目的  建立有效的透析器中有害物质的检测方法。 方法  分别对行业标准中溶血试验方法、还原物质含量检测方法进行优化：延长中空纤维与红细胞的接触时间，增加将中空纤维在红细胞悬液中往复滑动的动态接触；对透析器全面浸提，浸提结束后充分获取所有浸提液，计算整个透析器中还原物质的总量。用行业标准方法和优化方法检测16批透析器的溶血率和还原物质含量，比较2种方法所得检测结果。进一步优化方法后检测28批透析器的溶血率和还原物质含量，分析溶血率和还原物质含量之间的相关性。另外还进行了透析器浸提液最高吸收峰所在波段及当前生物学试验浸提液获取方式是否合理的相关研究。 结果  与行业标准方法相比，优化溶血试验方法(t=-5.987，P＜0.001)和优化还原物质含量检测方法(t=-4.601，P＜0.001)的检测效率更高。行业标准方法所测得16批透析器的溶血率和还原物质含量均很低，而优化后方法检测各透析器溶血率在0.5%～12.2%，还原物质总量在3.8～90.4 ml。28批透析器的溶血率与还原物质总量呈正相关(r=0.478，P=0.013：还原物质总量大于30 ml，溶血率不小于5%。透析器浸提液的紫外吸收最高峰在200 nm。以常用方式获取浸提液后，透析器中空纤维内仍残余大量液体。 结论  ①优化后还原物质含量和溶血率检测方法均是有效的有害物质含量检测方法。控制还原物质总量在一定程度上可达到控制有害物质含量的目的。②行业标准YY0053需进行修订：还原物质含量检测方法、溶血试验方法均需加严，参考本文中优化方法；修正紫外吸光度检测波长；生物学试验方法需明确浸提液获取方式：用真空泵反复加压抽取透析器内残余液体。

bjective To establish effective methods for detecting hazardous substances in dialyzers. Method  The industry-standard of hemolysis test and reducing substance assay were optimized: ①the contact time between hollow fibers and red blood cells was prolonged and a dynamic, back-and-forth sliding motion of the fibers in the erythrocyte suspension was introduced; ②the entire dialyzer was exhaustively extracted and, after extraction, fully obtain all the extraction solutions to determine the total amount of reducing substances in the device. The hemolysis rate and reducing substance content of 16 batches of dialyzers were tested by both the standard and optimized protocols; results were compared. After further refinement, the optimized methods were applied to 28 additional  batches of dialyzers to determine hemolysis rate and total reducing substances and to analyze their correlation. In addition, relevant studies on the wavelength band of the maximum absorption peak of the dialyzer extract and the appropriateness of the current extract-collection protocol in biological experiments were also conducted.  Result  The optimized hemolysis test (t=-5.987, P＜ 0.001) and reducing substance content (t=-4.601, P ＜0.001) assay demonstrated higher sensitivity than the standard protocols. With the standard methods, hemolysis rate and reducing substance content levels of the 16 batches of dialyzers were uniformly low; with the optimized methods, hemolysis rate ranged from 0.5 % to 12.2 %, and total reducing substances from 3.8 mL to 90.4 mL. For the 28 batches of dialyzers, hemolysis rate correlated positively with total reducing substances (r=0.478, P=0.013); when total reducing substances exceeded 30 mL, hemolysis rate was ≥5 %. The dialyzer extract showed maximum UV absorbance at 200 nm. After obtaining extract liquid in the common way, a substantial volume of fluid remained inside the hollow fibers.   Conclusion  ①The optimized methods for the reducing substances content and hemolysis rate are effective for quantifying hazardous components. Controlling the total amount of reducing substances can, to a certain extent, achieve the goal of limiting the content of hazardous substances.  ② Industry standard YY0053 needs to be revised: the reducing substance assay and hemolysis rate test should be tightened according to the optimized protocols mentioned in our study. the UV absorbance wavelength should be corrected; and the      extraction procedure for biological tests should specify complete removal of residual fluid from the dialyzer using repeated vacuumassisted aspiration.