ASTM-F1088 › Historical Revision Information
Beta-Tricalcium Phosphate for Surgical Implantation, Standard Specification For
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This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate for surgical implant applications. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate. The calcium and phosphorus content shall be determined using a suitable method such X-ray fluorescence. A quantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95 % as determined using powder diffraction method. The analysis of other trace elements may be required, based on the conditions, apparatus, or environment. It is recommended that all metals or oxides present in concentrations equal or greater than 0.1 % be noted in material descriptions.
Scope
1.1 This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate (β-TCP) for surgical implant applications. For a material to be identified as medical grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).
Keywords
advanced ceramics; β-TCP; beta -tricalcium phosphate; calcium phosphate material; ceramic; surgical implant; 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-F1088-04ae1
Revision Level
2004A(E1) EDITION
Status
Superseded
Modification Type
Editorially changed
Publication Date
June 1, 2006
Document Type
Specification
Page Count
2 pages
Committee Number
F04.13