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1. Formulation Composition
Resin:Medical‑grade PVC (K‑value 55–60)
Plasticizers (two types):
(1) Conventional general plasticizer (DEHP)
(2) New environmentally friendly plasticizers (DOTP, DINCH, TOTM)
Stabilizers:
(1) Calcium‑zinc (Ca/Zn) composite stabilizer
(2) Auxiliary stabilizer: epoxidized soybean oil (ESO)
â‘ Lubricants:
Oxidized polyethylene wax Stearate esters
â‘¡Functional additives:
Colorants are added according to specific application requirements.
2. Key Quality Control Points
1.Precise control of the formulation component ratios to ensure hardness stability;
2.Installation of a 200‑mesh screen at the extruder head to trap impurities and unmelted particles ("fish eyes");
3.Visual inspection of finished product appearance (shape, color, scorch spots) every hour;
4.Cooling is carried out in a Class 100,000 cleanroom.
3. Physical, Chemical, and Biological Properties
1. Physical Properties:
(1) Hardness: in accordance with customer's technical requirements for the finished product;
(2) Tensile strength: ≥15 MPa;
(3) Thermal stability time at 180 ℃: >100 minutes.
2. Chemical Properties:
(1) Reducing substances: ≤1.3;
(2) Zinc content: ≤0.4;
(3) pH change: ≤1;
(4) Total heavy metals: ≤1.
3. Biological Properties:
(1) Complies with ISO 10993‑11 (acute systemic toxicity, mouse LD50 >5 g/kg);
(2) Hemolysis rate: ≤5%;
(3) Sensitization: negative;
(4) Intracutaneous irritation: negative;
(5) Pyrogen: no pyrogenic response (≤0.6 ℃);
(6) Cytotoxicity: not higher than Grade I.
4. Technical Support and Certification
Provision of technical documentation (TOS) and Material Safety Data Sheet (MSDS).
5. Packaging and Storage
• 25 kg/bag: low‑plastic composite bag + double‑layer PE bag;
• 800 kg/bag: polypropylene (PP) woven bag + single‑layer PE bag;
• Store in a dark, ventilated, dry warehouse, away from sources of contamination and thermal radiation;
• Product 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.
