6.12 Component specifications from Directive 2004/33/EC

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These are summarised in table 6.1

Table 6.1 Summary of specifcations for blood components Directive 2004/33/EC.

This table contains the information given in annex v, para 2.4
Blood Component
Haemoglobin Haemolysis Leucocyte Content

RED CELLS: Volume
Valid for storage characteristics to maintain product within specifcations or haemoglobin and haemolysis



Red Cells

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

Not less than 43 g per unit

Red Cells, leucocytedepleted

Not less than 40 g per unit

< 1 × 106 per unit

Red Cells, in additive solution

Not less than 45 g per unit

Red Cells, buffy coatremoved, in additive solution

Not less than 43 g per unit

Red Cells, leucocyte-depleted, in additive solution
Not less than 40 g per unit

<1 × 106 per unit

Red Cells, apheresis

Not less than 40 g per unit

Whole blood Not referenced in annex V, para 2.4 of Directive 202/98 EC



PLATELETS: Volume Valid for storage characteristics to maintain product within specifcations for pH

Platelet content

pH

Leucocyte content

Platelets, apheresis

Variations permitted within limits that comply with validated preparation and preservation conditions

6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

Platelets, apheresis, leucocyte-depleted


< 1 × 106 per unit

Platelets, recovered, pooled platelet-rich plasma method


< 0,2 × 109 per single unit

Platelets, recovered, pooled buffy coat method


< 0,05 × 109 per single

Platelets, recovered, pooled, leucocyte depleted


< 1 × 106 per pool

Platelets, recovered, single unit


< 0,2 × 109 per single unit (platelet-rich plasma method)

Platelets, recovered, single unit, leucocyte depleted


< 1 × 106 per unit

PLASMA
Stated volume +/- 10 %

Factor VIIIc
Average (after freezing and thawing):

Fibrinogen

Total protein

Residual cellular content

Plasma, fresh-frozen

= / > 70 % value of the freshly collected plasma unit

Not less than 50 g/l

Red cells: < 6,0 × 109 /l Leucocytes: < 0, 1 × 109 /l Platelets: less than 50 × 109 /l




Red cells: < 6,0 × 109
/l Leucocytes: < 0,1 × 109
/l Platelets: < 50 × 109/l

Cryoprecipitate

= / > 70 international units per unit

= / > 70 140 mg per unit

GRANULOCYTES
Volume Less than 500 ml

Granulocyte content


Granulocytes, apheresis

>1 × 1010 granulocytes per unit