GB/T 4506-1984
Abolished
GB/T 19335-2022
Active
National standards
GB/T 19335-2022 Blood flow products for single use—General specification
GB/T 19335-2022 Blood flow products for single use—General specification
Basic Information
Standard Code:
GB/T 19335-2022
Standard Type:
National 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:
2022-04-15
Implement Date:
2023-05-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
13 pages
Scope
本文件规定了一次性使用血路产品的通用技术条件。
本文件适用于一次性使用血路以及与其连为一体的附属管路,包括液路和压力监测管路等组成的产品(以下简称“血路”)。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、苏州百特医疗用品有限公司、山东中保康医疗器具有限公司、费森尤斯卡比(中国)投资有限公司、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
Drafting Persons:
张博、许凯、吴淼、巩家富、洪梅、余克龙、李未扬、李松华、郝树彬、赵增琳
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
YY/T 1288-2015 Nylon blood filter nets for transfusion equipments for single use
ISO 18250-8:2018
ISO 80369-7
GB 8369-1998 Transfusion sets for single use
GB 8369-2005 Transfusion sets for single use
GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed
GB 8369.2-2020 Transfusion sets for single use—Part 2:With pressure infusion apparatus use
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/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 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
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/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
YY/T 0923-2014 Needleless access ports for fluid lines and blood lines—Test method for microbial ingress
YY/T 0923-2024 Test method for microbial ingress on infusion access adapters for fluid lines and blood lines
YY/T 1556-2017 Test methods for particle contamination of infusion,transfusion and injection equipments for medical use
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
YY/T 0581.2-2024 Infusion access adapter—Part 2:Needleless access adapters
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced