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Hideharu Shintani
Hideharu Shintani
1-10-60, Minamidaira, Hino, Tokyo 191-0041
Japan
Publications
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Research Article
Formation and Elution of Toxic Compounds from γ-Ray Sterilized Medical Products: Toxic Compound Formation and Ames test of Eluted Components
Author(s): Hideharu ShintaniHideharu Shintani
No formation of MDA was observed in chain-extended thermoplastic polyurethane (PU) when sterilized by autoclave or γ-ray irradiation. No formation of MDA was observed in nonchain-extended thermoplastic PU when sterilized by γ-ray irradiation. Less than 1 ppm of MDA was produced in nonchain-extended thermoplastic PU sterilized by autoclave sterilization. Autoclave sterilization did not produce MDA in thermosetting PU potting material. MDA formation in potting material was promoted by γ-ray irradiation and increased with increasing irradiation doses at a quadratic equation of regression. MDA formation at 100 kGy irradiation is a few ppm and less than one ppm at 25 kGy irradiation, therefore the potential risk to human recipients was not significant. The elution of compounds other than MDA from potting material was more problematic. Solvent extracts from potting materia.. View More»
DOI: 10.4172/2153-2435.1000185