Vink P, Pleijsier K
Biomaterials. 1986 May;7(3):225-30. doi: 10.1016/0142-9612(86)90108-0.
The ethylene oxide (EO) content of 17 polymers sterilized with 100% EO under conditions normally used in practice was determined as a function of aeration time, and for some polymers also as a function of sample thickness. The determination of the amount of residual EO has been carried out by gas chromatography, applying Discontinuous Gas Extraction and Head Space analysis. Generally, aeration was confirmed to be a diffusion-controlled process. Diffusion coefficients of EO for the investigated materials were determined from the rates of desorption. For a number of materials the EO content appeared to be well above the levels for EO which currently are considered to be safe, even after aeration for 15 d. For a reliable determination of aeration times required for EO-sterilized medical devices, the type and in particular also the thickness of the material from which the device is made should be considered.
测定了17种在实际常用条件下用100%环氧乙烷（EO）灭菌的聚合物中环氧乙烷含量随通气时间的变化情况，对于一些聚合物还测定了其随样品厚度的变化情况。残留环氧乙烷量的测定采用气相色谱法，应用间断气体萃取和顶空分析。一般来说，通气被确认为是一个扩散控制过程。根据解吸速率测定了所研究材料中环氧乙烷的扩散系数。对于许多材料，即使通气15天后，环氧乙烷含量似乎仍远高于目前认为安全的环氧乙烷水平。为了可靠地确定环氧乙烷灭菌医疗器械所需的通气时间，应考虑器械所使用材料的类型，尤其是材料的厚度。
