ASTM F1609-23
Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Standard No.

ASTM F1609-23

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

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 covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phosphate dihydrate) coatings, or a coating containing a combination of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate),3 and applied by methods including, but not limited to, the following: (1) plasma spray deposition, (2) solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) sputtering. 1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2. 1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms. 1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F1609-23 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 F1609-23 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