GB/T 4506-1984
Abolished
GB 15810-2019
Active
National standards
force_standard
GB 15810-2019 Sterile syringes for single use
GB 15810-2019 Sterile syringes for single use
Basic Information
Standard Code:
GB 15810-2019
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2019-10-14
Implement Date:
2020-11-01
Publisher:
国家市场监督管理总局、中国国家标准化管理委员会
Technical Committee:
国家药品监督管理局
Pages:
29 pages
Scope
本标准规定了一次性使用无菌注射器(以下简称“注射器”)的命名、物理要求、化学要求、生物要求、包装、标志、贮存等。
本标准适用于供抽吸液体或抽吸液体后立即注射用的手动注射器。
本标准不适用于胰岛素注射器、玻璃注射器、永久带针注射器、带有动力驱动注射泵的注射器、自毁型固定剂量疫苗注射器、防止重复使用注射器、由制造厂预装药液的注射器以及与药液配套的注射器等。
Development Information
Drafting Units:
上海康德莱企业发展集团股份有限公司、山东威高集团医用高分子制品股份有限公司、江西洪达医疗器械集团有限公司、成都市新津事丰医疗器械有限公司、上海市医疗器械检测所
Drafting Persons:
高亦岑、夏欣瑞、李君、王海银、熊荣荣、田兴龙、丁彪、花松鹤
Replace the following standards
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
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 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 14233.2-1993 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
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
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
Adopt standards
ISO 7886-1:2017
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