医用手术台罩辐射灭菌适应性的系统研究

SYSTEMATIC STUDY ON SUITABILITY OF RADIATION STERILIZATION OF MEDICAL OERATION TABLE COVER

为系统研究医用手术台罩辐射灭菌适应性,采用微生物定量检验方法以及染料渗漏试验、加速老化试验和封口剥离试验,进行了初始污染菌回收率、校正因子和包装性能的检测。结果,医用手术台罩初始污染菌数为3117cfu/件,平均回收率为72.8%;校正因子为1.37,验证剂量(SAL=10-2,)范围为12.6 kGy,最低灭菌剂量(SAL=10-6)范围为26.8 kGy。经最低辐照剂量辐照并完成老化试验后产品包装材料性能良好,可保持产品无菌,生物学实验均无不良反应。结论,按验证剂量辐照以无菌检查评估,阳性数均末超过2件,该系统验证合格。

In order to study systematically suitability of radiation sterilization of medical operation table cover, microbio-logical quantitative examination method, dye seepage test, accelerating ageing test and seal stripping test were used to examine the recovery rate of original contaminating bacteria, correctio factor and packing properties. Results： The original contaminating bacteria count of the medical operation table cover was 3117 cfu/piece, the average recovery rate was 72.8%, the correction factor was 1.37, the range of verification dose （SAL = 10^-2） was 12.6 kGy and the range of minimum sterilization dose （SAL = 10^-6） was 26.8 kGy. After irradiation with minimum radiation dose and completion of ageing test, the properties of packing material of the product were good, which could keep the product sterile. No adverse reaction occurred in biological experiment. Conclusion： After the products were irradiated with verification dose and evaluted by sterility examination, the number of microorganism positive products did not exceed 2 pieces, indicating that thesterilization system is up to standard.