Preclinical studies (in vitro)
Membranes for medical use are mainly produced as hollow-fibers as part of class IIb medical devices studies. Dialysis und oxygenation membranes in extracorporal circuits are in contact with heparinised patient blood.
We determine the following performance parameters e.g. of hemodialysers.
Due to growth of microorganisms such as fungi and bacteria dialysate may, in particular in developing countries, occasionally be contaminated with pyrogens.
We perform in vitro cytotoxicity tests of chemicals (e.g. compounds, drugs or cosmetics), or with extracts from medical devices according to EN/ISO 10993-5.
To ensure that our tests meet the requirements of our customers, we have established a quality system that fulfils all the requirements of DIN EN ISO/IEC 17025:2018 and ensures the implementation of our quality policy. This makes us an accredited testing and research institute in the areas mentioned. Our accreditation is valid in around 46 countries worldwide (including the EU, the USA and Japan), as a mutual recognition agreement, known as the ILAC Arrangement, applies between the laboratory accreditation bodies of these countries.
