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Commission Directive 2005/62/ECShow full title
Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance)
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3.PREMISES
3.1.General
Premises including mobile sites shall be adapted and maintained to suit the activities to be carried out. They shall enable the work to proceed in a logical sequence so as to minimise the risk of errors, and shall allow for effective cleaning and maintenance in order to minimise the risk of contamination.
3.2.Blood donor area
There shall be an area for confidential personal interviews with and assessment of individuals to assess their eligibility to donate. This area shall be separated from all processing areas.
3.3.Blood collection area
Blood collection shall be carried out in an area intended for the safe withdrawal of blood from donors, appropriately equipped for the initial treatment of donors experiencing adverse reactions or injuries from events associated with blood donation, and organised in such a way as to ensure the safety of both donors and personnel as well as to avoid errors in the collection procedure.
3.4.Blood testing and processing areas
There shall be a dedicated laboratory area for testing that is separate from the blood donor and blood component processing area with access restricted to authorised personnel.
3.5.Storage area
1.Storage areas shall provide for properly secure and segregated storage of different categories of blood and blood components and materials including quarantine and released materials and units of blood or blood components collected under special criteria (e.g. autologous donation).
2.Provisions shall be in place in the event of equipment or power failure in the main storage facility.
3.6.Waste disposal area
An area shall be designated for the safe disposal of waste, disposable items used during the collection, testing, and processing and for rejected blood or blood components.
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