YY 0585.1-2019 Active Industry standards-Medicine

YY 0585.1-2019 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 1:Fluid lines

Publish Date: 2019-05-31 Implement Date: 2020-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0585.1-2019

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: 2019-05-31

Implement Date: 2020-12-01

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: 12 pages

Scope

YY 0585的本部分规定了压力输液设备用一次性使用无菌液路的物理、化学和生物等要求。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、山东威高集团医用高分子制品股份有限公司、山东新华安得医疗用品有限公司、费森尤斯卡比(中国)投资有限公司

Drafting Persons:

卢文博、李未扬、孙首禹、洪梅、姚秀军

Word Count: 24 Thousand words Pages: 12 pages

Same series standard

YY 0585.2-2019 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 2:Accessories

Replace the following standards

YY 0585.1-2005 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 1:Fluid lines

Referenced Standards

中华人民共和国药典 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 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 GB 18671-2002 Intravenous needles for single use GB 18671-2009 Intravenous needles for single use 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 YY 0585.2-2005 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 2:Accessories YY 0585.2-2019 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 2:Accessories YY 0585.3-2005 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 3:Filters YY 0585.3-2018 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 3:Filters YY 1282-2016 Intravenous catheter for single use YY/T 1282-2022 Intravenous catheter for single use GB 15811-2025 Sterile hypodermic needles for single use

Adopt standards

ISO 8536-9:2015

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