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1. Core Performance Parameters
1.Shore hardness 60/3A
2.Tensile strength ≥13 MPa
3.Elongation at break ≥300%
4.Hemolysis rate ≤0.3%
5.Anticoagulation (platelet adhesion rate) ≤15%
6.Fatigue resistance: no cracking after 10⁶ cycles
2. Formulation Design
1.Uses medical‑grade polyvinyl chloride (PVC) resin (K‑value 85).
2.Plasticizers:
(1) Traditional plasticizer: di(2‑ethylhexyl) phthalate (DOP).
(2) New environmentally friendly plasticizers: di(2‑ethylhexyl) terephthalate (DOTP), trioctyl trimellitate (TOTM), diisononyl cyclohexane‑1,2‑dicarboxylate (DINCH).
3.Epoxidized soybean oil.
4.Heat stabilizer (calcium/zinc).
5.Lubricant: oxidized polyethylene wax.
3. Production Process Control
1.PLC metering with an error of ≤1%. PLC
2.High‑speed mixing at 100 ℃–110 ℃ for 10 minutes.
3.External cooling of powder to 80 ℃ for 8 minutes.
4.Low‑temperature, low‑pressure extrusion at 100 ℃–125 ℃.
5.Hot pellet cutting using Class 100,000 clean air conveying.
6.Pellet cooling in a Class 100,000 cleanroom.
7.Automatic metering filling at 25 kg/bag with robotic palletizing.
4. Physical, Chemical, and Biological Properties
1. Physical Properties:
(1) Shore hardness: 60 ± 3 A.
(2) Tensile strength: ≥13 MPa.
(3) Elongation at break: ≥300%.
(4) Thermal stability (oil bath at 180 ℃): ≥60 min.
2. Chemical Properties:
(1) Reducing substances: ≤1.3 mL.
(2) pH change: ≤1.
(3) Zinc content: ≤0.4.
(4) Total heavy metals: ≤1.
3. Biological Properties:
Complies with the requirements of ISO 10993‑1 and ISO 10993‑4 (Biological Evaluation of Medical Devices) as well as the standard YY 0581.3‑2019 (Hemodialysis Equipment – Part 3: Pump Tubes).
5. Packaging, Storage, and Shelf Life
1.25 kg/bag: outer low‑plastic composite bag + inner double‑layer PE bags, robotic palletizing; 800 kg/bag: outer PP woven bag + inner single‑layer PE bag.
2.Store in a ventilated, dry environment at room temperature, free from thermal radiation and chemical contamination sources.
3.Shelf life: 18 months from the date of extrusion and packaging.
6. Services and Support
2.E‑mail: kegfzxz@126.com / kechemxz@126.com
3.Tel: 400‑008‑5899; 0086‑514‑84634665 / 84661852
4.Fax: 0086‑514‑84661500
5.ISO 13485 quality management system certified.
6.MSDS provided upon request for product technology.
7.24‑hour response to customer inquiries.
