| 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 Characteristics
• Base Material: Medical-grade PVC resin with excellent elasticity and good molding 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 elasticity and good resilience; the cuff maintains stable sealing after inflation with no air leakage; resistant to low temperatures (no embrittlement at -10℃), aging, and EO sterilization; excellent biocompatibility, non-irritating and non-sensitizing to human airway mucosa; good chemical stability with no leaching of hazardous substances.
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 70 ± 5
- Tensile Strength: ≥13.0 MPa
- Elongation at Break: ≥350%
- Water Absorption (24h): ≤0.1%
(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
- Skin Irritation: No irritation
- Delayed-type Hypersensitivity: No sensitization
- Mucous Membrane 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, does not discolor, become brittle, or crack, with no leaching of hazardous substances, and the cuff shows no air leakage after inflation. EO residue in the finished product is ≤10 μg/g (in compliance with GB 15980-2009).
4. Reference Molding Process
Drying: Temperature 60–70℃, time 1.5–2 hours, moisture content ≤0.05% to avoid bubbles and pinholes after molding
2.Molding Temperature: Extrusion/blow molding temperature: 130–160℃. Do not exceed 175℃ to prevent PVC degradation and the release of toxic gases.
3. Mold Temperature: 25–40℃, controlled by a water chiller to ensure uniform cuff wall thickness, free from pinholes and burrs.
4. Molding Speed:Medium speed to avoid internal stress generation and ensure cuff elasticity and sealing performance.
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 indicating quality inspection results.
(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 to maintain packaging integrity.
(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 (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.
6. Precautions
1. This product is a specialized raw material for medical devices, intended solely for the manufacture of single-use endotracheal tube cuffs. It must not be used in non-medical or non-medical-device applications.
2. 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 molding temperature and do not exceed 175℃. Exceeding this temperature may cause PVC degradation and the release of toxic gases such as hydrogen chloride, which may affect product safety and elasticity.
4. Dried material should be used within 4 hours. If left for too long, re-drying is required to prevent moisture absorption that may affect molding quality.
5. 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.
6. After the finished cuffs are produced, they must undergo strict sterilization treatment. The sterilization process shall comply with ethylene oxide sterilization standards to ensure thorough sterilization, residue levels within acceptable limits, and no air leakage after inflation.
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
