Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings

1.1 This test method covers calcium phosphate coatings 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 coatings such as calcium hydroxyapatite (see Specification F1185), beta-tricalcium phosphate (see Specification F1088), and biphasic mixtures thereof with or without intentional addition of other minor components (< 10%).

1.4 The coating(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions.

1.5 The coatings may be applied to porous, nonporous, textured, and other implantable topographical substrate forms representative of the end-use product.

1.6 The calcium phosphate coating may constitute the only coating on a substrate or be one of a multiple coated device.

1.7 This test method is limited to the laboratory evaluation of the dissolution rate of a calcium phosphate coatings. No correlation of the results to in vivo performance is implied.

1.8 The values stated in both inch-pound units and SI units are to be regarded separately as the standard. The values given in parentheses are for information only.

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.