ASTM F1926/F1926M-14
Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings

Standard No.

ASTM F1926/F1926M-14

Release Date

2014

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F1926/F1926M-14(2021)

Latest

ASTM F1926/F1926M-14(2021)

Scope

4.1 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use (1-11).3

4.2 The requirements of this test method apply to calcium phosphate materials 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 (lt;10 %).

4.3 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. Therefore, it is recommended that a control material be included in the evaluation. The control material can be a standardized material such as NIST SRM 2910 or a historical control.

1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications.

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

1.3 The materials may be in the form of powders, granules, spall material, fabricated forms or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product.

1.4 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.

1.5 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 nonconformance with the standard.

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.

ASTM F1926/F1926M-14 Referenced Document

• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
• ASTM F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
• ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants

ASTM F1926/F1926M-14 history

• 2021 ASTM F1926/F1926M-14(2021) Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• 2014 ASTM F1926/F1926M-14 Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• 2010 ASTM F1926/F1926M-10 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• 2008 ASTM F1926/F1926M-08 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
• 2003 ASTM F1926-03 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
• 1999 ASTM F1926-99 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings