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输液连接件(肝素帽)可沥滤物检测浸提条件的确定

The Determination of the Extraction Conditions on the Inspection of the Leachable Substances of the Infusion Access Adapters (Heparin Plugs)

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【Author】 LIU Bin;LIU Ye;LUO Hong-yu;Shandong Quality Inspection Center For Medical Devices,Shandong Biology Evaluation Key Laboratories for Medical Devices;SFDA-Jinan Quality Supervision and Inspection Center for Medical Devices;Shandong Heng-xin Inspection Technology Development Center;

【机构】山东省医疗器械产品质量检验中心,山东省医疗器械生物学评价重点实验室；国家食品药品监督管理局济南医疗器械质量监督检验中心；山东恒信检测技术开发中心；

【摘要】通过各种标准中浸提比例的比较和实际产品表面积的测量,确定浸提比例为1克样品加20ml蒸馏水。在不同浸提条件下,对产品化学性能(还原物质、酸碱度、重金属、紫外吸光度)测定结果进行了比较,确定最佳浸提条件为37±1?C,24h。更多还原

【Abstract】 Through the comparison of some standards on extraction ratio and measurements of the surface of products, the extraction ratio was determined, which was 1 gram of sample with 20 ml of distilled water. The chemical requirements, such as reducing matters, pH, metal ions and UV absorbance, were tested under different extraction conditions. The best extraction conditions were determined as 37±1?C and 24 h.更多还原

【关键词】输液连接件；肝素帽；可沥滤物；浸提比例；浸提条件；化学性能；
【Key words】 infusion access adapter； heparin plug； leachable substance； extraction ratio； extraction condition； chemical requirements；

【文献出处】中国医疗器械信息 ,China Medical Device Information , 编辑部邮箱 ,2014年04期

【分类号】R197.39
【被引频次】1
【下载频次】161

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