Particle counting laboratory for medical devices according to ISO 19227
Do you need particle counting according to ISO 19227?
What does ISO 19227 say about particle counting on medical devices?
The ISO 19227 standard sets out the requirements for the cleanliness of orthopedic implants as well as the validation of the cleaning processes used.
Particulate contamination poses risks to solution quality and human health; therefore, monitoring the presence or absence of particulate contaminants and/or determining a level of particulate contamination is one of the key steps in a process.
FILAB, an ISO 17025 laboratory accredited by COFRAC for particle counting according to ISO 19227
Why choose FILAB?
FILAB is COFRAC ISO 17025 accredited for particle counting analysis on medical devices made of ceramic, metal and polymer according to ISO 19227. (For more information: www.cofrac.fr – accreditation number 1-1793)
FILAB offers medical device manufacturers technical expertise and state-of-the-art analytical equipment to respond as effectively and quickly as possible to their needs and provide them with the most suitable services and tailor-made support.
Our analysis services
To provide precise and reliable answers to these issues, FILAB offers tailor-made support for surface particle counting analysis on your medical devices to validate your cleaning processes:
- Particle counting after filtration by optical microscope (OM) 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 19227: HCT/COT, inorganic and detergent analysis
- Particle counting according to PE 2.9.19, AAMI TIR42, USP 788
- Validation of analytical and extraction methods
How to check the particulate cleanliness of your medical device?
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