GB/T 4506-1984
Abolished
YY/T 0321.1-2022
Active
Industry standards-Medicine
YY/T 0321.1-2022 Single-use puncture set local anaesthesia
YY/T 0321.1-2022 Single-use puncture set local anaesthesia
Basic Information
Standard Code:
YY/T 0321.1-2022
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:
2022-05-18
Implement Date:
2023-06-01
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:
16 pages
Scope
YY/T 0321的本部分规定了一次性使用麻醉穿刺包的分类与标记、配置器械、物理性能、化学性能、生物性能、标志、包装、运输和贮存的要求。
本部分适用于人体硬脊膜外腔神经阻滞（简称硬膜外麻醉）、蛛网膜下腔阻滞（简称腰椎麻醉）、硬膜外和腰椎联合麻醉、神经阻滞局部麻醉的一次性使用麻醉穿刺包。
Development Information
Drafting Units:
浙江伏尔特医疗器械股份有限公司、上海埃斯埃医械塑料制品有限公司、上海市医疗器械检测所、江西洪达医疗器械集团有限公司、河南驼人医疗器械集团有限公司、贝朗医疗(上海)国际贸易有限公司
Drafting Persons:
苏卫东、孙洪荣、张彬彬、熊荣荣、刘艳红、张燕
Same series standard
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 1962.2-2001 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
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 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 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
YY 0321.2-2000 Single-use needle for anaesthesia
YY 0321.2-2009 Single-use needle for anaesthesia
YY/T 0321.2-2021 Single-use needle for anaesthesia
YY 0321.3-2000 Single-use filter for anaesthesia
YY 0321.3-2009 Single-use filter for anaesthesia
YY/T 0321.3-2022 Single-use filter for anaesthesia
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
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