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D Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Biological test: limits and methods

Test for the in vivo survival of red cells (See Item II, 4 of Annex above):

(a) Limit:

Of the erythrocytes on whole human blood with ACD anticoagulant, which has been stored for 21 days at 4-6° C, at least 70% shall have a post-transfusion survival time of 24 hours. This can be determined according to one of the methods proposed in (b) below.

(b) Suggested methods:

1. Method of ISO/TC/76/WGD/3, App. E.

2. Ashby Technique- Ashby, W. The determination of the length of life of transfused blood corpuscules in man.

J. Exp. Med. 29 : 267-82, 1919.

Young L. E., Platzer, R. F. and Rafferty, J. A. Differential agglutination of human erythrocytes. J. Lab. Clin. Med. 32 : 489-501, 1947.

3. The Gibson-Scheitlin method - Gibson, J. G. and Scheitlin, W. A. A method employing radio-active chromium for assaying the viability of human erythrocytes returned to the circulation after refrigerated storage.

J. Lab. Clin. Med. 46 : 679-88, 1955.

4. The Strumia method - Strumia, M. M., Taylor, L., Sample A. B., Colwell, L. S. and Dugan, A. Uses and limitations of survival studies of erythrocytes tagged with Cr 51.

Blood 10 : 429-40, 1955.

5. Cr51-I 12S technique - Button, L. N., Gibson, J. G. and Walter, C. W. Simultaneous determination of the volume of red cells and plasma for survival studies of stored blood.

Transfusion 5 : 143-148, 1965.

6. Recommended Method for Radioisotope Red Cell Survival Studies Brit. J. Haemat. 21 : 241, 1971.

Regeling
Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd
Soort
Verdrag
Geldend vanaf
19-04-1982
BWB-id
BWBV0002901
Versie
1982-04-19_0

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