五层共挤输液用膜拉伸强度测定的不确定度评定
Evaluation of the uncertainty on measurement of tensile strengthof 5-layer co-extrusion films used for infusion
分类号：
出版年·卷·期（页码）：2015,35 (11):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的:建立五层共挤输液用膜拉伸强度测定的不确定度评定方法。方法:依据标准YBB00112003拉伸性能测定法进行拉伸强度的测定,分析测量结果的不确定来源,并对其进行不确定评定,对不确定度分量进行量化,计算合成标准不确定度,并提出该方法的扩展不确定度。宽度和厚度采用极差法进行不确定度评定,拉力和拉伸强度采用贝塞尔法进行不确定度评定。结果:合成不确定度为0.55 MPa,扩展不确定度为1.1 MPa,结果表示为(23.98±1.1)MPa,k=2。结论:在温湿度等条件不变的情况下,五层共挤输液用膜的拉伸强度测定的不确定度,主要来源于仪器示值误差和检测人员操作误差。
-----英文摘要：---------------------------------------------------------------------------------------
Objective:To establish an evaluation method of the uncertainty for the tensile strength of the 5-layer co-extrusion films.Methods:The tensile strength was tested by the method of YBB00112003.The uncertainty measurement was analyzed and evaluated.The combined standard uncertainty and the expanded uncertainty were calculated.The range method was used to evaluate the uncertainty of breadth and depth.The Bessel method was used to evaluate the uncertainty of pulling force and tensile strength.Results:The combined uncertainty was 0.55 MPa and the expanded uncertainty was 1.1 MPa.The results were expressed as(23.98±1.1)MPa,k=2.Conclusion:On the premise of constant temperature-humidity conditions,the uncertainty of determination of the tensile strength is due to the errors of instrument testing and personnel operation.
-----参考文献：---------------------------------------------------------------------------------------
[1] CNAS CL07:2006 General Requirements for Evaluating and Reporting Measurement Uncertainty(测量不确定度评估和报告通用要求)[S].2006
[2] ZHANG YL(张毅兰),YU CW(俞春伟),CHEN F(陈芳).Evaluation of the uncertainty on measurement of tensile strength of plastic sheet(塑料硬片拉伸强度测量的不确定度评价)[J].Chin J Pharm(中国医药工业杂志),2008,39(5):369
[3] YBB00112003 Tests for Tensile Properties(YBB00112003聚丙烯输液瓶)[G]//Standard Compilation of State Food and Drug Administration in Packaging Materials and Containers of Drugs(国家食品药品监督管理局直接接触药品的包装材料和容器标准汇编).2003
[4] NI YC(倪育才).Practical Measurement Uncertainty Evaluation(实用测量不确定度评定)[M]Beijing(北京):China Metrology Press(中国计量出版社),2012
[5] NI YC(倪育才).The understanding and application of measurement uncertainty-Comparison between the range method and Bessel method(测量不确定度的理解与应用-极差法和贝塞尔法之间的比较)[J].China Metrol(中国计量),2004,8(52):78
[6] JJF 1059.1-2012 Evaluation and Expression of Uncertainty in Measurement(测量不确定度评定与表示)[S].2012
欢迎阅读《药物分析杂志》！您是该文第 656位读者！
