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1. Applicable Standards
GB/T 15593-2020 Polyvinyl chloride plastics 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 disposable medical products
2. Product Characteristics
Good flexibility, smooth surface, easy insertion and withdrawal
Resistant to bending and fatigue
Odorless and resistant to sterilization
Excellent biocompatibility
3. Technical Requirements
- Appearance: Transparent or translucent pellets
- Shore hardness: A 65±2
- Tensile strength: ≥13.0 MPa
- Chemical extractables, heavy metals, and cytotoxicity all meet requirements
4. Recommended Molding Process
Extrusion temperature: 135–165 ℃. Raw materials must be thoroughly dried before processing.
5. Packaging, Transport, and Storage
Packaging:25 kg/bag, double-layer medical-grade PE bag under vacuum, plus paper-plastic composite bag
- Transport: Protect from sunlight, rain, and moisture. Do not transport together with toxic, hazardous, or odorous substances.
- Storage: Store in a cool, dry, well-ventilated, and clean environment at 0–30 ℃. Shelf life: 12 months.
6. Precautions
For use exclusively in the production of medical scalp vein needle assemblies. Process in a clean environment and ensure sterilization of finished products before use.
7. 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
