Medical Device industry professionals, would you like to analyze particulate contaminants in your products in accordance with ISO 19227?
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 based on their:
- nature
- origin
- size, etc.
Furthermore, particulate contamination can occur at various stages, particularly during manufacturing, transport, or storage.
Why analyze your medical devices in accordance with ISO 19227?
When medical devices are placed on the market, it is necessary to verify that they do not contain impurities that could be released into the human body after implantation.
Particulate contamination can pose risks to the quality of Medical Devices and to human health.
Therefore, checking for the presence or absence of particulate contaminants and/or determining a level of particulate contamination is a key step in a process.
It is also mandatory for the release of batches onto the market, in accordance with strict standards.
FILAB supports you with the analysis of your medical devices in accordance with Standard 19227
Why choose FILAB?
The FILAB laboratory is accredited by COFRAC ISO 17025 (www.cofrac.fr), according to validated and documented methods, helping you bring your activities into compliance with the requirements of ISO 19227 for your metal, ceramic and polymer medical devices.
