GB/T 4506-1984
Abolished
GB 8369.2-2020
Active
National standards
force_standard
GB 8369.2-2020 Transfusion sets for single use—Part 2:With pressure infusion apparatus use
GB 8369.2-2020 Transfusion sets for single use—Part 2:With pressure infusion apparatus use
Price:
$ 59
Basic Information
Standard Code:
GB 8369.2-2020
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2020-11-17
Implement Date:
2022-06-01
Pages:
28 pages
Scope
This part of GB 8369 specifies the material, physical, chemical, and biological requirements for disposable transfusion devices used in blood transfusion equipment that can generate a pressure of 200 kPa (2 bar) or less.
This part applies to disposable transfusion devices used in pressure transfusion equipment that are compatible with containers of blood and blood components and intravenous injection devices.
Development Information
Referenced Standards
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB 14232.1-2020 Plastics collapsible containers for human blood and blood components—Part 1:Conventional containers
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
ISO 80369-7:2016
GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed
GB/T 14232.2-2015 Plastics collapsible containers for human blood and blood components—Part 2:Graphical symbols for use on labels and instruction leaflets
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 25915.1-2010 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness
GB/T 25915.1-2021 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness by particle concentration
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY/T 1288-2015 Nylon blood filter nets for transfusion equipments for single use
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
Adopt standards
ISO 1135-5:2015
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced