YY 0053-2008 Translated English of Chinese Standard. YY0053-2008: Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentratorshttps://www.chinesestandard.net, 2016. gada 4. marts - 23 lappuses This Standard specifies the technical requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which are used in human body. |
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According to 1.5 applicable artificial organs Assemble test circuit Biological evaluation blood and dialysate blood flow rate clearance-rate compartment of haemodiafilters concentration of blood Conduct inspection according cover the scope creatinine Declaration of sterility device identification code dialysate compartment dialysate flow rate ethylene oxide evaluation of medical extracorporeal blood line fill the blood filtrate interface following test methods GB/T haemodiafilters and haemofilters haemodialysers or haemodiafilters haemofilters and haemoconcentrators haemofilters or haemoconcentrators hemofiltration interface of haemofilters international standards inulin kPa 700 mmHg manufacturer Manufacturer’s name Measured pressure value medical devices methods and requirements model or device molar concentration myoglobin negative pressure Pharmacopoeia Pressure drop principles Conduct inspection Product specification model Product’s name provisions in Figure pyrogen free reuse Screening factors Solution concentration steps Assemble test sterile and pyrogen symbols in YY test circuit according test equipment Test solution transmembrane pressure stipulated ultrafiltration rate urea value of blood value of dialysate vitamin B12