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ASTM F 1609 Document Information:
Title
Standard Specification for Calcium Phosphate Coatings for Implantable Materials
ASTM International
Publication Date:
May 1, 2008
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 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
(http://www.epa.gov/mercury/faq.htm) for additional information.
Users should be aware that selling mercury or mercurycontaining
products, or both, in your state may be prohibited by state
law.
Keywords:
- bone implant
- calcium phosphate
- coating
- dental implant materials
- hydroxylapatite
- mechanical tests
- orthopedic medical devices
- physical characterizations
- tricalcium phosphate
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