GB18469-2012
Quality requirements for whole blood and blood components
全血及成分血质量要求
GB 18469-2012 is a current mandatory Chinese national standard for Quality requirements for whole blood and blood components. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jul 1, 2012.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard specifies the quality requirements for whole blood and blood components provided by general blood stations and for clinical transfusion. It is applicable to various blood products, including red blood cells, platelets, plasma, and granulocytes. Chapter 4 of this standard is mandatory, while the rest are recommended. It does not cover the labeling requirements of whole blood and blood components, which are addressed by other relevant national standards.
Technical requirements
The standard outlines comprehensive quality control parameters for a wide array of blood products. It categorizes the requirements into blood safety testing and blood quality control. For safety, it mandates correct blood typing (ABO and RhD) and negative screening results for infectious disease markers, including HIV, HBV, HCV, and Syphilis. Compliance with these safety screening protocols is strictly enforced. For quality control, the standard specifies visual appearance criteria, requiring no abnormal coloration, hemolysis, clots, or bubbles, and intact blood bags with specific minimum tubing lengths. It also defines volume tolerances based on labeled volumes or source whole blood volumes (e.g., 200mL, 300mL, 400mL specifications). Hemoglobin content and hemolysis rate at the end of storage are critical parameters for red blood cell components. Platelet components must meet specific pH levels and platelet content thresholds, while plasma products are evaluated for plasma protein content and Factor VIII content. For leukocyte-reduced components, strict limits on residual leukocyte counts are established. Manufacturers must ensure all products pass sterility tests with no bacterial growth.
Testing methods
The standard references various testing methodologies to verify compliance. Key evaluations include visual inspection for appearance, volumetric measurement, and hematological analysis for hemoglobin and hematocrit. Sterility testing is conducted to ensure no bacterial growth. For safety testing, ELISA reagents and nucleic acid detection methods are utilized for infectious disease markers. Specific assays are also required for measuring residual substances like glycerol and methylene blue in treated blood components.
FAQs
What products are regulated under GB 18469-2012?
It regulates whole blood and various blood components provided by blood stations, including concentrated red blood cells, suspended red blood cells, washed red blood cells, apheresis platelets, fresh frozen plasma, and cryoprecipitated antihemophilic factor.
Are there any updates from the previous version of GB 18469-2012?
Yes, compared to GB 18469-2001, it adds quality requirements for leukocyte-reduced whole blood, virus-inactivated fresh frozen plasma, and pooled platelets. It also modifies pH ranges for platelets and updates terminology.
Is GB 18469-2012 a mandatory standard?
Chapter 4, which covers blood safety testing requirements, is mandatory. The remaining chapters detailing quality control requirements are recommended.
The summary above provides a high-level overview of GB 18469-2012. To ensure complete compliance for your blood products and facilities entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 18469-2012 today to access all detailed parameters, tables, and testing procedures.
Applicability hints
- Type
- Health and hygiene
- CCS
- C05
- ICS
- 11.020
- Competent department
- National Health Commission
- Technical committee
- National Health Commission
Relationships
Replaces:GB 18469-2001