Medical devices must be produced so that they do not have any adverse and undesired effects on the user. The EN ISO 10993 series of norms describes the biological assessment and testing as part of a risk management system. Testing for cytotoxicity is an important test point for all medical products having direct contact with the body.
In accordance with the standard, investigations are carried out in UFAG Laboratorien AG into whether extracts of medical products have a negative influence in-vitro in mammal cells. The vitality of cells in contact with the extract is measured and evaluated microscopically and by using photometric measurement of cellular metabolic processes.
The examination according to EN ISO 10993-5 provides important information for both product development and the selection of suitable materials, and also for batch release.
We are a GMP certified and ISO 17025 accredited contract laboratory in Switzerland with many years of experience in the testing of medical devices. We shall be pleased to provide support for any of your questions.
Read on to see which points you need to observe, or alternatively you can contact us.