YY/T 0321.2-2021 Active Industry standards-Medicine

YY/T 0321.2-2021 Single-use needle for anaesthesia

YY/T 0321.2-2021 Single-use needle for anaesthesia

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0321.2-2021
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: 2021-03-09
Implement Date: 2022-04-01
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: 15 pages

Scope

YY 0321的本部分规定了公称外径为0.4 mm~2.1 mm的一次性使用麻醉用针的分类与标记、材料、物理性能、化学性能、生物性能、标志、包装、运输和贮存。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、神经阻滞局部麻醉时进行穿刺、注射药物的一次性使用麻醉用针。

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、浙江康德莱医疗器械股份有限公司、贝朗医疗(上海)国际贸易有限公司

Drafting Persons:

苏卫东、孙洪荣、花松鹤、熊荣荣、刘艳红、张谦、张燕

Word Count: 28 Thousand words Pages: 15 pages

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 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/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

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