医药工业洁净室悬浮粒子的测量不确定度评定

目的：评定洁净室悬浮粒子的测量不确定度。方法对悬浮粒子的测量不确定度来源分析，建立数学模型，逐项评定悬浮粒子的不确定度的分量，合成标准不确定度，最后得出测量结果的扩展不确定度。结果粒径≥0.5μm的悬浮粒子数为（10490±2472）粒/m3，k=2；粒径≥5μm的悬浮粒子数为（923±296）粒/m3， k=2。结论悬浮粒子的测量不确定度主要来源是仪器的计量性能及试验重复性引起的不确定度，测量时应注意采样点的均匀性及代表性，多点采样，以减少不确定度，提高结果的可靠性。

Assessment of uncertainty of measurement of suspended particles in medical industrial clean room

Objective To assess the uncertainty of measurement of suspended particles in clean room. Methods Reasons of uncertainty of measurement of suspended particles were analyzed, mathematical model was established, the uncertainty of suspended particles were assessed component by component, standard uncertainty was synthesized and eventually expanded uncertainty of measured results was acquired. Results The number of suspended particles with diameter ≥ 0.5 μm was （10490±2472）/m3, k=2; the number of suspended particles with diameter ≥ 5 μm was （923±296）/m3, k=2. Conclusion The main reasons of uncertainty of measurement of suspended particles are metrological performance of the instrument and repeatability of the experiments. Therefore, uniformity and representativeness of the sampling points during the measurement should be the focus, and sampling should be carried out in various points so as to reduce uncertainty and improve the reliability of the results.