GB 8662-1988
Replaced
YY/T 1628-2019
Active
Industry standards-Medicine
YY/T 1628-2019 Plasticized polyvinyl chloride (PVC) compounds for infusion and transfusion equipments for medical use
YY/T 1628-2019 Plasticized polyvinyl chloride (PVC) compounds for infusion and transfusion equipments for medical use
Basic Information
Standard Code:
YY/T 1628-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Surgical instruments and materials
Publish Date:
2019-05-31
Implement Date:
2019-09-01
Pages:
10 pages
Scope
This standard specifies the requirements, test methods, marking, packaging, and storage for polyvinyl chloride (PVC) granules used in medical transfusion and infusion devices.
This standard applies to PVC granules modified by blending, which are mainly composed of PVC resin, with diethylhexyl phthalate (DEHP) as a plasticizer and additives such as epoxy soybean oil or epoxidized linseed oil.
Development Information
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 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 14232.1-2004 Plastics collapsible containers for human blood and blood components-Part1:Conventional containers
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
中华人民共和国药典(2015年版) 四部
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and 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
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced