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Laboratory characterization of materials used in medical devices
Used for their mechanical properties, for their resistance to corrosion and for their biocompatibility, materials used in medical devices can be quite diverse :
- Metallic alloys : austenitic, martensitic or precipitation hardening stainless steel, titanium alloys, cobalt alloys…
- Ceramics : alumina, zircon, hydroxyapatite (HAP)…
- Plastics and Polymers : polyethylene, polyether ether ketone…
Faced with everchanging regulations in the field of medical devices, the materials being used need to meet the requirements of scope statements that are becoming more and more stringent in terms of substance lifespan, biocompatibility and toxicity.
For metallic alloys, chemical composition has a direct impact of mechanical properties (elasticity, strength, creep…) and resistance to outside phenomena such as corrosion. Metallurgical examinations of metallic alloys are therefore crucial to be able to understand and anticipate the performance a material will have when used.
At FILAB laboratory, metallic alloy characterizations for medical devices are done by ICP-AES spectrometry or using elemental analyzers (O/N, C/S and H)
Plastics and Polymers
The use of thermoplastics in the production of medical devices, though recent, continues to gain momentum in replacing more traditional materials. Thermoplastics are used for their useful properties (transparency, lightweight) and to reduce production costs. These plastics are mostly used in disposable devices.
Before becoming the ideal material for future Medical Devices, the use of plastics had to be adapted to comply with certain standards such as sterilization and traceability along with regular monitoring to abide by new regulations. to achieve all this, FILAB laboratory supports industrialists by using FTIR, ATG and DSC characterization techniques.
Mostly used to produce dental and bone prosthetics, ceramics (bioactive, inert or bioresorbable) are subject to strict requirements in terms of chemical composition and crystallography.
To evaluate the compliance of ceramics, FILAB laboratory uses two analytical techniques : ICP-AES spectrometry and XRD characterization. The aim being to test the biocompatibility of these materials in accordance with relevant standards and to identify degradation phenomena.
Why FILAB ?
With over 20 years’ experience in analyzing and characterizing materials used in the field of Medical Devices, FILAB laboratory is able to offer personalized support by providing its analytical techniques adapted to suit your materials.
FILAB is also able to provide the following services :
- Biocompatibility studies in accordance with the ISO 10993 set (10993-18 / 10993-12 / 10993-13 / 10993-14 / 10993-15 / 10993-19 / 10993-22)
- R&D support : custom chemical analyses, material characterization, surface characterization, analytical development
- Procedural validation : Cleaning (ISO 19227), surface treatments
The fact that we work on a human scale, our continuous investments and our extensive knowledge of the field of Medical Devices all ensure the reliability of our results, a quick turnaround for requests and tailored support suited to your needs.
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²