GB/T 4506-1984
Abolished
YY/T 1617-2018
Active
Industry standards-Medicine
YY/T 1617-2018 PVC calendered film for blood bag
YY/T 1617-2018 PVC calendered film for blood bag
Basic Information
Standard Code:
YY/T 1617-2018
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:
2018-11-07
Implement Date:
2019-11-01
Pages:
8 pages
Scope
This standard specifies the technical requirements, test methods, and packaging, marking, transportation, and storage requirements for polyvinyl chloride extruded films used in blood bags (hereinafter referred to as extruded films).
This standard applies to extruded films made from a mixture of materials, the main raw material of which is medical-grade polyvinyl chloride resin, to which a certain amount of plasticizers, stabilizers, and other additives are added and then extruded.
Note: This extruded film is mainly used in traditional blood bags and platelet component storage bags.
Development Information
Referenced Standards
GB 14232.1-2004 Plastics collapsible containers for human blood and blood components-Part1:Conventional containers
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 1031-1995 Surface roughness parameters and their values
GB/T 1031-2009 Geometrical Product Specifications (GPS)—Surface texture:Profile method—Surface roughness parameters and their values
GB/T 1040.3-2006 Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets
GB/T 4615-1984 Determination method of residual vinyl chloride monomer contents in polyvinyl chloride
GB/T 4615-2008 Poly(vinyl chloride)—Determination of residual vinyl chloride monomer content—Gas chromatographic method
GB/T 4615-2013 Poly(vinyl chloride)—Determination of residual vinyl chloride monomer—Gas-chromatographic method
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/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
YY/T 1286.1-2015 Platelets storage container performances—Part 1:Determination of gas permeability of the film—Differential-pressure method
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