Particle counting laboratory on DM according to ISO 19227 standard
ISO 19227 describes the requirements for the cleanliness of orthopedic implants and the validation of the cleaning processes used.
Particulate contamination poses risks to the quality of solutions and to human health; therefore, monitoring the presence or absence of particulate contaminant and/or determining a level of particulate contamination is one of the key steps in a process.
FILAB, laboratory accredited ISO 17025 by COFRAC for particle counting according to the ISO 19227 standard
FILAB is COFRAC ISO 17025 accredited for particle counting analysis on medical devices in accordance with the ISO 19227 standard (for more information: www.cofrac.fr – accreditation number 1-1793).
FILAB offers manufacturers of medical devices technical skills and a state-of-the-art analytical facility in order to respond to their requests in the best possible way and to provide them with the most appropriate services and a tailor-made follow-up.
In order to respond accurately and reliably to these issues, FILAB offers customized support for the analysis of particle counts on the surface of your medical devices to validate your cleaning processes:
- Particle counting after filtration and counting by image analyzer
- Identification of particles in your medical devices by scanning electron microscopy (SEM) and infrared microscopy (µ-IRTF)
- Analysis of cleaning residues according to ISO 109227: HCT/TOC, inorganic and leachate analysis
- Particle counting according to PE 2.9.19, AAMI TIR42, USP 788
- Validation of analytical and extraction methods
