Standard Historical Last Updated: Dec 31, 2010 Track Document
ASTM F1609-03e1

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Standard Specification for Calcium Phosphate Coatings for Implantable Materials F1609-03E01 ASTM|F1609-03E01|en-US Standard Specification for Calcium Phosphate Coatings for Implantable Materials Standard new BOS Vol. 13.01 Committee F04
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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.

1.6 WarningMercury 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 EPAs website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.13
Pages: 4
DOI: 10.1520/F1609-03E01
ICS Code: 11.040.40