GB/T 4506-1984
Abolished
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
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
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
国家药品监督管理局
Pages:
24 pages
Scope
本文件规定了针管公称外径为0.18 mm~1.2 mm 的一次性使用无菌注射针(以下简称“注射针”)的要求。
本文件适用于与GB 15810配套使用的注射针,也适合于与其他相适宜的注射器具配套使用,作为
人体皮内、皮下、肌肉、静脉等注射药液用。非灭菌状态下提供的GB 15810配套的一次性使用注射针参照使用。
本文件不适用于一次性使用牙科注射针、针式注射系统(NIS)配套使用的针、一次性使用配药用注射针。
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 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