Industrialists in the field of Medical Devices, you wish to analyze the leachate residues on your finished products according to ISO 19227
What is a leachate residue?
The cleaning process is a crucial step in the manufacturing of an implantable medical device.
With the objective of eliminating all residual contamination, the manufacturer of a medical device must adapt the cleaning process to its own needs or those of its customer by precisely identifying the type of contaminant related to the manufacture of the device, its handling, packaging and storage.
Therefore, the analysis of leachate residues is an integral part of good manufacturing practices for medical devices.
Why analyze leachate residues according to ISO 19227?
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.
Indeed, these analysis are carried out within a regulatory framework linked to the quality assurance of medical devices.
In this process, the support of a laboratory specialized in the chemical analysis of cleaning residues on medical devices is a considerable asset for the marketing of your products.
FILAB: 1st COFRAC ISO 17025 accredited laboratory for cleaning residue analysis 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.
