1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications. 1.2 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use. 1.3 The requirements of this specification apply to calcium phosphate materials such as calcium hydroxyapatite (see Specification F 1185), beta-tricalcium phosphate (see Specification F 1088), and biphasic mixtures thereof with or without intentional addition of other minor components (10%). 1.4 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions. 1.5 The materials may be in the form of powders, granules, fabricated forms or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product.
There is no current standard and regulatory bodies requirement this analysis.
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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