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
Price:
$ 36.00
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
Pages:
13 pages
Scope
This document specifies the general technical requirements for single-use blood lines products.
This document applies to single-use blood lines and the ancillary pipelines integrated with them, including liquid lines and pressure monitoring pipelines, etc. (hereinafter referred to as "blood lines").
Development Information
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