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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)
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Under exceptional circumstances, individual donations from donors who do not comply with the following criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases must be clearly documented and subject to the quality management provisions in Articles 11, 12, and 13 of Directive 2002/98/EC.
The following criteria do not apply to autologous donations.
Haemoglobin | for females ≥ 125 g/l | for males ≥ 135 g/l | Applicable to allogeneic donors of whole blood and cellular components |
Protein | ≥ 60 g/l | The protein analysis for apheresis plasma donations must be performed at least annually |
Platelets | Platelet number greater than or equal to 150 × 109/l | Level required for apheresis platelet donors |
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