YY/T 1282-2022 Active Industry standards-Medicine

YY/T 1282-2022 Intravenous catheter for single use

YY/T 1282-2022 Intravenous catheter for single use

Publish Date: 2022-05-18 Implement Date: 2023-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1282-2022
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: 全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages: 21 pages

Scope

本文件规定了供插入人体的外周静脉系统输液或输血的一次性使用静脉留置针(以下简称“留置针”)的要求,以保证与相应的输液、输血器具相适应。
本文件适用于插入人体的外周静脉系统用以输液或输血的留置针。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、泰尔茂医疗产品(杭州)有限公司、碧迪医疗器械(上海)有限公司、苏州林华医疗器械股份有限公司、浙江康德莱医疗器械股份有限公司、威海洁瑞医用制品有限公司、山东新华安得医疗用品有限公司、河南驼人贝斯特医疗器械有限公司、江西三鑫医疗科技股份有限公司

Drafting Persons:

李元彧、吴力群、徐源梅、王国辉、张谦、亓晓庆、张德海、陈建胜、张菁、刘晓红、石凯

Word Count: 42 Thousand words Pages: 21 pages

Replace the following standards

Referenced Standards

GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods YY 0285.1-2017 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements YY/T 0285.5-2018 Intravascular catheters—Sterile and single-use catheters—Part 5:Over-needle peripheral catheters YY/T 0581.1-2011 Infusion access adapters—Part 1:Needle access adapters(Heparin plugs) YY/T 0581.2-2011 Infusion access adapter—Part 2:Needleless access adapters YY 0585.2-2019 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 2:Accessories ISO 23908 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 8368-1998 Infusion sets for single use GB 8368-2005 Infusion sets for single use, gravity feed GB 8368-2018 Infusion sets for single use—Gravity feed 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 GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices

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