选定辐照灭菌剂量-VD_(max)方法的验证  

Verification on a selected irradiation sterilization dose-VD_(MAX) method

作　　者：张悦[1] 沈以凌[1] 李梦媛[1] 王晨 尚宏忠[3] 

机构地区：[1]北京市射线应用研究中心,北京100015 [2]北京市食品药品监督管理局医疗器械技术审评中心 [3]北京市辐射中心

出　　处：《中国消毒学杂志》2015年第3期205-207,210,共4页Chinese Journal of Disinfection

基　　金：北京市财政支持项目(京财科文指[2014]178号)

摘　　要：目的验证《医疗保健产品灭菌辐射证实选定的灭菌剂量-VDmax方法》的可行性和实用性,为其推广应用提供依据。方法以同种异体骨、医用海绵和钛合金螺钉3种产品为模型,进行了辐照灭菌剂量验证。结果根据3种产品生物负载选定的辐照灭菌剂量分别为15 k Gy、17.5 k Gy和20 k Gy均得到证实,用此剂量作为产品的最终灭菌剂量,可以使产品达到10-6的灭菌保证水平。以所选择的辐照灭菌剂量对3种产品进行建立灭菌剂量实验均获得通过,此灭菌剂量得到验证。结论在我国生产的医疗器械按照AAMI TIR33:2005的方法建立灭菌剂量具有适用性,此方法为医疗器械的灭菌参数设定提供了更为广阔的选择空间。Objective To verify the feasibility and practicability of＂Sterilization of health care products- Radiation- Substantiation of a selected sterilization dose- Method VDmax＂,and provide the basis for its popularization and application. Methods 3 kinds of medical devices product（ allogeneic bone,medical sponge and titanium screws） were used as models to verify the irradiation sterilization dose. Results According to the bioburden of 3 kinds of product,the selected irradiation sterilization dose（ 15 k Gy,17. 5 k Gy and 20 k Gy） was confirmed. The product was irradiated by the confirmed sterilization dose,and it could achieve the SAL of 10^- 6. Using the selected irradiation sterilization dose,the establishing sterilization dose of 3 kinds of product was passed. So the sterilization doses were verified. Conclusion The method of establishing sterilization dose about health care products is applicable on the basis of AAMI TIR33： 2005 in China. This method provides a wider choice for sterilization parameters setting of health care products.

关 键 词：辐照灭菌 医疗器械 灭菌剂量 验证 

分 类 号：R187.4[医药卫生—流行病学]