GB/T 4506-1984
Abolished
GB 8369.1-2019
Active
National standards
force_standard
GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed
GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed
Basic Information
Standard Code:
GB 8369.1-2019
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:
2021-05-01
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:
22 pages
Scope
GB 8369的本部分规定了一次性使用、重力输血式医用输血器的材料、物理、化学和生物等要求。
本部分适用于一次性使用的、与血液及血液成分容器和静脉器具配合使用的重力输血式输血器。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、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、山东新华安得医疗用品有限公司、天津哈娜好医材有限公司、江西三鑫医疗科技股份有限公司
Drafting Persons:
贾彧飞、卢文博、高亦岑、王毅、王海银、孟凯、董超群、乔春霞、朱丽、刘炳荣
Replace the following standards
Referenced Standards
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
ISO 3826-1:2013
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 14232.2-2015 Plastics collapsible containers for human blood and blood components—Part 2:Graphical symbols for use on labels and instruction leaflets
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 15811-2001 Sterile hypodermic needles for single use
GB 15811-2016 Sterile hypodermic needles 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 25915.1-2010 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness
GB/T 25915.1-2021 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness by particle concentration
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/T 1288-2015 Nylon blood filter nets for transfusion equipments for single use
GB 15811-2025 Sterile hypodermic needles 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 1135-4:2015
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