GB 15811-2025
Pending
National standards
force_standard
GB 15811-2025 Sterile hypodermic needles for single use
GB 15811-2025 Sterile hypodermic needles for single use
Price:
$ 53
Basic Information
Standard Code:
GB 15811-2025
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
yes
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2025-08-29
Implement Date:
2028-09-01
Pages:
24 pages
Scope
This document specifies the requirements for disposable sterile injection needles (hereinafter referred to as "injection needles") with a nominal outer diameter of 0.18 mm to 1.2 mm.
This document applies to injection needles used in conjunction with GB 15810, and is also suitable for use with other suitable injection devices, for injecting drugs into the human body, including intradermal, subcutaneous, intramuscular, and intravenous injections. GB 15810-compatible disposable injection needles provided in a non-sterile state may also be used as a reference.
This document does not apply to disposable dental injection needles, needles used with needle injection systems (NIS), or disposable injection needles for drug preparation.
Development Information
Replace the following standards
Referenced Standards
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 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.3-2024 Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological test methods
GB 15810-2001 Sterile hypodermic syringes for single use
GB 15810-2019 Sterile syringes 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 18457-2024 Stainless steel needle tubing for the manufacture of medical devices—Requirements and test methods
GB/T 42063-2022 Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles,introducers for catheters and needles used for blood sampling
YY/T 0296-1997 Hypodermic needles for single use—Colour coding for identification
YY/T 0296-2013 Hypodermic needles for single use—Colour coding for identification
YY/T 0296-2022 Hypodermic needles for single use—Colour coding for identification
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
Related Standards
GB/T 4506-1984
Abolished
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