sterilization process for the manufacture of implantierbarem or transplantierbarem biological material

摘要

The sterilization of biological material of animal or human origin, which is to be used as an implant or transplant, is performed according to a validated sterilization method with a margin of safety of 10SUP6 /SUPgerms by which harmful microorganisms are physically separated and chemically sterilized in four successive steps, initially in an antibiotic, then in deoxicholic acid, then in a surface-active substance and finally in primary alcohol, respectively accompanied by rinsing steps involving an aqueous solution after steps two to four. A bioprosthesis sterilized with a margin of safety10SUP6 /SUPgerms can be implanted without any further treatment, does not have a tendency towards calcification, and ensures a long service life.