GB 2639-1990
Replaced
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
Price:
$ 24.00
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
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)
Related Standards
GB 2641-1990
Abolished
GB 2641-1990 Tube vial for antibiotic use
GB/T 2640-1990
Replaced
GB/T 2640-1990 Injection vials for antibiotics
GB 2637-1995
Replaced
GB 2637-1995 Ampoule
GB/T 12414-1995
Replaced
GB/T 12414-1995 Pharmaceutical glass tube
GB 15980-1995
Abolished