This part specifies the principles, test conditions, test reagents and materials, test instruments and equipment, test samples, test procedures, test data processing, test precision and measurement uncertainty, test quality assurance and control, and test results for dialyzer performance index tests. Report etc. This section applies to the test method for total solute removal of dialyzers used on humans. The applicable evaluation objects of this section are qualified dialyzer products. This standard does not apply to the evaluation of plasma separators, hemoperfusion devices (hemoperfusion devices, plasma adsorbers), hemofilters, hemodiafilters, and equipment used for continuous renal replacement therapy.
T/ZSA 96.5-2021 history
2021T/ZSA 96.5-2021 Test methods for dialyzer — Part 5: Performance parameters of total solute removal