Sterilization method for the production of implantable or...

Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance

Reexamination Certificate

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C422S001000, C623S915000, C623S920000

Reexamination Certificate

active

07438850

ABSTRACT:
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 106germs 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 safety>106germs can be implanted without any further treatment, does not have a tendency towards calcification, and ensures a long service life.

REFERENCES:
patent: 7014655 (2006-03-01), Barbarash et al.
patent: 100 60 660 (2002-06-01), None
patent: 0 889 690 (2003-02-01), None
patent: WO 97/36479 (1997-10-01), None

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