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1. Applicable Standards
GB/T 15593-2020 Plastics — Poly(vinyl chloride) for transfusion (infusion) equipment
GB/T 14233.1-2008 Test methods for infusion, transfusion and injection equipment for medical use — Part 1: Chemical analysis methods
GB/T 16886 Biological evaluation of medical devices
GB 15980-2009 Hygienic standard for single-use medical supplies
2. Material Composition
Medical-grade PVC resin, medical-grade environmentally friendly stabilizers, plasticizers, and processing aids. May be DEHP-free.
3. Product Characteristics
• High transparency and low haze, facilitating observation of fluid flow and air bubbles
• Good flexibility, resistant to kinking, folding, and breakage
• Low-temperature resistance, drug solution resistance, and ethylene oxide sterilization resistance
• Good chemical stability and excellent biocompatibility
4. Technical Requirements
• Appearance: Transparent uniform pellets, free from impurities, black spots, and bubbles
• Shore Hardness: A 80 ± 2
• Tensile Strength: ≥15.0 MPa
• Reducing substances, pH level, UV absorbance, evaporation residue, and heavy metal content all meet medical requirements
• Cytotoxicity ≤ Grade 1, no skin irritation, no sensitization reaction
5. Reference Molding Process
-Extrusion temperature: 130–165℃
-Water-cooling shaping is recommended to ensure a transparent, smooth, and dimensionally stable catheter
6. Packaging, Transportation, and Storage
- Packaging: 25 kg/bag, double-layer medical-grade PE vacuum bag with paper-plastic composite outer bag
- Transportation: Protect from sunlight, rain, and moisture. Do not transport together with toxic, hazardous, or odoriferous materials
- Storage: Store in a cool, dry, well-ventilated, and clean environment at 0–30℃. Shelf life: 12 months
7. Precautions
1. This product is intended solely for the production of transparent catheters for single-use medical infusion sets and transfusion sets.
2. The processing must be carried out in a clean room for medical devices.
3. The finished product must be sterilized and pass inspection before use.
8. Services and Support
1. Website: www.kegfz.com
2. Email: kegfzxz@126.com / kechemxz@126.com
3. Telephone: 400 008 5899 00886-514-84634665 / 84661852
4. Fax: 00886-514-84661500
5. ISO 13485 Quality System Certification
6. MSDS provided upon request for product technology
7. 24-hour response to customer needs
