YY/T 0821-2022 Active Industry standards-Medicine

YY/T 0821-2022 Dispensing syringe for single use

YY/T 0821-2022 Dispensing syringe for single use

Publish Date: 2022-07-01 Implement Date: 2023-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0821-2022

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: 2022-07-01

Implement Date: 2023-07-01

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: 17 pages

Scope

本标准规定了一次性使用配药用注射器（以下简称“配药器”）的要求。
本标准适用于临床抽取或配制药液用的配药器。
本标准不适用于抽吸液体后立即注射用的手动注射器、胰岛素注射器、玻璃注射器、永久带针注射器、带有动力驱动注射泵用注射器、自毁型固定剂量疫苗注射器、防止重复使用注射器、由制造厂预装药液的注射器以及与药液配套的注射器等。本标准不涉及注射药液用过滤器。

Development Information

Drafting Units:

成都市新津事丰医疗器械有限公司、上海市医疗器械检测所、四川省医疗器械检测中心、重庆医疗器械质量检验中心、安徽天康医疗科技股份有限公司

Drafting Persons:

田兴龙、凌霞、花松鹤、王丹、杨婧、周晴、柏保东

Word Count: 32 Thousand words Pages: 17 pages

Replace the following standards

YY/T 0821-2010 Dispensing syringe for single use

Referenced Standards

GB 15810-2019 Sterile syringes for single use GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices GB 18671-2009 Intravenous needles for single use YY/T 0908-2013 Single-use filter for syringe ISO 80369-7 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 15811-2001 Sterile hypodermic needles for single use GB 15811-2016 Sterile hypodermic needles for single use YY/T 0296-1997 Hypodermic needles for single use—Colour coding for identification YY/T 0296-2013 Hypodermic needles for single use—Colour coding for identification YY/T 0296-2022 Hypodermic needles for single use—Colour coding for identification GB 15811-2025 Sterile hypodermic needles for single use

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