GB/T 15593-2020 Active National standards

GB/T 15593-2020 Plasticized poly(vinyl chloride) compounds for transfusion (infusion) equipment

GB/T 15593-2020 Plasticized poly(vinyl chloride) compounds for transfusion (infusion) equipment

Publish Date: 2020-11-19 Implement Date: 2021-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: GB/T 15593-2020
Standard Type: National standards
Standard Status: Active
is_force_gb: no
CCS Name: Synthetic resins and plastics
ICS Name: Thermoplastic plastics
Publish Date: 2020-11-19
Implement Date: 2021-10-01
Pages: 12 pages

Scope

This standard specifies the requirements, test methods, marking, packaging, transportation, and storage of polyvinyl chloride (PVC) plastic used in blood transfusion devices.
This standard applies to PVC plastics that are mainly made of polyvinyl chloride resin, and are modified by blending with dimethyl phthalate (DEHP) plasticizer, epoxy soybean oil, and/or epoxy linseed oil, as well as other necessary additives, for the manufacture of disposable blood transfusion bags, blood transfusion catheters, and accessories.

Development Information

Word Count: 22 Thousand words Pages: 12 pages

Replace the following standards

Referenced Standards

GB/T 1040.2-2006 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics GB/T 2411-2008 Plastics and ebonite—Determination of indentation hardness by means of a durometer(shore hardness) GB/T 5470-2008 Plastics—Determination of the brittleness temperature by impact GB/T 9345.5-2010 Plastics—Determination of ash—Part 5:Poly (vinyl chloride) GB 14232.1-2020 Plastics collapsible containers for human blood and blood components—Part 1:Conventional containers GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 2917.1-2002 Determination of compounds and products based on vinyl chloride homopolymers and copolymers to evolve hydrogen chloride and any other acidic products at elevoted temperatures—Congo red method 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 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

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