GB/T 15593-2020 Active National standards

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

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

Publisher: 国家市场监督管理总局、国家标准化管理委员会

Technical Committee: 全国塑料标准化技术委员会(SAC/TC 15)

Pages: 12 pages

Scope

本标准规定了输血(液)器具用聚氯乙烯塑料(以下简称“PVC塑料”)的要求、试验方法、标志、包装、运输和贮存。
本标准适用于以聚氯乙烯树脂为主体，采用邻苯二甲酸二(2-乙基己)酯(DEHP)增塑剂以及环氧大豆油和/或环氧亚麻籽油及其他必要的添加剂，经共混改性，用于制造一次性使用的输血（液）袋、输血（液）导管、配件的PVC塑料。

Development Information

Drafting Units:

上海新上化高分子材料有限公司、上海市血液中心、上海天原集团胜德塑料有限公司、中国医学科学院输血研究所、上海长征富民金山制药有限公司、青岛海湾化学有限公司、锦西化工研究院有限公司

Drafting Persons:

钟伟勤、姜跃琴、路中伟、王红、李泓、高自建、高旭东、唐艳芳

Word Count: 22 Thousand words Pages: 12 pages

Replace the following standards

GB/T 15593-1995 Plasticized polyvinyl chloride (PVC) compounds for transfusion (infusion) equipment

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

Related Standards

GB/T 6595-1986 Replaced

GB/T 6595-1986 Test method for fish eye count of polypropylene resin

Publish Date: 1986-07-24

GB/T 6598-1986 Active

GB/T 6598-1986 Determination of weight-average molecular weight of polystyrene standards by low angle laser light scattering method

Publish Date: 1986-07-24

GB/T 6599-1986 abolished_transferred

GB/T 6599-1986 Determination of molecular weight averages and molecular weight distribution of polystyrene standards by steric exclusion chromatography

Publish Date: 1986-07-24

GB/T 8330-1987 Replaced

GB/T 8330-1987 Method for the determination of true density of ion exchange resins in wet state

Publish Date: 1987-11-15

GB/T 8331-1987 Replaced

GB/T 8331-1987 Method for the determination of bulk density of ion exchange resins in wet state

Publish Date: 1987-11-15

GB/T 8324-1987 Replaced

GB/T 8324-1987 Test method for bulk factor of moulding materials

Publish Date: 1987-12-01