This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marking and operation instructions, transportation and storage for single use bilirubin hemoperfutor (hereinafter referred to as hemoperfutor). This Standard applies to single use bilirubin hemoperfutor. The hemoperfutor uses plasma separator and hemopurification system to take the blood of hyperbilirubinemia patients out of their body; the plasma is separated through the plasma separator; and then plasma absorption is conducted to lower the level of bilirubin in plasma.