YY/T 0321.3-2022 Active Industry standards-Medicine

YY/T 0321.3-2022 Single-use filter for anaesthesia

Publish Date: 2022-08-17 Implement Date: 2023-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0321.3-2022

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: 2022-08-17

Implement Date: 2023-09-01

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: 12 pages

Scope

YY/T 0321的本部分规定了一次性使用麻醉用过滤器的分类与标记、材料、物理性能、化学性能、生物性能、标志、包装、运输和贮存。
本部分适用于一次性使用麻醉用过滤器(以下简称过滤器)，是一次性使用麻醉穿刺包的部件。

Development Information

Drafting Units:

浙江伏尔特医疗器械股份有限公司、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、武汉智迅创源科技发展股份有限公司

Drafting Persons:

苏卫东、花松鹤、熊荣荣、张菁、张燕、吴其玉

Word Count: 22 Thousand words Pages: 12 pages

Same series standard

YY/T 0321.1-2022 Single-use puncture set local anaesthesia

Replace the following standards

YY 0321.3-2009 Single-use filter for anaesthesia

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods YY/T 0929.1-2014 Sterilizing-grade filters for medical infusion equipments—Part 1:Integrity test for fluid filters 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 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

Related Standards

GB/T 4506-1984 Abolished

GB/T 4506-1984 Method for the test of sharpness and strength of needles tips

Publish Date: 1984-06-22

GB/T 11751-1989 Abolished

GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension

Publish Date: 1989-10-20

GB/T 12256-1990 Abolished

GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing

Publish Date: 1990-01-08

GB/T 13074-1991 Replaced

GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration

Publish Date: 1991-07-17

GB 14232-1993 Abolished

GB 14232-1993 Bags for human blood and blood components

Publish Date: 1993-03-16

GB/T 14233.2-1993 Replaced

GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods

Publish Date: 1993-03-16