At Tentamus Pharma & Med, we use cell culture-based in vitro techniques when carrying out functional bioassays or effector cell assays in order to test and certify the biocompatibility of medical devices (DIN EN ISO 10993). This allows us to examine devices for factors such as cytotoxicity as well as skin irritation and sensitisation in various cell culture models.
We conduct ex vivo trials using fresh human blood (ISO 10993-4) in order to analyse human immunological and inflammatory responses (e.g. haemolysis, blood coagulation, complement activation) to medical devices.
In vitro analytics
for medical device certification
- Tests for in vitro cytotoxicity (ISO 10993 – 5)
- Tests for skin irritation (ISO 10993 – 10/OECD 439)
- Tests for skin sensitisation (ISO 10993 – 10 / OECD 442 d/e
- Tests for ocular irritation/corrosion (OECD 460)
- Tests for ocular irritation (OECD 492)
- Tests for skin corrosion (OECD 431)
- Effector cell assays using various cell lines (cytotoxicity, apoptosis, ADCC, CDC)
- Proliferation/reporter gene assays
- In vitro potency assays