ASTM-F1088 › Historical Revision Information
Beta-Tricalcium Phosphate for Surgical Implantation, Standard Specification For

ASTM-F1088 - 2004A R10 EDITION - SUPERSEDED
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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.

ORDER

Scope

1.1 Thisastm 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; Alpha-tricalcium phosphate; Beta-tricalcium phosphate; Bone implant materials/applications--specifications; Ceramic materials/applications--specifications; Ceramic surgical materials/applications--specifications; Crystallographic characteristics; Orthopaedic medical devices--specifications; Tribasic calcium phosphate; Whitlockite; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F1088-04a(2010)

Revision Level

2004A R10 EDITION

Status

Superseded

Modification Type

Reapproval

Publication Date

Oct. 1, 2010

Document Type

Specification

Page Count

2 pages

Committee Number

F04.13