Actors of the Medical Devices sector, you wish to analyze the particulate contaminants in your products according to the ISO 19227 standard
What is a particulate contaminant?
Particulate contamination is an inert, immobile, insoluble substance that is unintentionally present in the finished product. There are several types of contamination according to their :
- nature
- origin
- size, etc…
In addition, particulate contamination can appear at different stages including during manufacture, transport or storage.
Why analyze your medical devices according to ISO 19227?
When medical devices are put on the market, it is necessary to verify that they do not contain impurities that could be released into the human body after implantation.
Indeed, particulate contamination presents risks for the quality of medical devices and for human health.
Therefore, controlling the presence or absence of particulate contaminants and/or determining a level of particulate contamination is one of the key steps in a process.
It is mandatory for the release of batches on the market, according to strict standards.
FILAB supports you in the analysis of your medical devices according to the 19227 standard
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), using validated and documented methods, thus helping you to bring your activities into compliance with the requirements of ISO 19227.
