scope:

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 (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.

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.

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.

Substrates may include smooth, porous, textured, and other implantable topographical forms.

This specification excludes organic coatings that may contain calcium and phosphate ionic species.

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.

² The boldface numbers in parentheses refer to the list of references at the end of this specification.

³ The Joint Committee on Powdered Diffraction has established a Powder Diffraction File. The committee operates on an international basis and cooperates closely with the Data Commission of the International Union of Crystallinity and ASTM. Hydroxylapatite data can be found on file card No. 9-432; beta tricalcium phosphate data can be found on file card No. 9-169.