T/CSBME 001.4-2018 Active Group standards

T/CSBME 001.4-2018 DEHCH plasticized polyvinyl chloride(PVC)-Part 4:Hard material for medical use

T/CSBME 001.4-2018 DEHCH plasticized polyvinyl chloride(PVC)-Part 4:Hard material for medical use

Publish Date: 2018-12-20 Implement Date: 2019-03-01 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: T/CSBME 001.4-2018
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Medical materials
Publish Date: 2018-12-20
Implement Date: 2019-03-01
Pages: 16 pages

Scope

This part of T/CSBME 001 specifies the materials, technical requirements, test methods, marking, packaging, transportation, and storage of polyvinyl chloride (PVC) plasticized with diethylhexyl phthalate (DEHCH) for medical hard-wall materials. This part applies to PVC resins, DEHCH as plasticizers, and necessary additives, which are blended and modified to produce hard PVC granules, mainly used for the preparation of hard PVC granules. This part does not apply to hard PVC that comes into contact with blood solutions.

Development Information

Word Count: 20 Thousand words Pages: 16 pages

Same series standard

Referenced Standards

GB/T 1040.2-2006 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics GB/T 1043.1-2008 Plastics—Determination of charpy impact properties—Part 1:Non-instrumented impact test GB/T 1843-2008 Plastics—Determination of izod impact strength GB/T 2411-2008 Plastics and ebonite—Determination of indentation hardness by means of a durometer(shore hardness) 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 4615-2013 Poly(vinyl chloride)—Determination of residual vinyl chloride monomer—Gas-chromatographic method GB/T 6678-2003 General principles for sampling chemical products GB/T 9345.5-2010 Plastics—Determination of ash—Part 5:Poly (vinyl chloride) GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis 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 17037.1-1997 Injection moulding of test specimens of thermoplastic materials—Part 1:General principles and moulding of multipurpose and bar test specimens GB 31604.30-2016 Food Safety National Standards: Determination of Phthalates in Food Contact Materials and Products, Determination of Migration Levels 中华人民共和国药典(2015年版 四部)

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