Sandid I
Cellule réglementation et traçabilité des produits sanguins labiles, agence française de sécurité sanitaire des produits de santé, 143-147, boulevard Anatole-France, 93285 Saint-Denis cedex, France.
Transfus Clin Biol. 2010 Dec;17(5-6):310-4. doi: 10.1016/j.tracli.2010.09.168. Epub 2010 Nov 2.
The European regulation on blood and blood components is declined in four directives: the Directive 2002/98/EC known as "mother Directive" and three directives called "daughter Directives" 2004/33/EC, 2005/61/EC and 2005/62/EC. It constitutes a common basis of provisions of quality and safety of blood in the European Union (EU), thus guaranteeing this safety and this quality with the whole of the citizens circulating in Member States of the Union. It cannot prevent a Member State for maintaining or introducing more stringent protective measures. It encourages the anonymous, voluntary and unpaid blood donations. It envisages many provisions for the prospective blood donor eligibility, the blood collection, the testing, processing, storage, transport, distribution and issuing of blood and blood components and the haemovigilance. In the field of the haemovigilance, this European regulation widened the field of competence of the national systems to the notification of serious adverse events of the transfusion chain and the serious adverse reactions, which have occurred in the blood donors. The European directives were transposed in the French national law between 2004 and 2007 by legislative and lawful ways.
被称为“母指令”的2002/98/EC号指令以及三项“子指令”，即2004/33/EC号、2005/61/EC号和2005/62/EC号指令。它构成了欧盟血液质量与安全规定的共同基础，从而保障了在欧盟成员国流动的全体公民的血液安全与质量。它并不妨碍成员国维持或引入更严格的保护措施。它鼓励匿名、自愿和无偿献血。它针对未来献血者的资格、采血、检测、加工、储存、运输、血液及血液成分的分发与发放以及血液警戒等方面设想了诸多规定。在血液警戒领域，该欧洲法规将国家系统的职权范围扩大到输血链严重不良事件以及献血者发生的严重不良反应的通报。欧洲指令于2004年至2007年间通过立法及合法途径转化为法国国内法。
