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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
High elasticity and excellent resilience
Good airtightness, no leakage
Resistant to repeated compression and fatigue
Resistant to blood and sterilization; biocompatibility meets requirements for blood-contact applications
3. Technical Requirements
-ppearance: Transparent or translucent pellets
-Shore hardness: A 70±2
-Tensile strength: ≥14.0 MPa
-Good elastic recovery, no permanent deformation
-Chemical and biological properties comply with requirements for blood-contact materials
4. Recommended Molding Process
Blow molding / injection molding temperature: 130–165℃. 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
-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 blood circuit tubing components. Process in a cleanroom environment and ensure strict sterilization before use.
7. Service and Support
1. Website: www.kegfz.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
