The assessment of the biocompatibility of a medical device is carried out in accordance with the ISO 10993-18 standard. The FILAB laboratory is ISO 17025 accredited by COFRAC for chemical characterization of materials in accordance with ISO 10993-18.
ISO 10993-18 describes a process for identifying a material and determining and quantifying its chemical makeup.
The chemical characterization of a material allows us to:
- Better understand a material from a biological safety point of view (Biocompatibility testing in accordance with the ISO 10993 set)
- Testing for leachable substances from Medical Devices
- Measuring the amount of material used in medical devices in the context of double or multisource
Chemical characterization of a material used in medical devices must be representative of the chemical nature, the physical form and the clinical exposure duration, and the duration in particular must be calculated based on toxicological risk factors.
The success or failure of chemical characterization depends on collaboration and the exchange of information between characterization specialists, analytical specialists and toxicologists.
It is important to note that the ISO 10993-18 regulation does not involve the identification or the quantification of degradation products from polymer-based, ceramic or metallic materials as these aspects are covered by other regulations relating to Medical Devices.
The FILAB laboratory is ISO 17025 accredited by COFRAC for chemical characterization of materials in accordance with ISO 10993-18
For over 20 years, FILAB laboratory has been developing a wide skillset in analytical chemistry and material characterization and has been collaborating with toxicology experts to provide the best characterization services for your biomaterials :
- Chemical characterization of materials in accordance with ISO 10993-18
- Sampling of reference materials in accordance with ISO 10993-12
- Identification and quantification of degradation of materials from Medical Devices in accordance with ISO 10993-13, ISO 10993-14 and ISO 10993-15
- Sterilization residue analysis in accordance with ISO 10993-7
- Cleaning residue analysis (THC/TOC)
- Metallurgical analysis of Medical Devices
- Physicochemical, morphological and topographical characterization of materials in accordance with ISO 10993-19
- Nanomaterial analysis of Medical Devices in accordance with ISO 10993-22
- Cytotoxicity testing in accordance with ISO-10993-5 (with aid from a partner laboratory)
FILAB can also offer the following services :
- R&D support : custom chemical analysis, material and surface characterization, analytical development
- Problem-solving : non-compliance, rupture, adhesive problems, corrosion…
