcium phosphate; coating; dental implant materials; hydroxylapatite; mechanical tests; orthopedic medical devices; physical characterizations; tricalcium phosphate; Calcium phosphate coatings--specifications; Coatings (surgical implants)--specifications; Orthopaedic medical devices--specifications; Surgical implants--specifications

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1609-03E01

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