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心室辅助装置溶血检测及关键问题研究

侯晓旭 李澍 王浩 罗维娜 王权 任海萍

中国医疗设备2018,Vol.33Issue(9):15-18,4.
中国医疗设备2018,Vol.33Issue(9):15-18,4.DOI:10.3969/j.issn.1674-1633.2018.09.004

心室辅助装置溶血检测及关键问题研究

Study on Testing and Key Problems of Hemolysis Evaluation in Ventricular Assist Device

侯晓旭 1李澍 1王浩 1罗维娜 1王权 1任海萍1

作者信息

  • 1. 中国食品药品检定研究院 医疗器械检定所,北京 102629
  • 折叠

摘要

Abstract

Objective The physical significance of the hemolytic index is to reflect the content of free hemoglobin in 100 L output hematocrit and to reflect the safety of the ventricular assist device content, which is recognized as the standard in the world to evaluate the hemolysis performance of the blood pump. Methods Based on the introduction of ASTM F1841-97, this paper focused on the refinement and discussion of the parts that not specified in the standard. It included the initial blood quality requirement and the free hemoglobin test method. Results The detecting platform for hemolysis testing was successfully designed and built, and was used for the test of hemolysis performance of one blood pump, indicating the effectiveness of the platform. Conclusion Based on the introduction of ASTM F1841-97, we have established a detecting platform to realize the hemolysis testing for blood pump and explicate the test methods and details, which would provide some reference for the researcher and tester.

关键词

溶血指数/血泵/剪切力/心室辅助装置

Key words

haemolytic index/blood pump/shear force/ventricular assist device

分类

医药卫生

引用本文复制引用

侯晓旭,李澍,王浩,罗维娜,王权,任海萍..心室辅助装置溶血检测及关键问题研究[J].中国医疗设备,2018,33(9):15-18,4.

基金项目

国家重点研发计划(2016YFC0103201). (2016YFC0103201)

中国医疗设备

OACSTPCD

1674-1633

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