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 strength of 5-layer co-extrusion films used for infusion

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。

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 YBBO0112003. The uncertainty meas- urement 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.