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1. Formulation Design
1.Resin: Medical‑grade PVC resin (K‑value 70).
2.Plasticizer: Di(2‑ethylhexyl) phthalate (DEHP).
3.Epoxidized soybean oil (ESBO).
4.Heat stabilizer: Calcium‑zinc (Ca/Zn) composite stabilizer.
5.Lubricants:
(1) Oxidized polyethylene wax
(2) Phenylmethyl silicone oil (or Methyl phenyl silicone oil)
2. Production Process Control
3. Quality Control Points
1.PLC-controlled metering feeding.
2.Process parameters are recorded once per hour, with patrol inspections twice per hour.
3.Finished product sample inspection is performed once per hour.
4. Core Physical, Chemical, and Biological Properties
1. Physical Properties
(1) Hardness: 78 ± 2 Shore A
(2) Tensile strength: ≥13 MPa
(3) Elongation at break: ≥250%
(4) Thermal stability yellowing time (oil bath at 180 ℃): ≥60 min
2. Chemical Properties
(1) Reducing substances: ≤1.3 mL
(2) pH change: ≤1
(3) Zinc (Zn) content: ≤0.4
(4) Total heavy metals: ≤1
(5) Alcohol extractables (100 mL): ≤15 (as DEHP)
3. Biocompatibility
Pyrogen, hemolysis, sensitization, cytotoxicity, acute systemic toxicity, and intracutaneous irritation meet the requirements of ISO 10993‑1 and GB/T 15593‑2020.
5. Packaging and Storage
• 25 kg/bag: outer low‑plastic composite bag, inner double‑layer PE bags.
• Store in a ventilated, moisture‑proof environment, free from contamination and heat radiation.
• Shelf life: 18 months from the date of extrusion.
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.
