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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 a method to evaluate the uncertainty of film tensile strength of five-layer co-extrusion infusion solution. Methods: Tensile strength was measured according to the standard YBB00112003 tensile properties test method, the sources of uncertainty were analyzed, and the uncertain sources were evaluated. The uncertainty components were quantified and the standard uncertainty was calculated. The method’s extended uncertainty. The width and thickness of the method using the difference method to assess the uncertainty, tensile and tensile strength using Bessel method to assess the uncertainty. Results: The uncertainty of synthesis was 0.55 MPa and the uncertainty of expansion was 1.1 MPa. The results were expressed as (23.98 ± 1.1) MPa, k = 2. CONCLUSION: The uncertainty of the tensile strength of the five-layer co-extruded infusion film under the condition of constant temperature and humidity is mainly due to the indication error of the instrument and the operation error of the tester.