GB/T 4506-1984
Abolished
YY/T 0573.4-2020
Active
Industry standards-Medicine
YY/T 0573.4-2020 Sterile hypodermic syringes for single use—Part 4:Syringes with re-use prevention frature
YY/T 0573.4-2020 Sterile hypodermic syringes for single use—Part 4:Syringes with re-use prevention frature
Basic Information
Standard Code:
YY/T 0573.4-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2020-02-26
Implement Date:
2021-03-01
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:
23 pages
Scope
YY/T 0573的本部分规定了具有防止重复使用特性的一次性使用无菌注射器（以下简称注射器)的术语和定义、命名与分类、物理要求、化学要求、生物要求、包装、标志等。
本部分适用于由塑料材料制成，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，也适用于防意外针刺伤注射器的防止重复使用的性能，本部分并不涉及该类注射器的防止意外针刺损伤的性能。
本部分不适用于玻璃注射器、自毁型固定剂量疫苗注射器及预装药液的注射器。本部分中未涉及注射器与注射药液的相容性。
本部分没有规定自毁特性的设计要求。
注： 当注射器用于超出本部分规定的预期用途时，则其他标准适用。
Development Information
Drafting Units:
上海市医疗器械检测所、浙江灵洋医疗器械有限公司、安徽天康医疗科技股份有限公司
Drafting Persons:
花松鹤、罗建兵、柏保东、崇秀明
Replace the following standards
Referenced Standards
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 15811-2016 Sterile hypodermic needles for single use
GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices
GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement
GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
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
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 7886-4:2006
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