Standard Specification for Calcium Phosphate Coatings for Implantable Materials
|Publication Date:||1 May 2008|
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 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.
Substrates may include smooth, porous, textured, and other implantable topographical forms.
This specification excludes organic coatings that may contain calcium and phosphate ionic species.
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
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.