本文件提供了一种评估细胞计数测量质量方面的方法 通过稀释系列衍生的一组质量指标制备特定细胞的过程 实验设计和统计分析。质量指标基于产品的可重复性 测量和结果符合理想比例响应的程度 稀释。本方法适用于全、差、直接和间接细胞计数测量 过程，前提是测量过程符合实验设计的标准（e。 G 细胞悬浮在溶液中）。 该方法最适用于细胞计数方法的开发、优化、验证、评估和/或细胞计数测量过程的验证。 该方法尤其适用于需要评估适当参考材料的情况 准确度并不容易获得。这种方法不能直接提供细胞计数的准确性。 该方法主要适用于真核细胞。交叉引用:ISO 20391-1ISO/IEC指南99:2007 ISO 3534-1ISO/IEC 25062ISO/IEC指南98- 3:2008DIN 58932-1ISO 16732-1:2012ISO 8655-1:2002ISO 9000:2015ISO 5725-2:1994ISO 8655-6:2002ISO 15198:2004ISO 8655-2:2002ISO 5725-1:1994购买本文件时提供的所有当前修改件均包括在内。

This document provides a method for evaluating aspects of the quality of a cell counting measurement process for a specific cell preparation through a set of quality indicators derived from a dilution series experimental design and statistical analysis. The quality indicators are based on repeatability of the measurement and the degree to which the results conform to an ideal proportional response to dilution. This method is applicable to total, differential, direct and indirect cell counting measurement processes, provided that the measurement process meets the criteria of the experimental design (e.g. cells are suspended in a solution). This method is most suitable during cell counting method development, optimization, validation, evaluation and/or verification of cell counting measurement processes. This method is especially applicable in cases where an appropriate reference material to assess accuracy is not readily available. This method does not directly provide the accuracy of the cell count. This method is primarily applicable to eukaryotic cells.Cross References:ISO 20391-1ISO/IEC Guide 99:2007ISO 3534-1ISO/IEC 25062ISO/IEC Guide 98-3:2008DIN 58932-1ISO 16732-1:2012ISO 8655-1:2002ISO 9000:2015ISO 5725-2:1994ISO 8655-6:2002ISO 15198:2004ISO 8655-2:2002ISO 5725-1:1994All current amendments available at time of purchase are included with the purchase of this document.