YY 1290-2016 Translated English of Chinese Standard. YY1290-2016: Single use bilirubin plasma hemoperfutorThis 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. |
Common terms and phrases
absorbent air about 50 batch number bilirubin and total bilirubin hemoperfutor bilirubin in plasma Biological evaluation blank control solution capacity of hemoperfutor Carry out test chamber The capacity conical flask Cytotoxicity evaluation of medical exceed heat source hemoperfutor for bilirubin hemoperfutor’s blood chamber Hemopurification Inspection rules kits and relevant manufacturer name Marking and operation medical devices methods for infusion methods GB/T name and type negative control normal saline operation instructions oscillation absorption Outer package plasma inlet-outlet plasma of total Prepared bovine plasma product name product registration number product standard number property of hemoperfutor protein absorption rate Reducing substance readily Registered diagnostic kits relevant methods Residue on evaporation Sealability single use bilirubin specified in 5.4.1 specified in 5.7 specified in Annex specified in GB/T Sterility Hemoperfutor substance readily oxidizable terms and definitions test absorption property test as specified test Carry test solution test using method total bilirubin content Total protein absorption vitro