| 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
Enterprise Standard Q/KL 008-2026
2. Material Composition and Product Characteristics
• Base Material:Medical-grade PVC resin with high 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: High rigidity and high hardness; resistant to deformation and breakage; good dimensional stability with low molding shrinkage, suitable for needle assembly; smooth surface with no burrs, easy to connect with catheters; resistant to sterilization and chemical corrosion; excellent biocompatibility
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 78 ± 3
- Tensile Strength: ≥45.0 MPa
- Elongation at Break: ≥80%
- 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: 165–175℃, Zone 3: 170–180℃, Nozzle temperature: 165–175℃ (do not exceed 185℃)
• 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 1. This product is intended so≤60%. Keep away from heat sources. Shelf life: 12 months.
6. Precautions
1.lely for the manufacture of needle hubs for single-use infusion needles and transfusion needles, 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 the needle is securely assembled with no loosening.
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
