| 一次性使用输液器、注射器环氧乙烷灭菌验证方法 |
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| 引用本文： | 刘亚利,李军,黎隽.一次性使用输液器、注射器环氧乙烷灭菌验证方法[J].中国药业,2007,16(18):41-42. |
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| 作者姓名： | 刘亚利 李军 黎隽 |
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| 作者单位： | 1. 陕西省医疗器械检测中心,陕西,西安,710061
2. 陕西省食品药品监督管理局,陕西,西安,710061 |
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| 摘 要： | 目的确定和选择最佳灭菌工艺条件，寻求产品对环氧乙烷灭菌的适应性和符合性。方法对一次性使用输液器、一次性使用无菌注射器产品进行环氧乙烷灭菌。结果各种验证参数均符合灭菌工艺要求。结论该试验设计合理，灭菌工艺可靠。
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| 关 键 词： | 环氧乙烷 灭菌工艺 验证 |
| 文章编号： | 1006-4931（2007）18-0041-02 |
| 修稿时间： | 2007-06-07 |
Experimental Study on Sterilizition Infusion Sets and Syringes for Single Use by Ethylene Epoxide |
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| Liu Yali,Li Jun,Li Jun.Experimental Study on Sterilizition Infusion Sets and Syringes for Single Use by Ethylene Epoxide[J].China Pharmaceuticals,2007,16(18):41-42. |
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| Authors: | Liu Yali Li Jun Li Jun |
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| Institution: | L Shanxi Provincial Testing Center for Medical Equipments, Xian, Shanxi, China 710061; 2. Shanxi Food and Drug Administration, Xian, Sharvci, China 710061 |
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| Abstract: | Objective To determine and choose the optimal technological conditions of sterilizition. To investigate the suitability and compatibility for sterilizing the products by ethylene epoxide. Methods To use ethylene epoxide to sterilize infusion sets and syringes for single use. Results All kinds of verification parameters accorded with the demands of the sterilizion technologe. Conclusion The experiment is reasonable and the sterilizition technology is reliable. |
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| Keywords: | ethylene epoxide sterilizition technology test and verification |
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