血液透析导管中残留单体二苯基甲烷二异氰酸酯的检测OA北大核心CSTPCD
Detection of residual diphenylmethane diisocyanate monomer in a hemodialysis catheter
背景:目前,含聚氨酯医疗器械的质量控制文件和技术标准中均未明确残留单体二苯基甲烷二异氰酸酯(diphenylmethane diisocyanate,MDI)的控制指标及检测方法,考虑到MDI对人体具有致癌的潜在风险,为控制该类产品的安全有效性,应及早建立质量标准.目的:建立测量血液透析导管中残留单体MDI的测试方法,分析该产品的MDI溶出量对人体是否存在风险.方法:取血液透析导管样品用乙酸乙酯加热回流,采用气相色谱法分析MDI含量.色谱条件为:…查看全部>>
BACKGROUND:In the current quality control file or technical standards of the hemodialysis catheter,the indicators of the component contents and detection methods of the residual diphenylmethane diisocyanate (MDI) monomer are undefined.To ensure the safety and effectiveness of these products,we should try to establish and improve the quality standards.OBJECTIVE:To establish a method for determination of the residual MDI monomer in a hemodialysis catheter by g…查看全部>>
黄元礼;孙雪;柯林楠;王春仁
中国食品药品检定研究院医疗器械所,北京市102629中国食品药品检定研究院医疗器械所,北京市102629中国食品药品检定研究院医疗器械所,北京市102629中国食品药品检定研究院医疗器械所,北京市102629
医药卫生
血液透析导管气相色谱残留单体二苯基甲烷二异氰酸酯生物材料
《中国组织工程研究》 2018 (6)
927-931,5
国家重点研发计划(2016YFC1101202)the National Key Research and Development Program of China,No.2016YFC1101202
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