311. Regulation of the Federal Minister for health, modifies the regulation on medicinal products from human blood
On the basis of § § 5 and 62a of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by Federal Law Gazette I no. 146/2009 is prescribed:
The regulation on medicinal products from human blood, BGBl. II no 187/2005, as last amended by regulation BGBl. II No 156/2007 is amended as follows:
1. paragraph 10:
"§ 10. Through this regulation, following directives of the European communities and the European Union are implemented: 1. Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of blood and blood components and amending Directive 2001/83/EC, OJ L 33 of the 08.02.2003 S. 30;
2. Directive 2004/33/EC implementing Directive 2002/98/EC as regards certain technical requirements for blood and blood components OJ L 91 of the 30.03.2004 p. 25;
3. Directive 2005/61/EC implementing Directive 2002/98/EC as regards the requirements for traceability and the reporting of serious adverse events and serious adverse reactions, OJ L 256 of the 1 October 2005 p. 32;
4. implementing directive 2011/38/EC amending Annex V of Directive 2004/33/EC on the pH levels of platelet concentrates at the end of its shelf life, OJ "L 97 of the 12.04.2011 p. 28."
2. Annex A is as follows:
Appendix A
QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS 1 BLOOD COMPONENTS
1 red cell preparations
Under 1.1 blood components to 1.8 can be processed further in blood establishments and must be labelled accordingly.
1.1
Red blood cells
1.2
Red cells, buffy coat removed
1.3
Red cells, leucocyte-depleted
1.4
Red cells, in additive solution
1.5
Red cells, buffy coat removed, in additive solution
1.6
Red cells, leucocyte-depleted, in additive solution
1.7
Apheresis red blood cells
1.8
Whole blood
2. platelet preparations
The under 2.1 components listed up to 2.6 can be processed further in blood establishments and must be labelled accordingly.
2.1
Platelets, Apheresis
2.2
Platelets, Apheresis, leucocyte-depleted
2.3
Pool platelets, recovered
2.4
Reset won, leucocyte-depleted platelets, pool,
2.5
Platelets, recovered, single unit
2.6
Platelets, recovered, single unit, leukozytendepletiert
3. plasma preparations
The under 3.1 components listed to 3.3 can be processed further in blood establishments and must be labelled accordingly.
3.1
Fresh-frozen plasma
3.2
Fresh-frozen plasma, Cryoprecipitate
3.3
Cryoprecipitate
4.
Granulocytes, Apheresis 2. quality control for blood and blood components 2.1. blood and blood components the following technical quality measurements and acceptable results comply.
2.2. which is bacteriologically adequately to monitor extraction and production process.
2.3. for autologous donations which will be with an asterisk (*) marked measurements only recommended.
2.4. when unit is known from a donor in a loss obtained amount of blood or blood components.
Part
Quality measurements the required frequency of sampling for all measurements is required to determine on the basis of the statistical process monitoring
Acceptable results in the quality measurement
Red blood cells
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
Hemoglobin (*)
At least 45 g per unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Red cells, buffy-coatfrei
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
Hemoglobin (*)
At least 43 g per unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Red cells, leucocyte-depleted
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
Hemoglobin (*)
At least 40 g per unit
Leukocyte content
< 1 × 106/unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Red cells in additive solution
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
Hemoglobin (*)
At least 45 g per unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Red cells, buffy-coatfrei, in additive solution
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
Hemoglobin (*)
At least 43 g per unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Red cells, leucocyte-depleted, in additive solution
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
Hemoglobin (*)
At least 40 g per unit
Leukocyte content
< 1 × 106/unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Apheresis red blood cells
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
Hemoglobin (*)
At least 40 g per unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Whole blood
Volume
Depending on the storage characteristics to maintain product within specifications for Hämoglobin and haemolysis
450 ml +/-50 ml
For paediatric autologous whole blood samples - not exceed 10,5 ml per kg of body weight
Hemoglobin (*)
At least 45 g per unit
Hemolysis
Less than 0.8% of red cell mass at the end of the shelf life
Platelets, Apheresis
Volume
According to the storage characteristics to maintain product within specifications for Ph
Platelet count
Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to
pH
At least 6.4 cleans up to 22 ° C at the end of the shelf life
Platelets, Apheresis, leucocyte-depleted
Volume
According to the storage characteristics to maintain product within specifications for Ph
Platelet count
Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to
Leukocyte content
< 1 × 106/unit
pH
At least 6.4 cleans up to 22 ° C at the end of the shelf life
Pool platelets, recovered
Volume
According to the storage characteristics to maintain product within specifications for Ph
Platelet count
Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to
Leukocyte content
< 0,2 × 109/single donation (PRP method)
< 0,05 × 109/single unit (Buffy coat method)
pH
At least 6.4 cleans up to 22 ° C at the end of the shelf life
Reset won, leucocyte-depleted platelets, pool,
Volume
According to the storage characteristics to maintain product within specifications for Ph
Platelet count
Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to
Leukocyte content
< 1 × 106/pool
pH
At least 6.4 cleans up to 22 ° C at the end of the shelf life
Platelets, recovered, single unit
Volume
According to the storage characteristics to maintain product within specifications for Ph
Platelet count
Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to
Leukocyte content
< 0,2 × 109/single donation (PRP method)
< 0,05 × 109/single unit (Buffy coat method)
pH
At least 6.4 cleans up to 22 ° C at the end of the shelf life
Platelets, recovered, single unit, leukozytendepletiert
Volume
According to the storage characteristics to maintain product within specifications for Ph
Platelet count
Fluctuations in the platelet count per single donation are permitted within the limits, the validated processing and preservation conditions correspond to
Leukocyte content
< 1 × 106/unit
pH
At least 6.4 cleans up to 22 ° C at the end of the shelf life
Fresh-frozen plasma
Volume
Specified volume +/-10%
Factor VIIIc (*)
Average (after freezing and thawing): at least 70% of the value of the freshly collected plasma unit
Total protein (*)
At least 50 g / l
Remaining cells (*)
Erythrocytes: < 6.0 × 109/l
Leukocytes :< 0.1 × 109/l
Platelets: < 50 × 109/l
Fresh-frozen plasma, Cryoprecipitate
Volume
Specified volume +/-10%
Remaining cells (*)
Erythrocytes: < 6.0 × 109/l
Leukocytes :< 0.1 × 109/l
Platelets: < 50 × 109/l
Cryoprecipitate
Fibrinogen content (*)
≥ 140 mg per unit
Salary factor VIIIc (*)
≥ 70 international units/unit
Granulocytes, Apheresis
Volume
< 500 ml
Granulozytenzahl
> 1 × 1010 granulocytes per unit of sands
