T/CSBME 001.3-2018 Active Group standards

T/CSBME 001.3-2018 DEHCH plasticized polyvinyl chloride (PVC) Part 3: Specific material for infusion and blood transfusion devices

T/CSBME 001.3-2018 DEHCH plasticized polyvinyl chloride (PVC) Part 3: Specific material for infusion and blood transfusion devices

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 001.3-2018

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 DEHCH-plasticized PVC special materials for medical infusion and transfusion devices. This part is applicable to PVC granules mainly made of PVC resin, with DEHCH as a plasticizer and necessary additives, which are blended and modified and mainly used for the preparation of infusion and transfusion devices. This part is not applicable to PVC granules used for blood bags and blood (product) storage.

Development Information

Word Count: 19 Thousand words Pages: 16 pages

Same series standard

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

Referenced Standards

GB/T 1040.3-2006 Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets 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 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 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 2639-1990 Replaced

GB 2639-1990 Glass infusion bottles

Publish Date: 1990-07-17

GB 2641-1990 Abolished

GB 2641-1990 Tube vial for antibiotic use

Publish Date: 1990-07-17

GB/T 2640-1990 Replaced

GB/T 2640-1990 Injection vials for antibiotics

Publish Date: 1990-07-17

GB 2637-1995 Replaced

GB 2637-1995 Ampoule

Publish Date: 1995-12-26

GB/T 12414-1995 Replaced

GB/T 12414-1995 Pharmaceutical glass tube

Publish Date: 1995-12-26

GB 15980-1995 Abolished

GB 15980-1995 Hygienic standard of disinfection for single use medical products

Publish Date: 1996-01-23