Study on blood compatibility of the radiation sterilized disposable burette transfusion apparatus

CHEN Guochong; LIU Wen; LIU Qingfang

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Study on blood compatibility of the radiation sterilized disposable burette transfusion apparatus

更新时间：2023-03-27

- Study on blood compatibility of the radiation sterilized disposable burette transfusion apparatus
- Journal of Radiation Research and Radiation Processing Vol. 29, Issue 6, Pages: 371-376(2011)
- 作者机构：
  
  1.苏州大学医学部放射医学与公共卫生学院　江苏省放射医学与防护重点实验室　苏州　215123
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CHEN Guochong, LIU Wen, LIU Qingfang. Study on blood compatibility of the radiation sterilized disposable burette transfusion apparatus. [J]. Journal of Radiation Research and Radiation Processing 29(6):371-376(2011)
DOI：

CHEN Guochong, LIU Wen, LIU Qingfang. Study on blood compatibility of the radiation sterilized disposable burette transfusion apparatus. [J]. Journal of Radiation Research and Radiation Processing 29(6):371-376(2011) DOI：

摘要

评价辐照灭菌后一次性使用滴定管式输液器的血液相容性，为辐射灭菌后的医疗产品安全应用提供依据。采用ISO11137标准对一次性使用滴定管式输液器进行辐射灭菌剂量设定，对辐照灭菌后的样品测定全凝血时间（Whole blood clotting time，WBCT）、凝血酶原时间（Prothrombin time，PT）和部分凝血酶时间（Partial thromboplastin time，PTT）及溶血率。经辐照灭菌后的样品，WBCT、PT 和PTT与阴性对照比较，结果均无显著性差异（,p,>,0.05），溶血率为1.38%，,<,5%，符合医疗器械血液相容性实验要求。经设定剂量辐照灭菌后的一次性使用滴定管式输液器血液相容性良好，该器皿辐照灭菌值得推广。

Abstract

The blood compatibility of the radiation sterilized disposable burette tansfusion apparatus was investigated to provide evidence for the safety of radiation sterilized medical devices. The initial bacteria burden of the disposable burette transfusion apparatus was examined according to the ISO11737 standard, and the whole blood clotting time, prothrombin time, partial thromboplastin time and hemolysis rate of the samples were determined. There was no significant difference between the radiation sterilized samples and negative controls on WBCT, PT and PTT (,p,>,0.05). Haemolysis test showed that the haemolysis rate of the sample sterilized by irradiation was 1.38%, which was coincidence with the criteria of the medical devices. After sterilization by irradiation, disposable burette transfusion apparatus show good blood compatibility, which could be considered that radiation sterilization is a biologically safe method for the medical apparatus.

关键词

滴定管式输液器辐照灭菌血液相容性

Keywords

Burette transfusion apparatusRadiation sterilizationBlood compatibility

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