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| Blood Component |
| Haemoglobin | Haemolysis | Leucocyte Content |
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RED CELLS: Volume
Valid for storage characteristics to maintain product within specifcations or haemoglobin and haemolysis
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Red Cells
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Not less than 45 g per unit
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Haemolysis: Less than 0.8% of red cell mass at the end of the shelf life
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Red Cells, buffy coat removed
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Not less than 43 g per unit
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Red Cells, leucocytedepleted
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Not less than 40 g per unit
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< 1 × 106 per unit
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Red Cells, in additive solution
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Not less than 45 g per unit
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Red Cells, buffy coatremoved, in additive solution
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Not less than 43 g per unit
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| Red Cells, leucocyte-depleted, in additive solution |
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Not less than 40 g per unit |
<1 × 106 per unit
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Red Cells, apheresis
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Not less than 40 g per unit
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Whole blood Not referenced in annex V, para 2.4 of Directive 202/98 EC
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PLATELETS: Volume Valid for storage characteristics to maintain product within specifcations for pH
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Platelet content
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pH
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Leucocyte content
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Platelets, apheresis
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Variations permitted within limits that comply with validated preparation and preservation conditions
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6,4 – 7,4 corrected for 22 °C, at the end of the shelf life
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Platelets, apheresis, leucocyte-depleted
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< 1 × 106 per unit
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Platelets, recovered, pooled platelet-rich plasma method
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< 0,2 × 109 per single unit
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Platelets, recovered, pooled buffy coat method
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< 0,05 × 109 per single
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Platelets, recovered, pooled, leucocyte depleted
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< 1 × 106 per pool
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Platelets, recovered, single unit
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< 0,2 × 109 per single unit (platelet-rich plasma method)
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Platelets, recovered, single unit, leucocyte depleted
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< 1 × 106 per unit
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PLASMA
Stated volume +/- 10 %
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Factor VIIIc
Average (after freezing and thawing):
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Fibrinogen
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Total protein
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Residual cellular content
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Plasma, fresh-frozen
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= / > 70 % value of the freshly collected plasma unit
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Not less than 50 g/l
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Red cells: < 6,0 × 109 /l Leucocytes: < 0, 1 × 109 /l Platelets: less than 50 × 109 /l
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Red cells: < 6,0 × 109
/l Leucocytes: < 0,1 × 109
/l Platelets: < 50 × 109/l
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Cryoprecipitate
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= / > 70 international units per unit
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= / > 70 140 mg per unit
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GRANULOCYTES
Volume Less than 500 ml
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Granulocyte content
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Granulocytes, apheresis
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>1 × 1010 granulocytes per unit
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