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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 Characteristics
- Base Material: Medical-grade high-transparency PVC resin with excellent flowability and stable extrusion performance
- Stabilization System: Medical-grade environmentally friendly calcium-zinc stabilizers; may be DEHP-free (di-(2-ethylhexyl) phthalate), complying with hazardous substance control requirements for medical materials
- Characteristics:High transparency for easy observation of urine color and presence of sediment; excellent flexibility, easily bendable, resistant to breakage, ensuring smooth catheterization; smooth surface with low coefficient of friction, does not damage urethral mucosa; resistant to sterilization, low temperatures, and urine corrosion; excellent biocompatibility, non-irritating and non-sensitizing
3. Technical Requirements
(I) Appearance
Uniform pellets, colorless and transparent, with consistent color; free from black spots, impurities, scorched particles, bubbles, elongated strands, and fines; pellet size 2.0–2.8 mm, no agglomeration.
(II) Physical Properties
- Shore Hardness: A 80 ± 5
- Tensile Strength: ≥17.0 MPa
- Water Absorption (24h): ≤0.1%
- Light Transmittance (2 mm thickness): ≥88%
(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 and colorless, no turbidity, no odor
(IV) Biocompatibility
- Cytotoxicity: ≤ Grade 1
- Mucous Membrane Irritation: No irritation
- Delayed-type Hypersensitivity: No sensitization
- Hemolysis Test: Hemolysis rate ≤5%
(V) Sterilization Adaptability
Resistant to ethylene oxide (EO) sterilization; after sterilization, does not discolor, become brittle, or crack, with no leaching of hazardous substances and no tube deformation; EO residue in the finished product is ≤10 μg/g (in compliance with GB 15980-2009).
4. Reference Extrusion Process
1. Barrel Temperature: Zone 1: 125–135℃ (feed inlet), Zone 2: 140–150℃ (middle section), Zone 3: 145–155℃ (die head), Nozzle temperature: 140–150℃. Do not exceed 170℃.
2. Mold Temperature: 25–35℃. Water-cooling shaping is recommended to ensure a smooth tube surface, stable dimensions, and roundness.
3. Extrusion Speed: 8–18 m/min. The take-up speed should match the extrusion speed, with uniform take-up tension to prevent tube stretching deformation and uneven wall thickness.
5. Packaging, Labeling, 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) Labeling
Labels on both outer and inner packaging shall clearly indicate: product name, model, batch number, production date, net weight, manufacturer, applicable standards, "medical-grade material," "moisture-proof," "light-proof," and "keep away from heat sources" markings. Each batch shall be accompanied by a product certificate.
(III) 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.
(IV) 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, 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.
6. Precautions
1. This product is a specialized raw material for medical devices, intended solely for the manufacture of single-use urinary catheters. It must not be used in non-medical or non-medical-device applications.
2. Extrusion molding must be carried out in a clean room that meets the cleanliness requirements for medical device production to avoid product contamination.
3. Strictly control the extrusion temperature and do not exceed 170℃ to prevent PVC degradation and the release of toxic gases, which may affect product safety and transparency.
4. Dried material should be used within 4 hours. If left for too long, re-drying is required. After opening, remaining material should be sealed and stored to prevent moisture and contamination.
5. After the finished urinary catheters are produced, they must undergo strict sterilization treatment. The sterilization process shall comply with ethylene oxide sterilization standards to ensure thorough sterilization and residue levels within acceptable limits.
6. Enterprises using this product must possess the appropriate medical device production qualifications and strictly comply with relevant national medical device regulations and standards.
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
