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1. Formulation Design
1.Resin: Medical‑grade PVC resin (K‑value 75)
2.Impact modifier: MBS (methyl methacrylate‑butadiene‑styrene)
3.Heat stabilizer: Calcium‑zinc (Ca/Zn)
4.Lubricants:(1) Stearic acid (2) Oxidized polyethylene wax
2. Production Process Control
1.High‑speed mixing temperature: 100 ℃
2.Powder cooling with water to 70 ℃
3.Extruder screw: high‑shear type (melt temperature 170 ℃ – 175 ℃)
4.Granules air‑cooled to 30 ℃ (in a Class 100,000 cleanroom)
5.Sieved through a 10‑mesh screen to remove fines
3. Quality Control Points
1.PLC‑controlled automatic batching with metering accuracy ≤1‰ (0.1%).
2.Batch‑to‑batch hardness testing (variation ≤ ±2 Shore D).
3.Melt flow rate (MFR): 2.0 – 3.5 g/10 min.
4. Physical, Chemical and Biological Properties
1. Physical Properties
(1) Hardness: ≥75 Shore D ±2
(2) Tensile strength: ≥20 MPa
(3) Thermal stability (in oil at 180 ℃): ≥100 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. Biocompatibility，Meets the requirements of ISO 10993‑1 and GB/T 15593‑2020. Pyrogen, hemolysis, sensitization, cytotoxicity, acute systemic toxicity, and intracutaneous irritation tests are all compliant.
5. Packaging, Storage and Shelf Life
1.25 kg/bag: outer low‑density plastic composite bag, inner double‑layer PE bag.
2.800 kg/bag: outer PP woven bag, inner single‑layer PE bag.
3.Storage: in a well‑ventilated, dry place, free from heat radiation and pollution sources.
4.Shelf life: 18 months from the date of granulation.
6. Service and Support
1. Website: www.kegtz.com
2. E-mail: kegfzxz@126.com / kechemxz@126.com
3. Telephone: 400 008 5899 / 0086-514-84634665 / 84661852
4. Fax: 0086-514-84661500
5. ISO 13485 quality system certified
6. MSDS available upon request
7. 24-hour response to customer inquiries
