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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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
1.ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTSU.K.
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.
1.1.Age and body weight of donorsU.K.
Age | 18 to 65 years | |
17 to 18 years | —unless classified as a minor by law, or with written consent of parent or legal guardian in accordance with law |
First time donors over 60 years | —at the discretion of the physician in the blood establishment |
Over 65 years | —with permission of the physician in the blood establishment, given annually |
Body weight | ≥ 50 kg for donors either of whole blood or apheresis blood components |
1.2.Haemoglobin levels in donor's bloodU.K.
Haemoglobin | for females
≥ 125 g/l
| for males
≥ 135 g/l
| Applicable to allogeneic donors of whole blood and cellular components |
1.3.Protein levels in donor's bloodU.K.
Protein | ≥ 60 g/l | The protein analysis for apheresis plasma donations must be performed at least annually |
1.4.Platelet levels in donor's bloodU.K.
Platelets | Platelet number greater than or equal to 150 × 109/l | Level required for apheresis platelet donors |
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