1. Scope
1.1 This guide covers the chemical, physical, biological, and mechanical characterization requirements for calcium-based reactive bone void filler (BVF) used primarily for filling bone voids or defects of the skeletal system (such as the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. Example of reactive calcium-based bone void filler cements include, but are not limited to, alpha-tricalcium phosphate, dicalcium phosphate dehydrate, nonsintered apatites such as calcium-deficient hydroxyapatite, and carbonated apatites sulfates mixed with liquids, for example, buffer aqueous media, allegenous or autologous body fluids, or extracts. 1.2 The test methods described guide characterization of the bulk chemical, physical, and mechanical properties of the BVF paste prepared in accordance with the manufacturers recommendations. Units of premeasured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place. The set mixture of BVFs may be of solid, plastic, or viscoelastic nature after reaction. 1.3 While a variety of materials can be used to manufacture such a BVF, the composition of the final filler shall contain calcium ceramic or mineral components as its main solid ingredients. 1.4 The absorption profile can be very different between the different BVFs. 1.5 This guide covers also packaging, labeling, and storage requirements. It does neither address the biocompatibility of the powder, nor the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the powders. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- quality control - requested by FDA - standartization of test methods
Keywords
bone void filler; calcium; reactive; cementous; bone substitutes
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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