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

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

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

Related Standards

Contact Us