| 邻苯二甲酸二异辛酯增塑聚氯乙烯医疗器械的安全性评价 |
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| 引用本文： | 奚廷斐,王春仁. 邻苯二甲酸二异辛酯增塑聚氯乙烯医疗器械的安全性评价[J]. 中国医疗器械信息, 2005, 11(2): 27-30 |
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| 作者姓名： | 奚廷斐 王春仁 |
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| 作者单位： | 中国药品生物制品检定所医疗器械检测中心,北京,100050 |
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| 摘 要： | 本文总结了采用邻苯二甲酸二异辛酯(DEHP)增塑聚氯乙烯(PVC)生产的医疗器械的安全性评价结果.在大多数临床使用情况下从PVC医疗器械中释放出DEHP的量不会产生不良反应,但是根据研究资料表明对特殊人群主要是男性胎儿、男性新生儿和青春发育期的男性有潜在的高危风险.
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| 关 键 词： | 邻苯二甲酸二异辛酯 聚氯乙烯 安全性 |
| 文章编号： | 1006-6586(2005)02-0027-04 |
| 修稿时间： | 2005-02-16 |
The Safety Assessment of Medical Devices Manufactured from Di-(2-ethylhexyl) phthalate Plasticized Polyvinyl Chloride |
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| XI Ting-fei,WANG Chun-ren. The Safety Assessment of Medical Devices Manufactured from Di-(2-ethylhexyl) phthalate Plasticized Polyvinyl Chloride[J]. China Medical Devices Information, 2005, 11(2): 27-30 |
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| Authors: | XI Ting-fei WANG Chun-ren |
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| Affiliation: | Beijing 100050 |
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| Abstract: | This paper summarize the safety evaluation results of medical devices manufactured from di-(2-ethylhexyl)phthalate plasticizedpolyvinyl chloride. There is little or no risk posed by patients expose to the amount of DEHP released from the PVC medical productsat most clinical procedures. But based on the evidence cited from the literature, the male fetus, male neonate, and peripubertal malewould appear to be high-risk group. |
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| Keywords: | Di-(2-ethylhexyl)phthalate (DEHP) Polyvinyl chloride(PVC) Safety |
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