Analysis of the cleanliness of medical devices in the laboratory
Industrialists in the field of Medical Devices, you want to analyze the cleanliness of your finished products according to ISO 19227
Why analyze the cleanliness of your DM according to ISO 19227?
First of all, the ISO 19227 standard (formerly NF S 94-091) sets the parameters to be taken into account in the validation of the cleaning of orthopaedic implants before final packaging.
Thus, these analysis are carried out within a regulatory framework related to the quality assurance of medical devices.
The cleaning process is a crucial step to ensure the cleanliness of the medical device, but it is essential to verify it using specific techniques.
Indeed, the analysis of the cleanliness of your medical devices allows to verify the elimination of all residual contaminations. Thus, the manufacturer of a medical device can then adapt his cleaning process.
In this process, the support of a laboratory specialized in the chemical analysis of the cleanliness of medical devices is a considerable asset for the marketing of your products.
FILAB supports you in the analysis of the safety of your medical devices according to ISO 19227
FILAB laboratory offers a wide range of services thanks to its state-of-the-art analytical equipment and varied internal skills.
Some of these services are performed under COFRAC ISO 17025 accreditation (www.cofrac.fr), according to validated and documented methods, thus helping you to bring your activities into compliance with the requirements of the ISO 19227 standard.
To go further
Analysis of organic contaminations by TOC meter, GCMS, LCMS
Training in cleaning process validation
Search for traces in a cleaning product
Surface analysis by SEM-FEG or Optical Microscope
Inorganic contamination analysis by ICP-MS and CLI
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²
Tailor-made support
