GB/T 4506-1984
Abolished
YY/T 0573.4-2025
Pending
Industry standards-Medicine
YY/T 0573.4-2025 Sterile hypodermic syringes for single use—Part 4:Syringes with re-use prevention feature
YY/T 0573.4-2025 Sterile hypodermic syringes for single use—Part 4:Syringes with re-use prevention feature
Basic Information
Standard Code:
YY/T 0573.4-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2025-09-15
Implement Date:
2026-10-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用注射器(针)标准化技术委员会(SAC/TC 95)
Pages:
28 pages
Scope
本文件规定了一次性防止重复使用注射器(以下简称“注射器”)的特性和性能。
本文件适用于由塑料和橡胶材料制成，带针或不带针的，用于抽吸药液或抽吸液体后立即注射用的，且设计上能够防止再次使用的一次性使用无菌注射器。
本文件不适用于玻璃制注射器、固定剂量疫苗用自毁注射器和预充型注射器。
本文件不涉及注射器与注射液的兼容性。当注射器用于本文件规定以外的任何其他预期用途时，能适用其他标准。
注：旨在降低针刺伤风险的注射器也能遵守本文件关于其防止重复使用的特性，但需要强调的是，本文件中并没有涉及注射器的防针刺伤特性。
Development Information
Drafting Units:
上海市医疗器械检验研究院、山东威高集团医用高分子制品股份有限公司、浙江康德莱医疗器械股份有限公司、浙江灵洋医疗器械有限公司、上海康德莱企业发展集团股份有限公司、江西三鑫医疗科技股份有限公司
Drafting Persons:
陆离原、王泽玮、房爱华、张谦、罗建兵、高亦岑、彭玲
Same series standard
Replace the following standards
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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 14233.2-1993 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 15810-2001 Sterile hypodermic syringes for single use
GB 15810-2019 Sterile syringes for single use
GB 15811-2016 Sterile hypodermic needles for single use
GB 18457-2001 Stainless steel needle tubing for manufacture of medical devices
GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices
GB/T 18457-2024 Stainless steel needle tubing for the manufacture of medical devices—Requirements and test methods
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
YY 0497-2005 Sterile insulin syringe for single use
YY/T 0497-2018 Sterile insulin syringe for single use
YY/T 0497-2025 Sterile insulin syringe 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 7886-4:2018
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