ASTM F1609-08(2014)
Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Standard No.
ASTM F1609-08(2014)
Release Date
2008
Published By
American Society for Testing and Materials (ASTM)
Status
Replace By
ASTM F1609-23
Latest
ASTM F1609-23
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)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.

ASTM F1609-08(2014) Referenced Document

  • ASTM E376 Standard Practice for Measuring Coating Thickness by Magnetic-Field or Eddy-Current (Electromagnetic) Test Methods
  • ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
  • ASTM F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
  • ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
  • ASTM F1160 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
  • ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
  • ASTM F1854 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
  • ASTM F1926 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
  • ASTM F2024 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

ASTM F1609-08(2014) history

  • 2023 ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
  • 2008 ASTM F1609-08(2014) Standard Specification for Calcium Phosphate Coatings for Implantable Materials
  • 2008 ASTM F1609-08 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
  • 2003 ASTM F1609-03e1 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
  • 2003 ASTM F1609-03 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
  • 1995 ASTM F1609-95 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Standard Specification for  Calcium Phosphate Coatings for Implantable Materials



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