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1.1 The specification defines the chemical and crystallographic properties of beta-tricalcium phosphate intended for surgical implantation. It also informs the user that manufacturers and distributors are obligated to meet certain federal requirements.
1.2 It has been found that material meeting this specification engenders an acceptable biocompatible response as defined in Practice F981 (1). Other properties of calcium phosphates such as grain size, density, strength, and resorption rates are dependent upon certain process parameters (2-9).
1.3 This specification excludes tribasic calcium phosphate, whitlockite, alpha-tricalcium phosphate, and hydro-xyapatite.