医用手术台罩辐射灭菌适应性的研究  

Compatibility study of radiation sterilization for the covering of hospital operation table

作　　者：周璐[1] 张培男[1] 刘清芳[2] 

机构地区：[1]张家港出入境检验检疫局,215633 [2]苏州大学放射医学与公共卫生学院,215600

出　　处：《口岸卫生控制》2004年第2期18-21,共4页Port Health Control

摘　　要：目的　采用微生物信息进行医用手术台罩适应性的研究。方法　依据ISO 1 1 737标准检测初始污染菌回收率、校正因子 ;以ISO 1 1 1 37- 1完成剂量设定 ;按ISO 1 1 6 0 7和EN 86 8- 1标准选取染料渗漏试验、加速老化试验和封口剥离试验进行包装性能的测定 ;按ISO 1 1 6 0 6 - 1 997标准进行产品的抗拉强度试验 ;按ISO 1 0 993- 1 0标准进行致敏试验和皮内刺激试验。结果　医用手术台罩初始污染菌为 31 1 6 75CFU/件 ,平均回收率为 72 8% ,校正因子为 1 37,验证剂量 (SAL =1 0 2 )为 1 2 6KGy ,最低灭菌剂量 (SAL =1 0 6 )为 2 6 8KGy。经最低辐照剂量辐照后 ,产品包装材料性能良好 ,保持无菌 ,生物学实验不受影响。结论　对 1 0 0件产品 ,按验证剂量辐照以无菌检查评估 ,阳性数均未超过 2件 ,统计学提示验证通过。因此 。objective Conduct research on radiation sterilization adaptability of medical operation table cover using microbiological data.Methods Determine initial recovery ratio and correction co-efficiency of polluted bacteria according to ISO 11137-1;determine the dose setting based on the Method lin ISO 11737 standard;determine packing performance by selecting dye leakage test,aging acceleration test and seal-peeling test according to ISO 11607 and EN 868-1;conduct intensity-resistance test according to ISO 11606-1997;conduct allergy test and hypophloeodal stimulation test according to ISO 10993-10 methods.Results Initial scope of polluted bacteria of medical operation table cover is 3116.75 CFU/device,recovery ratio is 72.8%,correction co-efficiency is 1.37,scope of inspection dose(SAL=10 2 )is 12.6KGy,minimum scope of sterilization dose(SAL=10 6 ) is 26.8KGy.The product is processed with minimum radiation dose and the product is kept germfree,and no blight effects in biological test.Conclusion 100 products were sampled and processed with test dose radiation.In the sterilization test,no more than 2 samples were positive,which means it passed the statistical test.So radiation sterilization has been widely used in the sterilization of medical operation table.

关 键 词：医用手术台罩 辐射灭菌 适应性 微生物信息 生物学评价 

分 类 号：R613[医药卫生—外科学]