| 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
GB 15980-2009 Hygienic standard for single-use medical supplies
2. Material Composition
Made from medical-grade rigid PVC resin as the base material, combined with medical-grade environmentally friendly calcium-zinc stabilizers and processing aids. May be DEHP-free. All raw materials meet medical-grade requirements, contain no toxic or hazardous substances, and exhibit no odor or irritation after molding.
3. Product Characteristics
Good rigidity and high strength; the needle holder does not deform or break easily after molding, capable of withstanding hand force during puncture for convenient clinical operation
High dimensional precision; after injection molding, the needle holder and hub maintain stable dimensions, ensuring a precise and secure connection with scalp needles and infusion catheters without loosening
Smooth surface with no burrs, comfortable to hold, good wear resistance, and not prone to scratching the skin
Resistant to ethylene oxide (EO) sterilization; does not discolor, become brittle, or crack after sterilization, with all performance parameters remaining stable
Excellent biocompatibility; cytotoxicity ≤ Grade 1, no skin irritation, no sensitization reaction, meeting the requirements for medical contact materials
Good injection molding performance, excellent flowability, high molding efficiency, free from black spots, impurities, and with a neat appearance
4. Technical Requirements
(I) Appearance
Uniform pellets, colorless transparent or slightly transparent, with consistent color; free from black spots, impurities, scorched particles, bubbles, elongated strands, and fines; pellet size 2.0–3.0 mm, no agglomeration, hard and fine texture.
(II) Physical and Mechanical Properties
- Shore Hardness: D 35 ± 2
- Tensile Strength: ≥22.0 MPa
- Water Absorption (24h): ≤0.1%
- Impact Strength: ≥18 kJ/m²
(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
(IV) Biocompatibility
- Cytotoxicity: ≤ Grade 1
- Delayed-type Hypersensitivity: No sensitization
- Skin Irritation: No irritation
(V) Sterilization Adaptability
Resistant to ethylene oxide (EO) sterilization. Sterilization parameters: temperature 50 ± 5℃, relative humidity 60% ± 10%, EO concentration 800 ± 100 mg/L, sterilization time 6 hours. After sterilization, no hazardous substances are leached out, the needle holder shows no deformation or cracking, and the EO residue in the finished product is ≤10 μg/g (in compliance with GB 15980-2009).
5. Reference Molding Process
- Injection Temperature: Barrel Zone 1 (feed inlet): 135–145℃, Zone 2: 145–155℃, Zone 3: 155–165℃, Nozzle temperature: 150–160℃. Do not exceed 175℃.
- Mold Temperature: 25–35℃, controlled by a water chiller to ensure smooth surface, stable dimensions, and no sink marks or burrs on the needle holder
- Injection Speed: Medium speed (30–50 mm/s) to ensure complete filling, with no short shots or bubbles
- Cooling Time: 15–25 s, adjusted according to needle holder size to ensure thorough cooling with no deformation or mold sticking
6. Packaging, Transportation, and Storage
(I) Packaging
- Inner packaging: Double-layer medical-grade PE vacuum bags, moisture-proof and contamination-proof, net weight 25 kg per bag
- Outer packaging: Paper-plastic composite bags
(II) Transportation
Transport vehicles must be dry, clean, and enclosed. Do not transport together with toxic, hazardous, odorous, corrosive substances, or organic solvents. During transport, protect from sunlight, rain, moisture, heavy pressure, and severe impact to ensure packaging remains intact.
(III) Storage
Store in a cool, dry, well-ventilated, and clean warehouse, with temperature controlled at 0–30℃ and relative humidity ≤65%. Keep away from heat sources (at least 1 m away), open flames, and organic solvents. Under the specified storage conditions, the product has a shelf life of 12 months from the date of manufacture. After expiry, re-testing is required; the product may only be used if it meets the specifications.
7. Precautions
1. This product is a specialized raw material for medical devices, intended solely for the manufacture of infusion set needle holders and hubs for single-use infusion sets. It must not be used in non-medical or non-medical-device applications.
2. Molding processing must be carried out in a clean room that meets the requirements for medical device production, with controlled environmental cleanliness to avoid product contamination.
3. Strictly control the injection temperature and do not exceed 175℃ to prevent PVC degradation and the release of toxic gases, which may affect product safety and rigidity.
4. After opening, the product should be used as soon as possible. Remaining material should be sealed and stored to prevent moisture and contamination, and to avoid pellet moisture absorption and agglomeration.
5. After the finished needle holders are produced, they must undergo strict sterilization treatment to ensure thorough sterilization and EO residue within acceptable limits before clinical 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
