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医疗器械溶血性能评价方法-ASTM直接接触法和间接接触法的比较 被引量:2

Comparison between Direct and Indirect Methods of ASTM-One Evaluation Assay of Hemolytic Properties of Medical Devices
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摘要 采用ASTM直接接触法和间接接触法对六种不同材料的溶血性能进行比较,结果显示用两种方法检测的聚乙烯、丁腈手套和橡胶#2的溶血等级判定结果是一致的,而乳胶手套、橡胶#1和Buna橡胶用两种方法检测的溶血等级判定结果不一致,且乳胶手套和Buna橡胶的溶血指数差异显著。我们分析了采用这两种方法检测,导致结果不一致的原因,为医疗器械或材料的溶血性能检测提出了一些建议,为新标准的发布和实施提供了数据支持。 In this study,the direct and indirect methods of ASTM were used to assay the hemolytic properties of 6 kinds of different materials. The results showed that the hemolytic grade using the two methods were basically consistent on the Polyethylene,Nitrile glove and Rubber #2. The hemolytic grade using the two methods were inconsistent on the Latex glove,Rubber #1 and Buna rubber.The hemolytic index of the two methods of the Latex glove and Rubber #1 were significant different. We analyze the causes of the inconsistent and offer some suggestions about the measurement of hemolytic properties of medical devices or materials and supply data support for the publication and execution of the new standards.
出处 《生物医学工程研究》 2014年第4期264-267,共4页 Journal Of Biomedical Engineering Research
关键词 医疗器械 溶血性能 美国材料与试验协会方法 直接接触法 间接接触法 Medical devices Hemolytic properties ASTM method Direct methed Indirect method
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  • 1ISO 10993 -4. 2002/Amdl:2006, Biological evaluation of medical devices - Part 4 : Selection of tests for interactions with blood[ S].
  • 2GB/T16886.4-2003医疗器械生物学评价第4部分:与血液相互作用试验选择[S].2003.
  • 3National Institutes of Health. 1997. Evaluation of hemodialyzers and dialysis membranes [ M ]. DHEW Publication, 1977.1 (2) :59 - 77.
  • 4ASTM F 756 - 808. Standard Practice for Assessment of Hemolytic Properties of Materials [ S].
  • 5MHCW Notification. 0301 No. 20,2012,Basic principles of biological safety evaluation required for application for approval to market medi- cal devices[ S].
  • 6GB/T 16175 -2008, Organic silicone material for medical use - Biological evaluation test methods[ S].
  • 7GB/T 14233.2 - 2005 Infusion , transfusion , injection equipment for medical use - Part2 : Biologieal test methods [医用输液、输血医用输液、输血、注射器具检验方法第2部分:生物学试验方法].
  • 8ISO 10993 -12, Biological evaluation of medical devices -Part 12: Sample preparation and reference materials [ S ].
  • 9孙皎,刘义荣,钱云芳.生物材料试样形状对溶血率的影响[J].口腔材料器械杂志,1993,0(2):17-18. 被引量:22

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