EUROLAB laboratory provides testing and compliance services within the scope of ASTM F1926 standard. The ASTM F1926 standard covers calcium phosphate materials intended for use in surgical implant applications. Materials must represent those produced for sale. It will be produced and processed under standard manufacturing conditions.
The materials may be in the form of powders, granules, bulk material, fabricated forms or coatings; and it can be porous, non-porous, textured or other form of implantable topographic substrate representing the end-use product. Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use.
The requirements of this test method apply to calcium phosphate materials such as calcium hydroxyapatite, beta-tricalcium phosphate, and biphasic mixtures thereof, with or without the deliberate addition of other minor (<10%) components.
This test method is limited to laboratory evaluation of the dissolution rate of a calcium phosphate material. Correlation of results with in-vivo performance is not implied. Therefore, it is recommended to include a control material in the assessment. The control material may be a standardized material such as NIST SRM 2910 or a historical control.
The calcium phosphate material may be the only material in a substrate, or it may be one of multiple materials as long as all other materials present do not dissolve under the test conditions described in this test method.
Values stated in SI units or inch-pound units will be considered standard separately. The values specified in each system may not be exactly equivalent; therefore, each system should be used independently of the other. Combining values from the two systems may result in non-compliance with the standard.
This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.
Our organization, EUROLAB, provides dissolution testing services of calcium phosphate granules, produced forms and coatings within the framework of national and international standards, with its trained and expert staff and advanced technological equipment, among numerous test, measurement, analysis and evaluation studies. Provides testing services within the scope of ASTM F1926 standard.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
