Shintani H
Section of Medical Devices, National Institute of Sciences, Tokyo, Japan.
Biomed Instrum Technol. 1995 Nov-Dec;29(6):513-9.
Sterilization of polyurethane (PU) produces 4,4'-methylenedianiline (MDA), a known carcinogen, and various other compounds. The relationships of the components of PU to the formation of these compounds by sterilization were studied. Specimens of PU fabricated from different combinations of isocyanates and polyols were obtained from dialyzers. The molecular weight of the particular polyol was found to influence the production of MDA by sterilization. Sterilization also produced many unidentified compounds. MDA production was not always associated with the production of the other compounds. Compared with gamma-ray irradiation and ethylene oxide gas (EOG) sterilization, autoclave sterilization eluted more hydrophilic compounds. This phenomenon was significant for PUs produced from smaller-molecular-weight polyols. The combination of autoclave sterilization and a PU produced from a larger-molecular-weight polyol is recommended to minimize the production of potentially toxic compounds. Of the techniques studied, EOG sterilization produced the least amounts of MDA and the other compounds, but the residue of EOG is itself problematic. The risk posed by the amounts of MDA extracted was not significant, but the biological safety of the other compounds remains to be determined.
聚氨酯（PU）灭菌会产生已知致癌物4,4'-亚甲基二苯胺（MDA）以及各种其他化合物。研究了PU的成分与灭菌过程中这些化合物形成之间的关系。从透析器中获取了由异氰酸酯和多元醇不同组合制成的PU样本。发现特定多元醇的分子量会影响灭菌过程中MDA的产生。灭菌还会产生许多未鉴定的化合物。MDA的产生并不总是与其他化合物的产生相关。与伽马射线辐照和环氧乙烷气体（EOG）灭菌相比，高压蒸汽灭菌洗脱的亲水性化合物更多。这种现象对于由较小分子量多元醇制成的PU尤为明显。建议将高压蒸汽灭菌与由较大分子量多元醇制成的PU相结合，以尽量减少潜在有毒化合物的产生。在所研究的技术中，EOG灭菌产生的MDA和其他化合物量最少，但EOG残留物本身也存在问题。提取的MDA量所带来的风险并不显著，但其他化合物的生物安全性仍有待确定。
