ASTM F1609-03e1 - 10.9.2003
 
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.

 
2. Referenced Documents

F1926-99

Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings

F1088-23

Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices

F1044-05(2017)e1

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (Includes all amendments and changes 1/11/2018).

E376-19

Standard Practice for Measuring Coating Thickness by Magnetic-Field or Eddy Current (Electromagnetic) Testing Methods

F1185-23

Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants

F2024-10(2021)

Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings

F1160-14(2017)e1

Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings (Includes all amendments and changes 1/19/2018).

F1147-05(2017)e1

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).

F1854-15

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants