GB 8369.2-2020 (English Version) PDF

Scope: This part of GB8369 specifies the material, physical, chemical and biological requirements for disposable blood transfusion sets used in blood transfusion equipment that can generate pressures of 200 kPa (62 bar) and below. This section applies to single-use blood transfusion sets used in conjunction with blood and blood component containers and intravenous injection safety devices.

GB 8369.2-2020 Referenced Document

GB 14232.1 Plastics collapsible containers for human blood and blood components—Part 1: Conventional containers
GB 8369.1 Transfusion sets for single use—Part 1: Gravity feed
GB/T 14232.2 Bag plastic containers for human blood and blood components - Part 2: Graphical symbols for labeling and instructions for use
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use—Part 1: Chemical analysis methods*， 2022-10-14 Update
GB/T 14233.2 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 25915.1 Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration*， 2021-08-20 Update
GB/T 6682 Water for analytical laboratory use.Specification and test methods
ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1288 Nylon blood filter nets for transfusion equipments for single use

2020 GB 8369.2-2020 Transfusion sets for single use—Part 2: With pressure infusion apparatus use