{
  "url": "https://openlegislation.uk/eu-directive-2004-33/annex-V/division-2/division-2.4",
  "json_url": "https://openlegislation.uk/eu-directive-2004-33/annex-V/division-2/division-2.4.json",
  "legislation": "eudr/2004/33",
  "legislation_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)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-33",
  "path": "annex/V/division/2/division/2.4",
  "kind": "division",
  "number": "2.4",
  "heading": null,
  "text": "For autologous donations, the measures marked with an asterisk (*) are recommendations only.\nComponent\nQuality measurements required The required frequency of sampling for all measurements shall be determined using statistical process control\nAcceptable results for quality measurements\nRed cells\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\nHaemoglobin (*)\nNot less than 45 g per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nRed cells, buffy coat removed\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\nHaemoglobin (*)\nNot less than 43 g per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nRed cells, leucocyte-depleted\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\nHaemoglobin (*)\nNot less than 40 g per unit\nLeucocyte content\nLess than 1 × 106 per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nRed cells, in additive solution\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\nHaemoglobin (*)\nNot less than 45 g per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nRed cells, buffy coat removed, in additive solution\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\nHaemoglobin (*)\nNot less than 43 g per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nRed cells, leucocyte-depleted, in additive solution\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\nHaemoglobin (*)\nNot less than 40 g per unit\nLeucocyte content\nLess than 1 × 106 per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nRed cells, apheresis\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\nHaemoglobin (*)\nNot less than 40 g per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nWhole blood\nVolume\nValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis\n450 ml +/- 50ml\nFor paediatric autologous whole blood collections — not to exceed 10,5 ml per kg body weight\nHaemoglobin (*)\nNot less than 45 g per unit\nHaemolysis\nLess than 0,8 % of red cell mass at the end of the shelf life\nPlatelets, apheresis\nVolume\nValid for storage characteristics to maintain product within specifications for pH\nPlatelet content\nVariations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions\npH\nMinimum 6,4 corrected for 22 °C, at the end of the shelf life\nPlatelets, apheresis, leucocyte-depleted\nVolume\nValid for storage characteristics to maintain product within specifications for pH\nPlatelet content\nVariations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions\nLeucocyte content\nLess than 1 × 106 per unit\npH\nMinimum 6,4 corrected for 22 °C, at the end of the shelf life\nPlatelets, recovered, pooled\nVolume\nValid for storage characteristics to maintain product within specifications for pH\nPlatelet content\nVariations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions\nLeucocyte content\nLess than 0,2 × 109 per single unit (platelet-rich plasma method)\nLess than 0,05 × 109 per single unit (buffy coat method)\npH\nMinimum 6,4 corrected for 22 °C, at the end of the shelf life\nPlatelets, recovered, pooled, leucocyte-depleted\nVolume\nValid for storage characteristics to maintain product within specifications for pH\nPlatelet content\nVariations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions\nLeucocyte content\nLess than 1 × 106 per pool\npH\nMinimum 6,4 corrected for 22 °C, at the end of the shelf life\nPlatelets, recovered, single unit\nVolume\nValid for storage characteristics to maintain product within specifications for pH\nPlatelet content\nVariations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions\nLeucocyte content\nLess than 0,2 × 109 per single unit (platelet-rich plasma method)\nLess than 0,05 × 109 per single unit (buffy coat method)\npH\nMinimum 6,4 corrected for 22 °C, at the end of the shelf life\nPlatelets, recovered, single unit, leucocyte-depleted\nVolume\nValid for storage characteristics to maintain product within specifications for pH\nPlatelet content\nVariations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions\nLeukocyte content\nLess than 1 × 106 per unit\npH\nMinimum 6,4 corrected for 22 °C, at the end of the shelf life\nPlasma, fresh-frozen\nVolume\nStated volume +/- 10 %\nFactor VIIIc (*)\nAverage (after freezing and thawing): 70 % or more of the value of the freshly collected plasma unit\nTotal protein (*)\nNot less than 50 g/l\nResidual cellular content (*)\nRed cells: less than 6,0 × 109/l\nLeucocytes: less than 0, 1 × 109/l\nPlatelets: less than 50 × 109/l\nPlasma, fresh-frozen, cryoprecipitate-depleted\nVolume\nStated volume: +/- 10 %\nResidual cellular content (*)\nRed cells: less than 6,0 × 109/l\nLeucocytes: less than 0,1 × 109/l\nPlatelets: less than 50 × 109/l\nCryoprecipitate\nFibrinogen content (*)\nGreater than or equal to 140 mg per unit\nFactor VIIIc content (*)\nGreater than or equal to 70 international units per unit\nGranulocytes, apheresis\nVolume\nLess than 500 ml\nGranulocyte content\nGreater than 1 × 1010 granulocytes per unit",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2004/33/annex/V/division/2/division/2.4",
    "retrieved_at": "2026-11-01T15:22:49.438638+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}