1. Scope
This standard specifies quality requirements for whole blood and blood components provided by general blood station and for clinical infusion.
This standard is applicable to whole blood and blood components provided by general blood station and for clinical infusion.
2. Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the editions cited apply. For undated references, the latest editions of the normative documents (including any amendments) apply.
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 specified in GB 14232.1 and those listed below apply.
3.1
Preservative solution
The medicament mainly consisting of anticoagulant and glucose and for preventing blood coagulation and maintaining activities and physiological functions of various components in blood.
3.2
Blood product
Uniform product formed by the mixture of certain amounts of blood or blood compositions of the satisfactory blood donor and certain amounts of preservative solution.
3.3
Additive solution
Foreword
1. Scope
2. Normative References
3. Terms and Definitions
4 Requirements for Blood Safety Testing
5 Blood Quality Control Requirements