This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marking and operation instructions, packaging, 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.
Basic Data
Standard ID
YY 1290-2016 (YY1290-2016)
Description (Translated English)
Single use bilirubin plasma hemoperfutor
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marking and instruction manuals and packaging, transportation and storage of single-use bilirubin plasma adsorbers (hereinafter referred to as adsorbers). This standard applies to single-use bilirubin plasma adsorbent, the use of plasma separator separator and blood purification support system, the blood of hyperbilirubinemia who was drawn from the body, the plasma separator to separate the plasma, The plasma adsorption, reducing plasma bilirubin levels.
