YY 0326.3-2005 Translated English of Chinese Standard. YY0326.3-2005: Plasmapheresis centrifuge apparatus for single use - Part 3: Containers for plasmahttps://www.chinesestandard.net, 2015. 5. 6. - 23페이지 This Part of YY 0326 specifies the requirements for containers for plasma used together with hemostix specified in YY 0328, plasma tubing specified in YY 0326.2 and plasma centrifuge bowl specified in YY 0326.1. The plasma collected and stored in containers for plasma specified in this Part is used to prepare blood products. It cannot be used for clinical blood transfusion. |
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100 mL DEHP according to clause Annex anticoagulant apparatus for single bacillus subtilis Batch number biological testing method clause A.3 collect plasma colorless containers for plasma control suspension cultural dish cultured cells Dibutyl phthalate dilute discrete granules endotoxin ethanol ethylene oxide residue European Pharmacopoeia evaporated residue external packaging extraction solvent Fill the container g/mL GB/T granules in cytoplasm heavy metal Hemolysis hexamethylene tetraamine solution hydrazine sulfate hydrochloric acid injection water intake tubing leach liquor liquid is deemed manufacturer Materials of containers mg/L minutes mL DEHP content mL of solution mL of test mL of water mol/L negative control nominal capacity opalescent degree Pharmacopoeia plasma with water Plasmapheresis centrifuge apparatus positive control samples prepare control solution Reagents red blood cell requirements seal sodium chloride solution sodium hydroxide soft PVC solution prepared according solvent to 100 specified in YY sterile sodium chloride Table C.1 transparent tubes with inner turbid volume fraction