| 医疗产品辐照灭菌剂量设定的研究 |
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| 引用本文： | 张同成,钟宏良,刘清芳,米志苏,王春雷.医疗产品辐照灭菌剂量设定的研究[J].辐射研究与辐射工艺学报,2002,20(2):103-107. |
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| 作者姓名： | 张同成 钟宏良 刘清芳 米志苏 王春雷 |
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| 作者单位： | 1. 苏州大学核医学院,苏州,215007
2. 苏州大学辐照技术研究所,苏州,215007 |
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| 摘 要： | 按照ISO11737标准 ,检测了 7类医疗产品的初始污染菌 ,范围 10CFU/件—972 71CFU/件 ;回收率 5 4.6 %— 10 0 % ;校正因子 1.0— 1.83。并以ISO11137标准方法 1完成了辐照灭菌剂量的设定。验证剂量范围为 5 .1— 17.6kGy。取样品 10 0件 ,按各验证剂量辐照 ,以无菌检查法评估 ,阳性样品数均未超过 2件。所需灭菌剂量则从ISO11137标准方法附录B中表B·1外推选定
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| 关 键 词： | 初始污染菌 辐照灭菌 验证剂量 灭菌保证水平 医疗产品 辐照灭菌 剂量 |
| 修稿时间： | 2001年6月21日 |
RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE |
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| ZHANG Tongcheng ZHONG Hongliang LIU Qingfang,MI Zhisu.RESEARCH ON DOSE SETTING FOR RADIATION STERILIZATION OF MEDICAL DEVICE[J].Journal of Radiation Research and Radiation Processing,2002,20(2):103-107. |
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| Authors: | ZHANG Tongcheng ZHONG Hongliang LIU Qingfang MI Zhisu |
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| Abstract: | Bioburdens on seven kinds of medical products were determined in accordance with ISO 11737. Different data were obtained for different products. The bioburden changed from 10 cfu/device to 97271 cfu/device the recovery ratio from 54.6% to 100%,and the correcting coefficiency from 1.0 to 1.8. Based on such bioburden and method 1 of ISO 11137, the verification dose was set up for each kind of products, from 5.1 kGy to 17.6 kGy. 100 samples were taken respectively from each kind of products and exposed to the pre-defermined verificction dose. The sterility test showed the positive number was not more than 2. Thus the sterilication dose was determined according to Table B.1 of ISO11137. |
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| Keywords: | Bioburden Radiation sterilization Verification dose Sterility assurance level (SAL) |
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