T/CSBM 0028-2022 Tetracalcium phosphate for surgical implants

Scope

Main Technical Content: 1. Technical Requirements 1.1 Appearance: A white solid powder with no visible impurities or agglomeration, and uniform powder distribution. 1.2 Phase Composition and Content 1.2.1 According to quantitative X-ray diffraction analysis, the X-ray diffraction spectrum of TTCP crystals should comply with the ICDD’s PDF powder diffraction card No. 25-1137 or No. 70-1379. There should be no significant peaks of other calcium phosphates or crystalline phases, nor any obvious non-crystalline substances. 1.2.2 The content of TTCP crystalline phase should be no less than 95%. The CaO content should not exceed 1%. 1.3 Calcium and Phosphorus Atomic Ratios The elemental analysis of calcium and phosphorus should match the theoretical stoichiometry of TTCP [Ca3(PO4)2O], with a calcium (Ca) to phosphorus (P) atomic ratio of 2.0 ± 0.05. 1.4 Microelement Content 1.4.1 The content of arsenic, cadmium, mercury, and lead should meet the requirements of Table 1. Table 1: Microelement Content Microelement Content Arsenic (As) ≤ 3 mg/kg Cadmium (Cd) ≤ 5 mg/kg Mercury (Hg) ≤ 5 mg/kg Lead (Pb) ≤ 30 mg/kg 1.4.2 Total Heavy Metal Content 1.4.2.1 The maximum allowable total heavy metal content (calculated as Pb) is 30 mg/kg. 1.4.2.2 For metals or oxides not calculated as Pb, but with a content greater than or equal to 0.1%, it is recommended to list them in the packaging notes. 1.5 Hydrous Compression Strength The hydrous product formed by TTCP’s hydration reaction with water should have sufficient strength and should be tested for its hydrous compression strength according to its intended use. 1.6 Biological Activity TTCP should be evaluated for its biological activity based on in vitro hydroxyapatite deposition tests. 1.7 Biocompatibility α-TCP should be evaluated for its biocompatibility based on the intended use of surgical implants. 2. Test Methods 2.1 Appearance Visual inspection: Place the sample in a

Development Information

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