一次性使用麻醉用药液过滤器微粒含量测试方法的研究

目的：解决一次性使用麻醉用药液过滤器微粒含量试验方法的错误。方法：对实际试验中出现的问题进行理论分析和假定;采用微粒过滤的预处理方法,通过不同预处理的以达到不同微粒残留量的试验方案设计;实验验证,进而,应用数理统计方法以得到微粒含量试验方法的条件控制要求。结果：微粒含量试验方法中,所用的冲洗液以及本底液微粒残留量是造成过滤器自身微粒含量试验错误的根本原因。结论：一次性使用麻醉用药液过滤器微粒含量的检测方法中,本底液的微粒残留量和冲洗液的选择是影响试验的关键。本底液的微粒残留量控制在5μm以上的微粒不大于10个（在60 mL中）,并且选用纯净水作为冲洗液时,结果可靠。

Test method study of single-use filter for anaesthesia's particulate content

Objective:Correct the error of the test method for the single-use filter for anaesthesia.Method:Give the academic analysis and assume to the problem appeared in the actual test;Adopt the method of pretreatment of particulate-filter and give several different project design of particulate-hangover;Achieve the request of condition control of particulate content by test validation and analysis of academic statistic.Result:The flusher and particulate hangover result in the lost of particulate content test of the filter itself.Conclusion:The selection of the flusher and particulate hangover is the key factor in the test of single-use filter for anaesthesia,for credible result,the number of particulate hangover which size is more than 5um should be no more than 10(in 60 mL) and the filter should be pure water.