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

Publish Date: 2025-08-29 Implement Date: 2028-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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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

Word Count: 31 Thousand words Pages: 24 pages

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

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