Article 5.Storage, transport and distribution conditions for blood and blood components
Article 6.Quality and safety requirements for blood and blood components
1. ‘Autologous donation’ means blood and blood components collected from an...
2. ‘Allogeneic donation’ means blood and blood components collected from an...
3. ‘Validation’ means the establishment of documented and objective evidence that...
5. ‘Cryopreservation’ means prolongation of the storage life of blood components...
6. ‘Plasma’ means the liquid portion of the blood in which...
7. ‘Cryoprecipitate’ means a plasma component prepared from plasma, fresh-frozen, by...
8. ‘Washed’ means a process of removing plasma or storage medium...
10. ‘Red cells, buffy coat removed’ means the red cells from...
11. ‘Red cells, leucocyte-depleted’ means the red cells from a single...
12. ‘Red cells in additive solution’ means the red cells from...
13. ‘Additive solution’ means a solution specifically formulated to maintain beneficial...
14. ‘Red cells, buffy coat removed, in additive solution’ means the...
15. ‘Buffy coat’ means a blood component prepared by centrifugation of...
16. ‘Red cells, leucocyte-depleted, in additive solution’ means the red cells...
17. ‘Red cells, apheresis’ means the red cells from an apheresis...
18. ‘Apheresis’ means a method of obtaining one or more blood...
19. ‘Platelets, apheresis’ means a concentrated suspension of blood platelets obtained...
21. ‘Platelets, recovered, pooled’ means a concentrated suspension of blood platelets,...
22. ‘Platelets, recovered, pooled, leucocyte-depleted’ means a concentrated suspension of blood...
23. ‘Platelets, recovered, single unit’ means a concentrated suspension of blood...
24. ‘Platelets, recovered, single unit, leucocyte-depleted’ means a concentrated suspension of...
25. ‘Plasma, fresh-frozen’ means the supernatant plasma separated from a whole...
26. ‘Plasma, cryoprecipitate-depleted for transfusion’ means a plasma component prepared from...
27. ‘Granulocytes, apheresis’ means a concentrated suspension of granulocytes obtained by...
28. ‘Statistical process control’ means a method of quality control of...
PART A Information to be provided to prospective donors of blood or blood components
1. Accurate educational materials, which are understandable for members of the...
2. For both allogeneic and autologous donations, the reasons for requiring...
3. Information on the protection of personal data: no unauthorised disclosure...
4. The reasons why individuals are not to make donations which...
5. Specific information on the nature of the procedures involved either...
6. Information on the option for donors to change their mind...
7. The reasons why it is important that donors inform the...
8. Information on the responsibility of the blood establishment to inform...
9. Information why unused autologous blood and blood components will be...
10. Information that test results detecting markers for viruses, such as...
11. Information on the opportunity for donors to ask questions at...
PART B Information to be obtained from donors by blood establishments at every donation
ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS
STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS
QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
2.1. Blood and blood components must comply with the following technical...
2.2. Appropriate bacteriological control of the collection and manufacturing process must...
2.3. Member States must take all necessary measures to ensure that...
2.4. For autologous donations, the measures marked with an asterisk (*)...