医科器械学
Online ISSN : 1881-4875
Print ISSN : 0385-440X
ダイアライザーの放射線滅菌線量の検討(II) : 指標菌負荷試料のD値測定
木川 秋子三沢 昇立石 恒夫磯 勝明木村 俊夫真室 哲雄
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1986 年 56 巻 9 号 p. 415-419

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It was found in the preceding study that the strain that showed the highest radiation resistance among the strains washed out of dializers not yet sterilzed was Bacillus megaterium and the D-value of its spore was about 40 percent higher than that of B.pumilus ATCC27142 spore. In the present study, bundles of hollow fibers were inoculated with spores of both the B.megaterium and the B.pumilus and D-values of the spores were measured to be 0.42_7 and 0.16_9 Mrad, respectively. The dializer is consisted of several materials. Sterilization effect of gamma-ray irradiation is the least for hollow fibers, because they contain glycerin. It is concluded that 10^6 sterility assurance is achieved by setting the sterilization dose at 2.0 Mrad, about eight times of the D-value for the B.megaterium under the condition that the number of contaminants per product is less than 100.

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© 1986 一般社団法人日本医療機器学会
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