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

Publish Date: 2018-11-07 Implement Date: 2019-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 12 Thousand words Pages: 8 pages

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

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