Resorbable Biomaterials Based on Calcium Phosphates: Determination of In Vitro Solubility Applying the ISO 10993-14 (First Experiences)
To guarantee of the security of ceramic medical products the identification and quantification of the current degradation products is required by the ISO 10993-14 standard. Two methods - the gravimetrical registration of the mass loss and the quantitative determination of the leached ions by spectrometric methods - are planned. When checking the application of the ISO standard to calcium phosphate ceramics that can be used as implant materials a considerable difference in the results obtained with both methods was observed. It seems to be that precipitation reactions are responsible for that situation. To clear up the influence of precipitation reactions on the results the working procedure of the ISO standard was slightly modified. A first interpretation of the results is tried.
Panjian Li, Kai Zhang and Clifford W. Colwell, Jr.
U. Ploska et al., "Resorbable Biomaterials Based on Calcium Phosphates: Determination of In Vitro Solubility Applying the ISO 10993-14 (First Experiences) ", Key Engineering Materials, Vols. 284-286, pp. 485-488, 2005