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使用环氧乙烷对医疗器械进行灭菌的物理化学及毒理学卫生学方面。第一部分。环氧乙烷在聚合材料中的吸附与扩散。

Physico-chemical and toxicologo-hygienic aspects of using ethylene oxide for the sterilization of medical appliances. Part I. Sorption and diffusion of ethylene oxide in polymeric materials.

作者信息

Lyarskii P P, Likhtman T V, Kareyev N V, Komarkova N I, Gleiberman S E

出版信息

J Hyg Epidemiol Microbiol Immunol. 1984;28(2):119-28.

PMID:6470476
Abstract

Sorption ability of polymeric materials for medical purposes was studied with respect to the sterilizing gas - ethylene oxide - at 23, 35 and 55 degrees C. Sorption coefficients of ethylene oxide (EO) for the materials under study were calculated on the basis of results. Investigation of the kinetics of desorption of EO from the polymeric materials for medical purposes has shown that its content changes exponentially depending on the time of degassing. However, the lines in the 1g Q/Q0 - tau coordinates show a sharp break which testifies to a change in the mechanism of the process determining the character of the mentioned dependence. In the first region, corresponding to high concentrations and short periods of time, the determining process is diffusion while in the second region (low concentrations, long time intervals) - it is desorption of EO molecules most firmly bound to the polymer. Diffusion coefficients were calculated for the first region. The possibility of predicting the time periods of removing ethylene oxide from the polymeric materials was demonstrated for both stages on the basis of calculated diffusion coefficients and kinetic curves of degassing. Recommendations were given for the use of polymers for medical appliances and apparatuses.

摘要

研究了医用高分子材料在23℃、35℃和55℃下对杀菌气体环氧乙烷的吸附能力。根据实验结果计算了所研究材料对环氧乙烷(EO)的吸附系数。对医用高分子材料中环氧乙烷解吸动力学的研究表明,其含量随脱气时间呈指数变化。然而,在lgQ/Q0 - τ坐标中的曲线出现了明显的转折,这证明了决定上述依赖关系特征的过程机制发生了变化。在对应于高浓度和短时间的第一区域,决定过程是扩散,而在第二区域(低浓度、长时间间隔),是与聚合物结合最牢固的环氧乙烷分子的解吸。计算了第一区域的扩散系数。基于计算出的扩散系数和脱气动力学曲线,证明了在两个阶段预测从高分子材料中去除环氧乙烷的时间段的可能性。给出了关于将聚合物用于医疗器具和设备的建议。

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