As a manufacturer, you want to characterize the materials used in your medical devices
What materials are medical devices made from?
Used for their mechanical properties, corrosion resistance and biocompatibility, the materials used to manufacture medical devices are diverse:
- Metal alloys: austenitic, martensitic or precipitation-hardening stainless steel, titanium and titanium alloys, cobalt alloys, …
- Ceramics: alumina, zirconia, hydroxyapatite (HAP), TCP, …
- Polymers or plastics: polyethylene PE, polyether ether ketone PEEK, …
- Composites
As regulatory requirements in the medical device sector continue to evolve, the materials used must meet increasingly precise specifications in terms of product lifespan, compatibility with their environment and non-toxicity to the human body.
Metal alloys
For metal alloys, the chemical composition of the materials directly influences their mechanical properties (elasticity, hardness, elongation, creep, etc.) and their resistance to corrosion. Metallurgical examinations of the structure of metal alloys therefore help to better anticipate the material’s performance in its end use.
At FILAB, metal alloy characterization for medical devices is performed using techniques such as ICP-AES spectrometry or elemental analyzers (N/H, C/S and H).
Plastic polymers
Although the use of thermoplastics in medical device manufacturing is relatively recent, it continues to grow compared with more traditional materials. Indeed, thermoplastics offer new and valuable functionalities (transparency, lightness) while reducing production costs. Plastics are notably used in disposable devices, a segment experiencing strong growth.
Before becoming the materials of the future for medical devices, the use of plastics requires adaptations and compliance measures for plastics manufacturers, such as cleanroom production to ensure material sterilization, along with enhanced traceability and regular monitoring of new regulations. To this end, FILAB supports manufacturers through characterization techniques such as FTIR, TGA and DSC.
Ceramics
Used particularly in the production of dental and bone prostheses, ceramic materials (bioactive, bioinert or bioresorbable) are subject to strict requirements regarding their chemical composition and crystallography.
To assess the compliance of these ceramics for medical use, FILAB has two analytical techniques: ICP-AES spectrometry and characterization by XRD (X-ray diffraction). The aim is to study the biocompatibility of the materials according to regulatory standards and identify potential degradation phenomena.
FILAB supports you in characterizing materials used in your medical devices
Why choose FILAB?
FILAB is the only laboratory accredited by COFRRAC to ISO 17025 for the three material degradation tests: ISO 10993-13: polymers, ISO 10993-14: ceramics, ISO 10993-15: metals
With more than 30 years of experience in the analysis and characterization of materials in the medical device sector, FILAB offers tailored support by providing analytical techniques suited to your material types.
FILAB also supports you with the following services:
FILAB also supports you with the following services:
Process validation: Cleaning (ISO 19227), surface treatment
Our human scale, ongoing investment and in-depth knowledge of the medical device sector guarantee our clients reliable results, rapid processing of requests and tailored support to meet their needs.
