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ANNEX IIIU.K.ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS (as referred to in Article 4)

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.

Age18 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.

PlateletsPlatelet number greater than or equal to 150 × 109/l Level required for apheresis platelet donors