GB 18469-2001 Quality requirements for whole blood and blood components
Some standard content:
1 Scope
National Standard of the People's Republic of China
Quality requirements for whole blood and blood components
StandardsforwhalebloodandbloodcomponentsqualityThis standard specifies the quality standards for whole blood and blood components for clinical transfusion. This standard is applicable to whole blood and blood components for clinical transfusion in China. 2 Referenced standards
GR 18469—2001
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. At the time of publication of this standard, all versions are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest version of the following standards. GB14232--1993 Disposable plastic blood bags GB 18467-2001 Requirements for health examination of blood donors YY01681994 Blood refrigerator
3 Definitions
Technical standards are used (the definitions in 14232 and the following definitions, 3.1 Preservative solution: sulphuric acid is a type of medicine with seven main components, such as anticoagulants and glucose, used to prevent blood coagulation and maintain the activity and physiological functions of various components in the blood.
3.2 Blood preparations jproduct
A homogeneous product formed by mixing a certain amount of normal human blood or blood components with a certain amount of maintenance solution. 3.3 additivesolutuon
When a certain blood product is reprocessed, a type of agent added to a blood component that can maintain the biological activity of the blood component and maintain its physiological function. 3.4whaleblood
A liquid preparation made by collecting a certain amount of human blood into a blood collection bag containing a certain amount of maintenance solution. 3.5 blood components
A blood product made by separating one or several blood components in whole blood by physical methods under certain conditions. 3.6 red blood cellscomponentsred blood cellscomponentsA type or blood with red blood cells in whole blood as the main component. 3.7concentrated red blood cells ceilsRed blood cell component prepared by separating part of the plasma from the whole blood collected in the multi-link bag under fully closed conditions and then adding red blood cell supplementation fluid to the remaining part.
3.8 Suspended red blood cells Suspcnderl red blood cells Red blood cell component prepared by separating most of the plasma from the whole blood collected in the multi-link bag under fully closed conditions and adding red blood cell supplementation fluid to the remaining part.
Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on October 22, 2001 and implemented on March 1, 2002
GB184692001
3. 9 Concentrated leukocyte-reduced red blood cells Red blood cell component prepared by removing most of the white blood cells, platelets and plasma from the whole blood collected in the multi-link bag under fully closed conditions.
3.10 Suspended leukocyte reduced red blood cells 3.11 Washed red blood cells Washrl rccl blaorl cells Wash the whole blood, concentrated red blood cells and suspended red blood cells with 0.9% physiological saline in a large amount of intravenous injection under sterile conditions to remove most of the non-red blood cells and suspend the red blood cells in 0.9% physiological saline to make the red blood cell component.
3.12 Frozen thawed deglycerolized red blood The red blood cell component blood is made by physically separating the whole blood, concentrated red blood cells and suspended red blood cell blood products stored within 6 days under aseptic conditions, adding the red blood cell protective agent glycerol and freezing at low temperature (below -65°C). The red blood cells are thawed, deglycerolized and then added to 0.9% saline for intravenous injection or frozen separated plasma. 3.13 Concentrated platelets are made by separating the platelets from the whole blood in the color-linked bag stored at room temperature under full-time closed conditions at 20°C~21°C within 6 hours after blood collection and floating them in plasma. 3.4 Fresh frozen plasma esfrplas
Blood components made by separating and freezing plasma under fully closed conditions within 6 hours (whole blood maintenance solution is ACL) or 8 hours (whole blood maintenance solution is CPI, CPDA-1) after whole blood collection: 3.15 Cryoprecipitated antihenophilic factor cryoprecipitated antihenophilic factor Fresh frozen plasma on shelf life is thawed in a closed state at 1C~6C and then separated from the cold insoluble substances precipitated in the plasma under aseptic conditions and frozen within 1 hour; 3.16 Apheresis components Blood components made by separating one or more blood components from human blood using a blood apheresis machine: 3.17 Apheresis platelets Apheresis platelets made by automatically separating platelets from whole blood under fully closed conditions using a blood apheresis machine and suspending them in quantitative plasma.
3.18 Apheresis leukucyte-reduced platelets is a blood collection component made by using a blood collection machine to automatically separate blood platelets from whole blood under fully closed conditions, filter and remove the cells, and then float them in a quantitative plasma.
3.19 Apheresis fresh frozen plasma is a blood collection machine that automatically separates plasma from whole blood under fully closed conditions and collects it within 6 hours. 3.20 Single blood component made by freezing in whole blood
3.20 Single blood component made by using a blood apheresis machine to automatically separate the granulocytes in whole blood under gold sealing conditions and suspend them in a quantitative plasma:
4 Whole blood
4.1 Label
4.1.1 Whole blood should be labeled.
4.1.2 The content printed or written on the label should be complete, clear and in a standardized format: the label should be intact. 4.1.3 The label should have the following content:
a) Name of blood product: whole blood;
b) Blood type and blood type barcode:
GB184692
c) Identification barcode or number to indicate the source of whole blood and to find related information ：d) Whole blood volume;
e) Whole blood storage conditions Stored in a 2C~6C blood cold box (the blood cold box should comply with YY0168): f) Whole blood collection period, time and collector: 8) Type of maintenance solution and shelf life: The shelf life of whole blood containing ACI>-B and CPD maintenance solution is 21 days: The shelf life of whole blood containing CPDA-1 maintenance solution is 35 days;
V) Clinical indications: Suitable for patients with anemia who need to supplement blood volume: 1) Precautions: Before infusion, please check whether the blood product packaging is intact and the appearance of the blood product is normal. Blood products that do not meet the standards should not be used clinically; shake the blood product before infusion; except for 0.9% physiological saline, blood products must not be infused with any other drugs in the same infusion set; the rate of blood products should be within 5 ml./min 15 minutes before infusion; 1) Name and license number of the blood collection and supply institution. 4.2 Appearance
Visual observation of whole blood should show no clots, no loose blood, no jaundice, no bubbles and severe chyle. The blood storage container should be intact. The blood collection tube on the blood collection bag filled with whole blood should be heat-sealed for at least 20 cm (the blood collection bag should comply with GB 14232) for clinical blood matching. 4.3 Capacity
The capacity of whole blood with ACD-B as the maintenance solution has two specifications: 250mL110%500mL±10%
The capacity of individual blood with CP1)C:P1)A-1 as the maintenance solution has two specifications: 228mL±10%456mL±10%
4.4 Hematocrit
When the whole blood maintenance solution is ACD-B, the hematocrit is ≥0.30; the whole blood maintenance solution is CPD,When the whole blood maintenance solution is ACD-B, the potassium ion concentration is ≤21mmol/L; when the whole blood maintenance solution is CFD, the potassium ion concentration is ≥27 mmol/l; when the whole blood maintenance solution is CPDA-1, the potassium ion concentration is 27.3 mmal/L. 4.7 Sodium ion concentration
When the whole blood maintenance solution is ACD)-B, the sodium ion concentration is 146 nmol/L; when the whole blood maintenance solution is CPI), the sodium ion concentration is ≥152 1IIol/L: when the whole blood maintenance solution is CPDA-1, the sodium ion concentration = 104mmol/L. 4.8 Plasma hemoglobin
When the whole blood maintenance solution is ACI)-13, plasma hemoglobin is ≤0.29g/L; when the whole blood maintenance solution is CD, plasma hemoglobin = 0. 26 /L: when the whole blood maintenance solution is (PD)A 1, plasma hemoglobin ≤0. 72 g/L. c4.9 Blood type
ABO blood type should be reverse typing, and rare blood types should comply with blood type label markings. 4.10 Hepatitis B virus surface antigen (1II3sAg) negative. 4.11 Hepatitis C virus antibody (HCV-Ab) negative4.12 HIV antibody (HIV-Ab) negative4.13
Syphilis Treponema serological test negative
4.14 Alanine aminotransferase (AI.T) normal4.15 No bacterial growth
5 Red blood cell component blood
5.1 Concentrated red blood cells
5.1.1 Label
5.1.1.1 Same as 4.1.1,
5.1.1.2 Same as 4.1.2,
5.1.1.3 The label should contain the following information:
a) Name of blood product: Concentrated red blood cells; b) Same as 4.1.3b;
c) Same as 4.1.3c;
d) Concentrated red blood cell capacity:
+) Concentrated red blood cell storage conditions: Same as 1.1.3e; GB 184692001
Date, time and collector of concentrated red blood cells; g) Type of maintenance solution and storage period: The storage period of concentrated red blood cells containing ACI-B and CPI) maintenance solution is 21 days, and the storage period of concentrated red blood cells containing CPDA-1 maintenance solution is 35 days:
h) Clinical indications: Applicable to patients with anemia; 1) Precautions: Same as 4.1.3i;
j) Same as 4.1.3j.
5.1.2 Appearance
Observe the concentrated red blood cells with naked eyes. There should be no clots, no hemolysis, no jaundice, no bubbles and severe chyle. The storage container should not be damaged and should be heat-sealed to retain at least 20 cm of the blood collection tube on the multi-link bag filled with whole blood (the multi-link bag should comply with GB14232) for clinical blood matching. 5.1.3 Capacity
The capacity of concentrated red blood cells includes two specifications: 200 ml. The capacity of concentrated red blood cells separated from whole blood: 120 ml ± 10% The capacity of concentrated red blood cells separated from 400 ml whole blood: 240 ml ± 10 pieces. 5.1.4 Hematocrit is 0.65~0.80
5.1.5 pH is 6.7~7.2.
5.1.6 Same as 4.9.
5.1.7 Same as 4,10.
5.1.8 Same as 4.11.
5.1.9 4.12
Same as 4.13.
5.1.11 Same as 4.14.
2 Same as 4.15.
5. 2 Total floating red blood cells
5.2.1 Labeling
5. 2. 1. 1 Same as 4. 1. 1
5.2. 1.2 Same as 4. 1.2.
5.2.13 The label should contain the following contents:
a) Name of blood product: Total suspended red blood cell compartment:
b) Same as 4.1.3b;
c Same as 4.1.3e:
l) Suspended red blood cell capacity:
c) Suspended red blood cell storage conditions: Same as 1.1.3c1GB 18469: 2001
) Preparation phase, time and collection period of suspended red blood cells; h) Type of additive and shelf life: The additive is MAP, SAGM, CPIDA-1, and the shelf life is 35h; The additive is AS-1, AS3, A55. The shelf life is 42h; The additive is 0.9% sodium fluoride solution, and the shelf life is 24h: h) Clinical indications: Same as 5.1.1.3h; 1) Precautions: Same as 4.1. 31
j) [Same as 4.1.31.
5.2.2 Appearance
Under naked eye observation, the suspended red blood cells should be free of clots, hemolysis, and bubbles, and the supernatant should be transparent. The storage container should not be damaged, and the multi-tube collection tube filled with whole blood should be heat-sealed to retain at least 20cm (multi-tube assembly conforming to GB14232) for clinical use. 5.2.3 Capacity: labeled volume ±10%
5.2.4 Hematocrit is 0.50 ~~ C.65, 5.2.5 Same as 4.9.
5.2.6 Same as 4.10
5.2.7 Same as 4.11,
5.2.8 Same as 4.12.
5.2.9 is the same as 4.13.
5. 2. 10 is the same as 4. 11.
5. 2. 11 is the same as 4. 15.
5.3 Concentrated leukocyte-reduced red blood cells
5.3.1 Label
5. 3. 1. 1 to 4. 1. 1
5. 3. 1. 2i 4. 1. 2.
5. 3. 1. 3 The label should contain the following information: a) Name of blood product; concentrated leukocyte-reduced red blood cells; b) Same as 4.1. 3b;
Same as 4. 1. 30:
d) Concentrated leukocyte-reduced red blood cells capacity;
e) Concentrated leukocyte-reduced red blood cells storage conditions: Same as 4.1.3c; f) Concentrated leukocyte-reduced red blood cells preparation date, time and blood collection person; g) Type of maintenance fluid, and shelf life: The maintenance fluid is ACD-B, CPI) The storage period of concentrated leukocyte-reduced red blood cells is 21 days, the storage period of concentrated oligocytic red blood cells with CPDA-1 as the maintenance solution is 35 days; h) Clinical indications: Suitable for patients with transfusion fever reactions caused by leukocyte antibodies, long-term blood transfusions and organ transplantation: 1 Note: Same as 4.1.31;
) Same as 4.1.3].
5.3.2 Appearance
Observe the concentrated leukocyte-reduced red blood cells with naked eyes. There should be no clots, no loose blood, no jaundice, no bubbles and no severe chyle. The blood storage container should be intact and should be heat-sealed to retain at least 20cm of the blood collection tube on the multi-link bag filled with blood (the multi-link bag should comply with GB14232) for clinical blood matching. 5.3.3 Capacity
GB 18469—2001
The capacity of concentrated leukocyte-reduced red blood cells includes two specifications: 200ml. The capacity of concentrated leukocyte-reduced red blood cells prepared from whole blood is 100ml. ±10%. 400ml. The capacity of concentrated leukocyte-reduced red blood cells prepared from whole blood is 200ml. ±10%. 5.3.4 Hematocrit is 0.60~0.75, 5.3.5 Residual leukocytes
Used to prevent [Cytomervirus (CMV) infection or human leukocyte antigen (HI.A) immunization: 2.5×10°/200ml whole blood preparation;
5.0×10°/400 ml. whole blood preparation. For prevention of febrile hemolytic transfusion reactions: 2.5×[0°/200ml. whole blood preparation;
≤5.0×10/400ml. whole blood preparation
5.3.6 same as 4.9,
5. 3.7 same as 4. 10,
5. 3.8 same as 4, 11,
5.3.9 same as 4, 12.
5. 3.10 same as 4. [3.
5. 3.11 same as 4. 14.
5.3.12 to 415
5.4 Suspended leukocytes and erythrocytes
5.4.1 Labeling
5.4.1.1 Same as 4.1.1,
5. 4. 1 2 to 4.1. 2,
5.4.1.3 The label should contain the following information:
a) Name of blood product: suspended oligocytic red blood cells:
b) Same as 4.1.3b;
|) Same as 4.1.3c
d) Volume of suspended oligocytic red blood cells:
e) Storage conditions of suspended oligocytic red blood cells: Same as 4.1.3e;
f) Preparation period and blood collection time of suspended oligocytic red blood cells:
g) Same as 5.2.1.3g;
h) Clinical indications:
1) Precautions: Same as 4.1.3i;
|) Same as 4.1. 3].
5.4.2 Appearance
Visual observation of suspended leukocyte-poor red blood cells: There should be no clots, no blood, no bubbles, the supernatant should be colorless and transparent, the blood storage container should not be broken, and the blood collection tube on the multi-bag filled with whole blood should be heat-sealed for at least 20cm (the multi-bag should comply with GB14232) for clinical blood matching: 5.4.3 5.2.3.
5.4. 4 Hematocrit is 0. 45-~0. 605.4. 5
5.3.5.
5.4.7 Same as 4.10.
Same as 4.11.
5.4.9 4.12.
5. 4. 10 Same as 4. 13,
5. 4. 11 Same as 4. 14.
5. 4. 12 to 4. 15.
5.5 Washing red blood cells
5.5.1 Labeling
5. 5. 1. 1 Same as 4. 1. 1.
5. 5. 1. 2 Same as 4. 1. 2.
5. 5. 1.3 The label should contain the following information;
a) Name of blood product: Washed red blood cells: b) Same as 4.1.3b#
c) Same as 4. 1. 3c;
d) Capacity of washed red blood cells;
GB 184692001
c) Storage conditions of washed red blood cells: Stored in an environment of 2 (~-6 C) Preparation date, time and preparer of washed red blood cells g) Type of total suspension and shelf life: The suspension is 0.9% normal saline for intravenous injection, with a shelf life of 24h; h) Clinical indications: Suitable for anemic patients with allergic reactions to plasma proteins or fever reactions to transfusion;) Precautions: Same as 4.1.31;
J) Same as 4.1.3.
5.5.2 Appearance
Observe washed red blood cells with naked eyes. There should be no clots or hemolysis. The supernatant should be clear and transparent. The blood container should not be damaged. The multi-bag transfer tube filled with washed red blood cells should be heat-sealed for at least 20cm (the multi-bag should comply with GB14232) for clinical blood matching. 5.5.3 Volume
The washed red blood cell volume includes two specifications: the washed red blood cell volume prepared from 200 mL whole blood is 125 ml.±10% and the washed red blood cell volume prepared from 400 mL whole blood is 250 ml.±10%. 5.5.4 Red blood cell recovery rate is 70%.
5.5.5 Leukocyte clearance rate is 280%.
Plasma protein elimination rate is 8%.
Same as 4.9.
Same as 4.10,
5. 5. 9 Same as 4-11,
Same as 4.12,
5. 5. 11 Same as 4.13
5. 6 Frozen-thawed deglycerolized red blood cells
5.6.1 Labeling
5. 6. 1. 1 Frozen-thawed deglycerolized red blood cells should be labeled and suitable for ultra-low temperature storage. 5.6.1.2 Same as 4.1.2,
5.6.1.3 The label should contain the following information:
a) Name of blood product: Frozen-thawed deglycosylated red blood cells: b) Same as 4.1.3b;
c) Same as 4.1.3c t
) Frozen-thawed deglycosylated red blood cells capacity: GB 18469--2001
e) Storage conditions and shelf life of frozen-thawed deglycerolized red blood cells: Frozen red blood cells containing 20% glycerol are stored in an environment below 120°C, and frozen red blood cells containing 40% glycerol are stored in an environment below 65°C. The shelf life is 10 years from the month of blood collection; thawed deglycerolized red blood cell suspension is stored in 0.9% physiological water for intravenous injection or plasma containing various maintenance solutions at 2°C--6°C, and the shelf life is 24 h;
f) Preparation date, time and preparer of frozen thawed deglycerol red blood cells; g) Clinical indications: Applicable to patients with rare blood types, autotransfusion and fever or allergic reactions; h) 4.1.3j.
5.6.2 Appearance
Observe the frozen thawed deglycerol red blood cells with naked eyes. There should be no clots, hemolysis, yellow bottle, bubbles and severe chyle. The supernatant should be colorless and transparent. The blood storage container should not be damaged and should be heat-sealed. The transfer tube on the multi-link bag filled with thawed red blood cells should be at least 20cm (the multi-link bag should comply with GB14232) for clinical blood matching.
5.6.3 Capacity
The capacity of thawed red blood cells includes two specifications
200 mL whole blood preparation thaw group cell capacity is 200 ml. + 10%, 400ml. The capacity of thawed red blood cells prepared by whole blood is 400mL ± 10%. 5.6.4 Red cell recovery rate 80%, residual platelets in thawed red cells 1%. Residual platelets in thawed red cells ≤ 1%, glycerol content in thawed red cells ≤ 10 g/L. 5.6.8 Free hemoglobin content in thawed red cells ≤ 1 g/L. 5.6.9 In vitro hemolysis test of thawed red cells 50%. Same as 4.9, same as 4.10. Same as 4.12. Same as 4.14. 6 Concentrated platelets 6.1 Labeling 6.1.1 Same as 4.1.1. 6.1.2 Same as 4.1.2.
6.1.3 The label should have the following content:
a) Name of blood product: concentrated platelets; b) Same as 4.1.3h:
) Week 4.1.3c:
d) Concentrated platelet capacity;
e) Concentrated platelet storage conditions: temperature 20C~24 (, vibration frequency 60 times/min, amplitude 5cm: f) Concentrated platelet preparation date, time and preparer; g) Type of maintenance fluid and shelf life: maintenance fluid is ACDB, CPD, CPDA-1; the shelf life of concentrated platelets in ordinary blood bags is 24h, and the shelf life of concentrated platelets in platelet-specific blood bags is 5 days; h) Clinical indications: Applicable to patients with bleeding caused by thrombocytopenia or dysfunction: 1) Precautions: Same as 4.1.31;
) Same as 4.1. 3].
6.2 Appearance
GB 18469-2001
Visual observation of concentrated platelets: platelets should be light yellow and cloudy, with no fibrin precipitation, no yellow or shiny bubbles and severe chyle, and the blood storage container should not be damaged. The multi-bag transfer tube filled with platelets should be kept at least 15cm (multi-bag should comply with G13 14232) for clinical use.
The capacity of concentrated platelets with a shelf life of 24h is 25~30ml./200ml. or 40ml. of whole blood preparation; the capacity of concentrated platelets with a shelf life of 5 days is 25~35iml./200ml. of whole blood preparation: 5~70 mT./400 mT. of whole blood preparation.
6.4plI is 6.0~7.4
6.5 Platelet content 21.0×10/40ml. Whole blood preparation: 22.0×10\/209L whole blood preparation. 6.6 Red blood cell volume ≤2.0×10/40cml whole blood preparation; ≤1.0X×10/200ml whole blood preparation. 6.7 Same as 4.9.
6. 8 Same as 4. 10.
6. 9 Same as 4. 11.
6.10 Same as 4.12
6. 11 Same as 4. t3,
6.12 Same as 4.14,
6.13 Same as 4.15
7 Fresh frozen plasma
7.1 Label
7.1.1 Fresh frozen plasma shall be labeled.
7.1.2 Same as 4.1.2.
7.1.3 The label shall contain the following information:
a) Name of blood product: Fresh frozen plasma; b) Same as 4.1. 3b;
:) Same as 4.1. 3:
d) Fresh frozen plasma capacity,
e) Fresh frozen plasma storage conditions: temperature below -18°C; f) Fresh frozen plasma preparation period, time change: g) Validity period: 1 year;
h) Clinical indications: Suitable for patients with coagulation factor deficiency or blood transfusion with blood disorders: [Precautions: Same as 4, 1.31
Same as 4.1.3:
7.2 Appearance
Fresh frozen plasma melted at 30 (~-37°C) should be a light yellow clear liquid with no precipitated fibrin, no yellowing, no bubbles and no severe chyle. Blood storage container There should be no rupture, and the transfer tube on the multi-bag filled with fresh frozen plasma should be heat-sealed and retained for at least 10 cm (the multi-bag should comply with (B14232) for clinical use. 7.3 Rongxing
Fresh frozen plasma capacity includes two specifications: 200ml. Fresh frozen plasma prepared from whole blood is 100mL+10%. G18469-2001
Fresh frozen plasma prepared from 400mL whole blood is 200mL±10%. 7.4 Plasma protein content of fresh frozen plasma 50g/L 7.5 Factor content of fresh frozen plasma 20.7IU/mL. 7.6 Same as 4.9.
7.7 Same as 4. 10.
7.8 Same as 4.11.
7.9 Same as 4.12.
Same as 4.13.
7.11 Same as 4.14.
Same as 4.15.
8 Cryoprecipitated coagulation factor
8.1 Label
8.1.1 Cryoprecipitated coagulation factor should be labeled as suitable for ultra-low temperature storage. 8.1.2 Same as 4.1.2.
8.1.3 The label should contain the following information:
a) Name of blood product: Cryoprecipitated coagulation factor; b) Same as 4.1. 3b
c) Same as 4.1.3c;
d) Cryoprecipitated coagulation factor capacity;
e) Storage conditions of cryoprecipitated coagulation factor: Temperature -1 or below; f) Preparation date, time and preparer of cryoprecipitated coagulation factor; g) Shelf life: 1 year from the month of preparation of fresh plasma; h) Clinical indications: Suitable for patients with fibrinogen deficiency and hemophilia A; 1) Notes: Same as 4.1.31
) 4.1.3
8.2 Appearance
Observe the cryoprecipitated coagulation factor melted at 30C~37C with naked eyes. There is no fibrin precipitation, light yellow marks, light bubbles, and no severe chyle. The blood storage container should not be damaged and should be heat-sealed to keep the blood collection bag filled with cryoprecipitated coagulation factor, and the transfer tube on it should be at least 10 cm (the blood collection bag should comply with GB14232) for clinical use.
8.3 Volume 25ml±5mL/bag
8.4 Fibrinogen content 2150mg/200ml. Fresh frozen plasma preparation; =75mg/100ml. Fresh frozen plasma preparation. 8.5 Cytokine content 80 IUI/200 mI. Fresh frozen plasma preparation 1≥40 IU/100 mE Fresh frozen plasma preparation. 8.6 Same as 4.9.
8.7 Same as 4.10 Yuan
8.8冏4.11
8.9 Same as 4.12.
8.10 Same as 4.13.
8.11 Same as 4.14.
To 4.15.
9 Single blood component donation
Single platelet donation
9.1.1 Donor conditions (should comply with GB18467) GB 18469—2001
Blood donors must not take aspirin one week before donating platelets and their platelet count must be ≥150×10/1, and their hematocrit must be 0.36. 9.1.2 Labeling
9.1.2.1 Same as 4.1.1.
9.1.2.2 Between 4.1.2,
9.1.2.3 The label should contain the following information: a) Name of blood product: Single-donor platelet:
h) Same as 4.1.3b:
c) Same as 4.1.3c::
l) Single-donor platelet volume:
e) Single-donor platelet storage conditions: Same as 6.1.3etf) Single-donor platelet collection month, time and collector g) Type of maintenance fluid and shelf life: The maintenance fluid is ACID-A; the shelf life of single-donor platelets that have been opened and (or) use ordinary blood bags is 21 hours, and the shelf life of single-donor platelets that have been placed upright and use platelet-specific blood bags is 5 hours No; h) Clinical indications: Same as 6.1.3ht
1) Precautions: Same as 4.1.31:
i) Same as 4.1.3j.
9.1.3 Appearance similar to 6.2.
9.1.4 Platelet volume
The volume of single-collected platelets with a shelf life of 24 hours is 125 ml.~-200 mL; the volume of single-collected platelets with a shelf life of 5 days is 250mL~300mL, 9.1.5 pH is 6.7~7.4.
9.1.6 Platelet content 2.6×10l/bag. 9.1.7 White blood cell mixed volume $5.0×10/bag 9.1.8 Red blood cell mixed volume ≤8.0×10/bag. 9.1.9 Same as 4.9.
Same as 4.11.
Same as 41.13.
4Same as 4.14,
To 4.15,
9.2 Leukocyte-reduced platelet apheresis
9.2.1 Conditions for blood donors
9.2.2.1 Same as 4.1.1
9.2.2.2 Same as 4.1.2.
9.2.2.3 The label shall contain the following contents:
a) Name of blood preparation: Apheresis low-leukocyte platelet;
b) Same as 4.1.3h;
c) Same as 4.1.3c;
d) Apheresis low-leukocyte platelet capacity;
c) Storage conditions of apheresis low-leukocyte platelet: Same as 6.1.3e; GB 18469 2001
) Collection period and collection time of apheresis low-leukocyte platelet;
g) Type of maintenance solution and shelf life: Same as 9.1.2.3g;
h) Clinical indications: Suitable for patients with bleeding caused by decreased platelet count or dysfunction and with transfusion fever reaction and those who need long-term or long-term platelet transfusion;
i) Precautions: Same as 4, 1.3i;
j) Same as 4.1.3i.
9.2.3 Appearance is the same as 6.2.
9.2.4 Capacity is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5 × 10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0 × 10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 To 4. 15.
9.3 Single fresh frozen plasma
9.3.1 Labeling is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: marked amount ±10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Rate 4.10.
Rate 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Granulocyte Donoration
9.4.1 Conditions of Blood Donors (Should be in accordance with GB18467) Granulocyte count of blood donors 4.0×10/L-hematocrit 0.36. Depending on the blood donor’s condition, it can be chosen whether to give blood donors corticosteroids and (or) granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Label
9.4.2.1Same as 4.1.1.
9.4.2.2Same as 4.1.2.
9.4.2.3 The label should have the following content:
a) Name of blood product: Granulocyte Donoration: b)Same as 4.1.3b;
c)Same as 4.1.3c!2 Appearance
Visual observation: Fresh frozen plasma thawed at 30 (~-37℃ should be a light yellow clear liquid with no precipitated light fibrin, no yellowing, no bubbles and no severe chyle. The blood storage container should not be broken and should be heat-sealed. The transfer tube on the multi-bag filled with fresh frozen plasma should be retained for at least 10cm (the multi-bag should comply with (B14232) for clinical use. 7.3
Fresh frozen plasma capacity includes two specifications: 200ml. Fresh frozen plasma prepared from whole blood is 100mL+10%. G18469—2001
Fresh frozen plasma prepared from 400mL whole blood is 200mL±10%. 7.4 Plasma protein content of fresh frozen plasma 50g/L 7.5 Factor content of fresh frozen plasma 20.7IU/mL. 7.6 Same as 4.9.
7.7 Same as 4. 10.
7.8 Same as 4.11.
7.9 Same as 4.12.
Same as 4.13.
7.11 Same as 4.14.
Same as 4.15.
8 Cryoprecipitated coagulation factor
8.1 Label
8.1.1 Cryoprecipitated coagulation factor should be labeled as suitable for ultra-low temperature storage. 8.1.2 Same as 4.1.2.
8.1.3 The label should contain the following information:
a) Name of blood product: Cryoprecipitated coagulation factor; b) Same as 4.1. 3b
c) Same as 4.1.3c;
d) Cryoprecipitated coagulation factor capacity;
e) Storage conditions of cryoprecipitated coagulation factor: Temperature -1 or below; f) Preparation date, time and preparer of cryoprecipitated coagulation factor; g) Shelf life: 1 year from the month of preparation of fresh plasma; h) Clinical indications: Suitable for patients with fibrinogen deficiency and hemophilia A; 1) Notes: Same as 4.1.31
) 4.1.3
8.2 Appearance
Observe the cryoprecipitated coagulation factor melted at 30C~37C with naked eyes. There is no fibrin precipitation, light yellow marks, light bubbles, and no severe chyle. The blood storage container should not be damaged and should be heat-sealed to keep the blood collection bag filled with cryoprecipitated coagulation factor, and the transfer tube on it should be at least 10 cm (the blood collection bag should comply with GB14232) for clinical use.
8.3 Volume 25ml±5mL/bag
8.4 Fibrinogen content 2150mg/200ml. Fresh frozen plasma preparation; =75mg/100ml. Fresh frozen plasma preparation. 8.5 Cytokine content 80 IUI/200 mI. Fresh frozen plasma preparation 1≥40 IU/100 mE Fresh frozen plasma preparation. 8.6 Same as 4.9.
8.7 Same as 4.10 Yuan
8.8冏4.11
8.9 Same as 4.12.
8.10 Same as 4.13.
8.11 Same as 4.14.
To 4.15.
9 Single blood component donation
Single platelet donation
9.1.1 Donor conditions (should comply with GB18467) GB 18469—2001
Blood donors must not take aspirin one week before donating platelets and their platelet count must be ≥150×10/1, and their hematocrit must be 0.36. 9.1.2 Labeling
9.1.2.1 Same as 4.1.1.
9.1.2.2 Between 4.1.2,
9.1.2.3 The label should contain the following information: a) Name of blood product: Single-donor platelet:
h) Same as 4.1.3b:
c) Same as 4.1.3c::
l) Single-donor platelet volume:
e) Single-donor platelet storage conditions: Same as 6.1.3etf) Single-donor platelet collection month, time and collector g) Type of maintenance fluid and shelf life: The maintenance fluid is ACID-A; the shelf life of single-donor platelets that have been opened and (or) use ordinary blood bags is 21 hours, and the shelf life of single-donor platelets that have been placed upright and use platelet-specific blood bags is 5 hours No; h) Clinical indications: Same as 6.1.3ht
1) Precautions: Same as 4.1.31:
i) Same as 4.1.3j.
9.1.3 Appearance similar to 6.2.
9.1.4 Platelet volume
The volume of single-collected platelets with a shelf life of 24 hours is 125 ml.~-200 mL; the volume of single-collected platelets with a shelf life of 5 days is 250mL~300mL, 9.1.5 pH is 6.7~7.4.
9.1.6 Platelet content 2.6×10l/bag. 9.1.7 White blood cell mixed volume $5.0×10/bag 9.1.8 Red blood cell mixed volume ≤8.0×10/bag. 9.1.9 Same as 4.9.
Same as 4.11.
Same as 41.13.
4Same as 4.14,
To 4.15,
9.2 Leukocyte-reduced platelet apheresis
9.2.1 Conditions for blood donors
9.2.2.1 Same as 4.1.1
9.2.2.2 Same as 4.1.2.
9.2.2.3 The label shall contain the following contents:
a) Name of blood preparation: Apheresis low-leukocyte platelet;
b) Same as 4.1.3h;
c) Same as 4.1.3c;
d) Apheresis low-leukocyte platelet capacity;
c) Storage conditions of apheresis low-leukocyte platelet: Same as 6.1.3e; GB 18469 2001
) Collection period and collection time of apheresis low-leukocyte platelet;
g) Type of maintenance solution and shelf life: Same as 9.1.2.3g;
h) Clinical indications: Suitable for patients with bleeding caused by decreased platelet count or dysfunction and with transfusion fever reaction and those who need long-term or long-term platelet transfusion;
i) Precautions: Same as 4, 1.3i;
j) Same as 4.1.3i.
9.2.3 Appearance is the same as 6.2.
9.2.4 Capacity is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5 × 10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0 × 10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 To 4. 15.
9.3 Single fresh frozen plasma
9.3.1 Labeling is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: marked amount ±10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Rate 4.10.
Rate 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Granulocyte Donoration
9.4.1 Conditions of Blood Donors (Should be in accordance with GB18467) Granulocyte count of blood donors 4.0×10/L-hematocrit 0.36. Depending on the blood donor’s condition, it can be chosen whether to give blood donors corticosteroids and (or) granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Label
9.4.2.1Same as 4.1.1.
9.4.2.2Same as 4.1.2.
9.4.2.3 The label should have the following content:
a) Name of blood product: Granulocyte Donoration: b)Same as 4.1.3b;
c)Same as 4.1.3c!2 Appearance
Visual observation: Fresh frozen plasma thawed at 30 (~-37℃ should be a light yellow clear liquid with no precipitated light fibrin, no yellowing, no bubbles and no severe chyle. The blood storage container should not be broken and should be heat-sealed. The transfer tube on the multi-bag filled with fresh frozen plasma should be retained for at least 10cm (the multi-bag should comply with (B14232) for clinical use. 7.3
Fresh frozen plasma capacity includes two specifications: 200ml. Fresh frozen plasma prepared from whole blood is 100mL+10%. G18469—2001
Fresh frozen plasma prepared from 400mL whole blood is 200mL±10%. 7.4 Plasma protein content of fresh frozen plasma 50g/L 7.5 Factor content of fresh frozen plasma 20.7IU/mL. 7.6 Same as 4.9.
7.7 Same as 4. 10.
7.8 Same as 4.11.
7.9 Same as 4.12.
Same as 4.13.
7.11 Same as 4.14.
Same as 4.15.
8 Cryoprecipitated coagulation factor
8.1 Label
8.1.1 Cryoprecipitated coagulation factor should be labeled as suitable for ultra-low temperature storage. 8.1.2 Same as 4.1.2.
8.1.3 The label should contain the following information:
a) Name of blood product: Cryoprecipitated coagulation factor; b) Same as 4.1. 3b
c) Same as 4.1.3c;
d) Cryoprecipitated coagulation factor capacity;
e) Storage conditions of cryoprecipitated coagulation factor: Temperature -1 or below; f) Preparation date, time and preparer of cryoprecipitated coagulation factor; g) Shelf life: 1 year from the month of preparation of fresh plasma; h) Clinical indications: Suitable for patients with fibrinogen deficiency and hemophilia A; 1) Notes: Same as 4.1.31
) 4.1.3
8.2 Appearance
Observe the cryoprecipitated coagulation factor melted at 30C~37C with naked eyes. There is no fibrin precipitation, light yellow marks, light bubbles, and no severe chyle. The blood storage container should not be damaged and should be heat-sealed to keep the blood collection bag filled with cryoprecipitated coagulation factor, and the transfer tube on it should be at least 10 cm (the blood collection bag should comply with GB14232) for clinical use.
8.3 Volume 25ml±5mL/bag
8.4 Fibrinogen content 2150mg/200ml. Fresh frozen plasma preparation; =75mg/100ml. Fresh frozen plasma preparation. 8.5 Cytokine content 80 IUI/200 mI. Fresh frozen plasma preparation 1≥40 IU/100 mE Fresh frozen plasma preparation. 8.6 Same as 4.9.
8.7 Same as 4.10 Yuan
8.8冏4.11
8.9 Same as 4.12.
8.10 Same as 4.13.
8.11 Same as 4.14.
To 4.15.
9 Single blood component donation
Single platelet donation
9.1.1 Donor conditions (should comply with GB18467) GB 18469—2001
Blood donors must not take aspirin one week before donating platelets and their platelet count must be ≥150×10/1, and their hematocrit must be 0.36. 9.1.2 Labeling
9.1.2.1 Same as 4.1.1.
9.1.2.2 Between 4.1.2,
9.1.2.3 The label should contain the following information: a) Name of blood product: Single-donor platelet:
h) Same as 4.1.3b:
c) Same as 4.1.3c::
l) Single-donor platelet volume:
e) Single-donor platelet storage conditions: Same as 6.1.3etf) Single-donor platelet collection month, time and collector g) Type of maintenance fluid and shelf life: The maintenance fluid is ACID-A; the shelf life of single-donor platelets that have been opened and (or) use ordinary blood bags is 21 hours, and the shelf life of single-donor platelets that have been placed upright and use platelet-specific blood bags is 5 hours No; h) Clinical indications: Same as 6.1.3ht
1) Precautions: Same as 4.1.31:
i) Same as 4.1.3j.
9.1.3 Appearance similar to 6.2.
9.1.4 Platelet volume
The volume of single-collected platelets with a shelf life of 24 hours is 125 ml.~-200 mL; the volume of single-collected platelets with a shelf life of 5 days is 250mL~300mL, 9.1.5 pH is 6.7~7.4.
9.1.6 Platelet content 2.6×10l/bag. 9.1.7 White blood cell mixed volume $5.0×10/bag 9.1.8 Red blood cell mixed volume ≤8.0×10/bag. 9.1.9 Same as 4.9.
Same as 4.11.
Same as 41.13.
4Same as 4.14,
To 4.15,
9.2 Leukocyte-reduced platelet apheresis
9.2.1 Conditions for blood donors
9.2.2.1 Same as 4.1.1
9.2.2.2 Same as 4.1.2.
9.2.2.3 The label shall contain the following contents:
a) Name of blood preparation: Apheresis low-leukocyte platelet;
b) Same as 4.1.3h;
c) Same as 4.1.3c;
d) Apheresis low-leukocyte platelet capacity;
c) Storage conditions of apheresis low-leukocyte platelet: Same as 6.1.3e; GB 18469 2001
) Collection period and collection time of apheresis low-leukocyte platelet;
g) Type of maintenance solution and shelf life: Same as 9.1.2.3g;
h) Clinical indications: Suitable for patients with bleeding caused by decreased platelet count or dysfunction and with transfusion fever reaction and those who need long-term or long-term platelet transfusion;
i) Precautions: Same as 4, 1.3i;
j) Same as 4.1.3i.
9.2.3 Appearance is the same as 6.2.
9.2.4 Capacity is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5 × 10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0 × 10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 To 4. 15.
9.3 Single fresh frozen plasma
9.3.1 Labeling is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: marked amount ±10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Rate 4.10.
Rate 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Granulocyte Donoration
9.4.1 Conditions of Blood Donors (Should be in accordance with GB18467) Granulocyte count of blood donors 4.0×10/L-hematocrit 0.36. Depending on the blood donor’s condition, it can be chosen whether to give blood donors corticosteroids and (or) granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Label
9.4.2.1Same as 4.1.1.
9.4.2.2Same as 4.1.2.
9.4.2.3 The label should have the following content:
a) Name of blood product: Granulocyte Donoration: b)Same as 4.1.3b;
c)Same as 4.1.3c!
7.9 Same as 4.12.
Same as 4.13.
7.11 Same as 4.14.
Same as 4.15.
8 Cryoprecipitated coagulation factor
8.1 Label
8.1.1 Cryoprecipitated coagulation factor should be labeled as suitable for ultra-low temperature storage. 8.1.2 Same as 4.1.2.
8.1.3 The label should contain the following information:
a) Name of blood product: Cryoprecipitated coagulation factor; b) Same as 4.1. 3b
c) Same as 4.1.3c;
d) Cryoprecipitated coagulation factor capacity;
e) Storage conditions of cryoprecipitated coagulation factor: Temperature -1 or below; f) Preparation date, time and preparer of cryoprecipitated coagulation factor; g) Shelf life: 1 year from the month of preparation of fresh plasma; h) Clinical indications: Suitable for patients with fibrinogen deficiency and hemophilia A; 1) Notes: Same as 4.1.31
) 4.1.3
8.2 Appearance
Observe the cryoprecipitated coagulation factor melted at 30C~37C with naked eyes. There is no fibrin precipitation, light yellow marks, light bubbles, and no severe chyle. The blood storage container should not be damaged and should be heat-sealed to keep the blood collection bag filled with cryoprecipitated coagulation factor, and the transfer tube on it should be at least 10 cm (the blood collection bag should comply with GB14232) for clinical use.
8.3 Volume 25ml±5mL/bag
8.4 Fibrinogen content 2150mg/200ml. Fresh frozen plasma preparation; =75mg/100ml. Fresh frozen plasma preparation. 8.5 Cytokine content 80 IUI/200 mI. Fresh frozen plasma preparation 1≥40 IU/100 mE Fresh frozen plasma preparation. 8.6 Same as 4.9.
8.7 Same as 4.10 Yuan
8.8冏4.11
8.9 Same as 4.12.
8.10 Same as 4.13.
8.11 Same as 4.14.
To 4.15.
9 Single blood component donation
Single platelet donation
9.1.1 Donor conditions (should comply with GB18467) GB 18469—2001
Blood donors must not take aspirin one week before donating platelets and their platelet count must be ≥150×10/1, and their hematocrit must be 0.36. 9.1.2 Labeling
9.1.2.1 Same as 4.1.1.
9.1.2.2 Between 4.1.2,
9.1.2.3 The label should contain the following information: a) Name of blood product: Single-donor platelet:
h) Same as 4.1.3b:
c) Same as 4.1.3c::
l) Single-donor platelet volume:
e) Single-donor platelet storage conditions: Same as 6.1.3etf) Single-donor platelet collection month, time and collector g) Type of maintenance fluid and shelf life: The maintenance fluid is ACID-A; the shelf life of single-donor platelets that have been opened and (or) use ordinary blood bags is 21 hours, and the shelf life of single-donor platelets that have been placed upright and use platelet-specific blood bags is 5 hours No; h) Clinical indications: Same as 6.1.3ht
1) Precautions: Same as 4.1.31:
i) Same as 4.1.3j.
9.1.3 Appearance similar to 6.2.
9.1.4 Platelet volume
The volume of single-collected platelets with a shelf life of 24 hours is 125 ml.~-200 mL; the volume of single-collected platelets with a shelf life of 5 days is 250mL~300mL, 9.1.5 pH is 6.7~7.4.
9.1.6 Platelet content 2.6×10l/bag. 9.1.7 White blood cell mixed volume $5.0×10/bag 9.1.8 Red blood cell mixed volume ≤8.0×10/bag. 9.1.9 Same as 4.9.
Same as 4.11.
Same as 41.13.
4Same as 4.14,
To 4.15,
9.2 Leukocyte-reduced platelet apheresis
9.2.1 Conditions for blood donors
9.2.2.1 Same as 4.1.1
9.2.2.2 Same as 4.1.2.
9.2.2.3 The label shall contain the following contents:
a) Name of blood preparation: Apheresis low-leukocyte platelet;
b) Same as 4.1.3h;
c) Same as 4.1.3c;
d) Apheresis low-leukocyte platelet capacity;
c) Storage conditions of apheresis low-leukocyte platelet: Same as 6.1.3e; GB 18469 2001
) Collection period and collection time of apheresis low-leukocyte platelet;
g) Type of maintenance solution and shelf life: Same as 9.1.2.3g;
h) Clinical indications: Suitable for patients with bleeding caused by decreased platelet count or dysfunction and with transfusion fever reaction and those who need long-term or long-term platelet transfusion;
i) Precautions: Same as 4, 1.3i;
j) Same as 4.1.3i.
9.2.3 Appearance is the same as 6.2.
9.2.4 Capacity is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5 × 10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0 × 10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 To 4. 15.
9.3 Single fresh frozen plasma
9.3.1 Labeling is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: marked amount ±10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Rate 4.10.
Rate 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Granulocyte Donoration
9.4.1 Conditions of Blood Donors (Should be in accordance with GB18467) Granulocyte count of blood donors 4.0×10/L-hematocrit 0.36. Depending on the blood donor’s condition, it can be chosen whether to give blood donors corticosteroids and (or) granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Label
9.4.2.1Same as 4.1.1.
9.4.2.2Same as 4.1.2.
9.4.2.3 The label should have the following content:
a) Name of blood product: Granulocyte Donoration: b)Same as 4.1.3b;
c)Same as 4.1.3c!
7.9 Same as 4.12.
Same as 4.13.
7.11 Same as 4.14.
Same as 4.15.
8 Cryoprecipitated coagulation factor
8.1 Label
8.1.1 Cryoprecipitated coagulation factor should be labeled as suitable for ultra-low temperature storage. 8.1.2 Same as 4.1.2.
8.1.3 The label should contain the following information:
a) Name of blood product: Cryoprecipitated coagulation factor; b) Same as 4.1. 3b
c) Same as 4.1.3c;
d) Cryoprecipitated coagulation factor capacity;
e) Storage conditions of cryoprecipitated coagulation factor: Temperature -1 or below; f) Preparation date, time and preparer of cryoprecipitated coagulation factor; g) Shelf life: 1 year from the month of preparation of fresh plasma; h) Clinical indications: Suitable for patients with fibrinogen deficiency and hemophilia A; 1) Notes: Same as 4.1.31
) 4.1.3
8.2 Appearance
Observe the cryoprecipitated coagulation factor melted at 30C~37C with naked eyes. There is no fibrin precipitation, light yellow marks, light bubbles, and no severe chyle. The blood storage container should not be damaged and should be heat-sealed to keep the blood collection bag filled with cryoprecipitated coagulation factor, and the transfer tube on it should be at least 10 cm (the blood collection bag should comply with GB14232) for clinical use.
8.3 Volume 25ml±5mL/bag
8.4 Fibrinogen content 2150mg/200ml. Fresh frozen plasma preparation; =75mg/100ml. Fresh frozen plasma preparation. 8.5 Cytokine content 80 IUI/200 mI. Fresh frozen plasma preparation 1≥40 IU/100 mE Fresh frozen plasma preparation. 8.6 Same as 4.9.
8.7 Same as 4.10 Yuan
8.8冏4.11
8.9 Same as 4.12.
8.10 Same as 4.13.
8.11 Same as 4.14.
To 4.15.
9 Single blood component donation
Single platelet donation
9.1.1 Donor conditions (should comply with GB18467) GB 18469—2001
Blood donors must not take aspirin one week before donating platelets and their platelet count must be ≥150×10/1, and their hematocrit must be 0.36. 9.1.2 Labeling
9.1.2.1 Same as 4.1.1.
9.1.2.2 Between 4.1.2,
9.1.2.3 The label should contain the following information: a) Name of blood product: Single-donor platelet:
h) Same as 4.1.3b:
c) Same as 4.1.3c::
l) Single-donor platelet volume:
e) Single-donor platelet storage conditions: Same as 6.1.3etf) Single-donor platelet collection month, time and collector g) Type of maintenance fluid and shelf life: The maintenance fluid is ACID-A; the shelf life of single-donor platelets that have been opened and (or) use ordinary blood bags is 21 hours, and the shelf life of single-donor platelets that have been placed upright and use platelet-specific blood bags is 5 hours No; h) Clinical indications: Same as 6.1.3ht
1) Precautions: Same as 4.1.31:
i) Same as 4.1.3j.
9.1.3 Appearance similar to 6.2.
9.1.4 Platelet volume
The volume of single-collected platelets with a shelf life of 24 hours is 125 ml.~-200 mL; the volume of single-collected platelets with a shelf life of 5 days is 250mL~300mL, 9.1.5 pH is 6.7~7.4.
9.1.6 Platelet content 2.6×10l/bag. 9.1.7 White blood cell mixed volume $5.0×10/bag 9.1.8 Red blood cell mixed volume ≤8.0×10/bag. 9.1.9 Same as 4.9.
Same as 4.11.
Same as 41.13.
4Same as 4.14,
To 4.15,
9.2 Leukocyte-reduced platelet apheresis
9.2.1 Conditions for blood donors
9.2.2.1 Same as 4.1.1
9.2.2.2 Same as 4.1.2.
9.2.2.3 The label shall contain the following contents:
a) Name of blood preparation: Apheresis low-leukocyte platelet;
b) Same as 4.1.3h;
c) Same as 4.1.3c;
d) Apheresis low-leukocyte platelet capacity;
c) Storage conditions of apheresis low-leukocyte platelet: Same as 6.1.3e; GB 18469 2001
) Collection period and collection time of apheresis low-leukocyte platelet;
g) Type of maintenance solution and shelf life: Same as 9.1.2.3g;
h) Clinical indications: Suitable for patients with bleeding caused by decreased platelet count or dysfunction and with transfusion fever reaction and those who need long-term or long-term platelet transfusion;
i) Precautions: Same as 4, 1.3i;
j) Same as 4.1.3i.
9.2.3 Appearance is the same as 6.2.
9.2.4 Capacity is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5 × 10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0 × 10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 To 4. 15.
9.3 Single fresh frozen plasma
9.3.1 Labeling is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: marked amount ±10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Rate 4.10.
Rate 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Granulocyte Donoration
9.4.1 Conditions of Blood Donors (Should be in accordance with GB18467) Granulocyte count of blood donors 4.0×10/L-hematocrit 0.36. Depending on the blood donor’s condition, it can be chosen whether to give blood donors corticosteroids and (or) granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Label
9.4.2.1Same as 4.1.1.
9.4.2.2Same as 4.1.2.
9.4.2.3 The label should have the following content:
a) Name of blood product: Granulocyte Donoration: b)Same as 4.1.3b;
c)Same as 4.1.3c!9.
8.7 Same as 4.10 yuan
8.8冏4.11
8.9 Same as 4.12.
8.10 Same as 4.13.
8.11 Same as 4.14.
向4.15.
9 Single blood component donation
Single platelet donation
9.1.1 Donor conditions (should comply with GB18467) GB 18469—2001
Blood donors should not take aspirin drugs one week before donating platelets and their platelet count should be ≥150×10/1 and their hematocrit should be 0.36 9.1.2 Label
9.1.2.1 Same as 4.1.1.
9.1.2.2 Between 4.1.2,
9.1.2.3 The label should contain the following information: a) Name of blood product: Single-donor platelet:
h) Same as 4.1.3b:
c) Same as 4.1.3c::
l) Single-donor platelet volume:
e) Single-donor platelet storage conditions: Same as 6.1.3etf) Single-donor platelet collection month, time and collector g) Type of maintenance fluid and shelf life: The maintenance fluid is ACID-A; the shelf life of single-donor platelets that have been opened and (or) use ordinary blood bags is 21 hours, and the shelf life of single-donor platelets that have been placed upright and use platelet-specific blood bags is 5 hours No; h) Clinical indications: Same as 6.1.3ht
1) Precautions: Same as 4.1.31:
i) Same as 4.1.3j.
9.1.3 Appearance similar to 6.2.
9.1.4 Platelet volume
The volume of single-collected platelets with a shelf life of 24 hours is 125 ml.~-200 mL; the volume of single-collected platelets with a shelf life of 5 days is 250mL~300mL, 9.1.5 pH is 6.7~7.4.
9.1.6 Platelet content 2.6×10l/bag. 9.1.7 White blood cell mixed volume $5.0×10/bag 9.1.8 Red blood cell mixed volume ≤8.0×10/bag. 9.1.9 Same as 4.9.
Same as 4.11.
Same as 41.13.
4Same as 4.14,
To 4.15,wwW.bzxz.Net
9.2 Leukocyte-reduced platelet apheresis
9.2.1 Conditions for blood donors
9.2.2.1 Same as 4.1.1
9.2.2.2 Same as 4.1.2.
9.2.2.3 The label shall contain the following contents:
a) Name of blood preparation: Apheresis low-leukocyte platelet;
b) Same as 4.1.3h;
c) Same as 4.1.3c;
d) Apheresis low-leukocyte platelet capacity;
c) Storage conditions of apheresis low-leukocyte platelet: Same as 6.1.3e; GB 18469 2001
) Collection period and collection time of apheresis low-leukocyte platelet;
g) Type of maintenance solution and shelf life: Same as 9.1.2.3g;
h) Clinical indications: Suitable for patients with bleeding caused by decreased platelet count or dysfunction and with transfusion fever reaction and those who need long-term or long-term platelet transfusion;
i) Precautions: Same as 4, 1.3i;
j) Same as 4.1.3i.
9.2.3 Appearance is the same as 6.2.
9.2.4 Capacity is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5 × 10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0 × 10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 To 4. 15.
9.3 Single fresh frozen plasma
9.3.1 Labeling is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: marked amount ±10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Rate 4.10.
Rate 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Granulocyte Donoration
9.4.1 Conditions of Blood Donors (Should be in accordance with GB18467) Granulocyte count of blood donors 4.0×10/L-hematocrit 0.36. Depending on the blood donor’s condition, it can be chosen whether to give blood donors corticosteroids and (or) granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Label
9.4.2.1Same as 4.1.1.
9.4.2.2Same as 4.1.2.
9.4.2.3 The label should have the following content:
a) Name of blood product: Granulocyte Donoration: b)Same as 4.1.3b;
c)Same as 4.1.3c!9.
8.7 Same as 4.10 yuan
8.8冏4.11
8.9 Same as 4.12.
8.10 Same as 4.13.
8.11 Same as 4.14.
向4.15.
9 Single blood component donation
Single platelet donation
9.1.1 Donor conditions (should comply with GB18467) GB 18469—2001
Blood donors should not take aspirin drugs one week before donating platelets and their platelet count should be ≥150×10/1 and their hematocrit should be 0.36 9.1.2 Label
9.1.2.1 Same as 4.1.1.
9.1.2.2 Between 4.1.2,
9.1.2.3 The label should contain the following information: a) Name of blood product: Single-donor platelet:
h) Same as 4.1.3b:
c) Same as 4.1.3c::
l) Single-donor platelet volume:
e) Single-donor platelet storage conditions: Same as 6.1.3etf) Single-donor platelet collection month, time and collector g) Type of maintenance fluid and shelf life: The maintenance fluid is ACID-A; the shelf life of single-donor platelets that have been opened and (or) use ordinary blood bags is 21 hours, and the shelf life of single-donor platelets that have been placed upright and use platelet-specific blood bags is 5 hours No; h) Clinical indications: Same as 6.1.3ht
1) Precautions: Same as 4.1.31:
i) Same as 4.1.3j.
9.1.3 Appearance similar to 6.2.
9.1.4 Platelet volume
The volume of single-collected platelets with a shelf life of 24 hours is 125 ml.~-200 mL; the volume of single-collected platelets with a shelf life of 5 days is 250mL~300mL, 9.1.5 pH is 6.7~7.4.
9.1.6 Platelet content 2.6×10l/bag. 9.1.7 White blood cell mixed volume $5.0×10/bag 9.1.8 Red blood cell mixed volume ≤8.0×10/bag. 9.1.9 Same as 4.9.
Same as 4.11.
Same as 41.13.
4Same as 4.14,
To 4.15,
9.2 Leukocyte-reduced platelet apheresis
9.2.1 Conditions for blood donors
9.2.2.1 Same as 4.1.1
9.2.2.2 Same as 4.1.2.
9.2.2.3 The label shall contain the following contents:
a) Name of blood preparation: Apheresis low-leukocyte platelet;
b) Same as 4.1.3h;
c) Same as 4.1.3c;
d) Apheresis low-leukocyte platelet capacity;
c) Storage conditions of apheresis low-leukocyte platelet: Same as 6.1.3e; GB 18469 2001
) Collection period and collection time of apheresis low-leukocyte platelet;
g) Type of maintenance solution and shelf life: Same as 9.1.2.3g;
h) Clinical indications: Suitable for patients with bleeding caused by decreased platelet count or dysfunction and with transfusion fever reaction and those who need long-term or long-term platelet transfusion;
i) Precautions: Same as 4, 1.3i;
j) Same as 4.1.3i.
9.2.3 Appearance is the same as 6.2.
9.2.4 Capacity is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5 × 10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0 × 10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 To 4. 15.
9.3 Single fresh frozen plasma
9.3.1 Labeling is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: marked amount ±10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Rate 4.10.
Rate 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Granulocyte Donoration
9.4.1 Conditions of Blood Donors (Should be in accordance with GB18467) Granulocyte count of blood donors 4.0×10/L-hematocrit 0.36. Depending on the blood donor’s condition, it can be chosen whether to give blood donors corticosteroids and (or) granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Label
9.4.2.1Same as 4.1.1.
9.4.2.2Same as 4.1.2.
9.4.2.3 The label should have the following content:
a) Name of blood product: Granulocyte Donoration: b)Same as 4.1.3b;
c)Same as 4.1.3c!2.
9.2.4 Volume is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5×10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0×10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 Same as 4. 15.
9.3 Fresh frozen plasma
9.3.1 Label is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: labeled amount ± 10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Interval 4.10.
Interval 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Apheresis
9.4.1 Conditions of blood donors (should comply with GB18467) Blood donors’ granulocyte count 4.0×10/L-hematocrit 0.36. Depending on the donor’s condition, it may be decided whether to give the donor corticosteroids and/or granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Labels
9.4.2.1Same as 4.1.1.
9.4.2.2 Same as 4.1.2.
9.4.2.3 The label should contain the following information:
a) Name of blood product: Apheresis: b) Same as 4.1.3b;
c) Same as 4.1.3c!2.
9.2.4 Volume is the same as 9.1.4,
9.2.5 pH is the same as 6.4.
Platelet content ≥ 2.5×10%/bag.
White blood cell admixture volume is 5.3.5.
Red blood cell admixture volume is ≤ 8.0×10°/bag. 9.2.9
Same as 4.11.
Contrast 4.12.
9.2.13 Same as 4.13.
9.2.14 Same as 4.14.
9.2. 15 Same as 4. 15.
9.3 Fresh frozen plasma
9.3.1 Label is the same as 7.1.
2 Appearance is the same as 7.2.
Capacity: labeled amount ± 10%.
Same as 7.4.
Same as 7.5.
Same as 4.9.
Interval 4.10.
Interval 4.31.
9.3.9Same as 4.12.
Same as 4.14,
Same as 4.15,
9.4 Apheresis
9.4.1 Conditions of blood donors (should comply with GB18467) Blood donors’ granulocyte count 4.0×10/L-hematocrit 0.36. Depending on the donor’s condition, it may be decided whether to give the donor corticosteroids and/or granulocyte colony-stimulating factor (G-CSF) 4 hours before granulocyte donation. 9.4.2 Labels
9.4.2.1Same as 4.1.1.
9.4.2.2 Same as 4.1.2.
9.4.2.3 The label should contain the following information:
a) Name of blood product: Apheresis: b) Same as 4.1.3b;
c) Same as 4.1.3c!
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