1 Subject Content and Application Scope
This standard specifies product classification, technical requirements, test methods, inspection rules and marking, packaging, transport and storage of plasticized polyvinyl chloride (PVC) compounds for transfusion (infusion) equipment (hereafter referred to as plastics for transfusion (infusion) equipment).
This standard is applicable to plastics for transfusion (infusion) equipment that are made through such processes as mixing and plasticization by taking dedicated polyvinyl chloride resin plasticized with diethylhexyl phthalate (DEHP) as the main body and adding into necessary additives. Such plastics are mainly used to make disposable blown film bags, tubes, droppers and other medical accessories for transfusion (infusion).
2 Normative References
GB/T 1040 Plastics - Determination of Tensile Properties
GB/T 2411 Plastics - Shore Hardness Test
GB/T 2917 Test Methods for the Thermal Stability of Polyvinyl Chloride - Congo Red Method and pH Method
GB/T 4615 Determination Method of Residual Vinyl Chloride Monomer Contents in Polyvinyl Chloride
GB/T 6678 General Principles for Sampling Chemical Products
GB/T 9345 Plastics - Determination of Ash - General Methods
GB/T 14232 Bags for Human Blood and Blood Components
GB/T 14233.1 Test Methods for Infusion Transfusion Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233. 2 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods
1977 Edition Pharmacopoeia of People's Republic of China
3 Product Classification
3.1 Product model
Contents
1 Subject Content and Application Scope
2 Normative References
3 Product Classification
4 Technical Requirements
5 Test Methods
6 Inspection Rules
7 Marking, Packaging, Transport and Storage
Additional Information:
