Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
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 (1-10).
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.
1.6 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so long as all other materials present do not dissolve under the test conditions described in this test method.
1.7 This test method is limited to the laboratory evaluation of the dissolution rate of a calcium phosphate material. No correlation of the results to in vivo performance is implied.
1.8 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
1.9 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.
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