| 对GB7544《天然胶乳橡胶避孕套技术要求和试验方法》的几点商榷和建议 |
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| 引用本文： | 肖忆梅. 对GB7544《天然胶乳橡胶避孕套技术要求和试验方法》的几点商榷和建议[J]. 中国医疗器械杂志, 2010, 34(6): 448-449. DOI: 10.3969/j.isnn.1671-7104.2100.06.017 |
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| 作者姓名： | 肖忆梅 |
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| 作者单位： | [1]中国药品生物制品检定所,北京100050 [2]国家食品药品监督管理局医疗器械标准管理中心,北京100050 |
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| 摘 要： | 由于GB7544-2004标准在实施中发现存在对天然胶乳原料、橡胶避孕套产品安全性、橡胶避孕套产品微生物控制的要求以及包装与标志方面的一些问题,提出了商榷和几点建议。
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| 关 键 词： | 天然胶乳橡胶避孕套 标准 |
The Consideration and Several Suggestions on the National Standard GB 7544 Natural Latex Rubber Condoms-Requiements and Test Methods |
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| Xiao Yimei. The Consideration and Several Suggestions on the National Standard GB 7544 Natural Latex Rubber Condoms-Requiements and Test Methods[J]. Chinese journal of medical instrumentation, 2010, 34(6): 448-449. DOI: 10.3969/j.isnn.1671-7104.2100.06.017 |
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| Authors: | Xiao Yimei |
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| Affiliation: | Xiao Yimei National Institute for the Control of Pharmaceutical and Biological Products,Beijing,100050 Center for Medical Device Standardization Administration,SFDA |
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| Abstract: | It was found that several problems exist in the implementation of GB 7544-2004 in the aspects of requirements of natural latex materials and safety of rubber condom products,microorganisms to be controlled and the packaging and label.As a result,the suggestions were put forward. |
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| Keywords: | natural latex rubber condoms standard |
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