Dorpema JW ; Bisschop A ; Orzechowski T ; Machielsen
A ; Voogd CE ; Jansen PJCM
84 p
in Dutch
1991
Toon Nederlands
English 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.
