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.
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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).
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
American Society for Quality (ASQ) Document
International Organization for Standardization Document
ISO10993 Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
United States Pharmacopeia (USP) Documents
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)
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