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GB 18469-2012: Quality requirements for whole blood and blood components
GB 18469-2012
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.020
C 05
Replacing GB 18469-2001
Quality requirements for whole blood and blood components
ISSUED ON. MAY 11, 2012
IMPLEMENTED ON. JULY 01, 2012
Issued by. Ministry of Health of the People’s Republic of China;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 6
4 Blood safety testing requirements... 11
5 Blood quality control requirements... 12
Foreword
Chapter 4 of this Standard is mandatory and the rest are recommended.
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces GB 18469-2001 Standards for whole blood and blood
components quality. Compared with GB 18469-2001, the main technical changes are
as follows.
-- Change the English name from “Standards for whole blood and blood
components quality” to “Quality requirements for whole blood and blood
components”;
-- Adjust the framework structure of the standard, by dividing the requirements
for blood into two parts. blood safety testing requirements and blood quality
control requirements;
-- Add the definitions of whole blood leukocytes reduced, frozen red blood cells,
fresh frozen plasma methylene blue treated and removed, frozen plasma and
frozen plasma cryoprecipitate reduced, frozen plasma methylene blue treated
and removed, pooled platelets, irradiated blood components and freezing;
-- Revise the definitions of blood product, blood components, red blood cells
components, apheresis components, whole blood, red blood cells, red blood
cells in additive solution, washed red blood cells, deglycerolized red blood
cells, platelets, fresh frozen plasma, cryoprecipitated antihemophilic factor,
concentrated leukocyte-reduced red blood cells, suspended leukocyte-reduced
red blood cells, apheresis platelets, apheresis leukocyte-reduced platelets,
apheresis fresh frozen plasma and apheresis granulocytes;
-- Change the name of “leukocyte-reduced blood products” in GB 18469-2001
to “blood products leukocytes reduced”;
-- Add quality requirements for whole blood leukocytes reduced, red blood cells
in additive solution leukocytes reduced, fresh frozen plasma methylene blue
treated and removed, frozen plasma and frozen plasma cryoprecipitate
reduced, frozen plasma methylene blue treated and removed and pooled
platelets;
-- Delete the relevant content of whole blood and component blood labels and
connect with other relevant national standards;
-- Add quality requirements for 300 mL whole blood and corresponding blood
components;
Quality requirements for whole blood and blood components
1 Scope
This Standard specifies the quality requirements for whole blood and blood components
provided by general blood stations and used for clinical transfusion.
This Standard applies to whole blood and blood components provided by general blood
stations and used for clinical transfusion.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 14232.1, Plastics collapsible containers for human blood and blood
components - Part 1.Conventional containers
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 14232.1 and
the following apply.
3.1
preservative solution
A class of drugs with anticoagulants, glucose, etc. as main ingredients, used to prevent
blood coagulation and maintain the activity and physiological functions of various
components in the blood.
3.2
blood product
A uniform product formed by mixing a certain amount of blood or blood components
from qualified blood donors with a certain amount of preservative solution.
3.3
additive solution
red blood cells leukocytes reduced
The red blood cells components made by using a leukocyte filter to remove almost all
leukocytes from red blood cells and making the number of leukocytes remaining in the
red blood cells lower than a certain value; or the red blood cells components made by
the remaining part after separating most of the blood plasma in the whole blood
leukocytes reduced by using a multi-unit plastics container with a leukocyte filter to
collect whole blood, and removing almost all leukocytes from the whole blood through
the leukocyte filter.
3.11
red blood cells in additive solution
The red blood cells components made by separating most of the blood plasma from the
whole blood collected in a multi-link plastics container using a specific method, and
adding red blood cell additive solution into the remainder.
3.12
red blood cells in additive solution leukocytes reduced
The red blood cells components made by using a leukocyte filter to remove almost all
leukocytes from red blood cells in additive solution and making the number of
leukocytes remaining in the red blood cells in additive solution lower than a certain
value; or the red blood cells components made by using a multi-unit plastics container
with a leukocyte filter to collect whole blood, removing almost all leukocytes from the
whole blood through the leukocyte filter, separating most of the blood plasma in the
whole blood leukocytes reduced, and adding red cell additive solution to the remainder.
3.13
washed red blood cells
The red blood cells components made by using a large amount of isotonic solution to
wash the whole blood and red blood cells in additive solution within the storage period
by a specific method to remove almost all blood plasma components and some non-red
blood cell components, and suspending the red blood cells in sodium chloride injection
or red blood cells in additive solution.
3.14
frozen red blood cells
The red blood cells components made by separating red blood cells from whole blood
or red blood cells in additive solution within 6 days of collection using a specific
method, mixing it with glycerol of a certain concentration and volume, and quickly
The blood components, in solid state by quick freezing, made by separating the blood
plasma from the whole blood which is stored in a refrigerated environment, preferably
within 6 hours (ACD as preservative solution) or 8 hours (CPD or CPDA-1 as
preservative solution) after collection, but not more than 18 hours.
3.21
fresh frozen plasma methylene blue treated and removed
The blood components, in solid state by quick freezing, made by collecting the whole
blood stored in a refrigerated environment, separating the blood plasma according to
the requirements of 3.20, and using the methylene blue virus inactivation technology
for virus inactivation before quick freezing.
3.22
apheresis fresh frozen plasma
The apheresis components made by using a blood cell separator to automatically
separate the blood plasma from the blood of qualified blood donors under fully closed
conditions and quickly freezing it into a solid state within 6 hours.
3.23
frozen plasma and frozen plasma cryoprecipitate reduced
The blood components made by separating the blood plasma from the whole blood
within the valid period by a specific method and quickly freezing it into solid state; or
the blood components made by separating th...