Name: Laboratory analysis of your surgical implants according to the ASTM F1926 standard
Brand: FILAB
SKU: FILAB-187653
Rating: 4.9 (83 reviews)

Home • Sectors of activity • Laboratory analysis of Medical Devices • Laboratory analysis of your surgical implants according to the ASTM F1926 standard

As a manufacturer, you want to carry out analyses according to the ASTM F1926 standard

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 use in the manufacture of medical devices, particularly bone implants, due to their biocompatible and bioactive properties. The materials can take the form of powders, granules, flaked materials, fabricated shapes or coatings.

Why perform an analysis according to the ASTM F1926 standard ?

ASTM F1926 has several objectives :

Evaluate dissolution rate by providing standardized methods for measuring the dissolution rate of calcium phosphate 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 assessing dissolution rates, manufacturers can ensure that calcium phosphate implants resorb at an appropriate rate to promote bone regeneration without compromising implant stability.
Ensure safety compliance to meet regulatory requirements for medical device safety and efficacy, making it easier to obtain the necessary approvals from regulatory bodies.

What is the test method described in ASTM F1926 ?

This standard describes the procedures for exposing the material to conditions simulating the body environment, and measuring the mass loss or concentration of ions released into the environment. The various stages of the procedure are as follows:

Sample preparation
Immersion in simulated dissolution fluid
Periodic measurement of mass loss or ionic concentrations

The FILAB laboratory can assist you with your analyses according to the ASTM F1926 standard.

Why choose FILAB for your analysis according to the ASTM F1926 standard ?

For over 30 years, the FILAB laboratory has had the experience and specific analytical equipment to support manufacturers in the analysis of surgical implants.

The support of an expert laboratory like FILAB enables you to better understand the strategic challenges and changes in your sector. Our specialized engineers will support you throughout the laboratory analysis protocol for your surgical implants, according to the ASTM F1926 standard.