Laboratory for the analysis of your surgical implants according to ASTM F1926
As an industrial company, you wish to conduct analysis according to ASTM F1926
What is ASTM F1926?
The ASTM F1926 standard, published by the American Society for Testing and Materials (ASTM), concerns test methods for evaluating the dissolution rate of calcium phosphate-based materials. These materials are intended for the manufacture of medical devices, particularly bone implants, due to their biocompatible and bioactive properties. The materials may take the form of powders, granules, flakes, manufactured shapes or coatings.
Why conduct an analysis according to ASTM F1926?
The ASTM F1926 standard serves several purposes:
Evaluate the dissolution rate by providing standardized methods for measuring the dissolution rate of calcium phosphate-based materials. This makes it possible to determine the degradation and resorption of the material in a simulated biological environment, an essential step in predicting its in vivo behavior.
Ensure implant performance : by evaluating the dissolution rate, manufacturers can ensure that calcium phosphate-based implants resorb at an appropriate rate to promote bone regeneration without compromising implant stability.
Ensure compliance with safety requirements in order to meet regulatory requirements for the safety and efficacy of medical devices, thereby facilitating the necessary approvals from regulatory bodies.
What test method is described by ASTM F1926?
This standard describes procedures for exposing the material to conditions that simulate the body environment and measuring mass loss or the concentration of ions released into the medium. The various steps of the procedure are as follows:
- Sample preparation
- Immersion in a simulated dissolution fluid
- Periodic measurement of mass loss or ionic concentrations
FILAB laboratory supports you with your analysis according to ASTM F1926
Why choose FILAB for your analysis according to ASTM F1926
For more than 30 years, FILAB laboratory has had the experience and specialized analytical facilities needed to support industrial companies in the analysis of surgical implants
Working with an expert laboratory such as FILAB helps you better understand the strategic challenges and changes affecting your sector. Our specialized engineers support you throughout the laboratory analysis protocol for your surgical implants according to ASTM F1926.
ASTM STANDARDS AT FILAB
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Problem solving: non-conformity, failure, adhesion, corrosion...
R&D support: tailor-made chemical analysis, material and surface characterization, analytical development
Process validation: cleaning (ISO 19227), surface treatment
