Two different types of plasticized poly(vinyl chloride) (PVC) used for biomedical disposable devices-extruded and injection moulded-were studied in the non-sterilized condition and after 25 and 50 kGy of beta irradiation. The polymer surfaces were analysed by scanning electron microscopy (SEM) equipped with an x-ray energy-dispersive spectroscopy (XEDS) and by atomic force microscopy (AFM). The inner surface of two parts of a venous line showed a different morphology according to their original formulation (for extrusion or injection moulding process) and reacted differently on sterilization with beta irradiation. Moulded parts were affected only slightly by the radiation step, whereas the variations were bigger for the extruded parts. In order to gain the best performances for the medical devices studied, the utmost care must be taken in the sterilization step, which should be optimized as well as the other steps of the manufacturing process. Copyright
Radiation-induced migration of additives in PVC-based biomedical disposable devices. Part 1. Surface morphology by AFM and SEM/XEDS / M., Manfredini; D., Atzei; Marchetti, Andrea; B., Elsener; M., Malagoli; F., Galavotti; Rossi, Aldo. - In: SURFACE AND INTERFACE ANALYSIS. - ISSN 0142-2421. - ELETTRONICO. - 35:4(2003), pp. 395-402. [10.1002/sia.1547]
Radiation-induced migration of additives in PVC-based biomedical disposable devices. Part 1. Surface morphology by AFM and SEM/XEDS
MARCHETTI, Andrea;ROSSI, Aldo
2003
Abstract
Two different types of plasticized poly(vinyl chloride) (PVC) used for biomedical disposable devices-extruded and injection moulded-were studied in the non-sterilized condition and after 25 and 50 kGy of beta irradiation. The polymer surfaces were analysed by scanning electron microscopy (SEM) equipped with an x-ray energy-dispersive spectroscopy (XEDS) and by atomic force microscopy (AFM). The inner surface of two parts of a venous line showed a different morphology according to their original formulation (for extrusion or injection moulding process) and reacted differently on sterilization with beta irradiation. Moulded parts were affected only slightly by the radiation step, whereas the variations were bigger for the extruded parts. In order to gain the best performances for the medical devices studied, the utmost care must be taken in the sterilization step, which should be optimized as well as the other steps of the manufacturing process. CopyrightPubblicazioni consigliate
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