GB/T 4506-1984
Abolished
GB 8368-2018
Active
National standards
force_standard
GB 8368-2018 Infusion sets for single use—Gravity feed
GB 8368-2018 Infusion sets for single use—Gravity feed
Basic Information
Standard Code:
GB 8368-2018
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:
2018-03-15
Implement Date:
2021-04-01
Pages:
25 pages
Scope
This standard specifies the marking, material, physical, chemical, and biological requirements for single-use gravity infusion pumps.
This standard applies to single-use gravity infusion pumps used in conjunction with infusion containers and venous devices.
Development Information
Replace the following standards
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
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 15811-2001 Sterile hypodermic needles for single use
GB 15811-2016 Sterile hypodermic needles for single use
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
GB 15811-2025 Sterile hypodermic needles 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 8536-4:2010
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