Particle Counting Laboratory for Medical Devices
Do you need particle counting and identification on your medical devices?
What does the regulations say about particle counting and identification?
Particulate contamination of medical devices
Lorsqu'un dispositif médical est mis sur le marché, il est nécessaire de vérifier s'il ne contient pas d'impuretés qui pourrait être relarguées dans le corps humain après son implantation. En effet, la contamination particulaire présente des risques pour la qualité des Dispositifs Médicaux et pour la santé humaine. Aussi, contrôler la présence ou l’absence de contaminant particulaire et/ou déterminer un niveau de contamination particulaire constitue l’une des étapes clés d’un process. Elle est d'ailleurs obligatoire pour la libération des lots sur le marché, d'après des normes strictes.
The FILAB laboratory supports you in particle counting analysis on your medical devices in accordance with current standards
Why choose FILAB for particle counting and identification?
The FILAB laboratory is currently the only laboratory in France accredited ISO 17025 by COFRAC for these services, covering both particle counting and particle identification by SEM-EDX and Infrared Microscopy.
FILAB offers medical device manufacturers technical expertise and state-of-the-art analytical equipment to respond as effectively and promptly as possible to their needs.
Our particle counting and identification services for medical devices
To provide precise and reliable answers to these issues, FILAB offers tailor-made support for the identification of particles on the surface of your medical devices, and for the validation of your cleaning processes. The laboratory is ISO 17025 accredited by COFRAC for the following scopes:
Particle counting by Optical Microscope according to current standards: ISO 19227 (AAMI TIR), ISO 10993-19, USP 788, PE 2.9.19 (method 1 and method 2), AAMI TIR 42
More broadly, FILAB supports medical device manufacturers with:
