YY 0053-2016 Translated English of Chinese Standard. YY0053-2016: Hemodialysis and Relevant Therapies - Haemodialysers, Haemodiafilters, Haemofilters and HaemoconcentratorsThis Standard specifies the technical requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcenrators used for human body; the instruments involved in this document indicate the above-mentioned products. |
Common terms and phrases
anticoagulated bovine blood anticoagulated bovine plasma Biological evaluation blood and dialysate blood and filtrate Blood chamber interface Blood chamber pressure Blood chamber volume Blood Inlet blood pBI blood with protein buffer solution chamber pressure drop circulation blood line clearance rate concentration of 60g/L±5g/L Creatinine Dialysate space interface ethylene oxide extracorporeal circulation blood filtrate interface flow rate GB/T haemodiafilters and haemofilters haemodialysers and haemodiafilters haemofilters and haemoconcentrators hematocrit hemofiltration Instructions for single instrument identification code interface of haemoconcentrators interface of haemodialysers interface of haemofilters liquid enters manufacturer instrument identification maximum transmembrane pressure measure the pressure meet the requirements membrane non-pyrogen declaration phosphate PRC pharmacopoeia pressure value Product name Production batch number protein concentration provisions of Figure rate of blood screening coefficient solution concentration specification and model Standard and ISO sterile and non-pyrogen Sterilization method symbols in YY/T Technical Differences test methods test solution transmembrane pressure specified ultrafiltration rate Urea Valid period Vitamin B12