§ 864.9145. Processing system for frozen blood.
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/us/cfr/t21/s§ 864.9145·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.
(b)Classification. Class II (performance standards). [45 FR 60639, Sept. 12, 1980]