Abstract: 【Abstract】 This paper discusses preclinical research on hemodialyzers, including standards for hemodialyzer membranes, product control, biological evaluation, process control, and allowable limits for leachable substances. This paper also analyzes the requirements for clinical research on hemodialyzers, the key points to safety and efficacy evaluation of hemodialyzers, and the common questions from clinical researches.

Key words: Preclinical research, Clinical research