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Commission Directive 2004/33/ECShow full title
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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Changes over time for: ANNEX IV
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ANNEX IVU.K.STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS (as referred to in Article 5)
1.STORAGEU.K.
1.1.Liquid storageU.K.
| Component | Temperature of storage | Maximum storage time |
|---|---|---|
| Red cell preparations and whole blood (if used for transfusion as whole blood) | + 2 to + 6 °C | 28 to 49 days according to the processes used for collection, processing and storage |
| Platelet preparations | + 20 to + 24 °C | 5 days; may be stored for 7 days in conjunction with detection or reduction of bacterial contamination |
| Granulocytes | + 20 to + 24 °C | 24 hours |
1.2.CryopreservationU.K.
| Component | Storage conditions and duration |
|---|---|
| Red blood cells | Up to 30 years according to processes used for collection, processing and storage |
| Platelets | Up to 24 months according to processes used for collection, processing and storage |
| Plasma and cryoprecipitate | Up to 36 months according to processes used for collection, processing and storage |
| Cryopreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allowable storage period after thawing to depend on the method used. | |
2.TRANSPORT AND DISTRIBUTIONU.K.
Transport and distribution of blood and blood components at all stages of the transfusion chain must be under conditions that maintain the integrity of the product.
3.ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONSU.K.
3.1.Autologous blood and blood components must be clearly identified as such and stored, transported and distributed separately from allogeneic blood and blood components.U.K.
3.2.Autologous blood and blood components must be labelled as required by Directive 2002/98/EC and in addition the label must include the identification of the donor and the warning ‘FOR AUTOLOGOUS TRANSFUSION ONLY’.U.K.
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