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Release 1.7.16Description History

I: Preparation time

Preparation time has to be specified for plasma products. The qualifier can be applied for special products, too, if quality depends on preparation time. For any other product specify “not applicable”.
0
1.4.1
Not specified
?
for rethawed use only
1
1.4.1
Not applicable
NA
 
2
1.4.1; 1.7.4
≤ 6 hours
≤6h
for Fresh Frozen Plasma (FFP): The freezing process should commence within 6 hours and has to be completed within 1 hour. (according to the "Guide to the Preparation, Use and Quality Assurance of Blood Components").
3
1.4.1; 1.7.4
≤ 18 hours
≤18h
for Fresh Frozen Plasma (FFP):
The freezing process should commence within 18 hours.
I=3 could be used, if the freezing process is commenced within 24 hours. The plasma or whole blood, which was rapidly cool to temperatures between +20°C and +24°C immediately after donation and made of a special device validated to and to maintain the temperature in that range. According to the "Guide to the Preparation, Use and Quality Assurance of Blood Components"
4
1.4.1
> 18 hours
>18h
for Fresh Frozen Plasma (FFP): if I=2 or I=3 is not applicable
5
1.4.2; 1.7.4
≤ 24 hours
≤24h
for fractionation (K=3) only
6
1.4.2; 1.7.4
≤ 48 hours
≤48h
for fractionation (K=3) only
7
1.4.2
> 48 hours
>48h
for fractionation (K=3) only
8
1.4.2; 1.7.4
≤ 4 hours
≤4h
for fractionation (K=3) only
9
1.4.2; 1.7.4
≤ 8 hours
≤8h
depricated
10
1.4.2; 1.7.4
≤ 12 hours
≤12h
for fractionation (K=3) only

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