Art. 1 Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Whole Human Blood is blood which has been mixed with a suitable anti-coagulant, after collection from a human subject in normal health. The blood shall not be obtained from a human subject: who is known to be suffering from or to have suffered from syphilis or hepatitis, whose blood has not been tested with negative results for evidence of syphilitic infection, or who is not, as far as can be ascertained after medical examination and the study of his antecedents, free from disease transmissible by blood transfusion. The blood shall be withdrawn aseptically through a closed system of sterile tubing into a sterile container in which the anticoagulant solution has been placed before the container is sterilised. The equipment used must be pyrogen-free. When withdrawal is complete the container shall be immediately sealed and cooled to 4° to 6° C and not opened thereafter until immediately before the blood is to be used. The blood will be collected into a citrate solution of acid reaction containing dextrose. No antiseptic or bacteriostatic substance shall be added. The volume of the anticoagulant solution must not exceed 220 ml per litre of the Whole Human Blood and the haemoglobin concentration must not be less than 97 gram per litre. Blood Group - The blood group under the ABO system shall have been determined by examination of both corpuscles and serum and that under the Rh system by examination of the corpuscles, using a separate sample of the donor's blood. When there is a national standard, or nationally recommended technique of blood grouping, that technique shall be used. The term Rh negative is only to be used when specific tests have shown the absence of the antigens C, D, Du and E. All other blood must be labelled Rh positive. Blood exchange under this agreement should only be used for recipients of the corresponding ABO group. Storage - Whole human blood shall be kept in a sterile container sealed so as to exclude micro-organisms and stored at a temperature of 4° to 6° C until required for use, except during any period necessary for examination and transport at higher temperatures, any such period not to exceed thirty minutes after which the blood must immediately be cooled again to 4° to 6° C. Labelling - The label on the container shall give all the information shown on the model label (Annex 2). The Rhesus group shall be written as "Positive" or "Negative" or, in abbreviated form, "POS" or "NEG".

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