By definition, semi finished products are not medical or pharmaceutical products, but pre-products used for their production. As there is consequently no standardised requirement to evaluate the biological suitability of semi finished products and biocompatibility of polymers, Ensinger has made its own selection from the wide spectrum of different biocompatibility tests contained in ISO 10993 and USP. This is intended to provide our customers with the greatest possible assistance with the risk evaluation and approval process for their medical or pharmaceutical end products using biocompatible polymers.
Ensinger generally subjects its medical materials (MT semi finished plastics) intended for use in medical products, which are suitable for a contact period of 24 hrs. with skin and tissue, and where applicable, indirect contact with blood, to the following combined tests on biocompatibility:
- Cytotoxicity/growth inhibition (ISO 10993-5)
- Haemolysis (ISO 10993-4)
- Chemical analysis/"fingerprinting" (ISO 10993-18)
- Biological-toxicological evaluation (ISO 10993-1)
With this approach, Ensinger is following the recommendations of ISO 10993-1 with respect to step by step biological qualification.
By means of in vitro tests for cytotoxicity (ISO 10993-5) and haemolysis (ISO 10993-4), steps are taken to ensure that the products demonstrate sufficiently inert properties in contact with blood and tissue, and have a defined toxicological profile. In this process, the cytotoxicity/growth inhibition test, which is regarded as the standard test and basic biological test for all medical products, represents the basis for toxicological evaluation of the material.