ASTM-F1609 › Historical Revision Information
Standard Specification for Calcium Phosphate Coatings for Implantable Materials
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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 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 mercury-containing 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; Calcium phosphate coatings--specifications; Coatings (surgical implants)--specifications; Orthopaedic medical devices--specifications; Surgical implants--specifications; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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13.01 (Medical and Surgical Materials and Devices)
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Document Number
ASTM-F1609-03e1
Revision Level
2003(E1) EDITION
Status
Superseded
Modification Type
Editorially changed
Publication Date
April 1, 2008
Document Type
Specification
Page Count
4 pages
Committee Number
F04.13