T/ZSBT 001-2022
Standard for Structure and Component of Disposable Plastic Blood Bags (English Version)

Standard No.
T/ZSBT 001-2022
Language
Chinese, Available in English version
Release Date
2022
Published By
Group Standards of the People's Republic of China
Latest
T/ZSBT 001-2022
Scope
Disposable plastic blood bags and plastic blood bags containing leukocyte removal filters are made of high-grade medical-grade PVC materials for bag body membranes and hoses, and are equipped with leukocyte removal filters and different blood components suitable for application scenarios. Maintenance solution has the advantages of being suitable for blood collection and multi-component preparation and storage after light centrifugation or heavy centrifugation of blood. The blood component red blood cells can be stored for 21 days or 35 days at 2~6°C, and the plasma can be stored at low temperatures. Functional features include quick freezing at -50°C and conventional refrigeration at -20°C. Combined with the requirements of existing national standards for this type of products, the main ones are "GB14232.1-2020 Bag-type plastic containers for human blood and blood components Part 1: Traditional blood bags", "GB/T14232.3-2011 Human blood and blood components" Ingredient Bag Plastic Containers Part 3: Blood Bag Systems Containing Special Components", etc.; refer to the requirements for this type of products in Europe and the United States and other countries, mainly including EBA "Specification for Whole Blood Collection Systems including leucodepletion filters", etc., according to a survey in Zhejiang Province The status of disposable blood bags used in blood stations across the country is further refined and studied on the standardization of the structure, size, etc. of membrane bag catheters in blood collection and blood component preparation, so as to achieve the purpose of unifying operating standards and at the same time, blood Confirm and standardize the preservation solution formulas and standard requirements for different storage periods of ingredients. Domestic standards for plastic blood bag products mainly regulate the basic standards for plastic blood bag products, but have not fully verified and satisfied blood bag users; foreign standards for plastic blood bag products are more detailed and can better meet the needs of blood bag users. .

T/ZSBT 001-2022 history

  • 2022 T/ZSBT 001-2022 Standard for Structure and Component of Disposable Plastic Blood Bags
  • 2021 T/ZSBT 001-2021 Acceptance Standards for clinical blood use management in Zhejiang Province



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