Defined terms — Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
European Union · 32002L0098 · 264 provisions
13 defined in this instrument.
autologous transfusion — transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used (d)
blood — whole blood collected from a donor and processed either for transfusion or for further manufacturing (a)
blood component — a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods (b)
blood component release — a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification (i)
blood establishment — any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks (e)
blood product — any therapeutic product derived from human blood or plasma (c)
deferral — suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary (j)
distribution — the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion (k)
haemovigilance — a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors (l)
hospital blood bank — a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities (f)
inspection — formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems (m)
serious adverse event — any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity (g)
serious adverse reaction — an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity (h)