{
  "url": "https://openlegislation.uk/eu-decision-2011-869/annex/division-2",
  "json_url": "https://openlegislation.uk/eu-decision-2011-869/annex/division-2.json",
  "legislation": "eudn/2011/869",
  "legislation_title": "Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) (Text with EEA relevance) (2011/869/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2011-869",
  "path": "annex/division/2",
  "kind": "division",
  "number": "2",
  "heading": "The following table is added at the end of the Annex to Decision 2002/364/EC:",
  "text": "‘\nTable 11\nVariant Creutzfeldt-Jakob disease (vCJD) assays for blood screening\nMaterial\nNumber of specimens\nAcceptance Criteria\nAnalytical sensitivity\nvCJD brain spikes in human plasma (WHO reference number NHBY0/0003)\n24 replicates of each of three dilutions of the material WHO number NHBY0/0003\n(1×104, 1×105, 1×106)\n23 of the 24 replicates detected at\n1×104\nvCJD spleen spikes in human plasma (10 % spleen homogenate — NIBSC reference number NHSY0/0009)\n24 replicates of each of three dilutions of the material NIBSC number NHSY0/0009\n(1×10, 1×102, 1×103)\n23 of the 24 replicates detected at\n1×10\nDiagnostic sensitivity\nA)\nSpecimen from appropriate animal models\nAs many specimen as reasonably possible and available, and at least 10 specimens\n90 %\nB)\nSpecimen from humans with known clinical vCJD\nAs many specimen as reasonably possible and available, and at least 10 specimens\n90 %\nOnly in case where 10 specimens are not available:\nthe number of specimens tested shall be comprised between 6 and 9\nall available specimens shall be tested\nno more than one false negative result\nAnalytical specificity\nPotentially cross-reacting blood-specimens\n100\nDiagnostic specificity\nNormal human plasma samples from area of low BSE exposure\n5 000\nAt least 99,5 %\n’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2011/869/annex/division/2",
    "retrieved_at": "2026-11-01T15:15:35.673908+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."
}