This section specifies three test methods for solute clearance measurement, namely single clearance (in vitro) test method, single clearance (clinical) test method and fixed volume recirculation clearance (in vitro) test method. Each test method stipulates the principles, test conditions, test reagents and materials, test instruments and equipment, test samples, test steps, test data processing, test precision and measurement uncertainty, and test quality assurance of dialyzer performance index tests. and control and test reports, etc. This section is applicable to the determination of solute clearance of dialyzers used on the human body. The applicable evaluation objects of this section are qualified dialyzer products. This section does not apply to the evaluation of plasma separators, hemoperfusion devices (hemoperfusion devices, plasma adsorbers), and equipment used for continuous renal replacement therapy.
T/ZSA 96.3-2021 history
2021T/ZSA 96.3-2021 Test methods for dialyzer — Part 3:Performance parameters of clearance