ASTM-F1609:2008 Edition

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F1609-08 Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Published By	Publication Date	Number of Pages
ASTM	2008	4

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

ASTM F1609-08

Historical Standard: Standard Specification for Calcium Phosphate Coatings for Implantable Materials

ASTM F1609

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 Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1609-08

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology Chemical or Crystallographic Requirements, or Both Physical Characterization Mechanical Characterization Test Specimen Fabrication
3	Contact with Calcium Phosphate Coatings Quality Program Requirements Keywords X1. RATIONALE X1.1 X1.2 REFERENCES

Additional information

Standard Title	F1609-08 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Published Code	ASTM
Publication Date	2008
Pages Count	4
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics