ASTM F1926-14(R2021) pdf free download

ASTM F1926-14(R2021) pdf free download.Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
1. Scope
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 topographi- cal 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 ofmultiple 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 appro- priate safety, health, and environmental practices and deter- mine the applicability ofregulatory limitations prior to use. 1.7 This international standard was developed in accor- dance with internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
4. Significance and Use
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 Specifi- cation F1088), and biphasic mixtures thereof with or without intentional addition of other minor (<10 %) components. 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.
6. Analytical Parameters
6.1 The following procedure should be performed with each of the media listed: 6.1.1 The dissolution rate shall be measured under the conditions of a constant ratio of initial material mass (mg) to total dissolution media volume (mL). The ratio of test material mass to dissolution media shall typically be between 1 to 4 mg/mL. 6.1.2 The dissolved Ca ++ concentration (61 ppm) shall be measured as soon as practical after the start of the experiment and at appropriate time intervals thereafter to allow determi- nation of changes with time.
7. Analytical Procedures
7.1 Make pH measurements with an appropriately cali- brated pH meter and probe. 7.2 Measure the Ca ++ concentrations potentiometrically. Ionic strength adjuster (ISA) shall be added as required by the electrode manufacturer. Other methods (for example, colorimetrically, atomic absorption (AA), inductively coupled plasma (ICP) spectroscopy, or inductively coupled plasma mass spectroscopy (ICP/MS)) may be used if equivalency can be demonstrated. 7.3 An appropriate bacteriostat (for example, 0.1 v/v % Hibiclens or 0.1 w/v % sodium azide) may be added to the dissolution media before the start of an experiment.
8. Dissolution Apparatus
8.1 The dissolution vessel shall be of such design as to easily accommodate the test specimen, the stirrer, and the specific ion-electrode and reference electrode assemblies. It shall also be isolated from the atmosphere by an oxygen- and carbon dioxide-free inert gas purge. 8.1.1 A convenient apparatus (see Fig. 1) is a 100-mL jacketed beaker with circulating water from a thermostatically controlled vessel. A flat piece of polyethylene or other inert plastic with appropriate holes drilled to accommodate the probes, sample holder, and purge gas tube can serve as a lid.