Chabanel A, Folléa G
Rev Prat. 2001 Jun 30;51(12):1306-10.
Licensed labile blood components are put down on a regulatory list by the French Health Authority. They are prepared by the French National Blood Service and controlled according to regulatory and validated procedures. Depending on the origin of the blood, labile blood components are either homologous (donors) or autologous (from patients). Blood components (red cell concentrates, platelet concentrates and fresh frozen plasma) are processed within sterile closed disposable systems using either post-donation processing of whole blood or apheresis technology. All homologous blood components are leuco-reduced. Depending on specific settings, blood components could be washed, gamma irradiated or cryopreserved. Fresh frozen plasma is either "donor retested" after quarantine or viro-attenuated by solvent detergent treatment. Release is only allowed after a full conformity control of each blood component unit.
法国卫生当局将许可的不稳定血液成分列入监管清单。它们由法国国家血液服务机构制备,并按照监管和经过验证的程序进行控制。根据血液来源,不稳定血液成分要么是同源的(来自献血者),要么是自体的(来自患者)。血液成分(红细胞浓缩物、血小板浓缩物和新鲜冰冻血浆)在无菌封闭一次性系统中使用全血捐献后处理或单采技术进行处理。所有同源血液成分都经过白细胞滤除。根据具体情况,血液成分可进行洗涤、γ射线辐照或冷冻保存。新鲜冰冻血浆要么在检疫后进行“供体重新检测”,要么通过溶剂去污剂处理进行病毒灭活。只有在对每个血液成分单位进行全面合格控制后才允许放行。