| Quantity: | |
|---|---|
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
2. Material Composition and Product Characteristics
• Base Material: Medical-grade PVC resin with moderate rigidity and high molding precision
• Stabilization System: Medical-grade environmentally friendly calcium-zinc stabilization system; may be DEHP-free and free from other phthalate plasticizers
• Characteristics: Balanced rigidity and toughness; resistant to breakage and deformation; smooth surface with no burrs, comfortable to wear; resistant to sterilization and aging, with good chemical stability; low molding shrinkage and high dimensional accuracy, suitable for oxygen tube assembly
3. Technical Requirements
(I) Appearance
Uniform pellets, natural color or translucent, with consistent color; free from black spots, impurities, scorched particles, bubbles, elongated strands, and fines; pellet size 2.5–3.5 mm, no agglomeration.
(II) Physical and Mechanical Properties
- Shore Hardness: D 76 ± 4
- Tensile Strength: ≥13.0 MPa
- Water Absorption (24h): ≤0.1%
- Molding Shrinkage Rate: 0.4%–0.8%
(III) Chemical Properties
- Reducing Substances (0.002 mol/L KMnO₄ consumption): ≤0.5 mL
- pH Difference: ≤0.5
- Heavy Metals (as Pb): ≤1.0 μg/mL
- Color: Clear, no turbidity, no odor
(IV) Biocompatibility
- Cytotoxicity: ≤ Grade 1
- Skin Irritation: No irritation
- Delayed-type Hypersensitivity: No sensitization
(V) Sterilization Adaptability
Resistant to ethylene oxide (EO) sterilization; after sterilization, does not discolor, crack, or become brittle, with no leaching of hazardous substances; EO residue in the finished product is ≤10 μg/g (in compliance with GB 15980-2009).
4. Recommended Injection Molding Process
• Barrel Temperature: Zone 1: 145–155℃, Zone 2: 155–165℃, Zone 3: 160–170℃, Nozzle temperature: 155–165℃ (do not exceed 180℃)
• Mold Temperature: 30–45℃
• Injection Pressure: 60–80 MPa, Holding Pressure: 30–40 MPa, Injection Speed: Medium, Cooling Time: 15–30 s
5. Packaging, Labeling, Transportation, and Storage
(I) Packaging
-Inner packaging: Double-layer medical-grade PE vacuum bags, 25 kg per bag
-Outer packaging: Paper-plastic composite bags
(II) Labeling
Labels on outer packaging shall clearly indicate: product name, model, batch number, production date, net weight, manufacturer, "medical-grade material," "moisture-proof," and "light-proof" markings.
(III) Transportation
Transport vehicles must be dry, clean, and enclosed. Do not transport together with toxic, hazardous, odorous, or corrosive substances. Protect from sunlight, rain, and heavy pressure.
(IV) Storage
Store in a cool, dry, well-ventilated, and clean warehouse, with temperature controlled at 0–30℃ and relative humidity ≤60%. Keep away from heat sources. Shelf life: 12 months.
6. Precautions
1. This product is intended solely for the manufacture of single-use oxygen tube nasal prongs, and must not be used for non-medical purposes. Molding must be carried out in a clean room.
2. Strictly control the injection temperature to prevent PVC degradation, which may affect product rigidity and safety.
3. Finished products must be sterilized by EO before use. Ensure dimensional stability and freedom from burrs.
7. 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
