Abstract

Sterilization with irradiation of cardiovascular operation sets induced the release of some volatile components. Potential material changes affecting the safety of the product were chemically analysed and investigated in some essential required biocompatibility tests. The non hazardous risk of this volatile organic compounds was determined by the University of Goteborg and confirmed by the RIVM. The biocompatibility test results indicate the absence of inacceptable effects. In summary it was concluded that processing Klinidrape 100 by irradiation is a safe treatment.