# Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance), Division 2.4 Extent: E+W+S+N.I. For autologous donations, the measures marked with an asterisk (*) are recommendations only. Component Quality measurements required The required frequency of sampling for all measurements shall be determined using statistical process control Acceptable results for quality measurements Red cells Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 45 g per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Red cells, buffy coat removed Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 43 g per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Red cells, leucocyte-depleted Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 40 g per unit Leucocyte content Less than 1 × 106 per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Red cells, in additive solution Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 45 g per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Red cells, buffy coat removed, in additive solution Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 43 g per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Red cells, leucocyte-depleted, in additive solution Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 40 g per unit Leucocyte content Less than 1 × 106 per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Red cells, apheresis Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 40 g per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Whole blood Volume Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis 450 ml +/- 50ml For paediatric autologous whole blood collections — not to exceed 10,5 ml per kg body weight Haemoglobin (*) Not less than 45 g per unit Haemolysis Less than 0,8 % of red cell mass at the end of the shelf life Platelets, apheresis Volume Valid for storage characteristics to maintain product within specifications for pH Platelet content Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions pH Minimum 6,4 corrected for 22 °C, at the end of the shelf life Platelets, apheresis, leucocyte-depleted Volume Valid for storage characteristics to maintain product within specifications for pH Platelet content Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions Leucocyte content Less than 1 × 106 per unit pH Minimum 6,4 corrected for 22 °C, at the end of the shelf life Platelets, recovered, pooled Volume Valid for storage characteristics to maintain product within specifications for pH Platelet content Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions Leucocyte content Less than 0,2 × 109 per single unit (platelet-rich plasma method) Less than 0,05 × 109 per single unit (buffy coat method) pH Minimum 6,4 corrected for 22 °C, at the end of the shelf life Platelets, recovered, pooled, leucocyte-depleted Volume Valid for storage characteristics to maintain product within specifications for pH Platelet content Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions Leucocyte content Less than 1 × 106 per pool pH Minimum 6,4 corrected for 22 °C, at the end of the shelf life Platelets, recovered, single unit Volume Valid for storage characteristics to maintain product within specifications for pH Platelet content Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions Leucocyte content Less than 0,2 × 109 per single unit (platelet-rich plasma method) Less than 0,05 × 109 per single unit (buffy coat method) pH Minimum 6,4 corrected for 22 °C, at the end of the shelf life Platelets, recovered, single unit, leucocyte-depleted Volume Valid for storage characteristics to maintain product within specifications for pH Platelet content Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions Leukocyte content Less than 1 × 106 per unit pH Minimum 6,4 corrected for 22 °C, at the end of the shelf life Plasma, fresh-frozen Volume Stated volume +/- 10 % Factor VIIIc (*) Average (after freezing and thawing): 70 % or more of the value of the freshly collected plasma unit Total protein (*) Not less than 50 g/l Residual cellular content (*) Red cells: less than 6,0 × 109/l Leucocytes: less than 0, 1 × 109/l Platelets: less than 50 × 109/l Plasma, fresh-frozen, cryoprecipitate-depleted Volume Stated volume: +/- 10 % Residual cellular content (*) Red cells: less than 6,0 × 109/l Leucocytes: less than 0,1 × 109/l Platelets: less than 50 × 109/l Cryoprecipitate Fibrinogen content (*) Greater than or equal to 140 mg per unit Factor VIIIc content (*) Greater than or equal to 70 international units per unit Granulocytes, apheresis Volume Less than 500 ml Granulocyte content Greater than 1 × 1010 granulocytes per unit --- Source: https://www.legislation.gov.uk/eudr/2004/33/annex/V/division/2/division/2.4 (the official version) Page: https://openlegislation.uk/eu-directive-2004-33/annex-V/division-2/division-2.4 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.