CHAPTER I

GENERAL PROVISIONS

Definitions
Article 3
For the purposes of this Directive:
1. ‘blood’ shall mean whole blood collected from a donor and processed either for transfusion or for further manufacturing;
2. ‘blood component’ shall mean a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods;
3. ‘blood product’ shall mean any therapeutic product derived from human blood or plasma;
4. ‘autologous transfusion’ shall mean transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used;
5. ‘blood establishment’ shall mean 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;
6. ‘hospital blood bank’ shall mean 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;
7. ‘serious adverse event’ shall mean 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;
8. ‘serious adverse reaction’ shall mean 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;
9. ‘blood component release’ shall mean 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;
10. ‘deferral’ shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary;
11. ‘distribution’ shall mean 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.
12. ‘haemovigilance’ shall mean 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;
13. ‘inspection’ shall mean formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.